Table 2.
Secondary end points: response and progression
| Response | ||||
|---|---|---|---|---|
| EU | NA | |||
| Enzalutamide (n = 461) | Placebo (n = 223) | Enzalutamide (n = 263) | Placebo (n = 132) | |
| % of patients | ||||
| Patients with ≥1 post-baseline PSA assessment | 92.6 | 85.2 | 89.0 | 78.0 |
| Decrease ≥50%* | 55.0 | 1.6 | 51.3 | 1.9 |
| Decrease ≥90%* | 23.0 | 1.1 | 26.9 | 1.0 |
| Patients with measurable disease | 53.6 | 52.9 | 58.6 | 52.3 |
| CR or PR* | 29.1 | 5.1 | 26.6 | 2.9 |
| Patients with ≥1 post-baseline HRQL assessment† | 81.6 | 67.3 | 81.4 | 56.8 |
| HRQL response* | 44.1 | 18.7 | 42.1 | 17.3 |
| Progression | ||||||
|---|---|---|---|---|---|---|
| End point | EU | NA | ||||
| Enzalutamide (n = 461) | Placebo (n = 223) | HR | Enzalutamide (n = 263) | Placebo (n = 132) | HR | |
| Median (95% CI): | ||||||
| Time to PSA progression, months | 8.2 (5.7, 8.3) | 3.0 (2.8, 3.7) | 0.28* (0.22, 0.36) | 8.3 (5.8, 8.4) | 3.7 (3.0, 5.6) | 0.26* (0.17, 0.40) |
| rPFS, months | 8.5 (8.2, 10.5) | 2.9 (2.8, 4.5) | 0.38* (0.32, 0.47) | 8.3 (5.9, 9.7) | 2.9 (2.8, 3.6) | 0.43* (0.34, 0.55) |
| Time to first SRE, months | 17.4 (14.1, NYR) | 11.9 (9.0, 15.2) | 0.56* (0.43, 0.73) | 16.7 (13.6, NYR) | 18.2 (8.6, NYR) | 0.79†† (0.56, 1.12) |
CR, complete response; NYR, not yet reached; PR, partial response. *P < 0.001 for enzalutamide vs placebo. †Functional Assessment of Cancer Therapy-Prostate questionnaire. ††P = 0.185 for enzalutamide vs placebo.