Authors
Tomasz M Beer, Andrew J Armstrong, Dana E Rathkopf, Yohann Loriot, Cora N Sternberg, Celestia S Higano, Peter Iversen, Suman Bhattacharya, Joan Carles, Simon Chowdhury, Ian D Davis, Johann S De Bono, Christopher P Evans, Karim Fizazi, Anthony M Joshua, Choung-Soo Kim, Go Kimura, Paul Mainwaring, Harry Mansbach, Kurt Miller, Sarah B Noonberg, Frank Perabo, De Phung, Fred Saad, Howard I Scher, Mary-Ellen Taplin, Peter M Venner, Bertrand Tombal
Publication date
2014/7/31
Journal
New England Journal of Medicine
Volume
371
Issue
5
Pages
424-433
Publisher
Massachusetts Medical Society
Description
Background
Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy.
Methods
In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival.
Results
The study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide …
Total citations
Scholar articles
TM Beer, AJ Armstrong, DE Rathkopf, Y Loriot… - New England Journal of Medicine, 2014