Johns Hopkins Update - Very Good Article
AFTER YEARS OF TELLING PEOPLE CHEMOTHERAPY
IS THE ONLY WAY TO TRY ('TRY', BEING THE KEY WORD) TO ELIMINATE CANCER,JOHNS HOPKINS IS FINALLY STARTING TO TELL YOU THERE IS AN ALTERNATIVE WAY .
Cancer Update from Johns Hopkins :
1. Every person has cancer cells in the body. These cancer
cells do not show up in the standard tests until they have
multiplied to a few billion. When doctors tell cancer patients
that there are no more cancer cells in their bodies after
treatment, it just means the tests are unable to detect the
cancer cells because they have not reached the detectable
size.
2. Cancer cells occur between 6 to more than 10 times in a
person's lifetime .
3. When the person's immune system is strong the cancer
cells will be destroyed and prevented from multiplying and
forming tumors.
4. When a person has cancer it indicates the person has
nutritional deficiencies. These could be due to genetic,
to environmental, food and lifestyle factors.
5. To overcome the multiple nutritional deficiencies, changing
diet and including supplements will strengthen the immune
system.
6. Chemotherapy involves poisoning the rapidly-growing
cancer cells and also destroys rapidly-growing healthy cells
in the bone marrow, gastrointestinal tract etc, and can
cause organ damage, like liver, kidneys, heart, lungs etc.
7. Radiation while destroying cancer cells also burns, scars
and damages healthy cells, tissues and organs.
8. Initial treatment with chemotherapy and radiation will often
reduce tumor size. However prolonged use of
chemotherapy and radiation do not result in more tumor
destruction.
9. When the body has too much toxic burden from
chemotherapy and radiation the immune system is either
compromised or destroyed, hence the person can succumb
to various kinds of infections and complications.
10. Chemotherapy and radiation can cause cancer cells to
mutate and become resistant and difficult to destroy.
Surgery can also cause cancer cells to spread to other
sites.
11. An effective way to battle cancer is to starve the cancer
cells by not feeding it with the foods it needs to multiply.
*CANCER CELLS FEED ON:
a. Sugar is a cancer-feeder. By cutting off sugar it cuts off
one important food supply to the cancer cells. Sugar
substitutes like NutraSweet, Equal, Spoonful, etc are made
with Aspartame and it is harmful. A better natural substitute
would be Manuka honey or molasses, but only in very small
amounts. Table salt has a chemical added to make it white in
color Better alternative is Bragg's aminos or sea salt.
b. Milk causes the body to produce mucus, especially in the
gastro-intestinal tract. Cancer feeds on mucus. By cutting
off milk and substituting with unsweetened soy milk cancer
cells are being starved.
c. Cancer cells thrive in an acid environment. A meat-based
diet is acidic and it is best to eat fish, and a little chicken
rather than beef or pork. Meat also contains livestock
antibiotics, growth hormones and parasites, which are all
harmful, especially to people with cancer.
d. A diet made of 80% fresh vegetables and juice, whole
grains, seeds, nuts and a little fruits help put the body into
an alkaline environment. About 20% can be from cooked
food including beans. Fresh vegetable juices provide live
enzymes that are easily absorbed and reach down to
cellular levels within 15 minutes to nourish and enhance
growth of healthy cells. To obtain live enzymes for building
healthy cells try and drink fresh vegetable juice (most
vegetables including bean sprouts) and eat some raw
vegetables 2 or 3 times a day. Enzymes are destroyed at
temperatures of 104 degrees F (40 degrees C).
e. Avoid coffee, tea, and chocolate, which have high
caffeine. Green tea is a better alternative and has cancer
fighting properties. Water-best to drink purified water, or
filtered, to avoid known toxins and heavy metals in tap
water. Distilled water is acidic, avoid it.
12. Meat protein is difficult to digest and requires a lot of
digestive enzymes. Undigested meat remaining in the
intestines becomes putrefied and leads to more toxic
buildup.
13. Cancer cell walls have a tough protein covering. By
refraining from or eating less meat it frees more enzymes
to attack the protein walls of cancer cells and allows the
body's killer cells to destroy the cancer cells.
14.. Some supplements build up the immune system
(IP6, Flor-ssence, Essiac, anti-oxidants, vitamins, minerals,
EFAs etc.) to enable the bodies own killer cells to destroy
cancer cells. Other supplements like vitamin E are known
to cause apoptosis, or programmed cell death, the body's
normal method of disposing of damaged, unwanted, or
unneeded cells.
15. Cancer is a disease of the mind, body, and spirit.
A proactive and positive spirit will help the cancer warrior
be a survivor. Anger, un-forgiveness and bitterness put
the body into a stressful and acidic environment. Learn to
have a loving and forgiving spirit. Learn to relax and enjoy
life.
16. Cancer cells cannot thrive in an oxygenated
environment. Exercising daily, and deep breathing help to
get more oxygen down to the cellular level. Oxygen
therapy is another means employed to destroy cancer
cells.
1. No plastic containers in micro.
2. No water bottles in freezer.
3. No plastic wrap in microwave.
Johns Hopkins has recently sent this out in its newsletters. This information is being circulated at Walter Reed Army Medical Center as well. Dioxin chemicals cause cancer, especially breast cancer. Dioxins are highly poisonous to the cells of our bodies. Don't freeze your plastic bottles with water in them as this releases dioxins from the plastic. Recently, Dr Edward Fujimoto, Wellness Program Manager at Castle Hospital, was on a TV program to explain this health hazard. He talked about dioxins and how bad they are for us. He said that we should not be heating our food in the microwave using plastic containers. This especially applies to foods that contain fat. He said that the combination of fat, high heat, and plastics releases dioxin into the food and ultimately into the cells of the body. Instead, he recommends using glass, such as Corning Ware, Pyrex or ceramic containers for heating food. You get the same results, only without the dioxin. So such things as TV dinners, instant ramen and soups, etc., should be removed from the container and heated in something else. Paper isn't bad but you don't know what is in the paper. It's just safer to use tempered glass, Corning Ware, etc. He reminded us that a while ago some of the fast food restaurants moved away from the foam containers to paper. The dioxin problem is one of the reasons.
Also, he pointed out that plastic wrap, such as Saran, is just as dangerous when placed over foods to be cooked in the microwave. As the food is nuked, the high heat causes poisonous toxins to actually melt out of the plastic wrap and drip into the food. Cover food with a paper towel instead.
Tuesday, December 20, 2011
Sunday, December 18, 2011
FY 2012 DOD Funding for Prostate Cancer
From: pcaroundtable-bounces@malecare.com [mailto:pcaroundtable-bounces@malecare.com] On Behalf Of Kevin Johnson
Sent: Friday, December 16, 2011 12:14 PM
To: PCa Roundtable
Subject: [Pcaroundtable] Approps - further analysis
Here is a little more information from an email I sent to my board this morning:
I just wanted to let you know that contained within the funding package that the House and Senate should pass tonight is $80 million for the Prostate Cancer Research Program at DOD. The PCRP was the only non-combat related stand alone program that maintained level funding from last year. The Medical Research Program which is a pot of money used to fund several smaller research programs was also level funded (at $50 million respectively).
Only 3 programs received increased funding over last year's funding level – Traumatic Brain Injury research, Orthopedic research and Gulf War Illness research.
All other programs were cut by 20% including Breast Cancer Research and Ovarian Cancer Research which are generally seen along with the PCRP as the main programs of the CDRMP because they've been around the longest.
Let me know if you have any questions.Kevin
Kevin S. Johnson
Sr. Vice President, Government Relations & Advocacy
ZERO – The Project to End Prostate Cancer
---------------------------------------------------------------------------
This
Sent: Friday, December 16, 2011 12:14 PM
To: PCa Roundtable
Subject: [Pcaroundtable] Approps - further analysis
Here is a little more information from an email I sent to my board this morning:
I just wanted to let you know that contained within the funding package that the House and Senate should pass tonight is $80 million for the Prostate Cancer Research Program at DOD. The PCRP was the only non-combat related stand alone program that maintained level funding from last year. The Medical Research Program which is a pot of money used to fund several smaller research programs was also level funded (at $50 million respectively).
Only 3 programs received increased funding over last year's funding level – Traumatic Brain Injury research, Orthopedic research and Gulf War Illness research.
All other programs were cut by 20% including Breast Cancer Research and Ovarian Cancer Research which are generally seen along with the PCRP as the main programs of the CDRMP because they've been around the longest.
Let me know if you have any questions.Kevin
Kevin S. Johnson
Sr. Vice President, Government Relations & Advocacy
ZERO – The Project to End Prostate Cancer
---------------------------------------------------------------------------
This
Wednesday, December 14, 2011
cardiovascular comorbidity is associated with treatment regret among men with recurrent prostate
The "New" Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services.
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.
Copyright © 2008-11 Prostate Cancer International, Inc.Regret post-treatment in men with pre-existing cardiovascular disease
Posted on December 10, 2011 by Sitemaster
i 2 Votes
Another newly published paper, this time in the British Journal of Urology, addresses issues related to cardiovascular disease and the treatment of prostate cancer. However, in this case it is about the treatment of men who had an existing cardiovascular condition at the time of their initial treatment.
In this paper, Nguyen et al. sought to explore specifically whether cardiovascular comorbidity is associated with treatment regret among men with recurrent prostate cancer after first-line therapy. it has previously been demonstrated that treatment regret is associated with a lower level of educational attainment, non-White race, greater post-treatment declines in sexual function, and systemic symptoms.
Treatment regret can have an adverse impact on a patient’s overall outlook and has been associated with a poorer global quality of life. Understanding predictors of regret can help clinicians better counsel patients about their treatments so that later regret can be avoided. In previous studies, regret has been
The study was based on a retrospective analysis of data from 795 men enrolled in the Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma (COMPARE) registry. All patinets had a biochemical recurrence at an average (median) of 5.5 years after prostatectomy (n = 410), external beam radiation therapy (n = 237), brachytherapy (n = 124) or primary androgen deprivation therapy (n = 24).
The authors were able to show that:
14.8 percent of the patient cohort reported regret.
Patients with pre-existing cardiovascular comorbidity were more likely to experience post-therapy bowel toxicity (P = 0.022).
The factors significantly associated with increased treatment regret were
Cardiovascular comorbidity (adjusted odds ratio [AOR] = 1.52)
Younger age (AOR = 0.97 per year increase in age)
Bowel toxicity post-treatment (AOR = 1.58)
The authors conclude that the patients with pre-existing cardiovascular comorbidities were > 50 percent more likely to experience treatment regret than men without cardiovascular comorbidity, and that these data suggest that men with pre-existing cardiovascular comorbidities give additional consideration to active surveillance as a first-line form of management for newly diagnosed prostate cancer.
A further discussion of this paper on the Reuters web site provides supplementary information. In that discussion, Dr. Timothy Showalter, a radiation oncologist at Jefferson Medical College in Philadelphia who was not involved in the research is quoted as stating that “We’ve known for a while that men with other medical problems, like heart disease, may get a smaller benefit from radiation or surgery.” He want on to say that this study represents “another piece of evidence that supports closely monitoring men with prostate cancer” as opposed to implementing immediate treatment.
As noted by Reuters, “The study doesn’t show why patients with heart problems had more second thoughts about their treatment.” One possibility noted by the study’s lead author is that “men dealing with other diseases may not be able to cope with the extra distress from cancer treatment.”
It is important to note that this study only addresses regret in men who had a biochemical recurrence after first-line treatment and not all patients receiving first-line treatment for prostate cancer. As Dr. Nguyen is also quoted as saying, “This study tells men who have other diseases that maybe they should take a step back and not treat the cancer right away.”
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.
Copyright © 2008-11 Prostate Cancer International, Inc.Regret post-treatment in men with pre-existing cardiovascular disease
Posted on December 10, 2011 by Sitemaster
i 2 Votes
Another newly published paper, this time in the British Journal of Urology, addresses issues related to cardiovascular disease and the treatment of prostate cancer. However, in this case it is about the treatment of men who had an existing cardiovascular condition at the time of their initial treatment.
In this paper, Nguyen et al. sought to explore specifically whether cardiovascular comorbidity is associated with treatment regret among men with recurrent prostate cancer after first-line therapy. it has previously been demonstrated that treatment regret is associated with a lower level of educational attainment, non-White race, greater post-treatment declines in sexual function, and systemic symptoms.
Treatment regret can have an adverse impact on a patient’s overall outlook and has been associated with a poorer global quality of life. Understanding predictors of regret can help clinicians better counsel patients about their treatments so that later regret can be avoided. In previous studies, regret has been
The study was based on a retrospective analysis of data from 795 men enrolled in the Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma (COMPARE) registry. All patinets had a biochemical recurrence at an average (median) of 5.5 years after prostatectomy (n = 410), external beam radiation therapy (n = 237), brachytherapy (n = 124) or primary androgen deprivation therapy (n = 24).
The authors were able to show that:
14.8 percent of the patient cohort reported regret.
Patients with pre-existing cardiovascular comorbidity were more likely to experience post-therapy bowel toxicity (P = 0.022).
The factors significantly associated with increased treatment regret were
Cardiovascular comorbidity (adjusted odds ratio [AOR] = 1.52)
Younger age (AOR = 0.97 per year increase in age)
Bowel toxicity post-treatment (AOR = 1.58)
The authors conclude that the patients with pre-existing cardiovascular comorbidities were > 50 percent more likely to experience treatment regret than men without cardiovascular comorbidity, and that these data suggest that men with pre-existing cardiovascular comorbidities give additional consideration to active surveillance as a first-line form of management for newly diagnosed prostate cancer.
A further discussion of this paper on the Reuters web site provides supplementary information. In that discussion, Dr. Timothy Showalter, a radiation oncologist at Jefferson Medical College in Philadelphia who was not involved in the research is quoted as stating that “We’ve known for a while that men with other medical problems, like heart disease, may get a smaller benefit from radiation or surgery.” He want on to say that this study represents “another piece of evidence that supports closely monitoring men with prostate cancer” as opposed to implementing immediate treatment.
As noted by Reuters, “The study doesn’t show why patients with heart problems had more second thoughts about their treatment.” One possibility noted by the study’s lead author is that “men dealing with other diseases may not be able to cope with the extra distress from cancer treatment.”
