Politico
© August 31, 2010
By David Rogers
Age and Agent Orange are closing in on Vietnam veterans, a legacy of hurt for those who served — and a very big bill for American taxpayers.
It’s a world turned upside-down from decades ago when returning soldiers had to fight to get attention for deadly lymphomas linked to the herbicide. Now the frailties of men in their 60s — prostate cancer, diabetes, heart disease — lead the list of qualified Agent Orange disabilities, and the result has been an explosion in claims — and the government’s liability.
The latest expansion, approved by Veterans Affairs Secretary Eric Shinseki in October, adds ischemic heart disease and Parkinson’s and will cost at least $42 billion over the next 10 years. The VA estimates 349,000 individuals are already receiving Agent Orange disability benefits and that number could soon reach 500,000 — or one out of every four surviving Vietnam veterans by the VA’s count.
As the costs rise, so do the questions about the science involved and the box Washington put itself in by failing to address Agent Orange’s impact more directly at the outset.
And because Vietnam service is still such a political minefield for American politicians, the most telling, often edgy debate is among veterans themselves.
“It is what it is. The anecdotal evidence of Vietnam veterans dying and getting diseases earlier is enormous,” said an exasperated Richard Weidman, an Army medic in the war and now legislative director for Vietnam Veterans of America. “I know five people in the VVA leadership alone who have been diagnosed with Parkinson’s. In no other side of my life have I seen anything like that.”
Yet for many who saw Vietnam firsthand, a 1-to-4 ratio of service-connected disabilities for Agent Orange strains credibility. And this is especially the case when the top conditions are heart disease and diabetes, two illnesses so linked to diet and lifestyle.
“Heart disease is a common phenomenon regardless of potential exposure to Agent Orange,” wrote Sen.Jim Webb (D-Va.) in a June letter to Shinseki challenging the secretary’s decision. A decorated Marine infantry officer in the war, Webb has since softened his tone after catching heat for his stance. But with his urging, the Senate Veterans Affairs Committee has scheduled a hearing Sept. 23 on the new regulations, slated to take effect by December.
“I just want to understand the logic of how they decided this latest service connection,” said Webb. “This is a helluva awkward position to be in where I’ve been an advocate all my adult life on veterans’ benefits. I just want to know how they got to this point.”
Backing Webb is Anthony Principi, also a Vietnam veteran, and the VA secretary under President George W. Bush.
“He’s gotten some heat, but how can anyone question his patriotism and what he has done?” Principi said of Webb. “It’s got to be looked at; it’s got to be addressed. ... This is serious. The numbers are dramatic.”
“We’re 40 years later and we need to ask, is there a better way to do this? You want to do what’s right for veterans,” he told POLITICO. “At the same time, you want to protect the integrity of the disability compensation program.”
The convergence of cost pressures now is striking as captured by events on Tuesday this week.
That morning, the VA expects the Federal Register to publish the new Agent Orange rules to implement the latest expansion of benefits, including heart disease coverage. And that evening, President Barack Obama will speak to the nation on the U.S. transition between Iraq and Afghanistan, two fresh post-Vietnam wars with their own legacy of new disability claims.
In fiscal 2005, the annual cost of VA’s compensation obligations was $28.6 billion; for fiscal 2011, the number’s $48.8 billion — a $20.2 billion or 71 percent increase.
Still more worrisome is the government’s long-term unfunded liability, a number tucked away in VA’s annual financial reports. The latest for Sept. 30, 2009, shows an unfunded liability of $1.32 trillion for VA’s compensation and pensions account. That’s up almost $400 billion from $924 billion in a matter of five years.
Yet for many Vietnam veterans, now in their 60s and approaching retirement, the tax-free disability payments represent a valuable supplement to Social Security.
In the case of ischemic heart disease, VA is assuming that most claims will be treated as a 60 percent disability, which translates into about $1064 per month for a married veteran. If the same veteran were already on 20 percent disability for diabetes, the payment could be $1,333 or almost $16,000 annually.
The VA calculates that IHD claims will account for three-quarters — about $31.2 billion — of the 10-year costs associated with the latest expansion. Disability percentages are typically lower for diabetes, but the sheer number of claims — more than 239,000 since 2002 — dwarfs all others before heart disease was added.
For example, prostate cancer generated about 57,300 claims in the same period by VA’s count; lung cancer less than 11,600 and non-Hodgkin’s lymphoma half that again.
