作者
Kim N Chi, Neeraj Agarwal, Anders Bjartell, Byung Ha Chung, Andrea J Pereira de Santana Gomes, Robert Given, Álvaro Juárez Soto, Axel S Merseburger, Mustafa Özgüroğlu, Hirotsugu Uemura, Dingwei Ye, Kris Deprince, Vahid Naini, Jinhui Li, Shinta Cheng, Margaret K Yu, Ke Zhang, Julie S Larsen, Sharon McCarthy, Simon Chowdhury
发表日期
2019/7/4
期刊
New England Journal of Medicine
卷号
381
期号
1
页码范围
13-24
出版商
Massachusetts Medical Society
简介
Background
Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression–free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined.
Methods
In this double-blind, phase 3 trial, we randomly assigned patients with metastatic, castration-sensitive prostate cancer to receive apalutamide (240 mg per day) or placebo, added to ADT. Previous treatment for localized disease and previous docetaxel therapy were allowed. The primary end points were radiographic progression–free survival and overall survival.
Results
A total of 525 patients were assigned to receive apalutamide plus ADT and 527 to receive placebo plus ADT. The median age was 68 years. A total of 16.4% of …
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KN Chi, N Agarwal, A Bjartell, BH Chung… - New England Journal of Medicine, 2019