It is important to note that this study only addresses regret in men who had a biochemical recurrence after first-line treatment and not all patients receiving first-line treatment for prostate cancer. As Dr. Nguyen is also quoted as saying, “This study tells men who have other diseases that maybe they should take a step back and not treat the cancer right away.”
Saturday, December 10, 2011
Fairfax County Prescription Drug Discounts
Prescription Drug Discount Card Available to All Residents
Residents may be able to cut their prescription drug costs by almost half on average, thanks to a new, free discount card offered by Fairfax County through a partnership. This card will help the estimated 144,000-plus residents without health insurance, although it may offer savings to the insured too.
The county is making the card available because the number of uninsured has spiked in recent years. Their ranks have grown by 27 percent between 2009 and 2010, according to U.S. Census estimates. The latest figures show that 13.5 percent of residents lacked insurance last year.
There are several ways to get a Fairfax County Prescription Drug Discount Card:
Print a card at www.FairfaxRxDiscountCard.com.
Get a card at any participating pharmacy; supplies will be limited.
Look in the mail. In the next two weeks, they will be mailed to homes in areas with the highest concentration of uninsured residents.
On average, the card cuts the cost of a prescription by 45 percent, depending on the drug and amount bought. For brand-name drugs, discounts are estimated to be 10 to 20 percent, and 20 to 70 percent for generics. Based on use countywide, officials expect the card will produce a total savings of $280,000 per month.
Studies have shown that lack of insurance, economic hardship and drug costs cause many to forgo the medicines they need. This fall a nationwide survey by Consumer Reports found that 35 percent of people with low-incomes are skimping on their medicines, with:
percent not filling a prescription
percent taking an expired medicine
percent skipping a dose
percent splitting pills in half
percent sharing a prescription with someone else
Besides the uninsured, the discount card also may help insured residents anytime they must pay full price for a prescription because their plan doesn't cover a drug. The card cannot be used to reduce the cost of co-pays, co-insurance or deductibles.
Discounts are available for some pet medicines too. However, the drugs must be human medicines that can be taken by animals, and the prescription must be filled at a pharmacy, not a veterinarian's office.
Almost every pharmacy in the county accepts the card, plus 62,000 others across the nation. No enrollment or registration is needed to use it, and one card can be used for multiple people. To get discounts, just present the card at the pharmacy when buying medicine.
No personal or health information is collected when the card is used, and an individual's drug purchases are completely confidential. However, pharmacies will report the total types and amounts of drugs sold by discount in order for the county to track the total savings generated.
Fairfax County is offering the discount card through a partnership with ProAct, a pharmacy benefit management company. For information or help, call ProAct's help desk toll-free at 1-877-776-2285, TTY 711.
Help is available 24/7, and ProAct's customer service staff can answer questions in many languages. Visit www.FairfaxRxDiscountCard.com to print a card, get more information, or find participating pharmacies.
For members of the media who need more information, contact the Fairfax County Office of Public Affairs at 703-324-3187, TTY 711.
Residents may be able to cut their prescription drug costs by almost half on average, thanks to a new, free discount card offered by Fairfax County through a partnership. This card will help the estimated 144,000-plus residents without health insurance, although it may offer savings to the insured too.
The county is making the card available because the number of uninsured has spiked in recent years. Their ranks have grown by 27 percent between 2009 and 2010, according to U.S. Census estimates. The latest figures show that 13.5 percent of residents lacked insurance last year.
There are several ways to get a Fairfax County Prescription Drug Discount Card:
Print a card at www.FairfaxRxDiscountCard.com.
Get a card at any participating pharmacy; supplies will be limited.
Look in the mail. In the next two weeks, they will be mailed to homes in areas with the highest concentration of uninsured residents.
On average, the card cuts the cost of a prescription by 45 percent, depending on the drug and amount bought. For brand-name drugs, discounts are estimated to be 10 to 20 percent, and 20 to 70 percent for generics. Based on use countywide, officials expect the card will produce a total savings of $280,000 per month.
Studies have shown that lack of insurance, economic hardship and drug costs cause many to forgo the medicines they need. This fall a nationwide survey by Consumer Reports found that 35 percent of people with low-incomes are skimping on their medicines, with:
percent not filling a prescription
percent taking an expired medicine
percent skipping a dose
percent splitting pills in half
percent sharing a prescription with someone else
Besides the uninsured, the discount card also may help insured residents anytime they must pay full price for a prescription because their plan doesn't cover a drug. The card cannot be used to reduce the cost of co-pays, co-insurance or deductibles.
Discounts are available for some pet medicines too. However, the drugs must be human medicines that can be taken by animals, and the prescription must be filled at a pharmacy, not a veterinarian's office.
Almost every pharmacy in the county accepts the card, plus 62,000 others across the nation. No enrollment or registration is needed to use it, and one card can be used for multiple people. To get discounts, just present the card at the pharmacy when buying medicine.
No personal or health information is collected when the card is used, and an individual's drug purchases are completely confidential. However, pharmacies will report the total types and amounts of drugs sold by discount in order for the county to track the total savings generated.
Fairfax County is offering the discount card through a partnership with ProAct, a pharmacy benefit management company. For information or help, call ProAct's help desk toll-free at 1-877-776-2285, TTY 711.
Help is available 24/7, and ProAct's customer service staff can answer questions in many languages. Visit www.FairfaxRxDiscountCard.com to print a card, get more information, or find participating pharmacies.
For members of the media who need more information, contact the Fairfax County Office of Public Affairs at 703-324-3187, TTY 711.
Sunday, November 6, 2011
Long Term effects of Readiation Therapy
BOSTON -- A majority of prostate cancer survivors reported long-term treatment-related adverse effects with surgery or radiation therapy, data from a Michigan survey showed.
About 70% of 2,500 survey respondents reported ongoing problems with adverse events, some of whom were more than 15 years removed from primary treatment.
The most commonly reported symptoms involved sexual and urinary function, but a substantial proportion of the men also had problems related to bowel function and vitality, as reported here at the American Association for Cancer Research's Frontiers in Cancer Prevention Research meeting.
"Without question, sexual symptoms were the most common and the most troubling to the men," said May Darwish-Yassine, PhD, of the Michigan Public Health Institute in Okemos. "It's a very significant issue, and primary care providers are not very attentive to it, nor are they free or perhaps comfortable to manage the problem."
Most prostate cancer patients contend with a variety of physical and psychosocial issues following primary treatment. Survivorship studies have generally followed patients for two to five years. However, early diagnosis and modern treatment have transformed clinical outcomes for prostate cancer, such that many men can expect to have a long lifespan following treatment.
"In Michigan, as with the rest of the country, nearly 100% of men diagnosed at the local stage live at least five years after diagnosis, and more than 90% of men live at least 10 years," said Yassine.
In an effort to determine the current state of the postdiagnosis experience, investigators initiated the Michigan Prostate Cancer Survivors Study to describe and quantify long-term symptoms men report following prostate cancer treatment. The study comprises data collected from approximately 2,500 men who had prostate cancer diagnoses from 1985 to 2004 and remained alive as of the end of 2005.
Men ages 75 and older accounted for 53% of study participants, followed by those 65 to 74 (33.3%), and 64 or younger (13.8%). Three-fourths of the participants were white, and 19% were black.
Investigators found that 11.1% of the men were less than five years removed from diagnosis, 40.9% were five to nine years postdiagnosis, 28.8% were 10 to 14 years, and 19.3% were 15 years or more from diagnosis.
Yassine reported that 67.5% of the men had had radical prostatectomy, including 55.1% who had had surgery as the only treatment.
A third of the men had had external beam radiation, 20% received hormonal therapy, and 10% received some form of internal radiation therapy.
About 70% of the men received only one form of therapy.
Study participants were asked to describe any symptoms they had within the four weeks prior to the survey. Among those who reported posttreatment symptoms, the most common fell into four categories: urinary, bowel, sexual, and vitality. For each category, the proportion of men who reported symptoms was:
Sexual, 89.6%
Urinary, 69.9%
Bowel, 44.8%
Vitality, 45%
The proportion of men reporting just one symptom in a category ranged from 7.5% for sexual function to 30.6% for urinary function.
Sexual problems were far and away the most common, with a majority of the men (50.3%) reporting four problems related to sexual function, and an additional 24.1% reporting three symptoms in that area.
Those symptoms included poor or no erection (reported by 55% to 85%), erection not reliable (reported by 54% to 87%), and erection not firm (reported by 61% to 89%.
The proportion of men reporting no sexual symptoms ranged from 4% of men 75 and older to 30.6% of men younger than 65.
Analysis of specific symptoms by type of therapy and age showed that after prostatectomy a majority of men (52% to 60%) with urinary symptoms reported urine leakage, regardless of age, and 37% to 50% reported frequency problems.
Among those with bowel problems, urgency was the most commonly reported symptom (25% to 37%).
With respect to vitality, 26% to 33% of men reported a lack of energy. A majority of men across all age groups reported no vitality problems.
Substantially fewer men who received only external beam radiation therapy responded to questions about specific symptoms. Even so, sexual symptoms predominated, as 56% to 90% of men in each age group reported problems with the frequency, reliability, and quality of erections. Among urinary symptoms, frequency was reported by a majority of men in all age groups. Few men reported bowel or vitality symptoms.
For each of the four principal symptom categories, the men were asked to rate the severity of their problems, ranging from "no problem" to "big problem." About 46% of men rated sexual symptoms as moderate or big problems, followed by vitality (24%), urinary (20%), and bowel (14%).
Darwish-Yassine and coinvestigators had no financial disclosures.
About 70% of 2,500 survey respondents reported ongoing problems with adverse events, some of whom were more than 15 years removed from primary treatment.
The most commonly reported symptoms involved sexual and urinary function, but a substantial proportion of the men also had problems related to bowel function and vitality, as reported here at the American Association for Cancer Research's Frontiers in Cancer Prevention Research meeting.
"Without question, sexual symptoms were the most common and the most troubling to the men," said May Darwish-Yassine, PhD, of the Michigan Public Health Institute in Okemos. "It's a very significant issue, and primary care providers are not very attentive to it, nor are they free or perhaps comfortable to manage the problem."
Most prostate cancer patients contend with a variety of physical and psychosocial issues following primary treatment. Survivorship studies have generally followed patients for two to five years. However, early diagnosis and modern treatment have transformed clinical outcomes for prostate cancer, such that many men can expect to have a long lifespan following treatment.
"In Michigan, as with the rest of the country, nearly 100% of men diagnosed at the local stage live at least five years after diagnosis, and more than 90% of men live at least 10 years," said Yassine.
In an effort to determine the current state of the postdiagnosis experience, investigators initiated the Michigan Prostate Cancer Survivors Study to describe and quantify long-term symptoms men report following prostate cancer treatment. The study comprises data collected from approximately 2,500 men who had prostate cancer diagnoses from 1985 to 2004 and remained alive as of the end of 2005.
Men ages 75 and older accounted for 53% of study participants, followed by those 65 to 74 (33.3%), and 64 or younger (13.8%). Three-fourths of the participants were white, and 19% were black.
Investigators found that 11.1% of the men were less than five years removed from diagnosis, 40.9% were five to nine years postdiagnosis, 28.8% were 10 to 14 years, and 19.3% were 15 years or more from diagnosis.
Yassine reported that 67.5% of the men had had radical prostatectomy, including 55.1% who had had surgery as the only treatment.
A third of the men had had external beam radiation, 20% received hormonal therapy, and 10% received some form of internal radiation therapy.
About 70% of the men received only one form of therapy.
Study participants were asked to describe any symptoms they had within the four weeks prior to the survey. Among those who reported posttreatment symptoms, the most common fell into four categories: urinary, bowel, sexual, and vitality. For each category, the proportion of men who reported symptoms was:
Sexual, 89.6%
Urinary, 69.9%
Bowel, 44.8%
Vitality, 45%
The proportion of men reporting just one symptom in a category ranged from 7.5% for sexual function to 30.6% for urinary function.
Sexual problems were far and away the most common, with a majority of the men (50.3%) reporting four problems related to sexual function, and an additional 24.1% reporting three symptoms in that area.
Those symptoms included poor or no erection (reported by 55% to 85%), erection not reliable (reported by 54% to 87%), and erection not firm (reported by 61% to 89%.
The proportion of men reporting no sexual symptoms ranged from 4% of men 75 and older to 30.6% of men younger than 65.
Analysis of specific symptoms by type of therapy and age showed that after prostatectomy a majority of men (52% to 60%) with urinary symptoms reported urine leakage, regardless of age, and 37% to 50% reported frequency problems.
Among those with bowel problems, urgency was the most commonly reported symptom (25% to 37%).
With respect to vitality, 26% to 33% of men reported a lack of energy. A majority of men across all age groups reported no vitality problems.
Substantially fewer men who received only external beam radiation therapy responded to questions about specific symptoms. Even so, sexual symptoms predominated, as 56% to 90% of men in each age group reported problems with the frequency, reliability, and quality of erections. Among urinary symptoms, frequency was reported by a majority of men in all age groups. Few men reported bowel or vitality symptoms.
For each of the four principal symptom categories, the men were asked to rate the severity of their problems, ranging from "no problem" to "big problem." About 46% of men rated sexual symptoms as moderate or big problems, followed by vitality (24%), urinary (20%), and bowel (14%).
Darwish-Yassine and coinvestigators had no financial disclosures.
Monday, October 17, 2011
Posting ADT Piece: New Info on Intermittent therapy
We have known since the mid-1990’s that androgen suppressive therapy could be used in an interrupted fashion, but we didn’t know until now that men were not sacrificing length of life in the hopes of having a better quality of life,” says Juanita M. Crook, MD, principal investigator and radiation oncologist with the British Columbia Cancer Agency. “The results of this trial will change the standard of care.”
The Canadian study, supported by a team of cross-border North American scientists, administered intermittent androgen deprivation in patients for eight months then stopped and restarted only when their PSA levels reached >3 ng/ml when off the treatment, compared to men treated with continuous androgen deprivation (CAD). The data showed that intermittent antiandrogen treatment was equivalent to continuous antiandrogen treatment with similar overall survival and quality-of-life measures. Biostatiscally, intermittent therapy was called “a non-inferior” (in laymen’s terms, “comparable”) arm of the trial—disease specific death was 18% in the intermittent arm compared with 15% in the continuous arm.
Dr. Crook believes the IAD method will be widely accepted. “There is no detriment to survival, some men see quality-of-life benefit, and it also happens to be cheaper,” says Crook.