Congress will have 60 days to review the regulations put forward by Shinseki, but lawmakers already approved a $13.6 billion down payment to cover retroactive claims related to the secretary’s ruling. And with November’s election around the corner, no one expects a major rollback.
“The horse is out of the barn, it’s a mess.” said one outside scientist who has worked with VA on Agent Orange claims. House Veterans Affairs Committee Chairman Bob Filner (D-Calif.) would go even further, extending the same disability benefits to thousands more veterans, such as “blue water” sailors who served on ships off the Vietnam coast.
“We owe this. It’s like a debt in my opinion,” Filner told POLITICO. “My motto is if you were there, we care.”
Indeed few topics touch more raw nerves at once: the bitter history of the Vietnam War, the often bad treatment of soldiers returning and the military’s early refusal to come to grips with the health impacts of its unprecedented use of the herbicide.
Agent Orange, which got its name from the orange-colored band on the storage barrels in Vietnam, was the most common of several dioxin-contaminated herbicide blends employed in Indochina over an almost 10-year period during the war. Literally thousands of tons were sprayed by the U.S. to try to destroy the jungle canopy and mangroves but also to clear tall grasses around American fire support bases.
It follows that exposure was greatest for those assigned to the spraying or in combat infantry units on the ground underneath — a fraction of the total U.S. force. But after a period of denial, the government gave up sorting out military records and said any veteran who put “boots on the ground” in Vietnam from early 1962 to May 1975 would be presumed exposed.
“Do you deny the deserving, or do you include in the presumption those people who may not have been exposed?” adds Dr. Victoria Cassano, a senior VA official dealing with environmental agents and Agent Orange. “The greater evil is to deny people who deservedly should be compensated for diseases because of this exposure.”
But Principi admits he still struggles with his role in what proved a sea change in policy, adding Type 2 diabetes to the list of presumed Agent Orange disabilities. The regulations were among the first order of business on his desk when he arrived in 2001, and from his war experience and prior service in VA, the new secretary brought with him an emotional tie to the late Adm. Elmo Zumwalt, who commanded Navy swift boat forces in Vietnam and watched his own son — a Navy Vietnam veteran as well — die of a cancer that the father attributed to Agent Orange exposure.
“It puts secretaries in a very untenable position,” Principi said. “I didn’t really care about the cost, our responsibility was to take care of veterans. But at the same time, I wanted to make sure the science was there and I just struggled with it.”
In fact, there’s a real disconnect between the outside scientists who advise the VA and the decision makers themselves. Congress can be faulted for the loose standard of proof it set in the 1991 Agent Orange Act to guide the process. But without more science — especially studies of veterans themselves — the integrity of the disability process is vulnerable to attack.
The chief outside actor is the Institute of Medicine within the National Academy of Science. Every two years since the mid-90s, IOM has produced detailed reports — volumes as thick as 682 pages with recommendations and updates of what scientists worldwide have learned relevant to Agent Orange’s impact.
Over time, these reports have led to a steady expansion of the diseases presumed to be associated with exposure to the herbicide. But often IOM and the VA seem to talk past one another as to what the science means.
“You are asking for the balancing of two different value systems, to come up with an answer and address a harm done to a person,” said Dr. Jeanne Stellman of Columbia University who has done extensive research on Agent Orange. “How do you translate science into law and policy?”
“The decision is very easy if it says no or if it says absolutely. In between is when there is imprecision,” said Dr. Robert Jesse, VA’s principal deputy undersecretary for health. And that comes often comes back to this question: What does IOM really mean when it says there is “limited or suggestive evidence of an association” between a disease and exposure to Agent Orange?
To hear IOM tell it, the category was never meant to be all decisive but more of a middle niche: “Something might be emerging here, something to keep an eye on,” one scientist told POLITICO. Along the same lines, a special IOM panel in 2008 went back and looked at the 2001 decision on diabetes and argued that the VA would have done better to test the association against “high-quality data for a representative cohort of veterans.”
VA officials answer that they are bound by the legal construct of the 1991 Agent Orange Act, which requires the secretary to respond within 60 days to any evidence of a positive association cited by IOM — however tentative.
“We can’t dismiss it,” said Cassano. “We have to take it as a positive association even though it states it as the lowest level of a positive association. We have to consider it credible.”
Asked if she were comfortable, as a scientist, with an end result where one in four Vietnam veterans could soon be getting service-connected Agent Orange disability payments, Cassano didn’t back down.
