Authors
Karim Fizazi, Howard I Scher, Arturo Molina, Christopher J Logothetis, Kim N Chi, Robert J Jones, John N Staffurth, Scott North, Nicholas J Vogelzang, Fred Saad, Paul Mainwaring, Stephen Harland, Oscar B Goodman, Cora N Sternberg, Jin Hui Li, Thian Kheoh, Christopher M Haqq, Johann S de Bono
Publication date
2012/10/1
Journal
The lancet oncology
Volume
13
Issue
10
Pages
983-992
Publisher
Elsevier
Description
Background
Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events).
Methods
Between May 8, 2008, and July 28, 2009, this study enrolled 1195 patients at 147 sites in 13 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status, worst pain over the past 24 h on the Brief Pain Inventory-Short Form, number of previous chemotherapy regimens, and type of progression. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg …
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Scholar articles
K Fizazi, HI Scher, A Molina, CJ Logothetis, KN Chi… - The lancet oncology, 2012