Table 1.
Included RCTs (multi-center) comparing PARPi to placebo in patients with newly diagnosed ovarian cancer
| Author with publication year (Trial ID) | Sample size, n (PARPi/Placebo) | Stage of disease [No. (%)] | BRCA-mutation status [No. (%)] | HRD status [No. (%)] | Target outcomesa |
|---|---|---|---|---|---|
| Ray-Coquard 2019b (PAOLA-1, NCT02477644) | 806 (Olaparib 537/269) |
FIGO stage III 564 (70) IV 242 (30) |
Positive 241 (29.9) Negative or Unknown 565 (70.1) |
Positive 387 (48.0) Negative 277 (34.4) Unknown 142 (17.6) |
PFS; HRQoL; AE |
| Moore 2018 (SOLO1, NCT01844986) | 391 (Olaparib 260/131) |
FIGO stage III 325 (83.1) IV 66 (16.9) |
Positive 391 (100) | Not reported | PFS; OS; HRQoL; AE |
| González-Martín 2019 (PRIMA, NCT02655016) | 733 (Niraparib 487/246) |
FIGO stage III 476 (64.9) IV 257 (35.1) |
of patients with HRD (n = 373): Positive 223 (30.4) Negative 150 (20.5) Unknown 360 (49.1) |
Positive 373 (50.9) Negative or Unknown 360 (49.1) |
PFS; HRQoL; OS; AE |
|
Coleman 2019c (VELIA, NCT02470585) |
1140 (Veliparib 382/758) |
FIGO stage III 875 (76.8) IV 263 (23.1) Missing data 2 (0.1) |
Positive 298 (26.1) Negative 742 (65.1) |
Positive 627 (55) Negative 372 (32.6) Unknown 141 (12.4) |
PFS; HRQoL; AE |
CA-125 cancer antigen 125, CR complete response, PR partial response, PFS progression free survival, OS overall survival, HRQoL health-related quality of life, AE adverse event, FIGO International Federation of Gynecology and Obstetrics
aOS unable to use in PAOLA-1 and VELIA trials due to not sufficiently mature
bBevacizumab combined use in both olaparib and placebo groups
cThree compared groups in this RCT: (1) control group: chemotherapy plus placebo followed by placebo maintenance; (2) veliparib-combination-only group: chemotherapy plus veliparib followed by placebo maintenance; (3) veliparib-throughout group: chemotherapy plus veliparib followed by veliparib maintenance. Although the results contained a combination of ‘treatment phase’ and ‘maintenance treatment phase’ (no separate data available for ‘maintenance treatment phase’, i.e. group 2 versus group 1), data on group 3 versus group 1 were used in meta-analysis based on conclusions of this trial which PFS in group 2 does not differ from that in group 1