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Clinical Trial
. 2011 May 26;364(21):1995-2005.
doi: 10.1056/NEJMoa1014618.

Abiraterone and Increased Survival in Metastatic Prostate Cancer

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Free PMC article
Clinical Trial

Abiraterone and Increased Survival in Metastatic Prostate Cancer

Johann S de Bono et al. N Engl J Med. .
Free PMC article

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.).

Figures

Figure 1
Figure 1. Kaplan–Meier Estimates of Overall Survival, Time to PSA Progression, and Progression-free Survival According to Radiographic Evidence in the Intention-to-Treat Population
Figure 2
Figure 2. Hazard Ratios for the Risk of Death, According to Subgroup
Hazard ratios are based on a nonstratified proportional-hazards model. The Eastern Cooperative Oncology Group (ECOG) grades the performance status of patients with respect to activities of daily living, with 0 indicating that the patient is fully active and able to carry on all predisease activities without restriction; 1 indicating that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work; and 2 indicating that the patient is ambulatory and up and about more than 50% of waking hours and is capable of all self-care but unable to carry out any work activities. Dashes indicate that the median time to death had not been reached for the indicated patient subgroup. The size of the circles is proportional to the size of the subgroup. BPI denotes Brief Pain Inventory–Short Form, CI confidence interval, and PSA prostate-specific antigen.

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