Table 1.
Baseline characteristics
| BRCA1/2 subgroup | HRR+ population | |||
|---|---|---|---|---|
| NIRA + AAP (n = 113) | PBO + AAP (n = 112) | NIRA + AAP (n = 212) | PBO + AAP (n = 211) | |
| Median age, (range) years | 67 (45–100) | 68 (43–88) | 69 (45–100) | 69 (43–88) |
| ECOG PS, n (%) 0 / 1 | 69 (61.1) / 44 (38.9) | 80 (71.4) / 32 (28.6) | 130 (61.3) / 82 (38.7) | 146 (69.2) / 65 (30.8) |
| Bone metastases, n (%) | 99 (87.6) | 93 (83.0) | 183 (86.3) | 170 (80.6) |
| Visceral metastases, n (%) | 26 (23.0) | 22 (19.6) | 51 (24.1) | 39 (18.5) |
| Liver | 10 (8.8) | 7 (6.3) | 18 (8.5) | 13 (6.2) |
| Lung | 12 (10.6) | 11 (9.8) | 27 (12.7) | 18 (8.5) |
| PSA at study entry (μg/l), median (range) | 18.7 (0.1–2225.8) | 14.1 (0.1–4400.0) | 21.4 (0–4826.5) | 17.4 (0.1–4400.0) |
| Prior taxane-based chemotherapy for nmCRPC/mCSPC, n (%) | 26 (23.0) | 29 (25.9) | 41 (19.3) | 44 (20.9) |
| Prior AR-targeted therapy for nmCRPC/mCSPC, n (%) | 6 (5.3) | 5 (4.5) | 8 (3.8) | 5 (2.4) |
| Prior AAP therapy for L1 mCRPC,a n (%) | 30 (26.5) | 29 (25.9) | 50 (23.6) | 48 (22.7) |
| Key laboratory values, median (range) | ||||
| Alkaline phosphatase enzyme, U/l | 111.0 (36.0–5234.0) | 97.0 (47.0–1892.0) | 106.0 (36.0–5234.0) | 100.0 (47.0–2651.0) |
| Hemoglobin, g/l | 128.0 (64.0–160.0) | 131.0 (75.0–161.0) | 129.0 (64.0–172.0) | 131.0 (75.0–161.0) |
| Lactate dehydrogenase enzyme, U/l | 204.0 (98.0–2959.0) | 197.0 (98.0–1530.0) | 194.0 (84.0–645.0) | 202.0 (131.0–758.0) |
AAP, abiraterone acetate with prednisone; AR, androgen receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; HRR, homologous recombination repair; L1, first line; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; NIRA, niraparib; nmCRPC, nonmetastatic castration-resistant prostate cancer; PBO, placebo; PSA, prostate-specific antigen.
a
Patients could have received up to 4 months of AAP before study entry in the mCRPC setting.