“Yes,” she said flatly. “We are comfortable with it; it is the right thing to do; it is the legal thing to do. ... When you are working in the VA and you have statutory requirements and basically a directive, a mission to be advocates for veterans, you are therefore bound by those parameters, and it really doesn’t matter much what outside scientists say.”
A closer look at Shinseki’s decision on IHD illustrates some of these conflicts.
It was a 14-member panel for the IOM, which set the ball rolling in its 2008 update, released last year. A similar panel in 2006 had been divided on the heart disease question, but after revisiting the question, IOM elevated the illness to the category of “limited or suggestive evidence of association.”
That decision was driven in part by newly published evidence showing a dose-response curve: the greater the exposure to Agent Orange, the greater occurrence of heart ailments. “When you see a dose-response curve, then you are much more inclined to be thinking causal,” said Jesse.
The VA had contributed an important piece with a 2006 study analyzing the incidence of heart disease among Vietnam veterans who had served in the Army Chemical Corps. And Shinseki, who himself served in Vietnam, found that this built on well-established evidence that dioxins present in Agent Orange could damage blood vessels. “Veterans who endure health problems deserve timely decisions based on solid evidence,” he said.
Nonetheless, the leader of the IOM panel, Dr. Richard Fenske of the University of Washington, told POLITICO that he was “surprised by the speed” with which the VA decided to add the presumption for heart disease. And Weidman argues that the department repeatedly ignores what he sees as a central tenet of the 1991 law: that more should be invested in scientific studies of veterans themselves.
“The whole concept of the 1991 law was to leave it to science, not politics, but we haven’t invested in the science in the 20 years since,” he said. In a shot back at Webb, he adds: “If you want more scientific data, fund the damn science.”
For all the debate over Agent Orange, what’s most surprising is how little or no effort has been made to track down specific infantry units that operated in the widely sprayed areas of Vietnam.
Instead, decisions are more often dependent on extrapolating data from studies of other populations: European and Asian chemical and agricultural workers, for example. The VA study of the Army Chemical Corps stands out for at least being Vietnam-centric. But even here, the focus did not include the great many more ground troops who were not involved in the actual spraying.
With so many claims on file now, the VA could yet work backward, identifying what units veterans served with in the war and their location in respect to the spraying. “The associations may be very much stronger if we really had the proximity data of where people served,” Jesse said. But to his frustration, Weidman has found that the VA’s health data is kept in a manner where this is not easily searchable. “They don’t want to know,” he said.
The biggest new effort is an old one: After almost a decade of delay, the VA is preparing to make another run at the long-promised National Vietnam Veterans Longitudinal Study to take a broad view at lasting health problems. A contract is expected to be awarded this fall, and, if successful, this could be the broadest assessment of ongoing Vietnam veteran health problems since the late '80s.
But the more lasting impact of the Agent Orange experience may be on the treatment of future veterans — not Vietnam’s.
At the end of a long interview, VA officials perk up most when the subject turns to VLER — their new “virtual lifetime electronic records” initiative to track each future veteran’s health charts from enlistment to grave. Included would be data from the military as to what toxic threats a soldier might be exposed to; “We will be able to know what levels of exposure there were to chemicals,” said Cassano.
And did Agent Orange influence this?
“Oh, certainly it has,” she said.
Sunday, January 9, 2011
Thursday, January 6, 2011
NCCN Prostate Cancer Treatment Guidance, 2011
Prostate cancer is the most common cancer in men, with lung cancer the second most common. Because of significant improvements in screening and early detection of prostate cancer over the past 30 years, the outlook for many men diagnosed with this disease has improved.
If you have been diagnosed with prostate cancer, you probably have many questions. How it is likely to be treated? What happens when treatment is completed? This overview, which is based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for prostate cancer, will help you understand the treatments available for prostate cancer. Talk to your doctor about these options so that together you can decide on a treatment plan that is right for you.
BackgroundThe prostate gland lies just below the bladder and produces a fluid that forms part of the semen. Men older than 65 years, those with a family history of prostate cancer (especially if a brother or father has been diagnosed with prostate cancer), and those of African descent are at higher risk for prostate cancer.
Screening for Prostate CancerMany men are choosing to be screened for prostate cancer using prostate-specific antigen (PSA) testing and digital rectal examination (DRE). The decision about whether to be screened is personal, but it should be based on an understanding of the potential risks and benefits of screening. Risks include discomfort, the possible side effects if a biopsy is done, and the physical and mental implications of finding out you have a cancer that may not pose a threat to your life. Benefits include finding prostate cancer at its earliest and most treatable stages.
