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Document type:
journal article 
Author(s):
Ryan, Charles J; Smith, Matthew R; de Bono, Johann S; Molina, Arturo; Logothetis, Christopher J; de Souza, Paul; Fizazi, Karim; Mainwaring, Paul; Piulats, Josep M; Ng, Siobhan; Carles, Joan; Mulders, Peter F A; Basch, Ethan; Small, Eric J; Saad, Fred; Schrijvers, Dirk; Van Poppel, Hendrik; Mukherjee, Som D; Suttmann, Henrik; Gerritsen, Winald R; Flaig, Thomas W; George, Daniel J; Yu, Evan Y; Efstathiou, Eleni; Pantuck, Allan; Winquist, Eric; Higano, Celestia S; Taplin, Mary-Ellen; Park, Youn; Kh...    »
 
Title:
Abiraterone in metastatic prostate cancer without previous chemotherapy. 
Abstract:
Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy.In this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival.The study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P<0.001). Over a median follow-up period of 22.2 months, overall survival was improved with abiraterone-prednisone (median not reached, vs. 27.2 months for prednisone alone; hazard ratio, 0.75; 95% CI, 0.61 to 0.93; P=0.01) but did not cross the efficacy boundary. Abiraterone-prednisone showed superiority over prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use for cancer-related pain, prostate-specific antigen progression, and decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and abnormalities on liver-function testing were more common with abiraterone-prednisone.Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer. (Funded by Janssen Research and Development, formerly Cougar Biotechnology; ClinicalTrials.gov number, NCT00887198.). 
Journal title abbreviation:
N Engl J Med 
Year:
2013 
Journal volume:
368 
Journal issue:
Pages contribution:
138-48 
Language:
eng 
Print-ISSN:
0028-4793 
TUM Institution:
Urologische Klinik und Poliklinik