Table 1:
Patient demographics and baseline characteristics in intention-to-treat population
| Rucaparib group (n=375) |
Placebo group (n=189) |
|
|---|---|---|
| Age, years | 61·0 (53·0–67·0) |
62·0 (53·0–68·0) |
| ECOG performance status | ||
| 0 | 280 (75%) | 136 (72%) |
| 1 | 95 (25%) | 53 (28%) |
| Diagnosis | ||
| Epithelial ovarian cancer | 312 (83%) | 159 (84%) |
| Fallopian tube cancer | 32 (9%) | 10 (5%) |
| Primary peritoneal cancer | 31 (8%) | 19 (10%) |
| High-grade serous adenocarcinoma | 0 | 1 (1%)* |
| BRCA mutation in the carcinoma | ||
| BRCA mutant | 130 (35%) | 66 (35%) |
| BRCA1 | 80 (21%) | 37 (20%) |
| BRCA2 | 50 (13%) | 29 (15%) |
| Germline | 82 (22%) | 48 (25%) |
| Somatic | 40 (11%) | 16 (8%) |
| Unknown† | 8 (2%) | 2 (1%) |
| BRCA wild type | 245 (65%) | 123 (65%) |
| High LOH | 106 (28%) | 52 (28%) |
| Low LOH | 107 (29%) | 54 (29%) |
| Indeterminate LOH‡ | 32 (9%) | 17 (9%) |
| Number of previous platinum-based regimens | ||
| 2 | 236 (63%) | 126 (67%) |
| 3 | 109 (29%) | 47 (25%) |
| >3 | 30 (8%) | 16 (8%) |
| Time to progression with penultimate platinum-based regimen, months | ||
| 6 to ≤12 | 151 (40%) | 76 (40%) |
| >12 | 224 (60%) | 113 (60%) |
| Response to last platinum-based regimen | ||
| Complete response according to RECIST | 126 (34%) | 64 (34%) |
| Partial response according to RECIST or serological response according to GCIG CA 125 criteria | 249 (66%) | 125 (66%) |
Adapted from Coleman et al12 by permission of Elsevier. Data are median (IQR) or n (%). CA 125=cancer antigen 125. ECOG=Eastern Cooperative Oncology Group. GCIG=Gynecologic Cancer InterGroup. LOH=loss of heterozygosity.
RECIST=Response Evaluation Criteria In Solid Tumors version 1.1.
*
According to the patient records, origin was fallopian tube or ovary.
†
Tumour 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.
‡
Tumour sample was not evaluable for percentage of genomic LOH because of low tumour content or aneuploidy.