Abiraterone and increased survival in metastatic prostate cancer

January 01, 0001

Abiraterone and increased survival in metastatic prostate cancer

These investigators from multiple countries evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy. They 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.

They found: "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). 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), progression-free survival (5.6 months vs. 3.6 months), and PSA response rate (29% vs. 6%,), 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."

The authors concluded: "The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy."

A modest survival benefit. Additional information regarding cost and quality of life would be helpful.


For the full abstract, click here.

N Engl J Med 364:1995-2005, 26 May 2011
© 2011 to the Massachusetts Medical Society
Abiraterone and Increased Survival in Metastatic Prostate Cancer. Johann S. de Bono, Christopher J. Logothetis, Arturo Molina, et al. Correspondence to Dr. de Bono: [email protected]

Category: Y. Male Genital System, Breast. Keywords: prostate cancer, chemotherapy, abiraterone, prednisone, docetaxel, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 7 June 2011

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