Abiraterone and Increased Survival in Metastatic Prostate Cancer

Johann S. de Bono(Royal Marsden NHS Foundation Trust), Christopher J. Logothetis(The University of Texas MD Anderson Cancer Center), Arturo Molina(Los Angeles City College), Karim Fizazi(Institut Gustave Roussy), Scott North(Cancer Institute (WIA)), Luis Chu(Hematology Oncology Consultants), Kim N.(BC Cancer Agency), Robert J. Jones, Oscar B. Goodman, Fred Saad(Université de Montréal), John Staffurth(Velindre NHS Trust), Paul N. Mainwaring(Australasia Paediatric Endocrine Group), Stephen Harland(Cancer Institute (WIA)), Thomas W. Flaig(University of Colorado Cancer Center), Thomas E. Hutson(Texas Oncology), Tina Cheng(University of Calgary), Helen Patterson, John D. Hainsworth(Sarah Cannon Research Institute), Charles J. Ryan(University of California, San Francisco), Cora N. Sternberg(Nini Hospital), Susan Ellard(BC Cancer Agency), Aude Fléchon(Centre Léon Bérard), Mansoor N. Saleh(Georgia Cancer Specialists), Mark C. Scholz(Oncology Specialists), Eleni Efstathiou(The University of Texas MD Anderson Cancer Center), Andrea Zivi(Royal Marsden Hospital), Diletta Bianchini(Royal Marsden Hospital), Yohann Loriot(Institut Gustave Roussy), Nicole Chieffo(Los Angeles City College), Thian Kheoh(Los Angeles City College), Christopher M. Haqq(Los Angeles City College), Howard I. Scher(Memorial Sloan Kettering Cancer Center)
New England Journal of Medicine
May 25, 2011
10.1056/nejmoa1014618
Cited by 4,385Open Access
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Abstract

BACKGROUND: Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy. METHODS: We randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate. RESULTS: After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate-prednisone group than in the placebo-prednisone group. CONCLUSIONS: The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.).

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