We have known since the mid-1990’s that androgen suppressive therapy could be used in an interrupted fashion, but we didn’t know until now that men were not sacrificing length of life in the hopes of having a better quality of life,” says Juanita M. Crook, MD, principal investigator and radiation oncologist with the British Columbia Cancer Agency. “The results of this trial will change the standard of care.”
The Canadian study, supported by a team of cross-border North American scientists, administered intermittent androgen deprivation in patients for eight months then stopped and restarted only when their PSA levels reached >3 ng/ml when off the treatment, compared to men treated with continuous androgen deprivation (CAD). The data showed that intermittent antiandrogen treatment was equivalent to continuous antiandrogen treatment with similar overall survival and quality-of-life measures. Biostatiscally, intermittent therapy was called “a non-inferior” (in laymen’s terms, “comparable”) arm of the trial—disease specific death was 18% in the intermittent arm compared with 15% in the continuous arm.
Dr. Crook believes the IAD method will be widely accepted. “There is no detriment to survival, some men see quality-of-life benefit, and it also happens to be cheaper,” says Crook.
Summary
Intermittent androgen deprivation provides similar outcomes to continuous therapy with the potential for fewer side effects and less disruption to quality of life—good news for many men and their families. IAD patients complained of fewer hot flashes and 35% of them had full recovery of serum testosterone after completing IAD. Cardiac events and osteoporotic fracture events were equal in both arms. Further, intermittent androgen deprivation offers cost-savings to health systems as both patients and the systems pay only 27% of the cost of continuous treatment.
Monday, October 17, 2011
Thursday, October 6, 2011
No Prostate Cancer Screening,, Says USPSTF,
(CNN) -- The U.S. Preventive Services Task Force, the group that told women in their 40s that they don't need mammograms, will soon recommend that men not get screened for prostate cancer, according to a source privy to the task force deliberations.
The task force is set to recommend a "D" rating for prostate specific antigen, or PSA, testing. Such a rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. The task force is set to propose this recommendation Tuesday, and then allow for a comment period before issuing a final recommendation.
According to a draft copy of a report scheduled to be released Monday, a review of studies shows screening with the PSA blood test results in "small or no reduction" in prostate cancer deaths.
The report adds that PSA testing is "associated with harms related to subsequent evaluation and treatments."
The PSA test can help determine if a man has prostate cancer. It is sometimes accompanied by a digital rectal exam
The task force is set to recommend a "D" rating for prostate specific antigen, or PSA, testing. Such a rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. The task force is set to propose this recommendation Tuesday, and then allow for a comment period before issuing a final recommendation.
According to a draft copy of a report scheduled to be released Monday, a review of studies shows screening with the PSA blood test results in "small or no reduction" in prostate cancer deaths.
The report adds that PSA testing is "associated with harms related to subsequent evaluation and treatments."
The PSA test can help determine if a man has prostate cancer. It is sometimes accompanied by a digital rectal exam
Wednesday, October 5, 2011
Tools Predicting Erectile Function after Treatment
Context Sexual function is the health-related quality of life (HRQOL) domain most commonly impaired after prostate cancer treatment; however, validated tools to enable personalized prediction of erectile dysfunction after prostate cancer treatment are lacking.
Objective To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.
Design Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.
Main Outcome Measures Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.
Results Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).
Conclusion Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.
K
Objective To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.
Design Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.
Main Outcome Measures Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.
Results Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).
Conclusion Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.
K
ADT Does Not Increase Risk of Cariovascular Death
October 5, 2011 (Miami Beach, Florida) — Androgen-deprivation therapy (ADT) is an effective treatment for men with "unfavorable-risk" prostate cancer, and it does not increase the risk for cardiovascular (CV) death, concludes a new study. These results contradict earlier suggestions that this risk might be increased.
The new findings come from a meta-analysis, the first on ADT and CV-related mortality, presented here at the American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting.
This "should be reassuring for the vast majority of men who have received ADT or are considering it," said lead author Paul Nguyen, MD, from Dana-Farber/Brigham and Women's Cancer Center in Boston, Massachusetts.
The study has an important caveat: the findings could differ in men with congestive heart failure or who have had a myocardial infarction.
Still, even with the study's limitations, these data offer a counterpoint to retrospective studies that found a higher risk for CV mortality among men receiving ADT for prostate cancer, explained Dr. Nguyen.
Those studies, plus data indicating an association between ADT and an increased risk for CV complications, led to a consensus statement last year from the American Heart Association, the American Cancer Society and the American Urological Society.
The statement, which was endorsed by ASTRO, asserted that "there may be a relation between ADT and cardiovascular events and death."
Subsequently, in October 2010, the US Food and Drug Administration called for new labeling on gonadotropin-releasing hormone (GnRH) agonists. The black-box warning now states that the agents "increase risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke)."
Improve Analysis of the Problem
In an interview with Medscape Medical News, Dr. Nguyen described the consensus statement as "everybody lining up against androgen-deprivation therapy."
He and a group of colleagues sought to improve the power of the statistical analysis of the problem.
