Table 1.
Description of randomized trials included in the meta-analysis
| Trial | N (experimental arm) | N (control arm) | Primary endpoint | Secondary endpoint | HR for PFS (95% CI) Whole population |
HR for PFS (95% CI) germline BRCA mutated |
HR for PFS (95% CI) tumor BRCA mutated |
HR for PFS (95% CI) BRCA nonmutated |
HR for PFS (95% CI) HRD positive, including BRCA mutated |
HR for PFS (95% CI) HRD positive, excluding BRCA mutated |
HR for PFS (95% CI) HRD negative |
HR for PFS (95% CI) HRD unknown |
Median follow-up | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E/N (PARPi) | E/N (placebo) | E/N (PARPi) | E/N (placebo) | E/N (PARPi) | E/N (placebo) | E/N (PARPi | E/N (placebo) | E/N (PARPi | E/N (placebo) | E/N (PARPi | E/N (placebo) | E/N (PARPi | E/N (placebo) | |||||||||||
| Moore K17 (SOLO1) |
260 Olaparib |
131 Placebo |
PFS | OS, PFS2 Time until first and second subsequent therapies Quality of life |
— | 118/260 | 100/131 | — | — | — | — | — | — | 60 months | ||||||||||
| 0.33 (0.024-0.43) | ||||||||||||||||||||||||
| Martin AG19 (PRIMA) |
487 Niraparib |
246 Placebo |
PFS | OS, PFS2 Time until subsequent therapy Quality of life |
0.62 (0.50-0.76) | — | — | — | 49/152 | 40/71 | 32/95 | 33/55 | 111/169 | 56/80 | 40/71 | 26/40 | 13.8 months | |||||||
| 0.40 (0.27-0.62) | 0.50 (0.31-0.83) | 0.68 (0.49-0.94) | 0.85 (0.51-1.43) | |||||||||||||||||||||
| Coleman RL20 (VELIA) |
382 Veliparib throughout group 383 Veliparib combination only group |
375 Placebo |
PFS in veliparib throughout group versus control | OS, PFS, and OS in the veliparib combination only group versus control Disease-related symptom score |
0.68 (0.56-0.83) | 27/80 | 36/63 | 7/28 | 15/29 | 142/245 | 171/254 | 87/214 | 124/207 | — | 80/125 | 89/124 | — | 28 months | ||||||
| 0.50 (0.30-0.82) | 0.35 (0.14-0.87) | 0.80 (0.64-1.00) | 0.58 (0.44-0.76) | 0.81 (0.60-1.09) | ||||||||||||||||||||
| Coquard IR21 (PAOLA-1) |
537 Olaparib + bevacizumab |
269 Placebo + bevacizumab |
PFS | OS, PFS2 Time until subsequent therapy Quality of life |
0.59 (0.49-0.72) | — | 41/157 | 49/80 | 239/380 | 145/189 | 87/255 | 92/132 | 43/97 | 40/55 | 145/192 | 66/85 | 48/90 | 36//52 | 22.9 months | |||||
| 0.31 (0.20-0.47) | 0.71 (0.58-0.88) | 0.33 (0.25-0.45) | 0.43 (0.28-0.66) | 0.92 (0.72-1.17 | 0.71 (0.46-1.10) | |||||||||||||||||||
Germline BRCA mutated: includes patients with germline BRCA1 and or BRCA2 mutation positive; Tumor BRCA mutated: includes patients with tumor BRCA 1 and/or BRCA 2 mutation positive; BRCA nonmutated: includes patients with germline and tumor BRCA1/2 nonmutated cases. Homologous repair deficiency was defined as either HRD score of ≥42 (in the PRIMA and POALA1 trials) or HRD score of ≥33 (in the VELIA trial) and/or deleterious BRCA1/2 mutation (germline or tumor). HRD negative was defined as HRD score <33 (in the VELIA trial) and <42 (in the PRIMA and POALA1 trials). HRD unknown was defined as inconclusive, missing, or failed test.
CI, confidence interval; E, number of events in the respective subgroups and treatment arm; HR, hazard ratio; HRD, homologous repair deficiency; N, number of patients in the respective subgroups and treatment arm; N, number of patients; OS, overall survival; PARPi, poly(ADP-ribose) polymerase inhibitor; PFS, progression-free survival; PFS2, second progression-free survival.