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.
Wednesday, October 5, 2011
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.
AFP Home | About Us | Contact Us | Subscribe | AFP by E-Mail | Permissions
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Information for: Authors | Advertisers
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.
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