They performed a literature review of randomized trials in prostate cancer that compared GnRH-agonist-based ADT with no ADT and that reported CV-related deaths. They found 8 studies that met their inclusion criteria, comprising a total of 4141 patients, all of whom had intermediate-risk prostate cancer or higher (but no metastatic or hormone-refractory disease). In 5 of the studies, the local therapy patients received was radiation; in the other 3 studies, patients underwent surgery or received no local therapy.
The risk for CV death was similar in the ADT and no-ADT groups (11.0% vs 11.2%). The relative risk for CV death for ADT, compared with no ADT, was 0.93 (95% confidence interval, 0.79 to 1.10; P = .41).
The results were similar in all the subgroups the investigators examined, said Dr. Nguyen, including the subgroups of short-course ADT (6 months or less), long-course ADT (3 years or more), men older than 70 years, and radiation use.
The meta-analysis provides additional reassuring news: ADT improves outcomes. Specifically, compared with no ADT, ADT reduced prostate-cancer-specific mortality (relative risk [RR], 0.68; P < .001) and all-cause mortality (RR, 0.88; P = .005).
Men With Preexisting CV Disease
This is a "great paper" that "employs modern epidemiologic methodology to seek out differences that would not have been seen in smaller studies," Phillip Devlin, MD, secretary/treasurer of ASTRO, told Medscape Medical News. Dr. Devlin is also from Dana-Farber/Brigham and Women's Cancer Center, and acknowledged that he is not a completely impartial commentator, as he is Dr. Nguyen's boss.
Dr. Devlin believes that patients will be calmed by these results, which provide a "sense of greater comfort" and allow clinicians to say that "there may be less risk than we thought" with ADT and cardiac death.
Nevertheless, clinicians should provide careful monitoring of patients on ADT for CV disease, said Dr. Devlin.
The study did not examine whether ADT is associated with a reduction in CV events such as congestive heart failure and myocardial infarction.
Retrospective data suggest that ADT harms men with preexisting CV disease, said Dr. Nguyen.
The extent of the harm is unclear, he reported. For instance, a 2009 study indicated that only 5% of men with a history of congestive heart failure and myocardial infarction were harmed by ADT, as reported by Medscape Medical News.
Dr. Nguyen is also the author of a study that found that men with high-risk prostate cancer have an increased risk for death with ADT if they have a history of congestive heart failure and myocardial infarction (RR, 2.6; P = .01).
Dr. Nguyen reports receiving research funding from Varian. Dr. Devlin has disclosed no relevant financial relationships.
American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting: Abstract 11. Presented October 3, 2011.
[CLOSE WINDOW]
Authors and Disclosures
Journalist
Nick Mulcahy
Nick Mulcahy is a senior journalist for Medscape Hematology-Oncology. Before joining Medscape, Nick was a freelance medical news writer for 15 years, working for companies such as the International Medical News Group, MedPage Today, HealthDay, McMahon Publishing, and Advanstar. He is also the former managing editor of breastcancer.org. He can be contacted at nmulcahy@medscape.net.
The new findings come from a meta-analysis, the first on ADT and CV-related mortality, presented here at the American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting.
This "should be reassuring for the vast majority of men who have received ADT or are considering it," said lead author Paul Nguyen, MD, from Dana-Farber/Brigham and Women's Cancer Center in Boston, Massachusetts.
The study has an important caveat: the findings could differ in men with congestive heart failure or who have had a myocardial infarction.
Still, even with the study's limitations, these data offer a counterpoint to retrospective studies that found a higher risk for CV mortality among men receiving ADT for prostate cancer, explained Dr. Nguyen.
Those studies, plus data indicating an association between ADT and an increased risk for CV complications, led to a consensus statement last year from the American Heart Association, the American Cancer Society and the American Urological Society.
The statement, which was endorsed by ASTRO, asserted that "there may be a relation between ADT and cardiovascular events and death."
Subsequently, in October 2010, the US Food and Drug Administration called for new labeling on gonadotropin-releasing hormone (GnRH) agonists. The black-box warning now states that the agents "increase risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke)."
Improve Analysis of the Problem
In an interview with Medscape Medical News, Dr. Nguyen described the consensus statement as "everybody lining up against androgen-deprivation therapy."
He and a group of colleagues sought to improve the power of the statistical analysis of the problem.
They performed a literature review of randomized trials in prostate cancer that compared GnRH-agonist-based ADT with no ADT and that reported CV-related deaths. They found 8 studies that met their inclusion criteria, comprising a total of 4141 patients, all of whom had intermediate-risk prostate cancer or higher (but no metastatic or hormone-refractory disease). In 5 of the studies, the local therapy patients received was radiation; in the other 3 studies, patients underwent surgery or received no local therapy.
The risk for CV death was similar in the ADT and no-ADT groups (11.0% vs 11.2%). The relative risk for CV death for ADT, compared with no ADT, was 0.93 (95% confidence interval, 0.79 to 1.10; P = .41).
The results were similar in all the subgroups the investigators examined, said Dr. Nguyen, including the subgroups of short-course ADT (6 months or less), long-course ADT (3 years or more), men older than 70 years, and radiation use.