Summary
Intermittent androgen deprivation provides similar outcomes to continuous therapy with the potential for fewer side effects and less disruption to quality of life—good news for many men and their families. IAD patients complained of fewer hot flashes and 35% of them had full recovery of serum testosterone after completing IAD. Cardiac events and osteoporotic fracture events were equal in both arms. Further, intermittent androgen deprivation offers cost-savings to health systems as both patients and the systems pay only 27% of the cost of continuous treatment.
The Canadian study, supported by a team of cross-border North American scientists, administered intermittent androgen deprivation in patients for eight months then stopped and restarted only when their PSA levels reached >3 ng/ml when off the treatment, compared to men treated with continuous androgen deprivation (CAD). The data showed that intermittent antiandrogen treatment was equivalent to continuous antiandrogen treatment with similar overall survival and quality-of-life measures. Biostatiscally, intermittent therapy was called “a non-inferior” (in laymen’s terms, “comparable”) arm of the trial—disease specific death was 18% in the intermittent arm compared with 15% in the continuous arm.
Dr. Crook believes the IAD method will be widely accepted. “There is no detriment to survival, some men see quality-of-life benefit, and it also happens to be cheaper,” says Crook.
Summary
Intermittent androgen deprivation provides similar outcomes to continuous therapy with the potential for fewer side effects and less disruption to quality of life—good news for many men and their families. IAD patients complained of fewer hot flashes and 35% of them had full recovery of serum testosterone after completing IAD. Cardiac events and osteoporotic fracture events were equal in both arms. Further, intermittent androgen deprivation offers cost-savings to health systems as both patients and the systems pay only 27% of the cost of continuous treatment.
Thursday, October 6, 2011
No Prostate Cancer Screening,, Says USPSTF,
(CNN) -- The U.S. Preventive Services Task Force, the group that told women in their 40s that they don't need mammograms, will soon recommend that men not get screened for prostate cancer, according to a source privy to the task force deliberations.
The task force is set to recommend a "D" rating for prostate specific antigen, or PSA, testing. Such a rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. The task force is set to propose this recommendation Tuesday, and then allow for a comment period before issuing a final recommendation.
According to a draft copy of a report scheduled to be released Monday, a review of studies shows screening with the PSA blood test results in "small or no reduction" in prostate cancer deaths.
The report adds that PSA testing is "associated with harms related to subsequent evaluation and treatments."
The PSA test can help determine if a man has prostate cancer. It is sometimes accompanied by a digital rectal exam
The task force is set to recommend a "D" rating for prostate specific antigen, or PSA, testing. Such a rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. The task force is set to propose this recommendation Tuesday, and then allow for a comment period before issuing a final recommendation.
According to a draft copy of a report scheduled to be released Monday, a review of studies shows screening with the PSA blood test results in "small or no reduction" in prostate cancer deaths.
The report adds that PSA testing is "associated with harms related to subsequent evaluation and treatments."
The PSA test can help determine if a man has prostate cancer. It is sometimes accompanied by a digital rectal exam
Wednesday, October 5, 2011
Tools Predicting Erectile Function after Treatment
Context Sexual function is the health-related quality of life (HRQOL) domain most commonly impaired after prostate cancer treatment; however, validated tools to enable personalized prediction of erectile dysfunction after prostate cancer treatment are lacking.
Objective To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.
Design Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.
Main Outcome Measures Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.
Results Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).
Conclusion Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.
K
Objective To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.
Design Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.
Main Outcome Measures Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.
Results Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).
Conclusion Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.
K
ADT Does Not Increase Risk of Cariovascular Death
October 5, 2011 (Miami Beach, Florida) — Androgen-deprivation therapy (ADT) is an effective treatment for men with "unfavorable-risk" prostate cancer, and it does not increase the risk for cardiovascular (CV) death, concludes a new study. These results contradict earlier suggestions that this risk might be increased.
The new findings come from a meta-analysis, the first on ADT and CV-related mortality, presented here at the American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting.
This "should be reassuring for the vast majority of men who have received ADT or are considering it," said lead author Paul Nguyen, MD, from Dana-Farber/Brigham and Women's Cancer Center in Boston, Massachusetts.
The study has an important caveat: the findings could differ in men with congestive heart failure or who have had a myocardial infarction.
Still, even with the study's limitations, these data offer a counterpoint to retrospective studies that found a higher risk for CV mortality among men receiving ADT for prostate cancer, explained Dr. Nguyen.
Those studies, plus data indicating an association between ADT and an increased risk for CV complications, led to a consensus statement last year from the American Heart Association, the American Cancer Society and the American Urological Society.
The statement, which was endorsed by ASTRO, asserted that "there may be a relation between ADT and cardiovascular events and death."
Subsequently, in October 2010, the US Food and Drug Administration called for new labeling on gonadotropin-releasing hormone (GnRH) agonists. The black-box warning now states that the agents "increase risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke)."
Improve Analysis of the Problem
In an interview with Medscape Medical News, Dr. Nguyen described the consensus statement as "everybody lining up against androgen-deprivation therapy."
He and a group of colleagues sought to improve the power of the statistical analysis of the problem.
They performed a literature review of randomized trials in prostate cancer that compared GnRH-agonist-based ADT with no ADT and that reported CV-related deaths. They found 8 studies that met their inclusion criteria, comprising a total of 4141 patients, all of whom had intermediate-risk prostate cancer or higher (but no metastatic or hormone-refractory disease). In 5 of the studies, the local therapy patients received was radiation; in the other 3 studies, patients underwent surgery or received no local therapy.
The risk for CV death was similar in the ADT and no-ADT groups (11.0% vs 11.2%). The relative risk for CV death for ADT, compared with no ADT, was 0.93 (95% confidence interval, 0.79 to 1.10; P = .41).
The results were similar in all the subgroups the investigators examined, said Dr. Nguyen, including the subgroups of short-course ADT (6 months or less), long-course ADT (3 years or more), men older than 70 years, and radiation use.
The meta-analysis provides additional reassuring news: ADT improves outcomes. Specifically, compared with no ADT, ADT reduced prostate-cancer-specific mortality (relative risk [RR], 0.68; P < .001) and all-cause mortality (RR, 0.88; P = .005).
Men With Preexisting CV Disease
This is a "great paper" that "employs modern epidemiologic methodology to seek out differences that would not have been seen in smaller studies," Phillip Devlin, MD, secretary/treasurer of ASTRO, told Medscape Medical News. Dr. Devlin is also from Dana-Farber/Brigham and Women's Cancer Center, and acknowledged that he is not a completely impartial commentator, as he is Dr. Nguyen's boss.
Dr. Devlin believes that patients will be calmed by these results, which provide a "sense of greater comfort" and allow clinicians to say that "there may be less risk than we thought" with ADT and cardiac death.
Nevertheless, clinicians should provide careful monitoring of patients on ADT for CV disease, said Dr. Devlin.
The study did not examine whether ADT is associated with a reduction in CV events such as congestive heart failure and myocardial infarction.
Retrospective data suggest that ADT harms men with preexisting CV disease, said Dr. Nguyen.
The extent of the harm is unclear, he reported. For instance, a 2009 study indicated that only 5% of men with a history of congestive heart failure and myocardial infarction were harmed by ADT, as reported by Medscape Medical News.
Dr. Nguyen is also the author of a study that found that men with high-risk prostate cancer have an increased risk for death with ADT if they have a history of congestive heart failure and myocardial infarction (RR, 2.6; P = .01).
Dr. Nguyen reports receiving research funding from Varian. Dr. Devlin has disclosed no relevant financial relationships.
American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting: Abstract 11. Presented October 3, 2011.
[CLOSE WINDOW]
Authors and Disclosures
Journalist
Nick Mulcahy
Nick Mulcahy is a senior journalist for Medscape Hematology-Oncology. Before joining Medscape, Nick was a freelance medical news writer for 15 years, working for companies such as the International Medical News Group, MedPage Today, HealthDay, McMahon Publishing, and Advanstar. He is also the former managing editor of breastcancer.org. He can be contacted at nmulcahy@medscape.net.
The new findings come from a meta-analysis, the first on ADT and CV-related mortality, presented here at the American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting.
This "should be reassuring for the vast majority of men who have received ADT or are considering it," said lead author Paul Nguyen, MD, from Dana-Farber/Brigham and Women's Cancer Center in Boston, Massachusetts.
The study has an important caveat: the findings could differ in men with congestive heart failure or who have had a myocardial infarction.
Still, even with the study's limitations, these data offer a counterpoint to retrospective studies that found a higher risk for CV mortality among men receiving ADT for prostate cancer, explained Dr. Nguyen.
Those studies, plus data indicating an association between ADT and an increased risk for CV complications, led to a consensus statement last year from the American Heart Association, the American Cancer Society and the American Urological Society.
The statement, which was endorsed by ASTRO, asserted that "there may be a relation between ADT and cardiovascular events and death."
Subsequently, in October 2010, the US Food and Drug Administration called for new labeling on gonadotropin-releasing hormone (GnRH) agonists. The black-box warning now states that the agents "increase risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke)."
Improve Analysis of the Problem
In an interview with Medscape Medical News, Dr. Nguyen described the consensus statement as "everybody lining up against androgen-deprivation therapy."
He and a group of colleagues sought to improve the power of the statistical analysis of the problem.
They performed a literature review of randomized trials in prostate cancer that compared GnRH-agonist-based ADT with no ADT and that reported CV-related deaths. They found 8 studies that met their inclusion criteria, comprising a total of 4141 patients, all of whom had intermediate-risk prostate cancer or higher (but no metastatic or hormone-refractory disease). In 5 of the studies, the local therapy patients received was radiation; in the other 3 studies, patients underwent surgery or received no local therapy.
The risk for CV death was similar in the ADT and no-ADT groups (11.0% vs 11.2%). The relative risk for CV death for ADT, compared with no ADT, was 0.93 (95% confidence interval, 0.79 to 1.10; P = .41).
The results were similar in all the subgroups the investigators examined, said Dr. Nguyen, including the subgroups of short-course ADT (6 months or less), long-course ADT (3 years or more), men older than 70 years, and radiation use.
The meta-analysis provides additional reassuring news: ADT improves outcomes. Specifically, compared with no ADT, ADT reduced prostate-cancer-specific mortality (relative risk [RR], 0.68; P < .001) and all-cause mortality (RR, 0.88; P = .005).
Men With Preexisting CV Disease
This is a "great paper" that "employs modern epidemiologic methodology to seek out differences that would not have been seen in smaller studies," Phillip Devlin, MD, secretary/treasurer of ASTRO, told Medscape Medical News. Dr. Devlin is also from Dana-Farber/Brigham and Women's Cancer Center, and acknowledged that he is not a completely impartial commentator, as he is Dr. Nguyen's boss.
Dr. Devlin believes that patients will be calmed by these results, which provide a "sense of greater comfort" and allow clinicians to say that "there may be less risk than we thought" with ADT and cardiac death.
Nevertheless, clinicians should provide careful monitoring of patients on ADT for CV disease, said Dr. Devlin.
The study did not examine whether ADT is associated with a reduction in CV events such as congestive heart failure and myocardial infarction.
Retrospective data suggest that ADT harms men with preexisting CV disease, said Dr. Nguyen.
The extent of the harm is unclear, he reported. For instance, a 2009 study indicated that only 5% of men with a history of congestive heart failure and myocardial infarction were harmed by ADT, as reported by Medscape Medical News.
Dr. Nguyen is also the author of a study that found that men with high-risk prostate cancer have an increased risk for death with ADT if they have a history of congestive heart failure and myocardial infarction (RR, 2.6; P = .01).
Dr. Nguyen reports receiving research funding from Varian. Dr. Devlin has disclosed no relevant financial relationships.
American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting: Abstract 11. Presented October 3, 2011.
[CLOSE WINDOW]
Authors and Disclosures
Journalist
Nick Mulcahy
Nick Mulcahy is a senior journalist for Medscape Hematology-Oncology. Before joining Medscape, Nick was a freelance medical news writer for 15 years, working for companies such as the International Medical News Group, MedPage Today, HealthDay, McMahon Publishing, and Advanstar. He is also the former managing editor of breastcancer.org. He can be contacted at nmulcahy@medscape.net.
Excess Mortality for Older Patients with Prostate Cancer
population-based analysis of mortality data for men diagnosed with prostate cancer from three European nations suggests that “a small but important group of older patients” initially present with late stage prostate cancer and die rapidly as a consequence.
The study by Holmberg et al., published in Cancer Epidemiology, was designed to compare patterns of survival among men with prostate cancer from England, Norway, and Sweden between 2001 and 2004, taking account of the ages of the patients and the length of follow-up.
The study included data from 179,112 men in England, 23,192 in Norway and 59,697 in Sweden. All study data were based on information available from the national cancer registries for the three countries involved. Estimates of the “excess mortality” among men with prostate cancer were calculated using a period approach for relative survival.
The results of the study showed that:
The overall, age-standardized 5-year survival was
76.4 percent for English patients
80.3 percent for Norwegian patients
83.0 percent for Swedish patients
English patients had
The lowest overall survival
The lowest overall survival among men aged ≥ 80 years in particular
The majority of the excess deaths in England were confined to the first year of follow-up.
In their conclusion, the authors suggest that the early demise of the “small but important group of older patients” may be because (a) they first present with late stage disease and (b) they have severe concomitant comorbidities in addition to their prostate cancer. It is clear that this problem is more common in England than in Norway or Sweden, which may reflect male health-related behavior patterns in the UK by comparison with Scandinavian countries.
The study by Holmberg et al., published in Cancer Epidemiology, was designed to compare patterns of survival among men with prostate cancer from England, Norway, and Sweden between 2001 and 2004, taking account of the ages of the patients and the length of follow-up.
The study included data from 179,112 men in England, 23,192 in Norway and 59,697 in Sweden. All study data were based on information available from the national cancer registries for the three countries involved. Estimates of the “excess mortality” among men with prostate cancer were calculated using a period approach for relative survival.
The results of the study showed that:
The overall, age-standardized 5-year survival was
76.4 percent for English patients
80.3 percent for Norwegian patients
83.0 percent for Swedish patients
English patients had
The lowest overall survival
The lowest overall survival among men aged ≥ 80 years in particular
The majority of the excess deaths in England were confined to the first year of follow-up.
