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New Drug Increases Survival in Prostate Cancer Patients

Antiandrogen agent enzalutamide evaluated in phase III trial (Aug. 15)

Enzalutamide (formerly MDV3100), an experimental androgen-receptor—signaling inhibitor, prolonged the survival of men with metastatic castration-resistant prostate cancer after other treatments, according to an article published on August 15 in the online edition of The New England Journal of Medicine.

A total of 1,199 men with castration-resistant prostate cancer after chemotherapy were enrolled in the double-blind, placebo-controlled, phase III study. The men were randomly assigned to receive either oral enzalutamide 160 mg/day (n = 800) or placebo (n = 399). The primary endpoint was overall survival.

A single interim analysis was planned to be performed after 520 deaths had occurred. At that time point, the median overall survival was 18.4 months in the enzalutamide group versus 13.6 months in the placebo group (P

Enzalutamide was also significantly more effective than placebo in terms of secondary endpoints, including radiographic progression-free survival (8.3 vs. 2.9 months, respectively; P P P P P

Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group, and seizures were reported in five enzalutamide-treated patients (0.6%).

Castration-resistant prostate cancer was previously considered to be a hormone-refractory disease, the authors noted. In this study, the survival benefit with enzalutamide showed that androgen-receptor signaling contributes to disease progression despite castrate levels of testosterone and previous conventional antiandrogen therapy.

For more information, visit the NEJM Web site.

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