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Abiraterone/prednisone delayed pain progression in patients with advanced prostate cancer
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The addition of abiraterone acetate to prednisone delayed patient-reported pain progression and deterioration of health care-related quality of life among chemotherapy-naive patients with metastatic castration-resistant prostate cancer, according to results of a phase 3 study.
The multinational, double-blind study included 1,088 patients. Of them, 546 received 5 mg twice-daily prednisone plus 1 g daily oral abiraterone acetate (Zytiga, Janssen Biotech) in continuous 4-week cycles. The other 542 received prednisone plus placebo.
Researchers conducted a pre-planned interim analysis to evaluate patient-reported pain and functional status. Median follow-up was 22.2 months.
Patients assigned prednisone plus abiraterone acetate had a longer median time to progression of mean pain intensity (26.7 months vs. 18.4 months; HR=0.82; 95% CI, 0.67–1.00) than those assigned to prednisone alone. The regimen also extended median time to progression of pain interference with daily activities (10.3 months vs. 7.4 months; HR=0.79; P=.005).
The combination regimen also delayed median time to progression of worst pain (26.7 months vs. 19.4 months), but the difference was not significant (HR=0.85; 95% CI, 0.69–1.04).
“Our results will help treatment decision making for patients and practitioners who are concerned about symptomatic and functional status in metastatic castration-resistant prostate cancer,” the researchers wrote.
Disclosure: The researchers report consulting roles with Astellas, AstraZeneca, GlaxoSmithKline, Janssen and Johnson & Johnson. They also report research support from, as well as advisory roles and employment relationships with, Janssen.
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