In their conclusion, the authors suggest that the early demise of the “small but important group of older patients” may be because (a) they first present with late stage disease and (b) they have severe concomitant comorbidities in addition to their prostate cancer. It is clear that this problem is more common in England than in Norway or Sweden, which may reflect male health-related behavior patterns in the UK by comparison with Scandinavian countries.
Tuesday, October 4, 2011
New Bayer PCa Drug(QLGETA)
An experimental drug developed by Bayer AG (BAYN) and Algeta ASA (ALGETA) prolonged the lives of men with prostate cancer that’s spread to their bones, a study found.
A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.
The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.
“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”
Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.
To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net
A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.
The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.
“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”
Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.
To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net
Tuesday, September 20, 2011
New Chip to Test Compounds for Toxcicity Early on
http://news.sciencemag.org/scienceinsider/2011/09/white-house-boosts-transla
tional.html?ref=hp
The NIH and the Defense Advanced Research Projects Agency will each invest
as much as $70 million over five years on a chip to test compounds for
toxicity before they are administered to humans. The agencies will also
coordinate with the FDA, which could utilize the chip to accelerate the
drug-approval process. "If things are going to fail, you want them to fail
early," said NIH Director Francis Collins. "Now you'll be able to find out
much quicker if something isn't going to work." Meanwhile, the NIH is
searching for someone to lead its proposed National Center for Advancing
Translational Sciences.
tional.html?ref=hp
The NIH and the Defense Advanced Research Projects Agency will each invest
as much as $70 million over five years on a chip to test compounds for
toxicity before they are administered to humans. The agencies will also
coordinate with the FDA, which could utilize the chip to accelerate the
drug-approval process. "If things are going to fail, you want them to fail
early," said NIH Director Francis Collins. "Now you'll be able to find out
much quicker if something isn't going to work." Meanwhile, the NIH is
searching for someone to lead its proposed National Center for Advancing
Translational Sciences.
Prostate Cancer Info Link Interesting Article
If you are among the people in America who agree with one or other of the following two statements, you need an immediate crash course in what approval of a new drug by the U.S. Food & Drug Administration (FDA) does actually mean:
FDA only approves drugs without serious side effects.
FDA only approves “extremely effective” drugs.
According to a recent survey conducted by Schwartz and Woloshin and just published in the Archives of Internal Medicine:
25 percent of 2,944 people surveyed did indeed believe that the FDA only approves drugs without any serious side effects.
39 percent of 2,944 people surveyed did indeed believe that the FDA only approves “extremely effective” drugs.
In fact, neither of these two things are true at all. So what is the truth?
In reality, FDA approval only implies that — after careful review — the agency has determined that “the benefits [of the approved agent] are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Woloshin in a statement to Reuters, which has also reported on this study.
Schwartz and Woloshin also assessed people’s perceptions about the relative value of newer and older medicines based on FDA approval. The two drugs used in this test actually had approximately equal efficacy and approximately the same side effects in the management of heartburn, but some 66 percent of those questioned picked the newer medication when asked to make a choice between the two.
In fact, in many cases, FDA approval is not based on direct comparisons of effectiveness and safety between drug X and drug Y, so there may be no good reasons to believe that one is any better or safer than the other. In the case of new cancer drugs, the FDA does try hard to encourage drug developers to carry out trials that compare a new drug to the “standard of care” at the time a new trial is being designed, but it is not always possible to do this, and events may overtake reality.
As an example, it would be nice to know whether MDV3100 is or is not safer or more effective than abiraterone acetate in the treatment of castration-resistant prostate cancer (CRPC). However, abiraterone acetate wasn’t approved at the time the Phase III trials of MDV3100 were being designed. At that time, the standard of care for any man with CRPC — metastatic or otherwise — was still chemotherapy with docetaxel + predisone. Unless either the survival benefit demonstrated by MDV3100 is a lot more or a lot less than 3.9 months compared to placebo, or the side effects of MDV3100 are a lot worse or a lot better than those exhibited by patients on abiraterone acetate compared to placebo, there will be no way to assess whether one drug is any “better” than the other. For very similar reasons, we have no idea of the relative merits of treating men with CRPC with either abiraterone acetate of sipuleucel-T.
The FDA does its best to ensure that important new drugs for conditions like prostate cancer are moved through the regulatory process in a timely manner. In recent years, they have become pretty successful at this. However, we are likely, over time, to discover than some of these new drugs have additional, and potentially significant, side effects that were simply not seen or reported in the relatively small numbers of patients who participate in the clinical trials that customarily lead to drug approval.
Here is a brief list of some very simple things that it is well worth understanding about what an FDA approval of a new drug actually does and does not mean:
FDA approval means that, on average, the benefits of using a drug outweigh the risks in a well-defined set of patients with a specific disorder.
FDA approval means that the FDA has worked closely with the drug developer to create detailed prescribing information for the new drug
The prescribing information for every drug includes
Information about what types of patients the drug is approved for
Information about the effectiveness of the drug in this set of patients
Information about the side effects of the drug when used in this set of patients
Warnings about serious adverse effects (up to and including death) associated with the use of the drug
Information about the recommended dose of the drug and how it should be given to or taken by patients
FDA approval of a drug never implies that
A drug is completely safe
A drug has no side effects
All the side effects of a drug have been discovered
A drug will necessarily be effective for you as an individual
On average, the benefits of using a drug will outweigh the risks if the drug is used to treat an unapproved condition
A drug is “better” than other drugs for the approved condition (unless it has been compared to another drug or drug in a “head-to-head” clinical
FDA only approves drugs without serious side effects.
FDA only approves “extremely effective” drugs.
According to a recent survey conducted by Schwartz and Woloshin and just published in the Archives of Internal Medicine:
25 percent of 2,944 people surveyed did indeed believe that the FDA only approves drugs without any serious side effects.
39 percent of 2,944 people surveyed did indeed believe that the FDA only approves “extremely effective” drugs.
In fact, neither of these two things are true at all. So what is the truth?
In reality, FDA approval only implies that — after careful review — the agency has determined that “the benefits [of the approved agent] are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Woloshin in a statement to Reuters, which has also reported on this study.
Schwartz and Woloshin also assessed people’s perceptions about the relative value of newer and older medicines based on FDA approval. The two drugs used in this test actually had approximately equal efficacy and approximately the same side effects in the management of heartburn, but some 66 percent of those questioned picked the newer medication when asked to make a choice between the two.
In fact, in many cases, FDA approval is not based on direct comparisons of effectiveness and safety between drug X and drug Y, so there may be no good reasons to believe that one is any better or safer than the other. In the case of new cancer drugs, the FDA does try hard to encourage drug developers to carry out trials that compare a new drug to the “standard of care” at the time a new trial is being designed, but it is not always possible to do this, and events may overtake reality.
As an example, it would be nice to know whether MDV3100 is or is not safer or more effective than abiraterone acetate in the treatment of castration-resistant prostate cancer (CRPC). However, abiraterone acetate wasn’t approved at the time the Phase III trials of MDV3100 were being designed. At that time, the standard of care for any man with CRPC — metastatic or otherwise — was still chemotherapy with docetaxel + predisone. Unless either the survival benefit demonstrated by MDV3100 is a lot more or a lot less than 3.9 months compared to placebo, or the side effects of MDV3100 are a lot worse or a lot better than those exhibited by patients on abiraterone acetate compared to placebo, there will be no way to assess whether one drug is any “better” than the other. For very similar reasons, we have no idea of the relative merits of treating men with CRPC with either abiraterone acetate of sipuleucel-T.
The FDA does its best to ensure that important new drugs for conditions like prostate cancer are moved through the regulatory process in a timely manner. In recent years, they have become pretty successful at this. However, we are likely, over time, to discover than some of these new drugs have additional, and potentially significant, side effects that were simply not seen or reported in the relatively small numbers of patients who participate in the clinical trials that customarily lead to drug approval.
Here is a brief list of some very simple things that it is well worth understanding about what an FDA approval of a new drug actually does and does not mean:
FDA approval means that, on average, the benefits of using a drug outweigh the risks in a well-defined set of patients with a specific disorder.
FDA approval means that the FDA has worked closely with the drug developer to create detailed prescribing information for the new drug
The prescribing information for every drug includes
Information about what types of patients the drug is approved for
Information about the effectiveness of the drug in this set of patients
Information about the side effects of the drug when used in this set of patients
Warnings about serious adverse effects (up to and including death) associated with the use of the drug
Information about the recommended dose of the drug and how it should be given to or taken by patients
FDA approval of a drug never implies that
A drug is completely safe
A drug has no side effects
All the side effects of a drug have been discovered
A drug will necessarily be effective for you as an individual
On average, the benefits of using a drug will outweigh the risks if the drug is used to treat an unapproved condition
A drug is “better” than other drugs for the approved condition (unless it has been compared to another drug or drug in a “head-to-head” clinical
Tuesday, September 6, 2011
Family Physician Prostate Cancer Screening
Prostate Cancer: Who Should Be Treated?
Am Fam Physician. 2011 Aug 15;84(4):424.
See related article on prostate cancer treatments.
What are the pros and cons of treating prostate cancer?
Prostate cancer is usually found in the early stages, when treatment can cure it. Some men have more aggressive cancer that spreads quickly; treatment can be life-saving in these cases. However, treatment can also cause urinary, sexual, and bowel problems.
Why is treatment not recommended for some people?
In most men, prostate cancer grows so slowly that it will not lead to death within 10 years, even if the cancer is not treated. Prostate cancer is usually found late in life, so men who are expected to live less than 10 years and who have a slow-growing cancer will probably not benefit from treatment.
How do I know how aggressive my prostate cancer is?
Your doctor will do a biopsy and a blood test to find out your risk. These tests will also tell you whether the cancer has spread outside the prostate. Treatment is recommended if the risk of the cancer spreading is high, or if it has already spread.
What treatment options are there?
The two most common options are surgery and radiation therapy. Your doctor can help you choose which treatment is best for you. After either treatment, about two out of three patients have problems getting an erection. However, many of these patients usually had this problem before the cancer was found. Surgery is more likely to cause urinary problems, and radiation therapy is more likely to cause bowel problems. One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects. In brachytherapy, radioactive seeds are put inside the prostate gland.
What happens if I choose not to treat my prostate cancer?
If you choose not to treat your cancer, your doctor will have you follow a program called active surveillance. In this program, you will have blood tests and biopsies done on a regular basis. If these tests find that your risk has increased, your doctor may recommend that you consider treatment.
This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.
This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.
Copyright © 2011 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.
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Am Fam Physician. 2011 Aug 15;84(4):424.
See related article on prostate cancer treatments.
What are the pros and cons of treating prostate cancer?
Prostate cancer is usually found in the early stages, when treatment can cure it. Some men have more aggressive cancer that spreads quickly; treatment can be life-saving in these cases. However, treatment can also cause urinary, sexual, and bowel problems.
Why is treatment not recommended for some people?
In most men, prostate cancer grows so slowly that it will not lead to death within 10 years, even if the cancer is not treated. Prostate cancer is usually found late in life, so men who are expected to live less than 10 years and who have a slow-growing cancer will probably not benefit from treatment.
How do I know how aggressive my prostate cancer is?
Your doctor will do a biopsy and a blood test to find out your risk. These tests will also tell you whether the cancer has spread outside the prostate. Treatment is recommended if the risk of the cancer spreading is high, or if it has already spread.
What treatment options are there?
The two most common options are surgery and radiation therapy. Your doctor can help you choose which treatment is best for you. After either treatment, about two out of three patients have problems getting an erection. However, many of these patients usually had this problem before the cancer was found. Surgery is more likely to cause urinary problems, and radiation therapy is more likely to cause bowel problems. One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects. In brachytherapy, radioactive seeds are put inside the prostate gland.
What happens if I choose not to treat my prostate cancer?
If you choose not to treat your cancer, your doctor will have you follow a program called active surveillance. In this program, you will have blood tests and biopsies done on a regular basis. If these tests find that your risk has increased, your doctor may recommend that you consider treatment.
This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.
This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.
Copyright © 2011 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.
AFP Home | About Us | Contact Us | Subscribe | AFP by E-Mail | Permissions
About Online Access | Employment Opportunities
Information for: Authors | Advertisers
PCa Guidance to Family Doctors
The August 15 issue of American Family Physician — supposedly one of the most widely read medical journals in America — carried an article by Mohan and Schellhammer entitled “Treatment options for localized prostate cancer.” Unfortunately the full text of this article is not available on line for the average reader.
In their article, Mohan (a family physician) and Schellhammer (a urologic oncologist who is himself a prostate cancer patient with progressive disease) offer family doctors rather more than a standard review of the diagnosis and treatment of prostate cancer, and it is the first review of prostate cancer to appear in American Family Physician since 2005. To that extent, it should be seen as a key overview on the subject of prostate cancer for the primary care community.
The article makes a number of evidence-based key points about the treatment of localized prostate cancer for the family practitioner, as follows:
Treatment of localized prostate cancer is unlikely to improve the survival of [most] men with low- and very low-risk disease and all such active interventions have potentially negative effects on health-related quality 0f life.
Despite this information, some 70 to 90 percent of men with localized prostate cancer choose an interventional treatment shortly after a positive biopsy.
More than 50 percent of such patients significantly over-estimate the survival benefit of treatment.
Treatment of localized prostate cancer should normally be recommended for higher-risk patients.
Risk level can be estimated based on cancer stage and grade, PSA level, and comorbidity-adjusted life expectancy (CALE).
Patients can be counseled that surgery and external beam radiation therapy are almost equal in efficacy for the treatment of localized prostate cancer.
Brachytherapy is an appropriate form of monotherapy in low-risk, localized prostate cancer.
Active surveillance is a reasonable management option for low- and very low-risk, localized prostate cancer.
The article also includes a series of tools that may be useful to primary care physicians and their patients in assessing risk and the appropriateness of differing forms of treatment, including:
A questionnaire to assess patient understanding of the benefits and risks of different treatment options.
A simplified algorithm (derived from the prostate cancer guidelines of the National Comprehensive Cancer Center Network) that can be used to aid selection of appropriate management of localized prostate cancer
A table to assist in assessment of a patient’s Charlson comorbidity index (CCI)
A table to assist in assessment of a patient’s comorbidity-adjusted life expectancy (CALE)
A table summarizing expected adverse effects at 2 years after treatment for localized prostate cancer
The Klotz (Canadian) protocol for active surveillance of men with localized prostate cancer (including indications for interventional treatment)
The article is supplemented by a handout for family physicians to use with their patients entitled “Prostate Cancer: Who Should Be Treated?” The full text of this brief handout is available on line.
