Table 1.
Baseline characteristics
| Control group in the abiraterone trial (n=455) | Control group in the abiraterone and enzalutamide trial (n=533) | Combination therapy group in the abiraterone trial (n=459) | Combination therapy group in the abiraterone and enzalutamide trial (n=527) | |
|---|---|---|---|---|
| Age at randomisation, years | ||||
| Median (IQR) | 67 (62–73) | 69 (64–73) | 68 (63–73) | 68 (63–73) |
| Range | 48–83 | 43–86 | 44–84 | 46–86 |
| PSA at randomisation, ng/ml | ||||
| Median (IQR) | 40 (16–83) | 34 (15–74) | 34 (15–68) | 32 (13–74) |
| Range | 1–1000 | 1–2773 | 1–2300 | 0–556 |
| Nodal status of newly diagnosed patients | ||||
| N0 | 256 (56%) | 327 (61%) | 253 (55%) | 325 (62%) |
| N1 | 187 (41%) | 190 (36%) | 181 (39%) | 187 (35%) |
| Nodal status of relapsed patients | ||||
| N0 | 7 (2%) | 8 (2%) | 14 (3%) | 7 (1%) |
| N1 | 5 (1%) | 7 (1%) | 10 (2%) | 7 (1%) |
| Nx | 0 | 1 (<1%) | 1 (<1%) | 1 (<1%) |
| WHO performance status | ||||
| 0 | 375 (82%) | 435 (82%) | 370 (71%) | 429 (81%) |
| 1–2 | 80 (17%) | 98 (18%) | 89 (19%) | 98 (19%) |
| Time from diagnosis to randomisation | ||||
| Median (IQR) | 83 (63–107) | 84 (65–104) | 83 (62–105) | 85 (68–105) |
| Range | 5–2771 | 4–4807 | 1–5274 | 2–5434 |
| Gleason sum score | ||||
| <8 | 105 (23%) | 95 (18%) | 107 (23%) | 98 (19%) |
| 8–10 | 348 (76%) | 437 (82%) | 351 (77%) | 427 (81%) |
| Missing | 2 | 1 | 1 | 2 |
| T stage at randomisation | ||||
| T0–T2 | 39 (9%) | 30 (6%) | 30 (7%) | 26 (5%) |
| T3–T4 | 41 (90%) | 496 (93%) | 423 (92%) | 493 (94%) |
| TX | 5 (1%) | 7 (1%) | 6 (1%) | 8 (2%) |
| Local radiotherapy as standard of care | ||||
| No | 83 (18%) | 62 (12%) | 87 (19%) | 58 (11%) |
| Yes | 372 (82%) | 471 (88%) | 372 (81%) | 469 (89%) |
Data are n (%) or n, unless stated otherwise. PSA=prostate-specific antigen.