TY - JOUR
T1 - Abiraterone and increased survival in metastatic prostate cancer
AU - De Bono, Johann S.
AU - Logothetis, Christopher J.
AU - Molina, Arturo
AU - Fizazi, Karim
AU - North, Scott
AU - Chu, Luis
AU - Chi, Kim N.
AU - Jones, Robert J.
AU - Goodman, Oscar B.
AU - Saad, Fred
AU - Staffurth, John N.
AU - Mainwaring, Paul
AU - Harland, Stephen
AU - Flaig, Thomas W.
AU - Hutson, Thomas E.
AU - Cheng, Tina
AU - Patterson, Helen
AU - Hainsworth, John D.
AU - Ryan, Charles J.
AU - Sternberg, Cora N.
AU - Ellard, Susan L.
AU - Fléchon, Aude
AU - Saleh, Mansoor
AU - Scholz, Mark
AU - Efstathiou, Eleni
AU - Zivi, Andrea
AU - Bianchini, Diletta
AU - Loriot, Yohann
AU - Chieffo, Nicole
AU - Kheoh, Thian
AU - Haqq, Christopher M.
AU - Scher, Howard I.
PY - 2011/5/26
Y1 - 2011/5/26
N2 - 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 Clinical Trials. gov number, NCT00638690.)
AB - 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 Clinical Trials. gov number, NCT00638690.)
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UR - http://www.scopus.com/inward/citedby.url?scp=79957443342&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1014618
DO - 10.1056/NEJMoa1014618
M3 - Article
C2 - 21612468
AN - SCOPUS:79957443342
SN - 0028-4793
VL - 364
SP - 1995
EP - 2005
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 21
ER -
