Table 1. Characteristics of the patients at baseline in the Japan subset*.
| Characteristics | Olaparib + bevacizumab (n=15) | Placebo + bevacizumab (n=9) | ||
|---|---|---|---|---|
| Median age, yr (range) | 61.0 (44–71) | 59.0 (44–70) | ||
| ECOG performance status | ||||
| 0 | 15 (100) | 8 (89) | ||
| 1 | 0 | 1 (11) | ||
| Primary tumor location | ||||
| Ovary | 8 (53) | 6 (67) | ||
| Fallopian tube | 2 (13) | 0 | ||
| Primary peritoneal | 5 (33) | 3 (33) | ||
| FIGO stage | ||||
| III | 10 (67) | 7 (78) | ||
| IV | 5 (33) | 2 (22) | ||
| Normal serum CA-125 level | ||||
| Yes | 13 (87) | 8 (89) | ||
| No | 2 (13) | 1 (11) | ||
| Histology | ||||
| Serous | 14 (93) | 9 (100) | ||
| Endometrioid | 1 (7) | 0 | ||
| History of cytoreductive surgery | ||||
| Upfront surgery | 8 (53) | 5 (56) | ||
| Macroscopic residual disease | 8 (100) | 3 (60) | ||
| Complete resection | 0 | 2 (40) | ||
| Interval surgery | 7 (47) | 4 (44) | ||
| Macroscopic residual disease | 1 (14) | 0 | ||
| Complete resection | 6 (86) | 4 (100) | ||
| No surgery | 0 | 0 | ||
| Response after first-line chemotherapy | ||||
| No evidence of disease† | 5 (33) | 5 (33) | ||
| Complete response‡ | 6 (40) | 4 (44) | ||
| Partial response§ | 4 (27) | 2 (22) | ||
| Deleterious tumor BRCAm | ||||
| Yes | 3 (20) | 2 (22) | ||
| No | 12 (80) | 7 (78) | ||
| Myriad tumor HRD status∥ | ||||
| HRD positive | 10 (67) | 6 (67) | ||
| HRD negative | 3 (20) | 3 (33) | ||
| HRD test cancelled/failed | 2 (13) | 0 | ||
Values are presented as number (%).
BRCAm, BRCA mutation; CA-125, cancer antigen; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; HRD, homologous recombination repair deficiency; ULN, upper limit of normal.
*Percentages may not total 100% because of rounding. †No evidence of disease was defined as no measurable/assessable disease after cytoreductive surgery plus no radiologic evidence of disease and a normal CA-125 level after chemotherapy. ‡Complete response was defined as disappearance of all measurable/assessable disease and normalization of CA-125 levels. §Partial response was defined as radiologic evidence of disease and/or an abnormal CA-125 level. ∥HRD positive was defined as tumor BRCAm and/or genomic instability score of ≥42 with the myChoice® CDx assay (Myriad Genetic Laboratories, Inc., Salt Lake City, UT, USA). HRD negative was defined as genomic instability score of <42.