Table 1. Patient baseline characteristics among all patients randomised in the Phase II study (NCT00753545) (Ledermann et al, 2012, 2014).
|
Overall population |
BRCAm |
gBRCAm |
BRCAwt |
|||||
|---|---|---|---|---|---|---|---|---|
| Olaparib (n=136) | Placebo (n=129) | Olaparib (n=74) | Placebo (n=62) | Olaparib (n=53) | Placebo (n=43) | Olaparib (n=57) | Placebo (n=61) | |
| Age, years, median (range) | 58 (21–89) | 59 (33–84) | 58 (38–89) | 55 (33–84) | 56 (38–89) | 55 (33–84) | 62 (21–80) | 63 (49–79) |
| Jewish ancestry,a n (%) | 20 (15) | 17 (13) | 14 (19) | 14 (23) | 10 (19) | 12 (28) | 6 (11) | 3 (5) |
| ECOG performance status, n (%) | ||||||||
| 0 | 110 (81) | 95 (74) | 62 (84) | 45 (73) | 47 (89) | 32 (74) | 45 (79) | 45 (74) |
| 1 | 23 (17) | 30 (23) | 11 (15) | 15 (24) | 5 (9) | 10 (23) | 10 (18) | 14 (23) |
| 2 | 1 (1) | 2 (2) | 0 | 1 (2) | 0 (0) | 1 (2) | 1 (2) | 1 (2) |
| Unknown | 2 (2) | 2 (2) | 1 (1) | 1 (2) | 1 (2) | 0 (0) | 1 (2) | 1 (2) |
| Primary tumour location, n (%) | ||||||||
| Ovary | 119 (88) | 109 (85) | 65 (88) | 54 (87) | 47 (89) | 37 (86) | 50 (88) | 49 (80) |
| Fallopian tube or primary peritoneal | 17 (13) | 19 (15) | 9 (12) | 8 (13) | 6 (11) | 6 (14) | 7 (12) | 11 (18) |
| Other | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Time to progression after completion of most recent platinum-based regimen, n (%) | ||||||||
| >6 to ⩽12 months | 53 (39) | 54 (42) | 28 (38) | 26 (42) | 22 (42) | 21 (49) | 23 (40) | 24 (39) |
| >12 months | 83 (61) | 75 (58) | 46 (62) | 36 (58) | 31 (58) | 22 (51) | 34 (60) | 37 (61) |
| Objective response to most recent platinum-based regimen, n (%) | ||||||||
| Complete response | 57 (42) | 63 (49) | 36 (49) | 34 (55) | 29 (55) | 22 (51) | 20 (35) | 25 (41) |
| Partial response | 79 (58) | 66 (51) | 38 (51) | 28 (45) | 24 (45) | 21 (49) | 37 (65) | 36 (59) |
a
Abbreviations: BRCAm=BRCA mutation; BRCAwt=BRCA wild type; ECOG= Eastern Cooperative Oncology Group; gBRCAm= germline BRCAm. aAncestry was self-reported.