Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial
SourceLancet Oncology, 14, 12, (2013), pp. 1193-1199
Article / Letter to editor
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SubjectONCOL 3: Translational research; ONCOL 5: Aetiology, screening and detection; ONCOL 5: Aetiology, screening and detection
BACKGROUND: Abiraterone acetate plus prednisone significantly improves radiographic progression-free survival in asymptomatic or mildly symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer compared with prednisone alone. We describe analyses of data for patient-reported pain and functional status in a preplanned interim analysis of a phase 3 trial. METHODS: Between April 28, 2009, and June 23, 2010, patients with progressive, metastatic castration-resistant prostate cancer were enrolled into a multinational, double-blind, placebo-controlled trial. Patients were eligible if they were asymptomatic (score of 0 or 1 on item three of the Brief Pain Inventory Short Form [BPI-SF] questionnaire) or mildly symptomatic (score of 2 or 3) and had not previously received chemotherapy. Patients were randomly assigned (1:1) to receive oral abiraterone (1 g daily) plus prednisone (5 mg twice daily) or placebo plus prednisone in continuous 4-week cycles. Pain was assessed with the BPI-SF questionnaire, and health-related quality of life (HRQoL) with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. We analysed data with prespecified criteria for clinically meaningful pain progression and deterioration in HRQoL. All patients who underwent randomisation were included in analyses. FINDINGS: 1088 patients underwent randomisation: 546 were assigned to abiraterone plus prednisone and 542 to placebo plus prednisone. At the time of the second prespecified interim analysis, median follow-up was 22.2 months (IQR 20.2-24.8). Median time to progression of mean pain intensity was longer in patients assigned to abiraterone plus prednisone (26.7 months [95% CI 19.3-not estimable]) than in those assigned to placebo plus prednisone (18.4 months [14.9-not estimable]; hazard ratio [HR] 0.82, 95% CI 0.67-1.00; p=0.0490), as was median time to progression of pain interference with daily activities (10.3 months [95% CI 9.3-13.0] vs 7.4 months [6.4-8.6]; HR 0.79, 95% CI 0.67-0.93; p=0.005). Median time to progression of worst pain was also longer with abiraterone plus prednisone (26.7 months [95% CI 19.4-not estimable]) than with placebo plus prednisone (19.4 months [16.6-not estimable]), but the difference was not significant (HR 0.85, 95% CI 0.69-1.04; p=0.109). Median time to HRQoL deterioration was longer in patients assigned to abiraterone plus prednisone than in those assigned to placebo plus prednisone as assessed by the FACT-P total score (12.7 months [95% CI 11.1-14.0] vs 8.3 months [7.4-10.6]; HR 0.78, 95% CI 0.66-0.92; p=0.003) and by the score on its prostate-cancer-specific subscale (11.1 months [8.6-13.8] vs 5.8 months [5.5-8.3]; HR 0.70, 95% CI 0.60-0.83; p<0.0001). INTERPRETATION: Abiraterone plus prednisone delays patient-reported pain progression and HRQoL deterioration in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. These results provide further support for the efficacy of abiraterone in this population.
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