Table 1.
Baseline Characteristics at Randomization.
| CCVD− | p Value | CCVD+ | p Value | p Value CCVD− vs CCVD+ | ||||
|---|---|---|---|---|---|---|---|---|
| ENZ | ABI | ENZ | ABI | |||||
| n | 75 | 67 | 14 | 22 | ||||
| Age (years) | 74 (46-88) | 77 (53-92) | 0.1113 | 79.5 (65-88) | 77 (65-85) | 0.4199 | 0.1758 | |
| Performance status | >0.9999 | 0.4672 | 0.2781 | |||||
| 0 | 59 (79) | 52 (78) | 11 (79) | 14 (64) | ||||
| 1 | 16 (21) | 15 (22) | 3 (21) | 8 (36) | ||||
| Gleason score | 0.0804 | 0.5485 | 0.4043 | |||||
| 5-7 | 8 (11) | 13 (19) | 3 (21) | 3 (14) | ||||
| 8 | 14 (19) | 16 (24) | 3 (21) | 5 (23) | ||||
| 9 | 43 (57) | 28 (42) | 8 (57) | 12 (55) | ||||
| 10 | 9 (12) | 7 (10) | 0 | 1 (5) | ||||
| Not available | 1 (1) | 3 (4) | 0 | 1 (5) | ||||
| Local treatment* | >0.9999 | 0.0924 | 0.1481 | |||||
| Prostatectomy | 3 (4) | 4 (6) | 2 (14) | 1 (5) | ||||
| Irradiation† | 16 (21) | 13 (19) | 6 (42) | 5 (23) | ||||
| None | 55 (73) | 48 (72) | 6 (42) | 16 (73) | ||||
| Regional lymph node metastasis | 0.6017 | 0.4715 | >0.9999 | |||||
| Yes | 28 (37) | 22 (33) | 6 (43) | 6 (27) | ||||
| No | 47 (63) | 45 (67) | 8 (57) | 16 (73) | ||||
| Distant metastasis | 0.1587 | 0.4315 | 0.825 | |||||
| Bone | 52 (69) | 47 (70) | 8 (57) | 13 (59) | ||||
| Lymph node | 17 (23) | 7 (10) | 6 (43) | 6 (27) | ||||
| Lung | 5 (7) | 6 (9) | 2 (14) | 1 (5) | ||||
| Liver | 1 (1) | 1 (1) | 0 | 0 | ||||
| Others | 0 | 1 (1) | 1 (7) | 0 | ||||
| No | 13 (17) | 19 (28) | 2 (14) | 7 (32) | ||||
| No. of previous systemic therapy‡ | 2 (1-5) | 3 (1-5) | 0.4268 | 3 (1-4) | 2 (1-5) | 0.5164 | 0.9788 | |
| Prostate-specific antigen (ng/mL) | ||||||||
| At diagnosis§ | 114 (1.8-5400) | 102 (0.9-3888) | 0.4939 | 64.2 (9.0-2923) | 112 (12.7-6010) | 0.7966 | 0.2178 | |
| At nadir before registration|| | 0.3 (0.003-185) | 0.4 (0.001-28.3) | 0.0565 | 0.1 (0.003-2.3) | 0.829 (0.004-68.7) | 0.2035 | 0.5468 | |
| At registration | 6.8 (2.0-327) | 10.8 (2.0-479) | 0.264 | 7.1 (2.1-82.2) | 12.2 (2.4-549) | 0.2891 | 0.688 | |
| Time from diagnosis of prostate cancer to randomization (months)¶ | 29.0 (3.0-197) | 25.8 (4.5-190) | 0.609 | 54.8 (9.8-142) | 23.8 (7.6-111) | 0.023 | 0.6803 | |
| Time from castration resistance to randomization (months)** | 1.4 (0.0-122) | 1.3 (0.0-56.2) | 0.263 | 1.6 (0.0-23.3) | 1.2 (0.0-37.4) | 0.543 | 0.9761 | |
Data are median (range), n (%).
ABI: abiraterone plus prednisolone; CCVD: cardio-cerebrovascular disease; ENZ: enzalutamide.
*Data of 3 in the CCVD− group are not available.
†Including high and low dose rate brachytherapy, and external beam radiation therapy for primary site.
‡Medical or surgical castration is counted as 1, and data of 3 in CCVD− are not available.
§Data of 1 in the CCVD+ group is not available.
||Data of 5 in the CCVD− group and 2 in the CCVD+ group are not available.
¶Data of 2 in the CCVD− group and 1 in the CCVD+ group are not available.
**Data of 7 in the CCVD− group and 6 in the CCVD+ group are not available.