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Primary ADT Does Not Improve Survival in Prostate Cancer
July 9, 2008 — Primary androgen-deprivation therapy (ADT), used alone instead of surgery or radiation, does not improve survival, over conservative management, in the majority of elderly men with localized prostate cancer.
This finding, from an analysis of data from 19 271 men, appears in the July 9 issue of the Journal of the American Medical Association.
The study calls into question the increasingly common use of primary ADT, especially considering its significant adverse effects and cost, say the researchers. The findings contrast those for adjuvant ADT used alongside radiation and/or surgery, which does improve overall survival.
"I think that the bottom line is that primary androgen-deprivation therapy does not appear to benefit the average man with localized prostate cancer," senior author Siu-Long Yao, MD, from the Cancer Institute of New Jersey, in New Brunswick, told Medscape Oncology. "It is possible that certain subsets of men, such as those with poorly differentiated cancer, might derive some benefit, but you must carefully consider and justify the rationale for primary androgen-deprivation therapy if you are going to proceed with it."
"My conclusion would be that primary androgen-deprivation therapy does not appear to be a good alternative to surgery or radiation; outcomes appear to be no better than conservative management or watchful waiting," Dr. Yao commented.
"This study further reduces enthusiasm for the use of hormonal therapy in early-stage prostate cancer, and suggests that such treatment, if used at all, should be limited to high-grade disease, as defined by SEER [Surveillance, Epidemiology, and End Results]," commented Martin G. Sanda, MD, from the Beth Israel Deaconess Medical Center, in Boston, Massachusetts. Dr. Sanda was not involved in the study.
"Their findings of no survival benefit in intermediate- or low-risk disease add to other recent publications that elucidated flaws in hormonal therapy related to its adverse effects on quality of life and cardiac events among men with prostate cancer," Dr. Sandra added.
No Improvement in Overall or Cancer-Specific Survival
Primary ADT has become an increasingly popular option for localized prostate cancer, especially among older men, and is used in place of surgery, radiation, or conservative management, Dr. Yao and colleagues comment. However, the popularity of this option is not backed up by data; this is not a standard treatment approach, nor is it sanctioned by any major groups or guidelines, they point out.
And now they have shown that primary ADT is no better than conservative management.
Dr. Yao and colleagues performed an instrumental variable analysis on a population-based cohort of 19 271 men, aged 66 years or older, with clinical stage T1 or T2 prostate cancer. All the men were covered by Medicare and none received definitive local therapy; 7867 men (41%) received primary ADT and the remainder were followed with conservative management.
The 10-year overall survival was practically identical — 30.2% with ADT vs 30.3% with conservative management (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.96–1.05).
The 10-year prostate-cancer-specific survival was also very similar (80.1% with ADT vs 82.6% with conservative management; HR, 1.17; 95% CI, 1.03–1.33).
However, ADT has significant adverse effects and is costly, the researchers point out. Previous studies have suggested a 10% to 50% increase in the risk for fracture, diabetes, coronary heart disease, myocardial infarction, and sudden cardiac death; a 500% increase in the risk for gynecomastia and hot flashes; and a 267% increase in the risk for impotence. In the United States, ADT cost $1.2 billion in 2003, and was the second-highest Medicare Part B drug expenditure.
In light of significant adverse effects, cost, and lack of improvement in survival, Dr. Yao and colleagues suggest that clinicians "carefully consider the rationale for initiating primary ADT in elderly patients with T1–T2 prostate cancer."
Ongoing Controversy — To Treat or Not to Treat
"This has been an ongoing controversy for a long time — to treat or not to treat elderly men with prostate cancer," commented Kevin Kelly, DO, from the Yale Cancer Center, in New Haven, Connecticut. Dr. Kelly was not involved in the study.
"There are 2 things that I consider when I treat these older men," he explained. "Number 1 is the extent/grade of the current prostate cancer, and number 2 is the projected longevity of the patient. If the patient has a high-grade tumor and locally advanced disease, he will have disease progression, morbidity, and/or mortality from the cancer in 5 years. Therefore, this is a reasonable subset of patients to treat if they are expected to live the 5 years."
"At the end of the day, it is proper patient selection and understanding what you want to accomplish with androgen-deprivation therapy," Dr. Kelly commented. "Perhaps survival is not the only end point we should look at."
Dr. Yao and coauthors have disclosed no relevant financial relationships.
JAMA. 2008;300:173-181.
Möge jeder selber sein Urteil bilden.
