Authors
Howard I Scher, Karim Fizazi, Fred Saad, Mary-Ellen Taplin, Cora N Sternberg, Kurt Miller, Ronald De Wit, Peter Mulders, Kim N Chi, Neal D Shore, Andrew J Armstrong, Thomas W Flaig, Aude Fléchon, Paul Mainwaring, Mark Fleming, John D Hainsworth, Mohammad Hirmand, Bryan Selby, Lynn Seely, Johann S de Bono
Publication date
2012/9/27
Journal
New England Journal of Medicine
Volume
367
Issue
13
Pages
1187-1197
Publisher
Massachusetts Medical Society
Description
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 …
Total citations
Scholar articles
HI Scher, K Fizazi, F Saad, ME Taplin, CN Sternberg… - New England Journal of Medicine, 2012