Abiraterone extends survival in patients with metastatic prostate cancer

  Abiraterone may prolong survival in patients with metastatic prostate cancer Background:Extragonadal androgen biosynthesis may be associated with the progression of desmoid-refractory prostate cancer. We evaluated whether abiraterone acetate, an antagonist of androgen biosynthesis, could prolong overall survival in patients with metastatic debulking refractory prostate cancer treated with chemotherapy.  METHODS: A total of 1195 patients who were treated with docetaxel and were ready for twice-daily 5 mg prednisone therapy were randomly assigned 2:1 to the 1000 mg abiraterone acetate group (797 patients) and the placebo group (398 patients). The primary study endpoint was overall survival. Secondary study endpoints included time to progression of prostate-specific antigen (elevation of PSA levels by predefined criteria), progression-free survival by imaging based on predefined criteria, and PSA response rate.  Results:After a median follow-up of 12.8 months, survival was longer in the abiraterone acetate + prednisone group than in the placebo + prednisone group (14.8 months versus 10.9 months, hazard ratio 0.65, 95% confidence interval 0.54 to 0.77, p < 0.001) Data from this study were unblinded at the time of interim analysis because the results all exceeded the predefined criteria for study termination. All secondary endpoints, including time to progression of PSA (10.2 and 6.6 months, p < 0.001) progression-free survival (5.6 and 3.6 months, p < 0.001) and PSA response rate (29% and 6%, p < 0.001), favored the treatment group. Side effects due to salt corticosteroids, such as sodium retention, hypertension and hypokalemia, were more likely to occur in the abiraterone acetate group compared to the placebo group.  Discussion:Inhibition of androgen biosynthesis with abiraterone acetate prolongs survival in patients with metastatic desmoplastic refractory prostate cancer who have received chemotherapy.  (De Bono J S, Logothetis C J, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer[J]. New England Journal of Medicine, 2011, 364(21): 1995-2005.)