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Androgen deprivation therapy not associated with CV death
Nguyen PL. JAMA. 2011;306:2359-2366.
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Androgen deprivation therapy was not associated with an increased risk for CV death among patients with prostate cancer, according to researchers at Harvard Medical School.
Androgen deprivation therapy (ADT) was, however, associated with a lower risk for prostate cancer-specific mortality and all-cause mortality, they concluded.
Previous studies have shown that ADT may be associated with death related to CV causes, but this has not been confirmed in subsequent studies, according to the researchers. They performed a systematic review and meta-analysis of randomized trials to find out whether ADT is associated with CV mortality, prostate cancer-specific mortality and all-cause mortality in men with unfavorable risk, nonmetastatic prostate cancer.
Abstracts from 655 studies from 1966 to April 11, 2011, were identified using the Medline, Embase and Cochrane databases. The studies were included in the meta-analysis if the patients had nonmetastatic disease; the intervention group received gonadotropin-releasing hormone agonist-based ADT; the control group received no ADT; there was complete information on CV deaths; or the median follow-up was longer than 1 year.
Only eight of 655 trials met all of the criteria. All were randomized, multicenter, open-label phase 3 trials.
Among the 2,200 patients who were treated with ADT, there were 255 CV deaths, for an overall incidence of 11%. Among the 1,941 patients not treated with ADT, there were 252 CV deaths, for an overall incidence of 11.2%.
In trials with patients who received ADT for 6 months or less, the incidence of CV events was 10.5% vs. 10.3% in controls. In trials in which patients received ADT for at least 3 years, the incidence of CV death was 11.5% in both groups.
There was a lower risk for prostate cancer-specific mortality in patients who received ADT: 13.5% vs. 22.1% in controls (P<.001). Patients who received ADT also had a better overall survival. The incidence of all-cause mortality among men receiving ADT was 37.7% vs. 44.4% for controls (P<.001).
“For the majority of men considering ADT for aggressive prostate cancer, these results should be reassuring,” the researchers wrote. “It remains unknown whether these results are also applicable to the subgroup of men with a prior history of congestive HF or MI, and therefore, stratification of future randomized trials by CV comorbidity is needed.”
Several retrospective analyses reported in the last few years have suggested an increased risk for CV death related to ADT. These reports were concerning to patients and doctors, as the findings potentially could impact treatment decisions in settings where ADT has a clearly established survival advantage based on several prospective randomized trials. This report is a retrospective analysis but, unlike the prior reports, is based on data from several prospective clinical trials and adds reassurance that the risk is not as what it was perceived. However, it is critical that future trials of ADT capture not only important baseline comorbidities such as diabetes and obesity, but also actual causes of death.
– Maha Hadi Hussein, MD, FACP
Professor of
Medicine and Urology
University of Michigan Comprehensive Cancer Center
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