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Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

Authors :: Beer, Tm
Armstrong, Aj
Rathkopf, De
Loriot, Y
Sternberg, Cn
Higano, Cs
Iversen, P
Bhattacharya, S
Carles, J
Chowdhury, S
Davis, Id
de Bono JS
Evans, Cp
Fizazi, K
Joshua, Am
Kim, Cs
Kimura, G
Mainwaring, P
Mansbach, H
Miller, K
Noonberg, Sb
Perabo, F
Phung, D
Saad, F
Scher, Hi
Taplin, Me
Venner, Pm
Tombal, B
Prevail, Investigators
Scagliotti, Giorgio Vittorio
Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1)
Université Montpellier 1 (UM1)-CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
Source :: The New England journal of medicine, vol 371, iss 5, New England Journal of Medicine, 371(5), 424-433. MASSACHUSETTS MEDICAL SOC, The New England Journal of Medicine, 371, 424-33, New England Journal of Medicine, New England Journal of Medicine, Massachusetts Medical Society, 2014, 371 (5), pp.424-433. ⟨10.1056/NEJMoa1405095⟩, The New England Journal of Medicine, 371, 5, pp. 424-33
Publication Year :: 2014
Publisher :: Massachusetts Medical Society, 2014.
Abstract: Contains fulltext : 137932.pdf (Publisher’s version ) (Open Access) 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, as compared with 14% among patients receiving placebo (81% risk reduction; hazard ratio in the enzalutamide group, 0.19; 95% confidence interval [CI], 0.15 to 0.23; P