Experts estimate that deaths from prostate cancer have decreased 40% since PSA testing became widespread in 1992. At the same time, there is a lot of disagreement about the value of early diagnosis with PSA testing. This is because many of the cancers found with screening will probably never pose a threat to a man’s life. Therefore, some men may undergo treatment that has no benefits to their life expectancy---in other words, these men will live as long as they would if they did not have prostate cancer, and the side effects of treatment could decrease their quality of life.
Prostate cancer often can be present for a long time before any symptoms appear. However, some aggressive and life-threatening cancers will be found through screening and therefore will be treated before they can spread. The greatest benefits of screening are for men at high risk for prostate cancer either because of family history or African-American descent. Benefits of screening are also most significant in men younger than 70 years.
Diagnosis of Prostate CancerProstate cancer rarely causes any symptoms until it is advanced and usually incurable. However, prostate cancer may be suspected for several reasons, including:
A lump in the prostate gland or an asymmetric prostate
Inability to pass urine
Difficulty starting or stopping the urine flow
Need to urinate often, especially at night
Weak flow of urine
Urine flow that starts and stops
Pain or burning during urination
Difficulty having an erection
Blood in the urine or semen
Frequent pain in the lower back, hips, or upper thighs
Suspicious findings from a DRE or PSA test do not necessarily mean that a man has cancer, and the symptoms above are not always caused by cancer (they can also be caused by a noncancerous condition called benign prostatic hyperplasia, or BPH.
To determine whether symptoms or an abnormal DRE or PSA results are caused by benign enlargement or prostate cancer, the doctor will perform a biopsy, often called a transrectal biopsy, under ultrasound guidance. In this procedure, the prostate is viewed using a probe the size of a finger inserted in the rectum. Tissue is removed with small needles from many areas of the prostate and examined under a microscope to look for cancer cells. This is the only way to specifically diagnose prostate cancer; an elevated PSA or abnormal DRE does not necessarily mean you have prostate cancer.
More Testing
If the biopsy indicates that you have prostate cancer, tests may be done to find out how aggressive the cancer may be. You may be scheduled for tests that will help your doctor determine whether your tumor is confined to the area where it began (that is, it is localized) or whether it has spread (that is, it has metastasized). Your doctor also will take a detailed medical history and may request other tests to determine your health and whether certain treatments are appropriate for you.
More tests may be ordered depending on how large the tumor is, your PSA level, and the Gleason score of your tumor. The Gleason score or grade is scaled to the aggressiveness of the prostate cancer. The Gleason grade is determined by a pathologist using a microscope to examine your cancer; it reflects the ability of the cancer to form glands. Generally, the lower the score, the more likely the tumor is growing slowly and the less likely it is to spread.
Additional tests may include:
A radionuclide bone scan to see whether cancer cells have spread to the bone
Magnetic resonance imaging (MRI) and/or computed tomography (CAT or CT scan) to show detailed images of the insides of the body
A pelvic lymphadenectomy, which is a surgical procedure to remove lymph nodes in the pelvis to see whether cancer has spread to these nodes
Each of these procedures provides information about grade and characteristics of the cancer that is important for determining the stage of your disease. Knowing the stage of your disease, in turn, is vital to determining which treatment program promises the best results.
Staging of Prostate Cancer A formal system called staging is used to identify how localized or widespread your cancer is. Prostate cancer stages range from stage I (most localized; cancer cells are only in the prostate) to stage IV (cancer cells have spread to distant lymph nodes and/or organs in your body, including the bones).
Staging is an important part of developing the best treatment plan for you.
For a more detailed discussion of staging, see the Cancer Staging Guide.
An elevated Gleason score and an elevated PSA level indicate that the cancer is likely to spread and that there is an increased chance that it might recur (come back) after treatment. This risk (or chance) of recurrence is another important factor in making treatment decisions.
Risk of Prostate Cancer Recurrence The risk that cancer may recur after treatment is a significant consideration in the treatment decisions patients make with their doctors. Many factors influence the risk that prostate cancer might recur. Among the most important are the size and location of the tumor; the PSA level in your blood; how fast the cancer cells are growing; and how far, if at all, the cancer has spread from the place where the tumor began. Many prostate cancers, especially in older men, are relatively slow-growing and may not have an impact on their lifespan or general health. Others, however, are quite aggressive and can spread to the bones and vital organs.
