Abiraterone benefits chemo-naive with advanced prostate CA

Charles J. Ryan, M.D., from the University of California in San Francisco, and colleagues randomly allocated 1,088 patients with metastatic castration-resistant prostate cancer who had not received previous chemotherapy to receive abiraterone acetate (1,000 mg) plus prednisone or placebo plus prednisone.

The researchers found that the median radiographic progression-free survival was significantly improved for abiraterone-prednisone versus placebo-prednisone (16.5 versus 8.3 months; hazard ratio, 0.53). Overall survival improved with abiraterone-prednisone over a median follow-up of 22 months (median not reached versus 27.2 months with placebo-prednisone; hazard ratio, 0.75), but the efficacy boundary was not crossed. Abiraterone-prednisone was also superior with respect to time to initiation of cytotoxic chemotherapy, opiate use for pain related to cancer, prostate-specific antigen progression, and performance status decline. Abnormalities on liver-function testing and grade 3 or 4 mineralocorticoid-related adverse events were more common with abiraterone-prednisone.

"In summary, the results show benefit from the use of abiraterone in patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer who have not received previous chemotherapy," the authors write. "These findings include increased rates of radiographic progression-free survival and overall survival, as well as clinically meaningful secondary end points."

The study was funded by Janssen Research and Development, which manufacturers abiraterone acetate; several authors disclosed financial ties to pharmaceutical companies, including Janssen.

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Journal reference: New England Journal of Medicine

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