Table 4.
Clinical outcome of chemotherapy‐naïve patients with mCRPC in the present study†, pivotal clinical trial, and Asian cohorts
| Factors |
COU‐AA‐302 5 (n = 546) |
Japan 9 (n = 113) |
Hong Kong 8 (n = 58) |
China 15 (n = 103) |
Singapore 16 (n = 163) |
Malaysia† (n = 28) |
Thailand† (n = 41) |
|---|---|---|---|---|---|---|---|
| Median time on AA (range) | 13.8 (0.3‐34.9) | n.a | 6.8 (0.6‐21.5) | n.a | n.a | 11.8 (0.1‐61.0) | 9.7 (0.8‐43.1) |
| Median OS (95% CI) | 34.7 (32.7‐36.8) | n.a | 18.1 (9.9‐25.0) | 27.0 (n.a) | 20.0 (18.3‐22.9) | 17.8 (7.4‐28.2) | 27 (11.3‐42.7) |
| Median PFS (95% CI) | 16.5 a | 9 b | 6.7 c (4.5‐14.7) | 14.0 b (n.a) | 9.6 b 7.8‐11.7) | 10.4 b (8.8‐12.0) | 14 b (5.8‐22.2) |
| PSA decline ≥ 50% within 12 wks, n(%) | 374 (58) | 60 (53.1) | 36 (62.1) | 56 (54.4) | n.a | 13 (56.5) | 22 (57.9) |
| Grade ≥ 3 adverse events, n (%) | 290 (54) | 5 (4.4) | 9 (15.5) | n.a | n.a d | 6 (21.4) | 9 (22) |
Abbreviations: AA, abiraterone acetate; CI, confidence interval; IQR, interquartile range; n.a, not available; OS, overall survival; PFS, progression‐free survival.
†
Indicates that the Malaysia and Thailand cohorts were from the present study.
a
Radiological PFS.
b
Biochemical PFS.
c
Combination of clinical, radiological, or biochemical PFS.
d
Toxicity data for chemotherapy‐naïve patients alone were unavailable.