In recommending a treatment for you, your doctor will estimate how long you likely would live if you didn’t have prostate cancer based on your age and general medical condition (this is much the same process an insurance company uses in determining life insurance rates). Then, based on factors specific to your tumor, he or she will estimate how long it would take for your prostate cancer to become life-threatening to you. These two time periods are compared to help decide whether the prostate cancer is likely to reduce your lifespan and whether treatment is recommend.
Your doctor will review the results of your PSA test (and PSA tests that you had in the past, if any) to help determine how quickly your cancer is growing. The PSA level at the time your cancer is discovered is an important indicator. Generally, higher values indicate more aggressive cancer.
Additional important information may be obtained from the length of time it takes for your PSA value to double. For this “doubling” test to be valid, you must have had three separate PSA tests over a period of at least 18 months. In general, the faster the doubling time, the more aggressive the cancer. Some men with early-stage prostate cancer will have had enough tests over time for the doctor to compute this doubling time, but many will not have had enough PSA tests.
In addition to assigning a stage as described above, your doctor will also assign a Gleason score for your disease. This score, which ranges from 2 to 10, is a measure of the aggressiveness of your tumor. The pathologist assigns a number from 1 (least aggressive) to 5 (most aggressive) to the most frequently occurring appearance of cancer cells in the tissue sample used in the biopsy and the next most frequently occurring appearance of cancer cells in that tissue sample—this second sample is also assigned a score ranging from 1 to 5. The two scores are added together to get the Gleason score. The higher the score, the greater the chance that the cancer will (or already has) spread.
Based on your PSA level, cancer stage, and Gleason score, your doctor will estimate how likely the cancer is to grow and spread. Because all treatments for cancer can cause side effects, doctors aim to give patients treatments that will cause the fewest side effects while effectively curing the cancer. In some cases, the risk of the cancer getting worse may be relatively small compared with the side effects of treatment. However, when the risk is high that the cancer will grow quickly or recur after treatment, doctors may prescribe aggressive treatment to reduce that risk.
Treatment of Prostate CancerThe effectiveness of treatment depends on how localized the cancer is and whether or how far it has spread in your body. Depending on the stage of your disease and the other indicators discussed above, the characteristics of your tumor, and your age and general health, your doctor will recommend one or more of the following: active surveillance (also called observation, expectant management, or watchful waiting), surgery, radiation therapy, hormone therapy, chemotherapy, or targeted therapy. These options are discussed in the treatment summaries for localized prostate cancer and advanced prostate cancer.
Because some forms of prostate cancer treatment can cause infertility, if you want to father children you may want to discuss sperm banking before treatment begins. Your doctor can help you with this consideration.
Life After Prostate Cancer Treatment After completion of your treatment, you will begin a period called follow-up. During this period, you will visit your doctor at regular intervals. The doctor will perform a physical exam, ask you about how you are feeling, and order tests to make sure that you remain healthy and that any long-term effects of your prostate cancer or its treatment can be addressed. See Taking Care of Follow-Up Care.
NCCN.com Thanks Our Supporters:
ResourcesNCCN Physician Guidelines
NCCN Cancer Resources
NCCN Cancer Answers
Clinical Trials
FAQs
Glossary
Ask Jai
Advice For Caregivers Coming soon, Jai Pausch, widow of Randy Pausch, author of the internationally acclaimed best-selling book, The Last Lecture (see the video here), will share her experience and wisdom as a cancer caregiver. The new monthly column, “Ask Jai,” will offer real-world advice on coping with cancer’s challenges, managing your own life, and helping those you care for.
Have a concern or question to share? Email Jai at askjai@nccn.org.
NCCN Member Institutions
The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of 21 of the world’s leading cancer centers. We are dedicated to improving the quality and effectiveness of care provided to people with cancer.
If you have been diagnosed with prostate cancer, you probably have many questions. How it is likely to be treated? What happens when treatment is completed? This overview, which is based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for prostate cancer, will help you understand the treatments available for prostate cancer. Talk to your doctor about these options so that together you can decide on a treatment plan that is right for you.
BackgroundThe prostate gland lies just below the bladder and produces a fluid that forms part of the semen. Men older than 65 years, those with a family history of prostate cancer (especially if a brother or father has been diagnosed with prostate cancer), and those of African descent are at higher risk for prostate cancer.
