(HealthDay News) – Abiraterone acetate significantly improves overall survival in patients with metastatic castration-resistant prostate cancer that has progressed after docetaxel treatment, according to a study published online Sept 18 in The Lancet Oncology.
Karim Fizazi, MD, 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; 1,000mg, orally once daily) plus prednisone (5mg, 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% confidence interval, 0.64–0.86). For the abiraterone group vs. the placebo group, median time to prostate-specific antigen (PSA) progression (8.5 vs. 6.6 months; HR, 0.63), median radiologic progression-free survival (5.6 vs. 3.6 months; HR, 0.66), and proportion of patients who had a PSA response (29.5 vs. 5.5%) were all significantly improved. Fatigue, anemia, back pain, and bone pain were the most common grade 3–4 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.