Support group leaders and other prostate cancer educators are encouraged to ask the assistance of their family physicians or their local medical librarian in obtaining a copy of this article for their personal use.
It is inevitable that an article like this will not meet the approval of everyone in the prostate cancer community. It is an easy article to “pick holes in” if one is of a mind to do so. However, even with such limitations, what this article does do is to provide a series of tools and sound general information that will help the family practitioner to become more involved in the provision of appropriate guidance to patients diagnosed with prostate cancer — and particularly those patients of 60 to 80 years of age who comprise a significant majority of those being diagnosed with localized, low-risk prostate cancer today.
In their article, Mohan (a family physician) and Schellhammer (a urologic oncologist who is himself a prostate cancer patient with progressive disease) offer family doctors rather more than a standard review of the diagnosis and treatment of prostate cancer, and it is the first review of prostate cancer to appear in American Family Physician since 2005. To that extent, it should be seen as a key overview on the subject of prostate cancer for the primary care community.
The article makes a number of evidence-based key points about the treatment of localized prostate cancer for the family practitioner, as follows:
Treatment of localized prostate cancer is unlikely to improve the survival of [most] men with low- and very low-risk disease and all such active interventions have potentially negative effects on health-related quality 0f life.
Despite this information, some 70 to 90 percent of men with localized prostate cancer choose an interventional treatment shortly after a positive biopsy.
More than 50 percent of such patients significantly over-estimate the survival benefit of treatment.
Treatment of localized prostate cancer should normally be recommended for higher-risk patients.
Risk level can be estimated based on cancer stage and grade, PSA level, and comorbidity-adjusted life expectancy (CALE).
Patients can be counseled that surgery and external beam radiation therapy are almost equal in efficacy for the treatment of localized prostate cancer.
Brachytherapy is an appropriate form of monotherapy in low-risk, localized prostate cancer.
Active surveillance is a reasonable management option for low- and very low-risk, localized prostate cancer.
The article also includes a series of tools that may be useful to primary care physicians and their patients in assessing risk and the appropriateness of differing forms of treatment, including:
A questionnaire to assess patient understanding of the benefits and risks of different treatment options.
A simplified algorithm (derived from the prostate cancer guidelines of the National Comprehensive Cancer Center Network) that can be used to aid selection of appropriate management of localized prostate cancer
A table to assist in assessment of a patient’s Charlson comorbidity index (CCI)
A table to assist in assessment of a patient’s comorbidity-adjusted life expectancy (CALE)
A table summarizing expected adverse effects at 2 years after treatment for localized prostate cancer
The Klotz (Canadian) protocol for active surveillance of men with localized prostate cancer (including indications for interventional treatment)
The article is supplemented by a handout for family physicians to use with their patients entitled “Prostate Cancer: Who Should Be Treated?” The full text of this brief handout is available on line.
Support group leaders and other prostate cancer educators are encouraged to ask the assistance of their family physicians or their local medical librarian in obtaining a copy of this article for their personal use.
It is inevitable that an article like this will not meet the approval of everyone in the prostate cancer community. It is an easy article to “pick holes in” if one is of a mind to do so. However, even with such limitations, what this article does do is to provide a series of tools and sound general information that will help the family practitioner to become more involved in the provision of appropriate guidance to patients diagnosed with prostate cancer — and particularly those patients of 60 to 80 years of age who comprise a significant majority of those being diagnosed with localized, low-risk prostate cancer today.
Tuesday, August 30, 2011
AlphaPhosphatase S, One Patient's Experience
Alkaline Phosphatase
An alkaline phosphatase (ALP) test measures the amount of the enzyme ALP in the blood. ALP is made mostly in the liver and in bone with some made in the intestines and kidneys . It also is made by the placenta of a pregnant woman.
The liver makes more ALP than the other organs or the bones. Some conditions cause large amounts of ALP in the blood. These conditions include rapid bone growth (during puberty), bone disease (osteomalacia or Paget's disease), or a disease that affects how much calcium is in the blood (hyperparathyroidism), vitamin D deficiency, or damaged liver cells.
If the ALP level is high, more tests may be done to find the cause.
Why It Is Done
A test for alkaline phosphatase (ALP) is done to:
Check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken.
Check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone). The ALP level can be used to check how well treatment for Paget's disease or a vitamin D deficiency is working.
How To Prepare
An alkaline phosphatase test is often done at the same time as a routine blood test. You do not need to do anything before having a routine blood test.
If you are having a follow-up ALP test, you may be asked to not eat or drink for 10 hours before the test. The ALP level generally goes up after eating, especially after eating fatty foods.
Many medicines may change the results of this test. Be sure to tell your doctor about all the nonprescription and prescription medicines you take.
Talk to your doctor about any concerns you have regarding the need for the test, its risks, how it will be done, or what the results will mean. To help you understand the importance of this test, fill out the medical test information form(What is a PDF document?).
How It Is Done
The health professional drawing your blood will:
Wrap an elastic band around your upper arm to stop the flow of blood. This makes the veins below the band larger so it is easier to put a needle into the vein.
Clean the needle site with alcohol.
Put the needle into the vein. More than one needle stick may be needed.
Attach a tube to the needle to fill it with blood.
Remove the band from your arm when enough blood is collected.
Put a gauze pad or cotton ball over the needle site as the needle is removed.
Put pressure to the site and then a bandage.
One Patient's Experience with AlphaPhosphatase S
First, the prostate specific antigen (PSA) is a substance expressed by a healthy prostate gland. It is easily measured in the blood steam. While arguments rage about its use to diagnose the presence of prostate cancer in the beginning, there is little argument about its reliability to follow the post-treatment progress of men like me. Usually, a climbing PSA means an increase in the tumor population. Next, alkaline phosphatase (ALP). “ALP S” can be measured in the blood stream as part of a routine liver function test known as CMP (complete metabolic panel). Bone-specific ALP is measured from a separate blood specimen. It is believed to reliably track tumor progression in the skeleton during treatment, even when other indicators may be less reliable.
Comparing the values of these indicators from February 9, just after we started chemotherapy with Taxotere, with those from August 11, 75 days after starting Zytiga, we see disappointing increases in both ALPs and rocket-sled behavior from the PSA. What might this mean? Answer: we really don’t know.
There are several possibilities, but the bottom line at this point is: the September test must show some “benefit” from the Zytiga or I go back on chemotherapy - this time with a similar drug called Jevtana - and hope we can bring the three indicators back to the pre-Zytiga levels of early June
An alkaline phosphatase (ALP) test measures the amount of the enzyme ALP in the blood. ALP is made mostly in the liver and in bone with some made in the intestines and kidneys . It also is made by the placenta of a pregnant woman.
The liver makes more ALP than the other organs or the bones. Some conditions cause large amounts of ALP in the blood. These conditions include rapid bone growth (during puberty), bone disease (osteomalacia or Paget's disease), or a disease that affects how much calcium is in the blood (hyperparathyroidism), vitamin D deficiency, or damaged liver cells.
If the ALP level is high, more tests may be done to find the cause.
Why It Is Done
A test for alkaline phosphatase (ALP) is done to:
Check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken.
Check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone). The ALP level can be used to check how well treatment for Paget's disease or a vitamin D deficiency is working.
How To Prepare
An alkaline phosphatase test is often done at the same time as a routine blood test. You do not need to do anything before having a routine blood test.
If you are having a follow-up ALP test, you may be asked to not eat or drink for 10 hours before the test. The ALP level generally goes up after eating, especially after eating fatty foods.
Many medicines may change the results of this test. Be sure to tell your doctor about all the nonprescription and prescription medicines you take.
Talk to your doctor about any concerns you have regarding the need for the test, its risks, how it will be done, or what the results will mean. To help you understand the importance of this test, fill out the medical test information form(What is a PDF document?).
How It Is Done
The health professional drawing your blood will:
Wrap an elastic band around your upper arm to stop the flow of blood. This makes the veins below the band larger so it is easier to put a needle into the vein.
Clean the needle site with alcohol.
Put the needle into the vein. More than one needle stick may be needed.
Attach a tube to the needle to fill it with blood.
Remove the band from your arm when enough blood is collected.
Put a gauze pad or cotton ball over the needle site as the needle is removed.
Put pressure to the site and then a bandage.
One Patient's Experience with AlphaPhosphatase S
First, the prostate specific antigen (PSA) is a substance expressed by a healthy prostate gland. It is easily measured in the blood steam. While arguments rage about its use to diagnose the presence of prostate cancer in the beginning, there is little argument about its reliability to follow the post-treatment progress of men like me. Usually, a climbing PSA means an increase in the tumor population. Next, alkaline phosphatase (ALP). “ALP S” can be measured in the blood stream as part of a routine liver function test known as CMP (complete metabolic panel). Bone-specific ALP is measured from a separate blood specimen. It is believed to reliably track tumor progression in the skeleton during treatment, even when other indicators may be less reliable.
Comparing the values of these indicators from February 9, just after we started chemotherapy with Taxotere, with those from August 11, 75 days after starting Zytiga, we see disappointing increases in both ALPs and rocket-sled behavior from the PSA. What might this mean? Answer: we really don’t know.
There are several possibilities, but the bottom line at this point is: the September test must show some “benefit” from the Zytiga or I go back on chemotherapy - this time with a similar drug called Jevtana - and hope we can bring the three indicators back to the pre-Zytiga levels of early June
Sunday, July 31, 2011
We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
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As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
Sign In to E-Mail
Reprints
Get 50% Off The New York Times & Free All Digital Access.
More Headlines From Around the Web
Sponsored Links
Caring.com
Alzheimer's Activities: How Making Lemonade Can Trigger Hidden Memories
Health Central
My Fingers Are Numb, Should I Call the Doctor?
The Stir By CafeMom
Tuesday, July 26, 2011
Prostate Cancer Risks for Men inBreastCancerFamilies
THE "NEW" PROSTATE CANCER INFOLINKEntries RSS | Comments RSS Follow The "New" Prostate Cancer InfoLink news blog on TWITTER or FACEBOOK.
Copyright © 2008-11 Prostate Cancer International, Inc.Prostate cancer and prostate cancer-specific survival of men from breast cancer-prone families
Posted on July 26, 2011 by Sitemaster
i1 Votes
An Australian research team has used data from 148 men from 1,423 families identified through the Kathleen Cunningham Consortium for Research into Familial Breast Cancer (kConFab) to assess the risks associated with prostate cancer in males from breast cancer-prone families, and most particularly from those families in which the BRCA2 gene mutation is prevalent.
Although it is well understood that there is a strong association between the presence of the BRCA2 gene mutation and the risk for development of prostate cancer, the consequent clinical presentation of prostate caner in such men, and their treatment-related outcomes, have not previously been thoroughly characterized.
kConFab is a multi-center research consortium that identifies and studies families at high risk for breast cancer from across Australia and New Zealand. Thorne et al. were able to search the kConFab database to identify 148 male patients who met the following three criteria:
They had all been diagnosed with prostate cancer.
They were all confirmed as either a carrier or a non-carrier of a family-specific BRCA pathogenic mutation.
Comprehensive clinical and treatment data were available on all 148 men.
Detailed analysis of the clinical and familial data from these 148 male prostate cancer patients established the following:
The men all had high risk of disease progression, irrespective of mutation status.
Carriers of the BRCA2 mutation had an increased risk of overall and prostate cancer-specific mortality (hazard ratio [HR] = 4.5; P = 8.9 × 10-5) by comparison with non-carriers.
For both carriers and non-carriers of the BRCA2 mutation given first-line treatment with curative intent, long-term survival outcomes were relatively poor (when compared to the survival outcomes of men from non-breast cancer-prone families
Serum PSA readings taken prior to diagnosis in 90 percent of these men, after age adjustment, were above clinical significance.
Based on the D’Amico risk stratification criteria
77.5 percent of the carriers of the BRCA2 mutation had high-risk disease
58.7 percent of non-carriers also had high-risk disease.
BRCA2 mutation status was an independent prognostic indicator of overall survival.
Thorne et al. conclude that:
If diagnosed with prostate cancer, all men in breast cancer-prone families are at significant risk of developing an aggressive form of the disease.
This information should be made clear by genetic counselors and medical professionals in discussions about cancer risk with men in such families, whether the individual is a carrier or a non-carrier of a BRCA gene mutation.
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t
Copyright © 2008-11 Prostate Cancer International, Inc.Prostate cancer and prostate cancer-specific survival of men from breast cancer-prone families
Posted on July 26, 2011 by Sitemaster
i1 Votes
An Australian research team has used data from 148 men from 1,423 families identified through the Kathleen Cunningham Consortium for Research into Familial Breast Cancer (kConFab) to assess the risks associated with prostate cancer in males from breast cancer-prone families, and most particularly from those families in which the BRCA2 gene mutation is prevalent.
Although it is well understood that there is a strong association between the presence of the BRCA2 gene mutation and the risk for development of prostate cancer, the consequent clinical presentation of prostate caner in such men, and their treatment-related outcomes, have not previously been thoroughly characterized.
kConFab is a multi-center research consortium that identifies and studies families at high risk for breast cancer from across Australia and New Zealand. Thorne et al. were able to search the kConFab database to identify 148 male patients who met the following three criteria:
They had all been diagnosed with prostate cancer.
They were all confirmed as either a carrier or a non-carrier of a family-specific BRCA pathogenic mutation.
Comprehensive clinical and treatment data were available on all 148 men.
Detailed analysis of the clinical and familial data from these 148 male prostate cancer patients established the following:
The men all had high risk of disease progression, irrespective of mutation status.
Carriers of the BRCA2 mutation had an increased risk of overall and prostate cancer-specific mortality (hazard ratio [HR] = 4.5; P = 8.9 × 10-5) by comparison with non-carriers.
For both carriers and non-carriers of the BRCA2 mutation given first-line treatment with curative intent, long-term survival outcomes were relatively poor (when compared to the survival outcomes of men from non-breast cancer-prone families
Serum PSA readings taken prior to diagnosis in 90 percent of these men, after age adjustment, were above clinical significance.
Based on the D’Amico risk stratification criteria
77.5 percent of the carriers of the BRCA2 mutation had high-risk disease
58.7 percent of non-carriers also had high-risk disease.
