Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

HI Scher, K Fizazi, F Saad, ME Taplin, CN Sternberg, K Miller, Ronald de Wit, P Mulders, KN Chi, ND Shore, AJ Armstrong, TW Flaig, A Flechon, P Mainwaring, M Fleming, JD Hainsworth, M Hirmand, B Selby, L Seely, JS de Bono

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Abstract

BACKGROUND Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy. METHODS In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2: 1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival. RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy. (Funded by Medivation and Astellas Pharma Global Development; AFFIRM ClinicalTrials. gov number, NCT00974311.)
Original languageUndefined/Unknown
Pages (from-to)1187-1197
Number of pages11
JournalNew England Journal of Medicine
Volume367
Issue number13
DOIs
Publication statusPublished - 2012

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