Table 1.
Baseline characteristics of included studies.
| First author | Year | Registry number | Study code | Phase | Setting | Sample (Int/Con) | Intervention arm | Control arm | BRCA status | Follow-up (month) | Reported outcomes | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of BRCAm patients (Int/Con) | No. of BRCAw patients (Int/Con) | |||||||||||
| Ledermann (18, 21) | 2014 | NCT00753545 | Study 19 | II | Platinum-sensitive relapsed ovarian cancer | 265 (136/129) | Olaparib 400 mg twice daily | Placebo | 136 a (74/62) | 118 (57/61) | 78* | PFS, OS, grade ≥3 AEs |
| Pujade-Lauraine (12) | 2017 | NCT01874353 | SOLO2 | III | Platinum-sensitive relapsed ovarian cancer | 295 (196/99) | Olaparib 300 mg twice daily | Placebo | 295 b (196/99) | 0 | 22 | PFS, OS, grade ≥3 AEs |
| Moore (19) | 2018 | NCT01844986 | SOLO1 | III | Newly diagnosed advanced ovarian cancer | 391 (260/131) | Olaparib 300 mg twice daily | Placebo | 391 a (260/131) | 0 | 41 | PFS, OS, grade ≥3 AEs |
| Mirza (11) | 2016 | NCT01847274 | NOVA | III | Platinum-sensitive relapsed ovarian cancer | 553 (372/181) | Niraparib 300 mg once daily | Placebo | 203 b (138/65) | 249 (163/86) | 16.9 | PFS, grade ≥3 AEs |
| González-Martín (20) | 2019 | NCT02655016 | PRIMA | III | Newly diagnosed advanced ovarian cancer | 733 (487/246) | Niraparib 300 mg once daily | Placebo | 223 a (152/71) | 399 (264/135) | 13.8 | PFS, OS, grade ≥3 AEs |
| Coleman (13, 22) | 2017 | NCT01968213 | ARIEL3 | III | Platinum-sensitive relapsed ovarian cancer | 564 (375/189) | Rucaparib 600 mg twice daily | Placebo | 196 a (130/66) | 368 (245/123) | 36 | PFS, grade ≥3 AEs |
Int, intervention arm; Con, control arm; No., number; BRCAm, BRCA mutated; BRCAw, BRCA wild-type; PFS, progression-free survival; OS, overall survival; AEs, adverse events.
*Study 19 corresponded to 79% OS data maturity with a median follow-up of 78.0 months.
a
Patients with a germline or somatic BRCA mutation.
b
Patients with a germline BRCA mutation.