Table 1.
Demographics and baseline characteristics (ITT analysis set).
| China |
Russia |
Overalla |
|||||
|---|---|---|---|---|---|---|---|
| Abiraterone (n = 119) | Prednisone (n = 119) | Abiraterone (n = 35) | Prednisone (n = 34) | Abiraterone (n = 157) | Prednisone (n = 156) | Total (n = 313) | |
| Age (year) | |||||||
| Mean ± SD | 70.50 ± 9.00 | 71.80 ± 8.68 | 66.70 ± 7.30 | 67.40 ± 8.03 | 69.70 ± 8.72 | 70.80 ± 8.64 | 70.30 ± 8.69 |
| <65 years, n (%) | 31 (26) | 24 (20) | 11 (31) | 16 (47) | 42 (27) | 40 (26) | 82 (26) |
| ≥65 years, n (%) | 88 (74) | 95 (80) | 24 (69) | 18 (53) | 115 (73) | 116 (74) | 231 (74) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 2 (2) | 0 | 1 (3) | 2 (6) | 3 (2) | 2 (1) | 5 (2) |
| Not Hispanic or Latino | 117 (98) | 119 (100) | 34 (97) | 32 (94) | 154 (98) | 154 (99) | 308 (98) |
| Race, n (%) | |||||||
| White | 0 | 0 | 35 (100) | 34 (100) | 35 (22) | 34 (22) | 69 (22) |
| Asian | 119 (100) | 119 (100) | 0 | 0 | 122 (78) | 122 (78) | 244 (78) |
| Weight (kg) | |||||||
| Mean ± SD | 69.52 ± 10.80 | 68.76 ± 10.37 | 88.76 ± 13.25 | 82.59 ± 14.03 | 73.67 ± 13.90 | 71.74 ± 12.53 | 72.71 ± 13.25 |
| Years from initial diagnosis to 1st dose | |||||||
| Mean ± SD | 2.99 ± 2.18 | 3.49 ± 3.10 | 3.31 ± 2.20 | 4.02 ± 2.67 | 3.09 ± 2.22 | 3.63 ± 3.02 | 3.36 ± 2.66 |
| Years from staging to 1st dose | |||||||
| Mean ± SD | 2.10 ± 2.94 | 3.50 ± 3.29 | 2.60 ± 3.13 | ||||
| Baseline PSA (ng/mL) | |||||||
| Median (range) | 49.11 (0.37, 12,633.69) | 53.98 (2.37, 2438.76) | 40.30 (1.44, 1554.21) | 72.12 (11.36, 2850.24) | 48.57 (0.37, 12,633.69) | 55.73 (2.37, 2850.24) | 50.89 (0.37, 12,633.69) |
| Gleason score at initial diagnosis, n (%) | |||||||
| <7 | 6 (6) | 8 (8) | 2 (6) | 5 (19) | 8 (6) | 14 (11) | 22 (8) |
| 7 | 36 (36) | 29 (30) | 17 (55) | 13 (50) | 54 (40) | 42 (33) | 96 (37) |
| ≥8 | 58 (58) | 61 (62) | 12 (39) | 8 (31) | 72 (54) | 71 (56) | 143 (55) |
| Baseline extent of disease, n (%) | |||||||
| Bone | 117 (98) | 117 (98) | 27 (77) | 28 (82) | 147 (94) | 148 (95) | 295 (94) |
| Bone only | 94 (79) | 105 (88) | 12 (34) | 9 (27) | 109 (69) | 116 (74) | 225 (72) |
| Soft tissue or node | 22 (19) | 11 (9) | 20 (57) | 22 (65) | 42 (27) | 34 (22) | 76 (24) |
| Other | 6 (5) | 4 (3) | 12 (34) | 8 (24) | 18 (12) | 12 (8) | 30 (10) |
| ECOG performance status, n (%) | |||||||
| 0 | 65 (55) | 65 (55) | 13 (37) | 13 (38) | 80 (51) | 81 (52) | 161 (51) |
| 1 | 54 (45) | 54 (45) | 22 (63) | 21 (62) | 77 (49) | 75 (48) | 152 (49) |
| Evidence of disease progression, n (%) | |||||||
| PSA only | 109 (92) | 110 (92) | 23 (66) | 26 (77) | 135 (86) | 137 (88) | 272 (87) |
| Radiographic progression | 10 (8) | 9 (8) | 12 (34) | 8 (23) | 22 (14) | 19 (12) | 41 (13) |
ECOG, Eastern Cooperative Oncology Group; ITT, intent to treat; PSA, prostate specific antigen.
a
Overall includes subjects from Russia, China, Malaysia, and Thailand.