Table 1.
Baseline patient demographics, disease characteristics, and prior therapies according to age subgroup.
| Age <65 years |
Age 65–74 years |
Age ≥75 years |
||||
|---|---|---|---|---|---|---|
| Rucaparib (n = 237) |
Placebo (n = 117) |
Rucaparib (n = 113) |
Placebo (n = 64) |
Rucaparib (n = 25) |
Placebo (n = 8) |
|
| Age, median (range) | 56.0 (39.0–64.0) | 55.0 (36.0–64.0) | 68.0 (65.0–74.0) | 69.0 (65.0–74.0) | 76.0 (75.0–84.0) | 77.5 (76.0–85.0) |
| ECOG performance status, n (%) | ||||||
| 0 | 189 (79.7) | 88 (75.2) | 77 (68.1) | 44 (68.8) | 14 (56.0) | 4 (50.0) |
| 1 | 48 (20.3) | 29 (24.8) | 36 (31.9) | 20 (31.3) | 11 (44.0) | 4 (50.0) |
| Diagnosis, n (%) | ||||||
| Epithelial ovarian cancer | 205 (86.5) | 103 (88.0) | 87 (77.0) | 50 (78.1) | 20 (80.0) | 6 (75.0) |
| Fallopian tube cancer | 13 (5.5) | 4 (3.4) | 15 (13.3) | 6 (9.4) | 4 (16.0) | 0 |
| Primary peritoneal cancer | 19 (8.0) | 10 (8.5) | 11 (9.7) | 7 (10.9) | 1 (4.0) | 2 (25.0) |
| High-grade serous adenocarcinoma | 0 | 0 | 0 | 1 (1.6)a | 0 | 0 |
| BRCA mutation in carcinoma, n (%) | ||||||
| BRCA mutant | 96 (40.5) | 49 (41.9) | 29 (25.7) | 15 (23.4) | 5 (20.0) | 2 (25.0) |
| BRCA1 | 66 (27.8) | 31 (26.5) | 14 (12.4) | 5 (7.8) | 0 | 1 (12.5) |
| BRCA2 | 30 (12.7) | 18 (15.4) | 15 (13.3) | 10 (15.6) | 5 (20.0) | 1 (12.5) |
| Germline | 65 (27.4) | 38 (32.5) | 15 (13.3) | 8 (12.5) | 2 (8.0) | 2 (25.0) |
| Somatic | 25 (10.5) | 9 (7.7) | 12 (10.6) | 7 (10.9) | 3 (12.0) | 0 |
| BRCA unknownb | 6 (2.5) | 2 (1.7) | 2 (1.8) | 0 | 0 | 0 |
| BRCA wild-type | ||||||
| LOH high | 67 (28.3) | 29 (24.8) | 35 (31.0) | 21 (32.8) | 4 (16.0) | 2 (25.0) |
| LOH low | 57 (24.1) | 29 (24.8) | 40 (35.4) | 22 (34.4) | 10 (40.0) | 3 (37.5) |
| LOH indeterminatec | 17 (7.2) | 10 (8.5) | 9 (8.0) | 6 (9.4) | 6 (24.0) | 1 (12.5) |
| No. of prior chemotherapy regimens, median (range) | 2.0 (2.0–6.0) | 2.0 (2.0–5.0) | 2.0 (2.0–6.0) | 2.0 (2.0–6.0) | 2.0 (2.0–5.0) | 2.5 (2.0–4.0) |
| 2, n (%) | 149 (62.9) | 81 (69.2) | 68 (60.2) | 39 (60.9) | 14 (56.0) | 4 (50.0) |
| 3, n (%) | 63 (26.6) | 25 (21.4) | 37 (32.7) | 14 (21.9) | 8 (32.0) | 3 (37.5) |
| ≥4, n (%) | 25 (10.5) | 11 (9.4) | 8 (7.1) | 11 (17.2) | 3 (12.0) | 1 (12.5) |
| No. of previous Pt-based regimens, median (range) | 2.0 (2.0–5.0) | 2.0 (2.0–4.0) | 2.0 (2.0–6.0) | 2.0 (2.0–5.0) | 2.0 (2.0–4.0) | 2.5 (2.0–4.0) |
| 2, n (%) | 153 (64.6) | 82 (70.1) | 69 (61.1) | 40 (62.5) | 14 (56.0) | 4 (50.0) |
| ≥3, n (%) | 84 (35.4) | 35 (29.9) | 44 (38.9) | 24 (37.5) | 11 (44.0) | 4 (50.0) |
| TTP with penultimate Pt-based regimen, median (range) | 13.6 (6.0–115.4) | 16.9 (6.0–107.6) | 14.2 (5.8–120.0) | 12.3 (6.4–238.5) | 10.7 (6.1–106.7) | 13.3 (6.6–33.5) |
| 6 to ≤12, n (%) | 96 (40.5) | 38 (32.5) | 42 (37.2) | 34 (53.1) | 13 (52.0) | 4 (50.0) |
| >12, n (%) | 141 (59.5) | 79 (67.5) | 71 (62.8) | 30 (46.9) | 12 (48.0) | 4 (50.0) |
| Response to last Pt-based regimen, n (%) | ||||||
| CR according to RECIST | 93 (39.2) | 42 (35.9) | 26 (23.0) | 20 (31.3) | 7 (28.0) | 2 (25.0) |
| PR according to RECIST or serologic response according to GCIG CA-125 criteria | 144 (60.8) | 75 (64.1) | 87 (77.0) | 44 (68.8) | 18 (72.0) | 6 (75.0) |
CA-125, cancer antigen 125; CR, complete response; ECOG, Eastern Cooperative Oncology Group; GCIG, Gynecologic Cancer InterGroup; HRR, homologous recombination repair; LOH, loss of heterozygosity; PR, partial response; Pt, platinum; RECIST, Response Evaluation Criteria In Solid Tumors; TTP, time to progression.
According to the patient's records, origin was fallopian tube or ovary.
Tumor sample was BRCA mutant according to Foundation Medicine's T5 next-generation sequencing assay, but a blood sample was not available for central germline testing.
Tumor sample was not evaluable for percentage of genomic LOH because of low tumor content or aneuploidy.