Table 1.
Baseline characteristics (intent-to-treat population)
| Characteristic | East Asian (n=221) | Overall (n=1052) | ||
|---|---|---|---|---|
|
|
|
|||
| Apalutamide (n=111) | Placebo (n=110) | Apalutamide (n=525) | Placebo (n=527) | |
| Age (year), median (range) | 70 (47–89) | 70 (50–85) | 69 (45–94) | 68 (43–90) |
| ECOG performance status, n (%) | ||||
| 0 | 74 (66.7) | 77 (70.0) | 328 (62.5) | 348 (66.0) |
| 1 | 37 (33.3) | 32 (29.1) | 197 (37.5) | 178 (33.8) |
| 2 | 0 (0) | 1 (0.9) | 0 (0) | 1 (0.2) |
| Gleason score at diagnosis, n (%) | ||||
| ≤7 | 15 (13.5) | 15 (13.6) | 174 (33.1) | 169 (32.1) |
| >7 | 96 (86.5) | 95 (86.4) | 348 (66.9) | 349 (67.9) |
| Metastatic stage at diagnosis, n (%) | ||||
| M0 | 3 (2.7) | 3 (2.7) | 85 (16.2) | 59 (11.2) |
| M1 | 104 (93.7) | 105 (95.5) | 411 (78.3) | 441 (83.7) |
| Mx | 4 (3.6) | 2 (1.8) | 29 (5.5) | 27 (5.1) |
| Metastasis site at baseline, n (%) | ||||
| Bone | 111 (100) | 110 (100) | 525 (100) | 527 (100) |
| Bone only | 59 (53.2) | 48 (43.6) | 289 (55.0) | 269 (51.0) |
| Lymph node | 46 (41.4) | 52 (47.3) | 199 (37.9) | 219 (41.6) |
| Visceral | 8 (7.2) | 11 (10.0) | 56 (10.7) | 72 (13.7) |
| Lung | 7 (6.3) | 10 (9.1) | 47 (9.0) | 64 (12.1) |
| Liver | 0 (0) | 1 (0.9) | 12 (2.3) | 13 (2.5) |
| Soft tissue | 5 (4.5) | 8 (7.3) | 22 (4.2) | 27 (5.1) |
| Disease volume, n (%) | ||||
| Low | 37 (33.3) | 38 (34.5) | 200 (38.1) | 192 (36.4) |
| High | 74 (66.7) | 72 (65.5) | 325 (61.9) | 335 (63.6) |
| Prior prostate cancer treatment, n (%) | ||||
| Prostatectomy or radiotherapy | 4 (3.6) | 8 (7.3) | 94 (17.9) | 79 (15.0) |
| Hormonal therapy | 111 (100) | 110 (100) | 525 (100) | 527 (100) |
| Docetaxel | 7 (6.3) | 7 (6.4) | 58 (11.0) | 55 (10.4) |
| Vandetanib | 0 (0) | 0 (0) | 1 (0.2) | 0 (0) |
| PSA level (µg l−1), median (range) | 10.24 (0–2682) | 3.77 (0–803) | 5.97 (0–2682) | 4.02 (0–2229) |
PSA: prostate-specific antigen; ECOG: Eastern Cooperative Oncology Group