BRCA2 mutation status was an independent prognostic indicator of overall survival.
Thorne et al. conclude that:
If diagnosed with prostate cancer, all men in breast cancer-prone families are at significant risk of developing an aggressive form of the disease.
This information should be made clear by genetic counselors and medical professionals in discussions about cancer risk with men in such families, whether the individual is a carrier or a non-carrier of a BRCA gene mutation.
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t
Monday, July 18, 2011
Support for Provenge, a Prostate Cancer Dug
Provenge, a Prostate Cancer Dug
CloseLinkedinDiggMySpacePermalinkTo the Editor:
We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
CloseLinkedinDiggMySpacePermalinkTo the Editor:
We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
Wednesday, July 13, 2011
American Cancer Society on PSA Screening
The American Cancer Society (ACS) recommends that men have a chance to make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risks, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information.
The discussion about screening should take place at age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
This discussion should take place starting at age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
This discussion should take place at age 40 for men at even higher risk (those with several first-degree relatives who had prostate cancer at an early age).
After this discussion, those men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.
If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.
Men who choose to be tested who have a PSA of less than 2.5 ng/ml, may only need to be retested every 2 years.
Screening should be done yearly for men whose PSA level is 2.5 ng/ml or higher.
Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient's health, values, and preferences.
The discussion about screening should take place at age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
This discussion should take place starting at age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
This discussion should take place at age 40 for men at even higher risk (those with several first-degree relatives who had prostate cancer at an early age).
After this discussion, those men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.
If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.
Men who choose to be tested who have a PSA of less than 2.5 ng/ml, may only need to be retested every 2 years.
Screening should be done yearly for men whose PSA level is 2.5 ng/ml or higher.
Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient's health, values, and preferences.
Saturday, July 9, 2011
Mediterranean Diet Fundamentals
The Mediterranean diet has been shown to reduce the risk of death from both heart disease and cancer, lower the risk of developing type 2 diabetes, control weight, lower blood pressure and cholesterol levels, and even reduce the risk of Alzheimer’s disease. Convinced?
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Mediterranean Diet Fundamentals
The Mediterranean diet has been shown to reduce the risk of death from both heart disease and cancer, lower the risk of developing type 2 diabetes, control weight, lower blood pressure and cholesterol levels, and even reduce the risk of Alzheimer’s disease. Convinced?
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Malecare's Prostate Cancer Under (age) 50 program
Malecare's Prostate Cancer Under (age) 50 program began in late 2004 and Malecare's Advanced Prostate Cancer program began in late 2006. Today, we are asking you to tell us how we can make them better. Please email your suggestions and comments. We are asking in this free form way, as we know that each of you approaches your diagnosis, treatment and lives uniquely ... we want to fit your needs into our programs rather than create programs that you have to make an effort to fit into.
So, if you were diagnosed with prostate cancer before the age of 50, tell us what help is missing or what can be improved in your lives...in the services and support groups we offer....anything, everything....the sky and your imagination are your only limits. Family and friends are welcome to email their comments, too.
Same goes for those of you initially diagnosed with late stage prostate cancer, or were diagnosed with a recurrence of prostate cancer after a primary treatment.
I can tell you that we are revising the Advanced Prostate Cancer handbook that approx. 6,000 of you received. We're writing Version 2.0 and would welcome your critique of Version 1.x We're also planning many more teleconferences for you to attend.
All of our Malecare volunteer's have lots of work to do this summer, and we hope that you will help by taking just a few minutes to email your comments to me, Darryl, at darryl@malecare.org
P.S. Our advocacy efforts continue, with work focused on protecting the federal Prostate Cancer Research Program, building awareness with the second annual Men's Health Night on November 20 and trying to increase collaboration with our brother and sister cancer survivor nonprofits...more news about that, next month
So, if you were diagnosed with prostate cancer before the age of 50, tell us what help is missing or what can be improved in your lives...in the services and support groups we offer....anything, everything....the sky and your imagination are your only limits. Family and friends are welcome to email their comments, too.
Same goes for those of you initially diagnosed with late stage prostate cancer, or were diagnosed with a recurrence of prostate cancer after a primary treatment.
I can tell you that we are revising the Advanced Prostate Cancer handbook that approx. 6,000 of you received. We're writing Version 2.0 and would welcome your critique of Version 1.x We're also planning many more teleconferences for you to attend.
All of our Malecare volunteer's have lots of work to do this summer, and we hope that you will help by taking just a few minutes to email your comments to me, Darryl, at darryl@malecare.org
P.S. Our advocacy efforts continue, with work focused on protecting the federal Prostate Cancer Research Program, building awareness with the second annual Men's Health Night on November 20 and trying to increase collaboration with our brother and sister cancer survivor nonprofits...more news about that, next month
Wednesday, July 6, 2011
More Information on Provenge's FDA Approval
From: Dendreon Corporation Investor Relations
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
Dendreon Corporation
Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-
SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.
"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."
For information about these programs, please visit www.provenge.com
PROVENGE Indication and Safety
PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients
in four randomized clinical trials who underwent at least one leukapheresis
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion reactions were
reported in 3.5% of patients in the PROVENGE group. Reactions included
chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness,
headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1,500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were observed
in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in
the control group.
For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com
1-877-336-3736.
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
Dendreon Corporation
Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-
SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.
"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."
For information about these programs, please visit www.provenge.com
PROVENGE Indication and Safety
PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients
in four randomized clinical trials who underwent at least one leukapheresis
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion reactions were
reported in 3.5% of patients in the PROVENGE group. Reactions included
chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness,
headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1,500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were observed
in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in
the control group.
For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com
1-877-336-3736.
Medicare now covers first FDA-approved immunotherapy for PCa treatment
Medicare now covers first FDA-approved immunotherapy for prostate cancer treatment
Medicare patients with metastatic prostate cancer can get a first-of-its kind treatment just approved by the Food and Drug Administration, under a final coverage decision issued today by the Centers for Medicare & Medicaid Services (CMS).
Autologous cellular immunotherapy, known clinically as sipuleucel-T, is marketed in the United States as Provenge, for treating some forms of prostate cancer in seriously ill patients. Today’s decision is effective immediately.
Provenge activates a patient’s own immune system to defend him against prostate cancer. The treatment consists of a multi-day regimen in which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells. After the patient’s cells are treated, the patient receives his own cells back into his body in order to stimulate his immune system to fight the prostate cancer. This regimen is repeated over several weeks for a total of three treatments.
“We are optimistic that innovative str ategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”
Prostate cancer is the most common non-skin cancer in men in the United States. The cancer forms in the prostate, a gland in the male reproductive system, which can spread to other parts of the body and threaten life. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 men died. According to the National Cancer Institute, prostate cancer is most commmonly a cancer of older men, with most men diagnosed after 65 and the median age at diagnosis of 72.
CMS internally initiated the national coverage determination process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations.
CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.
Today’s coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
More information for patients and health professionals about FDA’s approved uses of Prpvemge is online at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm.
“CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label,” said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Similar to other tr eatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision.”
The final coverage decision is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Autologous%20Cellular% 20Immunotherapy%20Treatment%20of%20Metastatic%20Prostate%20Cancer&bc=ACAAAAAAIAAA&NCAId=247&.
Medicare patients with metastatic prostate cancer can get a first-of-its kind treatment just approved by the Food and Drug Administration, under a final coverage decision issued today by the Centers for Medicare & Medicaid Services (CMS).
Autologous cellular immunotherapy, known clinically as sipuleucel-T, is marketed in the United States as Provenge, for treating some forms of prostate cancer in seriously ill patients. Today’s decision is effective immediately.
Provenge activates a patient’s own immune system to defend him against prostate cancer. The treatment consists of a multi-day regimen in which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells. After the patient’s cells are treated, the patient receives his own cells back into his body in order to stimulate his immune system to fight the prostate cancer. This regimen is repeated over several weeks for a total of three treatments.
“We are optimistic that innovative str ategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”
Prostate cancer is the most common non-skin cancer in men in the United States. The cancer forms in the prostate, a gland in the male reproductive system, which can spread to other parts of the body and threaten life. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 men died. According to the National Cancer Institute, prostate cancer is most commmonly a cancer of older men, with most men diagnosed after 65 and the median age at diagnosis of 72.
CMS internally initiated the national coverage determination process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations.
CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.
Today’s coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
More information for patients and health professionals about FDA’s approved uses of Prpvemge is online at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm.
“CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label,” said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Similar to other tr eatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision.”
The final coverage decision is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Autologous%20Cellular% 20Immunotherapy%20Treatment%20of%20Metastatic%20Prostate%20Cancer&bc=ACAAAAAAIAAA&NCAId=247&.
Tuesday, June 21, 2011
Free New Cancer Support Services
WASHINGTON, D.C., June 14, 2011 - The Cancer Support Community (CSC) -- an
international non-profit dedicated to providing support, education and hope
to people impacted by cancer -- today announced a free new service:
CancerSupportSource(tm), an innovative mobile application providing cancer
patients and their caregivers with a unique set of tools addressing their
physical, social and emotional concerns related to living with cancer and
its treatment. The app is available for download
Store (category: Medical).
international non-profit dedicated to providing support, education and hope
to people impacted by cancer -- today announced a free new service:
CancerSupportSource(tm), an innovative mobile application providing cancer
patients and their caregivers with a unique set of tools addressing their
physical, social and emotional concerns related to living with cancer and
its treatment. The app is available for download
Store (category: Medical).
Whole Genome Sequencing for Prostate Cancer
Whole Genome Sequencing for Prostate Cancer
Today’s announcement regarding the sequencing of whole prostate cancer genomes is an historic development in the fight against prostate cancer. The ability to sequence whole genomes will spare some patients from unnecessary treatments and side effects while eliminating an estimated $1.5 billion that is spent each year on overtreatment. The complete research findings will be published in the February 10 issue of Nature. The following Q and A is from content discussed during a teleconference announcing the significance of the findings and of whole genome sequencing to prostate cancer research.
Why is this discovery historic for prostate cancer research, and all cancer research generally?
A great journey begins with a small step. This is PCF’s first “Lewis and Clark” moment exploring the genomic landscape of prostate cancer. For the first time, researchers have uncovered a comprehensive genetic map of seven patients’ prostate tumors. Each of the seven maps offers a macroscopic view of the complete genetic sequence and mutations that might underlie and cause each patient’s disease. The whole genome view also shows us how prostate cancer is complex in a way that is different from other cancers. Instead of having many “spelling errors” or point mutations, prostate cancer has an unprecedented number of large rearrangement segments called “DNA fusions.”
What should patients be asking urologists today that they couldn’t ask yesterday?
Although these findings have not yet been translated into widely employed clinical practices, patients can begin to ask their respective medical teams about participating in studies that use whole genome sequencing in clinical trials. Opportunities for employing genomic scans in research and treatment studies for prostate cancer patients are rapidly expanding.
How much does it cost to sequence a whole prostate cancer genome? How long does it take?
The current estimated cost of sequencing a whole genome is $20,000 or less. Experts predict that the cost of routine sequencing will ultimately be around $5,000 per genome. (This figure compares favorably to the cost of $90,000-$150,000 per patient for a radical prostatectomy followed by several years of androgen deprivation therapy using Lupron.) The process of whole genome sequencing for a single patient currently takes between 2 and 3 weeks.
How will whole genomic sequencing accelerate the development of new medicines and diagnostics for prostate cancer patients?
Knowledge of DNA fusions from leukemia genome sequencing led to breakthrough medicines for chemotherapy-resistant leukemia. PCF believes that prostate cancer genome sequencing could follow suit and lead to a cancer-specific tests or fusion-specific medicines for distinct types of prostate cancer. Additionally, information provided by sequencing a given tumor could facilitate matching up a patient to existing clinical trials targeting DNA fusions and mutations—PCF is currently monitoring 11 trials of this kind.
What does the genome look like to a doctor or a patient?
The DNA code of each of the multiple tumors sequenced contains 3 billion letters. Depicting the sequence of these letters in a linear fashion would make it hard to visualize the important patterns and features of the structural variation with the code. It would also be exceedingly long to read.
Instead of sifting through a 3-billion letter code, a diagram was developed as a short-hand tool for visualizing important relationships within the genome. It was created with Circos software and is called the Circos plot. Designed with the express purpose of aiding in the visualization of genomic data, its circular layout is analogous to a clock face. Just as a clock face displays time through the use of a fixed dial indicating the hours in a 12-hour cycle, the Circos plot displays the 23 chromosome pairs on which the entire human genome is stored.
These chromosomes are numbered clockwise on the outer circumference of a circle plot. The demarcations within the circle relate information about what might be important for a doctor or patient to know about the genome being studied. On the chart below, the green ticks represent losses of coding information and the purple arcs represent gene fusions, how genetic material goes from the “right place” to the “wrong place” in the genome.
Scientists can quickly assess a Circos plot just as patients can easily glance at a clock face and tell time. Essentially, the Circos plot is an individualized, unique portrait of each patient’s prostate cancer, akin to a CT Scan of the entire genome.
What kinds of cancers were sequenced? Does this data help us distinguish between aggressive and non-aggressive prostate cancer?
All seven patients had cancers that were Gleason Grade 7, 8, or 9 (aggressive prostate cancers). These patients’ cancers were hand-picked to represent meaningful, advanced cancers (i.e. cancers that, without surgery or treatment, could possibly progress and take the life of the patient). An important question to ask is what do lower grade tumors in patients undergoing proactive surveillance look like by whole genome sequencing on a Circos plot. It may well be that indolent tumors have a much “quieter” genome, missing far less code and showing far less damage—a Circos plot without many lines or ticks. If we broadened this study by sequencing thousands of patients and following them in the clinic, we might be better able to distinguish indolent cancers with the tendency to remain “quiet” from those that require aggressive treatment.
Were these genomes just a snapshot in time for these patients? If you were to sample the same patients again would they have changed already?
Yes. In this study, the sequencing captures a snapshot of the seven patients’ tumors at the time of surgery. Conceivably you could take multiple “snapshots” of the genome at the time of diagnosis, prognosis, treatment, and throughout survivorship.
Now that we have these genomic portraits, what do you expect scientists around the world to do with the information? How will the data be made publically available?