Screening for Prostate CancerMany men are choosing to be screened for prostate cancer using prostate-specific antigen (PSA) testing and digital rectal examination (DRE). The decision about whether to be screened is personal, but it should be based on an understanding of the potential risks and benefits of screening. Risks include discomfort, the possible side effects if a biopsy is done, and the physical and mental implications of finding out you have a cancer that may not pose a threat to your life. Benefits include finding prostate cancer at its earliest and most treatable stages.
Experts estimate that deaths from prostate cancer have decreased 40% since PSA testing became widespread in 1992. At the same time, there is a lot of disagreement about the value of early diagnosis with PSA testing. This is because many of the cancers found with screening will probably never pose a threat to a man’s life. Therefore, some men may undergo treatment that has no benefits to their life expectancy---in other words, these men will live as long as they would if they did not have prostate cancer, and the side effects of treatment could decrease their quality of life.
Prostate cancer often can be present for a long time before any symptoms appear. However, some aggressive and life-threatening cancers will be found through screening and therefore will be treated before they can spread. The greatest benefits of screening are for men at high risk for prostate cancer either because of family history or African-American descent. Benefits of screening are also most significant in men younger than 70 years.
Diagnosis of Prostate CancerProstate cancer rarely causes any symptoms until it is advanced and usually incurable. However, prostate cancer may be suspected for several reasons, including:
A lump in the prostate gland or an asymmetric prostate
Inability to pass urine
Difficulty starting or stopping the urine flow
Need to urinate often, especially at night
Weak flow of urine
Urine flow that starts and stops
Pain or burning during urination
Difficulty having an erection
Blood in the urine or semen
Frequent pain in the lower back, hips, or upper thighs
Suspicious findings from a DRE or PSA test do not necessarily mean that a man has cancer, and the symptoms above are not always caused by cancer (they can also be caused by a noncancerous condition called benign prostatic hyperplasia, or BPH.
To determine whether symptoms or an abnormal DRE or PSA results are caused by benign enlargement or prostate cancer, the doctor will perform a biopsy, often called a transrectal biopsy, under ultrasound guidance. In this procedure, the prostate is viewed using a probe the size of a finger inserted in the rectum. Tissue is removed with small needles from many areas of the prostate and examined under a microscope to look for cancer cells. This is the only way to specifically diagnose prostate cancer; an elevated PSA or abnormal DRE does not necessarily mean you have prostate cancer.
More Testing
If the biopsy indicates that you have prostate cancer, tests may be done to find out how aggressive the cancer may be. You may be scheduled for tests that will help your doctor determine whether your tumor is confined to the area where it began (that is, it is localized) or whether it has spread (that is, it has metastasized). Your doctor also will take a detailed medical history and may request other tests to determine your health and whether certain treatments are appropriate for you.
More tests may be ordered depending on how large the tumor is, your PSA level, and the Gleason score of your tumor. The Gleason score or grade is scaled to the aggressiveness of the prostate cancer. The Gleason grade is determined by a pathologist using a microscope to examine your cancer; it reflects the ability of the cancer to form glands. Generally, the lower the score, the more likely the tumor is growing slowly and the less likely it is to spread.
Additional tests may include:
A radionuclide bone scan to see whether cancer cells have spread to the bone
Magnetic resonance imaging (MRI) and/or computed tomography (CAT or CT scan) to show detailed images of the insides of the body
A pelvic lymphadenectomy, which is a surgical procedure to remove lymph nodes in the pelvis to see whether cancer has spread to these nodes
Each of these procedures provides information about grade and characteristics of the cancer that is important for determining the stage of your disease. Knowing the stage of your disease, in turn, is vital to determining which treatment program promises the best results.
Staging of Prostate Cancer A formal system called staging is used to identify how localized or widespread your cancer is. Prostate cancer stages range from stage I (most localized; cancer cells are only in the prostate) to stage IV (cancer cells have spread to distant lymph nodes and/or organs in your body, including the bones).
Staging is an important part of developing the best treatment plan for you.
For a more detailed discussion of staging, see the Cancer Staging Guide.
An elevated Gleason score and an elevated PSA level indicate that the cancer is likely to spread and that there is an increased chance that it might recur (come back) after treatment. This risk (or chance) of recurrence is another important factor in making treatment decisions.
Risk of Prostate Cancer Recurrence The risk that cancer may recur after treatment is a significant consideration in the treatment decisions patients make with their doctors. Many factors influence the risk that prostate cancer might recur. Among the most important are the size and location of the tumor; the PSA level in your blood; how fast the cancer cells are growing; and how far, if at all, the cancer has spread from the place where the tumor began. Many prostate cancers, especially in older men, are relatively slow-growing and may not have an impact on their lifespan or general health. Others, however, are quite aggressive and can spread to the bones and vital organs.
