Table 5.
Phase II trials (with results) of PARP inhibitors in gynecological cancers
| ID | Cancer/condition | No. | Intervention | ORR (%) | mPFS (mon.) | mOS (mon.) | SAEs (%) | Refs |
|---|---|---|---|---|---|---|---|---|
| NCT00494442 STUDY9 | OC/advanced, BRCAm | 58 | Olaparib | 33.3 | – | – | 36.4 | 411 |
| NCT00753545 STUDY19 | OC/serous, recurrent | 265 | (1) Placebo: BRCAm/BRCAwt | 4.2 | 4.3/5.5, P < 0.0001 | 34.9/30.2, P = 0.025 | 8.6 | 115,412 |
| (2) Olaparib: BRCAm/BRCAwt | 12.3 | 11.2/7.4, P = 0.0075 | 26.6/24.5, P = 0.37 | 22.8 | ||||
| NCT00679783 STUDY 20 | OC/recurrent, HGSOC | 91 | Olaparib: BRCAm/BRCAwt | 41/24 | 7.4/6.4 | – | 16 | 111 |
| NCT00628251 STUDY12 | OC/advanced, BRCAm | 98 | (1) Olaparib (200 mg twice daily) | 25 | 5 | 9 | 15.6 | 413 |
| (2) Olaparib (400 mg twice daily) | 31.3 | 5 | 11 | 18.8 | ||||
| (3) PLD | 18.2 | 4.8 | 13, All P > 0.5 | 15.6 | ||||
| NCT01078662 STUDY42 | OC/BRCAm | 193 | Olaparib | 31.1 | 7.03 | 16.62 | 30.2 | 118 |
| NCT01081951 | OC/advanced or platinum-sensitive recurrent | 173 | (1) PC | – | 9.6 | – | 20.99 | 414 |
| (2) Olaparib + PC | 12.2, P = 0.0012 | 25.33 | ||||||
| NCT01116648 | OC/platinum-sensitive recurrent | 90 | (1) Olaparib | 48.7 | 8.2 | 33.3 | – | 124,128 |
| (2) Cediranib + olaparib | 79.6 | 16.5, P = 0.007 | 44.2, P = 0.11 | 70 | ||||
| NCT02354586 QUADRA | OC/HGSOC, recurrent, HRD | 47 | Niraparib | 28 | 5.5 | 19 | 56 | 141 |
| NCT02657889 KEYNOTE-162 | OC/platinum-resistant recurrent | 62 | Niraparib + pembrolizumab | 18 | 3.4 | Not mature | – | 143 |
| NCT02354131 ENGOT-ov24 | OC/platinum-sensitive recurrent | 97 | (1) Niraparib | 30 | 5.5 | Not mature | – | 142 |
| (2) Niraparib + bevacizumab | 62 | 11.9, P < 0.0001 | 65 | |||||
| NCT01891344 ARIEL2 | OC/platinum-sensitive recurrent, HRD | 204 | Rucaparib: BRCAm | 80 | 12.8 | – | 24.5 | 133 |
| BRCAwt, LOH-high | 29.3 | 5.7 | ||||||
| BRCAwt, LOH-low | 10 | 5.2 | ||||||
| NCT01482715 STUDY10 | OC/BRCAm | 42 | Rucaparib | 59.5 | 76.2 | 134 | ||
| NCT01306032 | OC/HGSOC, BRCAm | 75 | (1) Cyclophosphamide | 19.4 | 3 | – | 0 | * |
| (2) Cyclophosphamide+ veliparib | 11.8 | 3, P = 0.68 | 8.11 | |||||
| NCT01540565 | OC/BRCAm | 52 | Veliparib | 26 | 8.18 | – | 20 | 146 |
| NCT01266447 | CC/persistent or recurrent | 27 | Veliparib + topotecan + filgrastim | 7 | 2 | 8 | 59.3 | 151 |
BRCAwt BRCA wild-type. LOH genomic loss of heterozygosity. *Unpolished data found in ClinicalTrials.gov