Table 4.
Phase III trials (with results) of PARP inhibitors in gynecological cancers
| ID | Cancer/condition | No. | Intervention | mPFS (Mos.) | SAEs (%) | Refs |
|---|---|---|---|---|---|---|
| NCT01844986 SOLO-1 | OC/BRCAm | 319 | (1) Placebo | 13.8 | 12.3 | 121 |
| (2) Olaparib | Not reached, P < 0.0001 | 20.8 | ||||
| NCT01874353 SOLO-2 | OC/recurrent, BRCAm | 295 | (1) Placebo | 5.5 | 8.08 | 120 |
| (2) Olaparib | 19.1, P < 0.0001 | 17.95 | ||||
| NCT02477644 PAOLA-1 | OC/stage III–IV | 806 | (1) Bevacizumab+ placebo | 16.6 | 31 | 122 |
| (2) Bevacizumab+ olaparib | 22.1, P < 0·0001 | 31 | ||||
| NCT01847274 NOVA | OC/platinum-sensitive recurrent | 553 | (1) Placebo | HRD:10.4; All:8.2 | 15.08 | 138 |
| (2) Niraparib | HRD: 21.9; All:13.8, *P < 0.0001 | 29.97 | ||||
| NCT02655016 PRIMA | OC/stage III–IV | 733 | (1) Placebo | 8.2 | 18.9 | 140 |
| (2) PC + Niraparib | 13.8, P < 0·0001 | 70.5 | ||||
| NCT01968213 ARIEL3 | OC/platinum-sensitive recurrent | 564 | (1) Placebo | BRCAm: 5.4; HRD: 5.4 | 10.58 | 136 |
| (2) Rucaparib | BRCAm: 16.6; HRD: 13.6, **P < 0.0001 | 21 | ||||
| NCT02470585 GOG-3005 | OC/stage III–IV, HGSOC | 1140 | (1) Placebo | BRCAm: 22.0; HRD: 20.5 | 32 | 150 |
| (2) Veliparib combination only | - | 27 | ||||
| (3) Veliparib throughout | BRCAm: 34.7; HRD: 31.9, ***P < 0.0001 | 45 |
HRD homologous-recombination deficiency, HGSOC high-grade serous ovarian cancer. *P-value of both HRD cohort and all population are <0.0001. ** and *** P-value of both BRCAm and HRD cohorts are <0.0001