In recommending a treatment for you, your doctor will estimate how long you likely would live if you didn’t have prostate cancer based on your age and general medical condition (this is much the same process an insurance company uses in determining life insurance rates). Then, based on factors specific to your tumor, he or she will estimate how long it would take for your prostate cancer to become life-threatening to you. These two time periods are compared to help decide whether the prostate cancer is likely to reduce your lifespan and whether treatment is recommend.
Your doctor will review the results of your PSA test (and PSA tests that you had in the past, if any) to help determine how quickly your cancer is growing. The PSA level at the time your cancer is discovered is an important indicator. Generally, higher values indicate more aggressive cancer.
Additional important information may be obtained from the length of time it takes for your PSA value to double. For this “doubling” test to be valid, you must have had three separate PSA tests over a period of at least 18 months. In general, the faster the doubling time, the more aggressive the cancer. Some men with early-stage prostate cancer will have had enough tests over time for the doctor to compute this doubling time, but many will not have had enough PSA tests.
In addition to assigning a stage as described above, your doctor will also assign a Gleason score for your disease. This score, which ranges from 2 to 10, is a measure of the aggressiveness of your tumor. The pathologist assigns a number from 1 (least aggressive) to 5 (most aggressive) to the most frequently occurring appearance of cancer cells in the tissue sample used in the biopsy and the next most frequently occurring appearance of cancer cells in that tissue sample—this second sample is also assigned a score ranging from 1 to 5. The two scores are added together to get the Gleason score. The higher the score, the greater the chance that the cancer will (or already has) spread.
Based on your PSA level, cancer stage, and Gleason score, your doctor will estimate how likely the cancer is to grow and spread. Because all treatments for cancer can cause side effects, doctors aim to give patients treatments that will cause the fewest side effects while effectively curing the cancer. In some cases, the risk of the cancer getting worse may be relatively small compared with the side effects of treatment. However, when the risk is high that the cancer will grow quickly or recur after treatment, doctors may prescribe aggressive treatment to reduce that risk.
Treatment of Prostate CancerThe effectiveness of treatment depends on how localized the cancer is and whether or how far it has spread in your body. Depending on the stage of your disease and the other indicators discussed above, the characteristics of your tumor, and your age and general health, your doctor will recommend one or more of the following: active surveillance (also called observation, expectant management, or watchful waiting), surgery, radiation therapy, hormone therapy, chemotherapy, or targeted therapy. These options are discussed in the treatment summaries for localized prostate cancer and advanced prostate cancer.
Because some forms of prostate cancer treatment can cause infertility, if you want to father children you may want to discuss sperm banking before treatment begins. Your doctor can help you with this consideration.
Life After Prostate Cancer Treatment After completion of your treatment, you will begin a period called follow-up. During this period, you will visit your doctor at regular intervals. The doctor will perform a physical exam, ask you about how you are feeling, and order tests to make sure that you remain healthy and that any long-term effects of your prostate cancer or its treatment can be addressed. See Taking Care of Follow-Up Care.
NCCN.com Thanks Our Supporters:
ResourcesNCCN Physician Guidelines
NCCN Cancer Resources
NCCN Cancer Answers
Clinical Trials
FAQs
Glossary
Ask Jai
Advice For Caregivers Coming soon, Jai Pausch, widow of Randy Pausch, author of the internationally acclaimed best-selling book, The Last Lecture (see the video here), will share her experience and wisdom as a cancer caregiver. The new monthly column, “Ask Jai,” will offer real-world advice on coping with cancer’s challenges, managing your own life, and helping those you care for.
Have a concern or question to share? Email Jai at askjai@nccn.org.
NCCN Member Institutions
The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of 21 of the world’s leading cancer centers. We are dedicated to improving the quality and effectiveness of care provided to people with cancer.
Wednesday, December 29, 2010
http://prostatecancerinfolink.net/2010/12/29/second-study-confirms-data-on-p
sadt-and-survival-post-surgery/
* Only PSA doubling time (™9.0 months vs 3.0-8.9 months vs < 3.0
months) remained independently predictive of overall and/or metastasis-free
survival in multivariate analysis.
The authors note that - based on this data set - overall and metastasis-free
survival "can be extensive for men with PSA-recurrent prostate cancer, even
in the absence of further therapy before metastasis."