The meta-analysis provides additional reassuring news: ADT improves outcomes. Specifically, compared with no ADT, ADT reduced prostate-cancer-specific mortality (relative risk [RR], 0.68; P < .001) and all-cause mortality (RR, 0.88; P = .005).
Men With Preexisting CV Disease
This is a "great paper" that "employs modern epidemiologic methodology to seek out differences that would not have been seen in smaller studies," Phillip Devlin, MD, secretary/treasurer of ASTRO, told Medscape Medical News. Dr. Devlin is also from Dana-Farber/Brigham and Women's Cancer Center, and acknowledged that he is not a completely impartial commentator, as he is Dr. Nguyen's boss.
Dr. Devlin believes that patients will be calmed by these results, which provide a "sense of greater comfort" and allow clinicians to say that "there may be less risk than we thought" with ADT and cardiac death.
Nevertheless, clinicians should provide careful monitoring of patients on ADT for CV disease, said Dr. Devlin.
The study did not examine whether ADT is associated with a reduction in CV events such as congestive heart failure and myocardial infarction.
Retrospective data suggest that ADT harms men with preexisting CV disease, said Dr. Nguyen.
The extent of the harm is unclear, he reported. For instance, a 2009 study indicated that only 5% of men with a history of congestive heart failure and myocardial infarction were harmed by ADT, as reported by Medscape Medical News.
Dr. Nguyen is also the author of a study that found that men with high-risk prostate cancer have an increased risk for death with ADT if they have a history of congestive heart failure and myocardial infarction (RR, 2.6; P = .01).
Dr. Nguyen reports receiving research funding from Varian. Dr. Devlin has disclosed no relevant financial relationships.
American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting: Abstract 11. Presented October 3, 2011.
[CLOSE WINDOW]
Authors and Disclosures
Journalist
Nick Mulcahy
Nick Mulcahy is a senior journalist for Medscape Hematology-Oncology. Before joining Medscape, Nick was a freelance medical news writer for 15 years, working for companies such as the International Medical News Group, MedPage Today, HealthDay, McMahon Publishing, and Advanstar. He is also the former managing editor of breastcancer.org. He can be contacted at nmulcahy@medscape.net.
Excess Mortality for Older Patients with Prostate Cancer
population-based analysis of mortality data for men diagnosed with prostate cancer from three European nations suggests that “a small but important group of older patients” initially present with late stage prostate cancer and die rapidly as a consequence.
The study by Holmberg et al., published in Cancer Epidemiology, was designed to compare patterns of survival among men with prostate cancer from England, Norway, and Sweden between 2001 and 2004, taking account of the ages of the patients and the length of follow-up.
The study included data from 179,112 men in England, 23,192 in Norway and 59,697 in Sweden. All study data were based on information available from the national cancer registries for the three countries involved. Estimates of the “excess mortality” among men with prostate cancer were calculated using a period approach for relative survival.
The results of the study showed that:
The overall, age-standardized 5-year survival was
76.4 percent for English patients
80.3 percent for Norwegian patients
83.0 percent for Swedish patients
English patients had
The lowest overall survival
The lowest overall survival among men aged ≥ 80 years in particular
The majority of the excess deaths in England were confined to the first year of follow-up.
In their conclusion, the authors suggest that the early demise of the “small but important group of older patients” may be because (a) they first present with late stage disease and (b) they have severe concomitant comorbidities in addition to their prostate cancer. It is clear that this problem is more common in England than in Norway or Sweden, which may reflect male health-related behavior patterns in the UK by comparison with Scandinavian countries.
The study by Holmberg et al., published in Cancer Epidemiology, was designed to compare patterns of survival among men with prostate cancer from England, Norway, and Sweden between 2001 and 2004, taking account of the ages of the patients and the length of follow-up.
The study included data from 179,112 men in England, 23,192 in Norway and 59,697 in Sweden. All study data were based on information available from the national cancer registries for the three countries involved. Estimates of the “excess mortality” among men with prostate cancer were calculated using a period approach for relative survival.
The results of the study showed that:
The overall, age-standardized 5-year survival was
76.4 percent for English patients
80.3 percent for Norwegian patients
83.0 percent for Swedish patients
English patients had
The lowest overall survival
The lowest overall survival among men aged ≥ 80 years in particular
The majority of the excess deaths in England were confined to the first year of follow-up.
In their conclusion, the authors suggest that the early demise of the “small but important group of older patients” may be because (a) they first present with late stage disease and (b) they have severe concomitant comorbidities in addition to their prostate cancer. It is clear that this problem is more common in England than in Norway or Sweden, which may reflect male health-related behavior patterns in the UK by comparison with Scandinavian countries.
Tuesday, October 4, 2011
New Bayer PCa Drug(QLGETA)
An experimental drug developed by Bayer AG (BAYN) and Algeta ASA (ALGETA) prolonged the lives of men with prostate cancer that’s spread to their bones, a study found.
A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.
The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.
“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”
Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.
To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net
A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.
The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.
“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”
Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.
To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net
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