Table 1.
Characteristics of the Patients at Baseline (Intention-to-Treat Population).*
| Characteristic | Rucaparib (N = 270) | Control (N = 135) |
|---|---|---|
| Demographic | ||
| Age | ||
| Median (range) — yr | 70 (45–90) | 71 (47–92) |
| ≥65 yr — no. (%) | 186 (69) | 103 (76) |
| Race — no. (%)† | ||
| White | 199 (74) | 103 (76) |
| Black | 10 (4) | 4 (3) |
| Asian | 4 (1) | 1 (1) |
| Other | 4 (1) | 0 |
| Missing data | 53 (20) | 27 (20) |
| Medical history | ||
| ECOG performance-status score — no. (%)‡ | ||
| 0 | 132 (49) | 68 (50) |
| 1 | 138 (51) | 67 (50) |
| Gene alteration — no. (%)‡ | ||
| BRCA1 | 29 (11) | 15 (11) |
| BRCA2 | 172 (64) | 86 (64) |
| ATM | 69 (26) | 34 (25) |
| Genomic test — no. (%) | ||
| Tissue | 79 (29) | 39 (29) |
| Plasma | 170 (63) | 79 (59) |
| Other | 21 (8) | 17 (13) |
| Distant metastasis — no. (%) | ||
| M0 | 110 (41) | 53 (39) |
| M1 | 112 (41) | 65 (48) |
| MX | 36 (13) | 16 (12) |
| Missing data | 12 (4) | 1 (1) |
| Median PSA (range) — ng/ml | 26.9 (0.1–1247) | 28.8 (0–1039) |
| Metastases on independent imaging-based review — no. (%) | ||
| Bone | 235 (87) | 114 (84) |
| Nodal | 118 (44) | 60 (44) |
| Visceral | 74 (27) | 46 (34) |
| Hepatic metastases — no. (%)‡ | 23 (9) | 11 (8) |
| Gleason score of ≥8 at diagnosis — no. (%)§ | 173 (64) | 96 (71) |
| Measurable disease on independent imaging-based review — no. (%) | 106 (39) | 55 (41) |
| Previous therapies | ||
| Any anticancer therapy — no. (%) | ||
| Second-generation ARPI | ||
| Abiraterone acetate | 150 (56) | 80 (59) |
| Apalutamide | 8 (3) | 1 (1) |
| Enzalutamide | 119 (44) | 61 (45) |
| Docetaxel for hormone-sensitive prostate cancer | 63 (23) | 28 (21) |
| Therapy for castration-resistant prostate cancer — no. (%) | ||
| 0 | 48 (18) | 26 (19) |
| ≥1 | 222 (82) | 109 (81) |
| Assigned control medication — no. (%) | ||
| Docetaxel | NA | 75 (56) |
| Abiraterone acetate | NA | 28 (21) |
| Enzalutamide | NA | 32 (24) |
*
Control medications were chosen by the treating physician and included docetaxel or a second-generation androgen-receptor pathway inhibitor (ARPI; abiraterone acetate or enzalutamide). ECOG denotes Eastern Cooperative Oncology Group, NA not applicable, and PSA prostate-specific antigen.
†
Race was reported by the patient. Some data regarding race were missing owing to region-specific privacy laws.
‡
This category was a stratification factor at randomization.
§
The scale for the Gleason score ranges from 2 to 10, with higher scores indicating a worse prognosis.