WEDNESDAY, Feb. 23, 2022 (HealthDay News) -- Survival is prolonged in patients with metastatic, hormone-sensitive prostate cancer receiving darolutamide versus placebo, in combination with androgen-deprivation therapy and docetaxel, according to a study published online Feb. 17 in the New England Journal of Medicine to coincide with the American Society of Clinical Oncology annual Genitourinary Cancers Symposium, held from Feb. 17 to 19 in San Francisco.
Matthew R. Smith, M.D., Ph.D., from the Massachusetts General Hospital Cancer Center in Boston, and colleagues randomly assigned patients with metastatic, hormone-sensitive prostate cancer to receive darolutamide or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. A total of 1,306 patients were randomly assigned (651 and 655 in the darolutamide and placebo groups, respectively); 86.1 percent had metastatic disease at the time of initial diagnosis.
The researchers found that the risk for death was significantly lower in the darolutamide group versus the placebo group at the data cutoff date for the primary analysis (Oct. 25, 2021; hazard ratio, 0.68). With respect to secondary end points and prespecified subgroups, darolutamide was also associated with consistent benefits. The groups had similar adverse events; in both groups, the incidences of the most common adverse events were highest during the overlapping docetaxel treatment period.
"The addition of darolutamide to androgen-deprivation therapy and docetaxel increased overall survival, and improvements were observed with respect to key secondary end points, with no increase in adverse events," the authors write.
The study was funded by Bayer and Orion Pharma; Bayer is the manufacturer of darolutamide.
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