COU-AA-301: abiraterone and increased survival in metastatic castration-resistant prostate cancer after docetaxel
Abiraterone, a pill that blocks androgen synthesis throughout the body, lengthened survival in men with metastatic prostate cancer that had progressed after docetaxel, proving that the disease remains hormone-driven even when castration-resistant.
Overview
Phase 3 placebo-controlled trial of 1,195 men with metastatic castration-resistant prostate cancer previously treated with docetaxel randomised 2:1 to abiraterone plus prednisone or placebo plus prednisone.
Median overall survival was 14.8 versus 10.9 months (hazard ratio 0.65), with improvements in PSA response, radiographic progression and pain; mineralocorticoid excess (fluid retention, hypokalaemia, hypertension) was the characteristic toxicity.
- Median overall survival 14.8 vs 10.9 months; hazard ratio 0.65.
- PSA response 29 percent vs 6 percent.
Abiraterone became a standard treatment for metastatic castration-resistant prostate cancer and, after later trials, for hormone-sensitive and high-risk localised disease.
- Requires concurrent prednisone.
- Cross-resistance with enzalutamide limits sequential use.
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