Gruss
fs
Primary ADT Does Not Improve Survival in Prostate Cancer
July 9, 2008 — Primary androgen-deprivation therapy (ADT), used alone instead of surgery or radiation, does not improve survival, over conservative management, in the majority of elderly men with localized prostate cancer.
This finding, from an analysis of data from 19 271 men, appears in the July 9 issue of the Journal of the American Medical Association.
The study calls into question the increasingly common use of primary ADT, especially considering its significant adverse effects and cost, say the researchers. The findings contrast those for adjuvant ADT used alongside radiation and/or surgery, which does improve overall survival.
"I think that the bottom line is that primary androgen-deprivation therapy does not appear to benefit the average man with localized prostate cancer," senior author Siu-Long Yao, MD, from the Cancer Institute of New Jersey, in New Brunswick, told Medscape Oncology. "It is possible that certain subsets of men, such as those with poorly differentiated cancer, might derive some benefit, but you must carefully consider and justify the rationale for primary androgen-deprivation therapy if you are going to proceed with it."
"My conclusion would be that primary androgen-deprivation therapy does not appear to be a good alternative to surgery or radiation; outcomes appear to be no better than conservative management or watchful waiting," Dr. Yao commented.
"This study further reduces enthusiasm for the use of hormonal therapy in early-stage prostate cancer, and suggests that such treatment, if used at all, should be limited to high-grade disease, as defined by SEER [Surveillance, Epidemiology, and End Results]," commented Martin G. Sanda, MD, from the Beth Israel Deaconess Medical Center, in Boston, Massachusetts. Dr. Sanda was not involved in the study.
"Their findings of no survival benefit in intermediate- or low-risk disease add to other recent publications that elucidated flaws in hormonal therapy related to its adverse effects on quality of life and cardiac events among men with prostate cancer," Dr. Sandra added.
No Improvement in Overall or Cancer-Specific Survival
Primary ADT has become an increasingly popular option for localized prostate cancer, especially among older men, and is used in place of surgery, radiation, or conservative management, Dr. Yao and colleagues comment. However, the popularity of this option is not backed up by data; this is not a standard treatment approach, nor is it sanctioned by any major groups or guidelines, they point out.
And now they have shown that primary ADT is no better than conservative management.
Dr. Yao and colleagues performed an instrumental variable analysis on a population-based cohort of 19 271 men, aged 66 years or older, with clinical stage T1 or T2 prostate cancer. All the men were covered by Medicare and none received definitive local therapy; 7867 men (41%) received primary ADT and the remainder were followed with conservative management.
The 10-year overall survival was practically identical — 30.2% with ADT vs 30.3% with conservative management (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.96–1.05).
The 10-year prostate-cancer-specific survival was also very similar (80.1% with ADT vs 82.6% with conservative management; HR, 1.17; 95% CI, 1.03–1.33).
However, ADT has significant adverse effects and is costly, the researchers point out. Previous studies have suggested a 10% to 50% increase in the risk for fracture, diabetes, coronary heart disease, myocardial infarction, and sudden cardiac death; a 500% increase in the risk for gynecomastia and hot flashes; and a 267% increase in the risk for impotence. In the United States, ADT cost $1.2 billion in 2003, and was the second-highest Medicare Part B drug expenditure.
In light of significant adverse effects, cost, and lack of improvement in survival, Dr. Yao and colleagues suggest that clinicians "carefully consider the rationale for initiating primary ADT in elderly patients with T1–T2 prostate cancer."
Ongoing Controversy — To Treat or Not to Treat
"This has been an ongoing controversy for a long time — to treat or not to treat elderly men with prostate cancer," commented Kevin Kelly, DO, from the Yale Cancer Center, in New Haven, Connecticut. Dr. Kelly was not involved in the study.
"There are 2 things that I consider when I treat these older men," he explained. "Number 1 is the extent/grade of the current prostate cancer, and number 2 is the projected longevity of the patient. If the patient has a high-grade tumor and locally advanced disease, he will have disease progression, morbidity, and/or mortality from the cancer in 5 years. Therefore, this is a reasonable subset of patients to treat if they are expected to live the 5 years."
"At the end of the day, it is proper patient selection and understanding what you want to accomplish with androgen-deprivation therapy," Dr. Kelly commented. "Perhaps survival is not the only end point we should look at."
Dr. Yao and coauthors have disclosed no relevant financial relationships.
JAMA. 2008;300:173-181.
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