Tuesday, September 18, 2012 (Last Updated: 09/19/2012)
Karim Fizazi, M.D., from University of Paris-Sud in Villejuif, and colleagues enrolled 1,195 participants in an international, multicenter study in which patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned (ratio 2:1) to receive either abiraterone acetate (797 participants; 1,000 mg, orally once daily) plus prednisone (5 mg, orally twice daily) or placebo (398 participants) plus prednisone.
The researchers found that, at a median follow-up of 20.2 months, median overall survival was significantly longer for the abiraterone group than the placebo group (hazard ratio [HR], 0.74; 95 percent confidence interval, 0.64 to 0.86). For the abiraterone group versus the placebo group, median time to prostate-specific antigen (PSA) progression (8.5 versus 6.6 months; HR, 0.63), median radiologic progression-free survival (5.6 versus 3.6 months; HR, 0.66), and proportion of patients who had a PSA response (29.5 versus 5.5 percent) were all significantly improved. Fatigue, anemia, back pain, and bone pain were the most common grade 3 to 4 adverse events in both groups.
"This final analysis confirms that abiraterone acetate significantly prolongs overall survival in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment," Fizazi and colleagues conclude.
Several authors disclosed financial ties to pharmaceutical companies, including Janssen Research & Development, which funded the study.
Hematology & Oncology
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