This data will be carefully studied to compare and contrast the prostate cancer genome with other cancer genomes (i.e. breast cancer genomes) where we might find clues for understanding how to design better drugs for both kinds of cancers. Additionally, learning more about how certain genes are mutated or fused gives us insight into the fundamental processes of why cancer is caused, how and why it does or does not spread, and why it does or does not go into remission with certain existing treatments. With regard to the seven tumors sequenced, the patients’ identities have all been protected; however, any scientist around the world who logs into a database and fills out the appropriate consent form can responsibly access the information. Every person who uses the data must identify him or herself.
Do the whole genome maps help us explain the disproportionate burden of prostate cancer incidence and death in African-Americans and other affected populations?
Not yet, but large-scale populations studies are now urgently needed to address this important question. For studies on this scale, it takes several thousand patient samples to compare and contrast the patterns that may exist in the Circos plots in order to assess whether the genome can tell us more about the undue burden.
Listen to the Entire Teleconference
Teleconference Participants:
Dr. Jonathan W. Simons (moderator)
President & CEO, PCF
Dr. Levi Garraway (Co-lead investigator)
Dana-Farber Cancer Institute, The Broad Institute
Dr. Michael Berger
Memorial Sloan-Kettering Cancer Center
Dr. Mark Rubin (Co-lead investigator)
Weill Cornell Medical College
Dr. Ash Tewari
Weill Cornell Medical College
Dan Zenka
VP of Communications & Patient Advocate, PCF
Today’s announcement regarding the sequencing of whole prostate cancer genomes is an historic development in the fight against prostate cancer. The ability to sequence whole genomes will spare some patients from unnecessary treatments and side effects while eliminating an estimated $1.5 billion that is spent each year on overtreatment. The complete research findings will be published in the February 10 issue of Nature. The following Q and A is from content discussed during a teleconference announcing the significance of the findings and of whole genome sequencing to prostate cancer research.
Why is this discovery historic for prostate cancer research, and all cancer research generally?
A great journey begins with a small step. This is PCF’s first “Lewis and Clark” moment exploring the genomic landscape of prostate cancer. For the first time, researchers have uncovered a comprehensive genetic map of seven patients’ prostate tumors. Each of the seven maps offers a macroscopic view of the complete genetic sequence and mutations that might underlie and cause each patient’s disease. The whole genome view also shows us how prostate cancer is complex in a way that is different from other cancers. Instead of having many “spelling errors” or point mutations, prostate cancer has an unprecedented number of large rearrangement segments called “DNA fusions.”
What should patients be asking urologists today that they couldn’t ask yesterday?
Although these findings have not yet been translated into widely employed clinical practices, patients can begin to ask their respective medical teams about participating in studies that use whole genome sequencing in clinical trials. Opportunities for employing genomic scans in research and treatment studies for prostate cancer patients are rapidly expanding.
How much does it cost to sequence a whole prostate cancer genome? How long does it take?
The current estimated cost of sequencing a whole genome is $20,000 or less. Experts predict that the cost of routine sequencing will ultimately be around $5,000 per genome. (This figure compares favorably to the cost of $90,000-$150,000 per patient for a radical prostatectomy followed by several years of androgen deprivation therapy using Lupron.) The process of whole genome sequencing for a single patient currently takes between 2 and 3 weeks.
How will whole genomic sequencing accelerate the development of new medicines and diagnostics for prostate cancer patients?
Knowledge of DNA fusions from leukemia genome sequencing led to breakthrough medicines for chemotherapy-resistant leukemia. PCF believes that prostate cancer genome sequencing could follow suit and lead to a cancer-specific tests or fusion-specific medicines for distinct types of prostate cancer. Additionally, information provided by sequencing a given tumor could facilitate matching up a patient to existing clinical trials targeting DNA fusions and mutations—PCF is currently monitoring 11 trials of this kind.
What does the genome look like to a doctor or a patient?
The DNA code of each of the multiple tumors sequenced contains 3 billion letters. Depicting the sequence of these letters in a linear fashion would make it hard to visualize the important patterns and features of the structural variation with the code. It would also be exceedingly long to read.
Instead of sifting through a 3-billion letter code, a diagram was developed as a short-hand tool for visualizing important relationships within the genome. It was created with Circos software and is called the Circos plot. Designed with the express purpose of aiding in the visualization of genomic data, its circular layout is analogous to a clock face. Just as a clock face displays time through the use of a fixed dial indicating the hours in a 12-hour cycle, the Circos plot displays the 23 chromosome pairs on which the entire human genome is stored.
These chromosomes are numbered clockwise on the outer circumference of a circle plot. The demarcations within the circle relate information about what might be important for a doctor or patient to know about the genome being studied. On the chart below, the green ticks represent losses of coding information and the purple arcs represent gene fusions, how genetic material goes from the “right place” to the “wrong place” in the genome.
Scientists can quickly assess a Circos plot just as patients can easily glance at a clock face and tell time. Essentially, the Circos plot is an individualized, unique portrait of each patient’s prostate cancer, akin to a CT Scan of the entire genome.
What kinds of cancers were sequenced? Does this data help us distinguish between aggressive and non-aggressive prostate cancer?
All seven patients had cancers that were Gleason Grade 7, 8, or 9 (aggressive prostate cancers). These patients’ cancers were hand-picked to represent meaningful, advanced cancers (i.e. cancers that, without surgery or treatment, could possibly progress and take the life of the patient). An important question to ask is what do lower grade tumors in patients undergoing proactive surveillance look like by whole genome sequencing on a Circos plot. It may well be that indolent tumors have a much “quieter” genome, missing far less code and showing far less damage—a Circos plot without many lines or ticks. If we broadened this study by sequencing thousands of patients and following them in the clinic, we might be better able to distinguish indolent cancers with the tendency to remain “quiet” from those that require aggressive treatment.
Were these genomes just a snapshot in time for these patients? If you were to sample the same patients again would they have changed already?
Yes. In this study, the sequencing captures a snapshot of the seven patients’ tumors at the time of surgery. Conceivably you could take multiple “snapshots” of the genome at the time of diagnosis, prognosis, treatment, and throughout survivorship.
Now that we have these genomic portraits, what do you expect scientists around the world to do with the information? How will the data be made publically available?
This data will be carefully studied to compare and contrast the prostate cancer genome with other cancer genomes (i.e. breast cancer genomes) where we might find clues for understanding how to design better drugs for both kinds of cancers. Additionally, learning more about how certain genes are mutated or fused gives us insight into the fundamental processes of why cancer is caused, how and why it does or does not spread, and why it does or does not go into remission with certain existing treatments. With regard to the seven tumors sequenced, the patients’ identities have all been protected; however, any scientist around the world who logs into a database and fills out the appropriate consent form can responsibly access the information. Every person who uses the data must identify him or herself.
Do the whole genome maps help us explain the disproportionate burden of prostate cancer incidence and death in African-Americans and other affected populations?
Not yet, but large-scale populations studies are now urgently needed to address this important question. For studies on this scale, it takes several thousand patient samples to compare and contrast the patterns that may exist in the Circos plots in order to assess whether the genome can tell us more about the undue burden.
Listen to the Entire Teleconference
Teleconference Participants:
Dr. Jonathan W. Simons (moderator)
President & CEO, PCF
Dr. Levi Garraway (Co-lead investigator)
Dana-Farber Cancer Institute, The Broad Institute
Dr. Michael Berger
Memorial Sloan-Kettering Cancer Center
Dr. Mark Rubin (Co-lead investigator)
Weill Cornell Medical College
Dr. Ash Tewari
Weill Cornell Medical College
Dan Zenka
VP of Communications & Patient Advocate, PCF
The FDA Warning on Drugs Treating Enlarged Prostate
By Steven Reinberg
HealthDay Reporter
Thursday, June 9 (HealthDay News) --The FDA issued a warning concerning drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.
In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).
According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.
The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.
According to the agency, this new warning is based on the results of two large prostate cancer trials.
Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."
All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.
Merck issued a statement Thursday on the FDA ruling.
"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."
Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.
In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.
Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."
"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."
Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.
The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.
"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.
Copyright © 2011 HealthDay. All rights reserved.
HealthDay Reporter
Thursday, June 9 (HealthDay News) --The FDA issued a warning concerning drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.
In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).
According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.
The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.
According to the agency, this new warning is based on the results of two large prostate cancer trials.
Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."
All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.
Merck issued a statement Thursday on the FDA ruling.
"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."
Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.
In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.
Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."
"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."
Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.
The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.
"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.
Copyright © 2011 HealthDay. All rights reserved.
Friday, June 17, 2011
Defense Department 2012 Prostate Research Prog
THE "NEW" PROSTATE CANCER INFOLINKEntries RSS | Comments RSS Follow The "New" Prostate Cancer InfoLink news blog on TWITTER or FACEBOOK.
The "New" Prostate Cancer InfoLink has been developed to become a primary source of accurate, current, and topical information about prostate cancer for patients and their families.
This web site is a service of Prostate Cancer International.
Other PCI web sites
El Cáncer de Próstata Latinoamérica
Prostate Cancer Africa
Prostate Cancer Caribbean
Solidarité Prostate InfoLink
The "New" Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services.
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.
The "New" Prostate Cancer InfoLink is not a substitute for professional care. If you have or suspect you may have a health problem, please consult your healthcare provider.
Perspective Confidentiality Disclosure Reliability Courtesy
Copyright © 2008-11 Prostate Cancer International, Inc.Funding for the DoD PCRP in FY 2012
Posted on June 16, 2011 by Sitemaster
iRate This
So here’s a quick status report on the potential funding for the US Department of Defense (DoD) Prostate Cancer Research Program (PCRP) for the fiscal year (FY) that begins on October 1, 2012 and runs through September 30, 2013.
As regular readers of this news blog may remember, funding for FY 2011 was renewed at the same level of $80 million as we had seen in the preceding few fiscal years. Congress has now initiated the process of looking at funding for the Department of Defense in FY 2012, and our current understanding is that there will be cuts to many of the Congressionally Directed Medical Research Program (CDMRP) initiatives, including the PCRP.
At this time, the House Appropriations Committee has proposed a 20 percent cut to the PCRP, which will mean a reduction in the total budget for PCRP from $80 million to $64 million for FY 2012. This is not good, but it could have been a lot worse. However, this is also just the first step in what may be a long process. We believe that the House of Representatives will vote on this bill some time next week. Hopefully, it will pass without any further fuss, but then we will have to wait and see what the Senate decides to do, and that could take a while.
For new readers, the PCRP is the largest single source of US government funding specifically dedicated to prostate cancer research. At its height, in FY 2001, a total of $100 million was dedicated to this initiative. Securing continuing funding for the PCRP is a critical priority for the Prostate Cancer Roundtable here in the USA. As a group, under the current economic circumstances, it is probably safe to say that the Roundtable members would be willing to live with a 20 percent budget cut of this type — even if we don’t like it! However, …
The "New" Prostate Cancer InfoLink has been developed to become a primary source of accurate, current, and topical information about prostate cancer for patients and their families.
This web site is a service of Prostate Cancer International.
Other PCI web sites
El Cáncer de Próstata Latinoamérica
Prostate Cancer Africa
Prostate Cancer Caribbean
Solidarité Prostate InfoLink
The "New" Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services.
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.
The "New" Prostate Cancer InfoLink is not a substitute for professional care. If you have or suspect you may have a health problem, please consult your healthcare provider.
Perspective Confidentiality Disclosure Reliability Courtesy
Copyright © 2008-11 Prostate Cancer International, Inc.Funding for the DoD PCRP in FY 2012
Posted on June 16, 2011 by Sitemaster
iRate This
So here’s a quick status report on the potential funding for the US Department of Defense (DoD) Prostate Cancer Research Program (PCRP) for the fiscal year (FY) that begins on October 1, 2012 and runs through September 30, 2013.
As regular readers of this news blog may remember, funding for FY 2011 was renewed at the same level of $80 million as we had seen in the preceding few fiscal years. Congress has now initiated the process of looking at funding for the Department of Defense in FY 2012, and our current understanding is that there will be cuts to many of the Congressionally Directed Medical Research Program (CDMRP) initiatives, including the PCRP.
At this time, the House Appropriations Committee has proposed a 20 percent cut to the PCRP, which will mean a reduction in the total budget for PCRP from $80 million to $64 million for FY 2012. This is not good, but it could have been a lot worse. However, this is also just the first step in what may be a long process. We believe that the House of Representatives will vote on this bill some time next week. Hopefully, it will pass without any further fuss, but then we will have to wait and see what the Senate decides to do, and that could take a while.
For new readers, the PCRP is the largest single source of US government funding specifically dedicated to prostate cancer research. At its height, in FY 2001, a total of $100 million was dedicated to this initiative. Securing continuing funding for the PCRP is a critical priority for the Prostate Cancer Roundtable here in the USA. As a group, under the current economic circumstances, it is probably safe to say that the Roundtable members would be willing to live with a 20 percent budget cut of this type — even if we don’t like it! However, …
Tuesday, June 14, 2011
Two-Tiered Prostate Cancer Surveillance
null
null
OncologyStat®One Source, Many Resources.® By Elsevier
News
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
J Smith
20110418
2011 May 18
Elsevier Global Medical News
Find more items about these cancer types:
ProstateTwo-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Elsevier Global Medical News. 2011 May 18, J Smith
A two-tiered system of surveillance could reduce prostate cancer deaths by half while also curbing overdiagnosis and overtreatment, according to results from a large Swedish study.
The system would allow men who test for high levels of prostate-specific antigen (more than 1.6 ng/mL) in their 40s to undergo close surveillance as they age, while the rest - approximately half of all men - would need to be tested only three times between the ages of 44 and 60 years.
The findings, released May 18 and highlighted during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June, could help lead to a more "rational" screening strategy, according to the study's investigators.
While there is evidence that PSA screening can detect prostate cancer at an early, curable stage, it is viewed as problematic because of the risk of overtreatment. PSA levels are not necessarily indicative of present cancer, and a large number of men must be screened to prevent a single death.
The investigators, led by Dr. Hans Lilja of Memorial Sloan-Kettering Cancer Center in New York, conducted a case-control study nested within a cohort of 12,090 Swedish men who provided blood between 1974 and 1986. A total of 4,999 provided repeat samples 6 years later. The investigators also looked at an independent cohort of 1,167 men who provided blood at age 60 years. Men with evidence of prostate cancer metastasis or death (n = 252) were matched 3:1 with controls.
