Table 1.
Baseline patient and disease characteristics
| mCRPC post-docetaxel |
mCRPC chemotherapy-naïve |
|||||||
|---|---|---|---|---|---|---|---|---|
| GS <8 (N =
503) |
GS ≥8 (N = 545) |
GS <8 (N =
479) |
GS ≥8 (N = 517) |
|||||
| AA + P (n = 342) | P (n = 161) | AA + P (n = 356) | P (n = 189) | AA + P (n = 225) | P (n = 254) | AA + P (n = 263) | P (n = 254) | |
| Age, median (range), years | 70 (42–95) | 70 (39–87) | 68 (45–86) | 67 (43–90) | 71 (45–95) | 71 (50–90) | 69 (44–90) | 69 (44–90) |
| Extent of disease, n (%) | ||||||||
| Bone only | 123 (36) | 70 (43) | 130 (37) | 81 (43) | 122 (54) | 119 (47) | 121 (46) | 128 (50) |
| Bone, soft tissue | 219 (64) | 91 (57) | 226 (63) | 108 (57) | 103 (46) | 135 (53) | 142 (54) | 126 (50) |
| ECOG PS, n (%) | ||||||||
| 0 | – | – | – | – | 170 (76) | 190 (75) | 203 (77) | 198 (78) |
| 1 | – | – | – | – | 55 (24) | 64 (25) | 60 (23) | 56 (22) |
| 0–1 | 308 (90) | 147 (91) | 317 (89) | 166 (88) | – | – | – | – |
| 2 | 34 (10) | 14 (9) | 39 (11) | 23 (12) | – | – | – | – |
| Baseline PSA, median (range), ng/ml | 123.3 (0.7–8099.9) | 176.5 (0.6–3595.1) | 141.7 (0.4–9253.0) | 123.7 (3.8–10 114.0) | 40.5 (0.0–3927.4) | 36.7 (1.7–1782) | 40.1 (0.6–1715.7) | 36.3 (0.7–6606.4) |
| Baseline haemoglobin, median (range), g/dl | 11.9 (8.1–16.1) | 11.9 (8.4–15.7) | 11.6 (7.3–15.2) | 11.6 (7.2–16.5) | 12.9 (9.3–16.6) | 13.2 (9.3–15.7) | 13.0 (7.2–16.2) | 13.0 (7.0–15.6) |
| Baseline LDH, median (range), IU/l | 216.0 (84.0–3373.0) | 238.0 (143.0–2104.0) | 226.0 (97.0–2232.0) | 238.5 (123.0–1384.0) | 185.0 (60.0–600.0) | 184.0 (108.0–554.0) | 187.0 (103.0–871.0) | 181.0 (87.0–781.0) |
| Time from initial diagnosis to first dose, months | 94.8 (5.8–237.2) | 93.6 (21.1–267.8) | 54.2 (6.9–226.6) | 46.7 (2.0–215.7) | 89.4 (5.9–267.2) | 84.8 (8.8–331.5) | 42.9 (5.6–235.6) | 39.9 (3.0–217.9) |
AA, abiraterone acetate; ECOG PS, Eastern Cooperative Oncology Group performance status; GS, Gleason score; LDH, lactate dehydrogenase; mCRPC, metastatic castration-resistant prostate cancer; P, prednisone; PSA, prostate-specific antigen.