Table 2.
Results of the most common patient-related outcome surveys on health-related quality of life and pain scores
| Trial | Instrument | Survey frequency | Response rate (response rate per arm) | % Response rate (% response rate per arm) | Median time to deterioration |
|---|---|---|---|---|---|
| HRQoL | |||||
| AFFIRM15 | FACT-P | Before randomization, Weeks 13, 17, 21, 25, and every 12 weeks thereafter | 938/1,199 (674/800, 264/399) | 78% (84%, 66%) | 9 months (enzalutamide) vs 3.7 months (placebo); p<0.0001 |
| PREVAIL16 | FACT-P | Baseline, Weeks 5, 13, and every 12 weeks thereafter | 1,669/1,717 (856/872, 813/845) | 97% (98%, 96%) | 11.3 months (enzalutamide) vs 5.6 months (placebo); p<0.001 |
| EQ-5D | Baseline, Week 13 and every 12 weeks thereafter | 1,448/1,717 (818/872, 630/845) | 84% (93%, 75%) | 19.2 months (enzalutamide) vs 11.1 months (placebo); p<0.0001 | |
| STRIVE17 | FACT-P | Not reported | Not reported | Not reported | 8.4 months (enzalutamide) vs 8.3 months (bicalutamide); p=0.49 |
| TERRAIN18 | FACT-P | Not reported | Not reported | Not reported | 13.8 months (enzalutamide) vs 8.5 months (bicalutamide); p=0.026 |
| Pain | |||||
| Pain progression at Week 13 | |||||
| AFFIRM15 | BPI-SF | Baseline, Week 13 daily for 7 days | 830/1,199 (591/800, 239/399) | 69% (74%, 60%) | 28% enzalutamide vs 38% placebo (p<0.0018) |
| PREVAIL16 | BPI-SF | Baseline, Weeks 13 and 25 | 1,379/1,717 (769/872, 610/845) | 80% (88%, 72%) | 29% enzalutamide vs 42% placebo (p<0.0001) |
Abbreviations: FACT-P, Functional Assessment of Cancer Therapy-Prostate; BPI-SF, Brief Pain Inventory – Short Form; HRQoL, health-related quality of life.