The study found that 44% of prostate cancer deaths occurred in men who had the top 10% of PSA levels (greater than 1.6 ng/mL) for their age group when they were tested for the first time between the ages of 44 and 50 years.
Men whose PSA levels remained below the median for the population in their age group saw a progressively declining rate of death or metastasis.
The investigators found that 28% of metastases or deaths from prostate cancer over the next 27 years occurred in men aged 44-50 years whose initial screens showed a PSA below the median in the population (0.7 ng/mL).
For men aged 51-55 years with a PSA lower than the median (0.8 ng/mL), the risk of metastatic prostate cancer or death was 18% over 27 years. At age 60 years, only 0.5% of deaths or metastases occurred in men with a PSA less than the median for that age (1.1 ng/mL).
The findings show that PSA levels at the time of initial screening among men aged 44-50 years can accurately predict the risk of death from prostate cancer or metastatic prostate cancer up to 30 years later. Concentrating surveillance in this group of men could allow the rest to undergo only three lifetime tests at the ages of 44, 51-55, and 60 years, the investigators concluded.
Dr. Lilja disclosed owning stock in Arctic Partners, a firm that holds patents for PSA assays.
Copyright © 2010 International Medical News Group
null
OncologyStat®One Source, Many Resources.® By Elsevier
News
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
J Smith
20110418
2011 May 18
Elsevier Global Medical News
Find more items about these cancer types:
ProstateTwo-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Elsevier Global Medical News. 2011 May 18, J Smith
A two-tiered system of surveillance could reduce prostate cancer deaths by half while also curbing overdiagnosis and overtreatment, according to results from a large Swedish study.
The system would allow men who test for high levels of prostate-specific antigen (more than 1.6 ng/mL) in their 40s to undergo close surveillance as they age, while the rest - approximately half of all men - would need to be tested only three times between the ages of 44 and 60 years.
The findings, released May 18 and highlighted during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June, could help lead to a more "rational" screening strategy, according to the study's investigators.
While there is evidence that PSA screening can detect prostate cancer at an early, curable stage, it is viewed as problematic because of the risk of overtreatment. PSA levels are not necessarily indicative of present cancer, and a large number of men must be screened to prevent a single death.
The investigators, led by Dr. Hans Lilja of Memorial Sloan-Kettering Cancer Center in New York, conducted a case-control study nested within a cohort of 12,090 Swedish men who provided blood between 1974 and 1986. A total of 4,999 provided repeat samples 6 years later. The investigators also looked at an independent cohort of 1,167 men who provided blood at age 60 years. Men with evidence of prostate cancer metastasis or death (n = 252) were matched 3:1 with controls.
The study found that 44% of prostate cancer deaths occurred in men who had the top 10% of PSA levels (greater than 1.6 ng/mL) for their age group when they were tested for the first time between the ages of 44 and 50 years.
Men whose PSA levels remained below the median for the population in their age group saw a progressively declining rate of death or metastasis.
The investigators found that 28% of metastases or deaths from prostate cancer over the next 27 years occurred in men aged 44-50 years whose initial screens showed a PSA below the median in the population (0.7 ng/mL).
For men aged 51-55 years with a PSA lower than the median (0.8 ng/mL), the risk of metastatic prostate cancer or death was 18% over 27 years. At age 60 years, only 0.5% of deaths or metastases occurred in men with a PSA less than the median for that age (1.1 ng/mL).
The findings show that PSA levels at the time of initial screening among men aged 44-50 years can accurately predict the risk of death from prostate cancer or metastatic prostate cancer up to 30 years later. Concentrating surveillance in this group of men could allow the rest to undergo only three lifetime tests at the ages of 44, 51-55, and 60 years, the investigators concluded.
Dr. Lilja disclosed owning stock in Arctic Partners, a firm that holds patents for PSA assays.
Copyright © 2010 International Medical News Group
Abiraterone ProlongsOverall Survival
Abiraterone Prolongs Survival in Metastatic Castration-Resistant Prostate Cancer
Elsevier Global Medical News. 2011 May 25, MA Moon
Abiraterone acetate, a selective inhibitor of androgen biosynthesis, prolonged overall survival, reduced mortality risk by 35%, and delayed time to disease progression in men with metastatic castration-resistant prostate cancer who had already undergone chemotherapy, according to a report in the May 26 issue of the New England Journal of Medicine.
"The use of hormonal agents is typically not considered in patients who have received chemotherapy. These results show that continued androgen-receptor signaling contributes to disease progression, and they provide support for the evaluation of other endocrine therapies in this [advanced] stage of the disease," wrote Dr. Johann S. de Bono of the Institute of Cancer Research and Royal Marsden Hospital, Sutton (England), and his associates.
Several previous studies have demonstrated that, despite medical or surgical castration, prostate cancers continue to have sufficient levels of androgens, perhaps from synthesis within the tumor itself, to propel tumor growth. In phase I and phase II trials, abiraterone acetate - which potently blocks cytochrome P450 c17 (CYP17), an enzyme critical to testosterone synthesis - has shown promising antitumor activity even in advanced prostate cancer.
Dr. de Bono and his colleagues performed this international phase III randomized double-blind trial at 147 sites to compare daily oral therapy with four 250-mg abiraterone acetate tablets plus low-dose prednisone against placebo plus low-dose prednisone. They enrolled 1,195 men who had previously received docetaxel and showed disease progression despite ongoing androgen deprivation.
The primary end point of the study was overall survival.
At a preplanned interim analysis, active treatment was found to reduce the risk of death by 35%, compared with placebo. Mortality was 42% with active treatment, compared with 55% with placebo. Median overall survival was 14.8 months with abiraterone, compared with 10.9 months with placebo, the investigators reported (N. Engl J. Med. 2011;364:1995-2005).
This survival benefit "was consistent across all subgroups, and ... robust after adjustment for stratification factors in a multivariate analysis," they said.
Based on these findings, the trial was unblinded and patients in the placebo group were allowed to switch to active treatment.
"All the secondary end points analyzed provided support for the superiority of abiraterone acetate over placebo," Dr. de Bono and his associates said. Treatment response was greater with abiraterone whether measured by PSA levels (29% response vs. 6%) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14% vs. 3%). Time to PSA progression was longer (10.2 months vs. 6.6 months), as was median progression-free survival on radiography (5.6 vs. 3.6 months).
Active treatment reduced the risk of disease progression by 42% when assessed by PSA levels and by 33% when assessed by radiographic imaging.
Exploratory end points, including pain palliation and time to 25% of patients having a skeletal event, also consistently favored abiraterone over placebo.
"This study validates the hypothesis that the biosyntehsis of steroid hormones downstream of CYP17 contributes to progression of castration-resistant prostate cancer in a subgroup of men for whom this disease remains driven by steroid ligands and should not be described as 'hormone refractory.' Since these men cannot be identified a priori, continuing to call this disease 'androgen independent' or 'hormone refractory' is imprecise," Dr. de Bono and his associates said.
"As our study shows, blocking androgen synthesis by inhibiting CYP17 can produce tumor responses in patients who no longer have a response to standard hormonal therapies and who had received docetaxel-based chemotherapy," they added.
Compliance with abiraterone acetate therapy was high, "and side effects were easily manageable and reversible, despite the advanced age and level of frailty of the study population," the investigators said.
Toxic effects included hypokalemia, hypertension, and fluid retention, "which were largely abrogated by the use of low-dose prednisone," they wrote.
The rates of drug discontinuation and dose reduction were low, and therapy "did not appear to increase the risk of metabolic changes or symptoms associated with chronic androgen deprivation. Nevertheless, longer follow-up is warranted to evaluate late toxic effects," they noted.
In editorial accompanying the study, Dr. Emmanuel S. Antonarakis and Dr. Mario A. Eisenberger wrote that the findings "provide a proof of principle that metastatic castration-resistant prostate cancer remains androgen-driven" (N. Engl. J. Med. 2011;364:2055-8).
The results of this phase III trial led to Food and Drug Administration approval of abiraterone [Zytiga] in late April for patients who had received docetaxel, but they also "provide sufficient evidence of efficacy to justify the use of abiraterone in all patients with metastatic castration-resistant prostate cancer (i.e., even those with no previous chemotherapy treatment)," said Dr. Antonarakis and Dr. Eisenberger, who are with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore.
Moreover, "it is clear ... that our knowledge of the biologic mechanisms involved in the progression of metastatic castration-resistant prostate cancer has reached a level at which the discovery of more effective targeted approaches will probably further improve outcomes," they added.
Johns Hopkins receives funding from Cougar Biotechnology and participated in this clinical trial, but Dr. Antonarakis and Dr. Eisenberger were not involved. They reported ties to Sanofi-Aventis, Millennium, Astellas, and Tokai.
This study was sponsored by Ortho Biotech Oncology Research and Development, a unit of Cougar Biotechnology, with further support provided by the Medical Research Council of the United Kingdom, the Experimental Cancer Medical Centre, the National Institute for Health Research Biomedical Research Centre, and the Prostate Cancer Foundation. Dr. de Bono is employed by the Institute of Cancer Research, where abiraterone was designed and synthesized, and which has a commercial interest in the drug. He and his associates reported ties to numerous drug and biotechnology companies.
Elsevier Global Medical News. 2011 May 25, MA Moon
Abiraterone acetate, a selective inhibitor of androgen biosynthesis, prolonged overall survival, reduced mortality risk by 35%, and delayed time to disease progression in men with metastatic castration-resistant prostate cancer who had already undergone chemotherapy, according to a report in the May 26 issue of the New England Journal of Medicine.
"The use of hormonal agents is typically not considered in patients who have received chemotherapy. These results show that continued androgen-receptor signaling contributes to disease progression, and they provide support for the evaluation of other endocrine therapies in this [advanced] stage of the disease," wrote Dr. Johann S. de Bono of the Institute of Cancer Research and Royal Marsden Hospital, Sutton (England), and his associates.
Several previous studies have demonstrated that, despite medical or surgical castration, prostate cancers continue to have sufficient levels of androgens, perhaps from synthesis within the tumor itself, to propel tumor growth. In phase I and phase II trials, abiraterone acetate - which potently blocks cytochrome P450 c17 (CYP17), an enzyme critical to testosterone synthesis - has shown promising antitumor activity even in advanced prostate cancer.
Dr. de Bono and his colleagues performed this international phase III randomized double-blind trial at 147 sites to compare daily oral therapy with four 250-mg abiraterone acetate tablets plus low-dose prednisone against placebo plus low-dose prednisone. They enrolled 1,195 men who had previously received docetaxel and showed disease progression despite ongoing androgen deprivation.
The primary end point of the study was overall survival.
At a preplanned interim analysis, active treatment was found to reduce the risk of death by 35%, compared with placebo. Mortality was 42% with active treatment, compared with 55% with placebo. Median overall survival was 14.8 months with abiraterone, compared with 10.9 months with placebo, the investigators reported (N. Engl J. Med. 2011;364:1995-2005).
This survival benefit "was consistent across all subgroups, and ... robust after adjustment for stratification factors in a multivariate analysis," they said.
Based on these findings, the trial was unblinded and patients in the placebo group were allowed to switch to active treatment.
"All the secondary end points analyzed provided support for the superiority of abiraterone acetate over placebo," Dr. de Bono and his associates said. Treatment response was greater with abiraterone whether measured by PSA levels (29% response vs. 6%) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14% vs. 3%). Time to PSA progression was longer (10.2 months vs. 6.6 months), as was median progression-free survival on radiography (5.6 vs. 3.6 months).
Active treatment reduced the risk of disease progression by 42% when assessed by PSA levels and by 33% when assessed by radiographic imaging.
Exploratory end points, including pain palliation and time to 25% of patients having a skeletal event, also consistently favored abiraterone over placebo.
"This study validates the hypothesis that the biosyntehsis of steroid hormones downstream of CYP17 contributes to progression of castration-resistant prostate cancer in a subgroup of men for whom this disease remains driven by steroid ligands and should not be described as 'hormone refractory.' Since these men cannot be identified a priori, continuing to call this disease 'androgen independent' or 'hormone refractory' is imprecise," Dr. de Bono and his associates said.
"As our study shows, blocking androgen synthesis by inhibiting CYP17 can produce tumor responses in patients who no longer have a response to standard hormonal therapies and who had received docetaxel-based chemotherapy," they added.
Compliance with abiraterone acetate therapy was high, "and side effects were easily manageable and reversible, despite the advanced age and level of frailty of the study population," the investigators said.
Toxic effects included hypokalemia, hypertension, and fluid retention, "which were largely abrogated by the use of low-dose prednisone," they wrote.
The rates of drug discontinuation and dose reduction were low, and therapy "did not appear to increase the risk of metabolic changes or symptoms associated with chronic androgen deprivation. Nevertheless, longer follow-up is warranted to evaluate late toxic effects," they noted.
In editorial accompanying the study, Dr. Emmanuel S. Antonarakis and Dr. Mario A. Eisenberger wrote that the findings "provide a proof of principle that metastatic castration-resistant prostate cancer remains androgen-driven" (N. Engl. J. Med. 2011;364:2055-8).
The results of this phase III trial led to Food and Drug Administration approval of abiraterone [Zytiga] in late April for patients who had received docetaxel, but they also "provide sufficient evidence of efficacy to justify the use of abiraterone in all patients with metastatic castration-resistant prostate cancer (i.e., even those with no previous chemotherapy treatment)," said Dr. Antonarakis and Dr. Eisenberger, who are with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore.
Moreover, "it is clear ... that our knowledge of the biologic mechanisms involved in the progression of metastatic castration-resistant prostate cancer has reached a level at which the discovery of more effective targeted approaches will probably further improve outcomes," they added.
Johns Hopkins receives funding from Cougar Biotechnology and participated in this clinical trial, but Dr. Antonarakis and Dr. Eisenberger were not involved. They reported ties to Sanofi-Aventis, Millennium, Astellas, and Tokai.
This study was sponsored by Ortho Biotech Oncology Research and Development, a unit of Cougar Biotechnology, with further support provided by the Medical Research Council of the United Kingdom, the Experimental Cancer Medical Centre, the National Institute for Health Research Biomedical Research Centre, and the Prostate Cancer Foundation. Dr. de Bono is employed by the Institute of Cancer Research, where abiraterone was designed and synthesized, and which has a commercial interest in the drug. He and his associates reported ties to numerous drug and biotechnology companies.
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