WEDNESDAY, May 25 (HealthDay News) -- Abiraterone acetate prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy, according to a study published in the May 26 issue of the New England Journal of Medicine.
Johann S. de Bono, M.B., Ch.B., Ph.D., from the Institute of Cancer Research in Sutton, U.K., and colleagues investigated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival in patients with metastatic prostate cancer who have previously undergone chemotherapy. A total of 797 patients were randomly assigned to receive 5 mg prednisone twice daily plus 1,000 mg abiraterone acetate, and 398 patients received 5 mg prednisone and placebo. The median follow-up in the overall study was 12.8 months. The primary end point measured was overall survival, and time to prostate-specific antigen (PSA) progression, progression-free survival, and PSA response rate were also measured.
The investigators found that, compared with the prednisone-placebo group, overall survival was significantly longer in the abiraterone acetate group (hazard ratio, 0.65). Time to PSA progression, progression-free survival, and PSA response rate were significantly improved in the treatment group. Mineralocorticoid-related adverse events were more common in the abiraterone-prednisone group compared to placebo, and they included fluid retention, hypertension, and hypokalemia.
"This study showed that abiraterone acetate plus prednisone, as compared with placebo plus prednisone, prolonged survival among patients with metastatic castration-resistant prostate cancer," the authors write.
Several of the study authors disclosed financial relationships with the pharmaceutical industry, including Ortho Biotech Oncology Research and Development, which supported the study. One of the authors disclosed a financial relationship with the Institute of Cancer Research, which has a commercial interest in abiraterone.
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