In other words, men with a PSA doubling time > 9 months after initial
biochemical failure have a high probability of long-term metastasis-free
survival, which may call into question the value of any form of second-line
therapy until there is clear evidence of the presence of metastatic disease.
Link is also available on the VPCC Facebook page.
sadt-and-survival-post-surgery/
* Only PSA doubling time (™9.0 months vs 3.0-8.9 months vs < 3.0
months) remained independently predictive of overall and/or metastasis-free
survival in multivariate analysis.
The authors note that - based on this data set - overall and metastasis-free
survival "can be extensive for men with PSA-recurrent prostate cancer, even
in the absence of further therapy before metastasis."
In other words, men with a PSA doubling time > 9 months after initial
biochemical failure have a high probability of long-term metastasis-free
survival, which may call into question the value of any form of second-line
therapy until there is clear evidence of the presence of metastatic disease.
Link is also available on the VPCC Facebook page.
Tuesday, December 21, 2010
Abiraterone Acetate Update
Marketing application also submitted to European Health Authorities
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.
Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.
"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."
If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.
About Metastatic Advanced Prostate Cancer
Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.
Prostate cancer occurs when cancer cells form in the tissues of the prostate. The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid. In some cases, cancer of the prostate can grow slowly compared with other cancers. However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.
Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).
Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
More information can be found at www.janssen-emea.com.
About Johnson & Johnson Pharmaceutical Research & Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.
About Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech Inc. and J&JPRD, in the research and development of oncology and supportive care treatments.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.
Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.
"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."
If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.
About Metastatic Advanced Prostate Cancer
Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.
Prostate cancer occurs when cancer cells form in the tissues of the prostate. The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid. In some cases, cancer of the prostate can grow slowly compared with other cancers. However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.
Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).
Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
More information can be found at www.janssen-emea.com.
About Johnson & Johnson Pharmaceutical Research & Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.
About Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech Inc. and J&JPRD, in the research and development of oncology and supportive care treatments.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.
Tuesday, December 7, 2010
Aspirin Therapy and Seniors'\Sexual Activity
To ensure you receive Physician's First Watch, add FirstWatch@jwatch.org to your address book.
Forward | Sign Up | My Alerts | About Physician's First Watch | Editorial Board
Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief
physician's first watch
Poll results are in!
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Sex Remains Important to Many Elderly Men
NIH Issues Guidelines on Managing Food Allergies
Featured in Journal Watch: Suicide Attempts in the Population — What Counts?
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.
Lancet article (Free abstract)
Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)
Sex Remains Important to Many Elderly Men
Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.
Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)
Among the findings:
Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.
Annals of Internal Medicine article (Free abstract)
Share: Digg this Add to del.icio.us Add to Reddit Forward to a friend Top
Forward | Sign Up | My Alerts | About Physician's First Watch | Editorial Board
Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief
physician's first watch
Poll results are in!
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Sex Remains Important to Many Elderly Men
NIH Issues Guidelines on Managing Food Allergies
Featured in Journal Watch: Suicide Attempts in the Population — What Counts?
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.
Lancet article (Free abstract)
Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)
Sex Remains Important to Many Elderly Men
Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.
Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)
Among the findings:
Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.
Annals of Internal Medicine article (Free abstract)
Share: Digg this Add to del.icio.us Add to Reddit Forward to a friend Top
Wednesday, December 1, 2010
Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of
Dutasteride for Prostate Cancer Prevention
Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.
Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”
The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.
“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”
The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).
Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.
The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.
“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”
As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.
Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”
About Prostate Cancer
Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.
About Dutasteride
Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.
Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.
In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).
About the Prostate Cancer Roundtable
The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.
###
The above statement has been issued on behalf of and endorsed by
American Urological Association Foundation
Dutasteride for Prostate Cancer Prevention
Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.
Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”
The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.
“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”
The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).
Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.
The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.
“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”
As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.
Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”
About Prostate Cancer
Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.
About Dutasteride
Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.
Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.
In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).
About the Prostate Cancer Roundtable
The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.
###
The above statement has been issued on behalf of and endorsed by
American Urological Association Foundation
Sunday, November 14, 2010
Cancer Survivor Bob Whitesel on Provenge treatment
Commenter: Whitesel, Robert
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]
[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.
I wish to make three (3) points in support of my affirmative response to the question above:
[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.
3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]
[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.
I wish to make three (3) points in support of my affirmative response to the question above:
[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.
3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.
Subscribe to:
Posts (Atom)