Authors | Design | Population | Number of participants | Treatment arms | PFS | Number of adverse events (grade ≥ 3) | ||
---|---|---|---|---|---|---|---|---|
HR | 95% CI | P value | ||||||
Burger et al. (2011) [7], GOG 218 | RCT, Phase 3 | Overall population with ovarian cancer (Serous type: 85%, stage III: 74.5%, stage IV: 25.5%) | Bevacizumab: 625 Control: 623 | Bevacizumab: (Carboplatin AUC6 + Paclitaxel 175 mg/m2) q21 × 6 cycles + Bevacizumab 15 mg/kg q21 for cycles 2 through 22 Control: (Carboplatin AUC6 + Paclitaxel 175 mg/m2 + Placebo) q21 × 6 cycles + Placebo maintenance * Bevacizumab or placebo was initiated at cycle 2, rather than cycle 1. | 0.717 | 0.625–0.824 | < 0.001 | Bevacizumab: 408/607 Control: 356/608 |
Perren et al. (2011) [8], ICON 7 | RCT, Phase 3 | Overall population with ovarian cancer (Serous type: 69%, stage I, II: 18.4%, stage III: 68.4%, stage IV: 13.2%) | Bevacizumab: 764 Control: 764 | Bevacizumab: (Carboplatin AUC5 or 6 + Paclitaxel 175 mg/m2) q21 × 6 cycles + Bevacizumab 7.5 mg/kg q21 concurrently for 5 or 6 cycles and continued for 12 additional cycles or until PD Control: (Carboplatin AUC5 or 6 + Paclitaxel 175 mg/m2) q21 × 6 cycles * Bevacizumab was omitted at cycle 1 if chemotherapy was started within 4 weeks of surgery | 0.81 | 0.70–0.94 | 0.004 | Bevacizumab: 491/745 Control: 419/753 |
Moore et al. (2018) [17], SOLO1 | RCT, Phase 3 | BRCAm cohort (High grade serous type: 96%, stage III: 83.1%, stage IV: 16.9%) | PARPi: 260 Control: 131 | Eligibility: Women who had a complete or partial clinical response after platinum-based chemotherapy Randomization: After completion of platinum-based chemotherapy PARPi: Oral Olaparib 300 mg twice daily until PD Control: Placebo | 0.3 | 0.23–0.41 | < 0.001 | PARPi: 208/260 Control: 42/130 |
González-Martín et al. (2019) [18], PRIMA | RCT, Phase 3 | Overall population with ovarian cancer (Serous type: 95%, stage III: 64.9%, stage IV: 35.1%) | PARPi: 487 Control: 246 | Eligibility: Women who had a complete or partial clinical response after platinum-based chemotherapy Randomization: Within 12 weeks after completion of the last dose of platinum-based chemotherapy PARPi: Oral Niraparib 300 mg once daily in 28-day cycles for 36 months or until PD (200 mg in some cases) Control: Placebo | 0.62 | 0.5–0.76 | < 0.001 | PARPi: 341/484 Control: 46/244 |
BRCAm cohort | PARPi: 152 Control: 71 | 0.4 | 0.27–0.62 | |||||
HRD cohort (Serous type: 93.8%, stage III: 64.1%, stage IV: 35.9%) | PARPi: 247 Control: 126 | 0.43 | 0.31–0.59 | < 0.001 | ||||
Coleman et al. (2019) [19], VELIA | RCT, Phase 3 | Overall population with ovarian cancer (High grade serous type: 100%, stage III: 77.6%, stage IV: 22.4%) | PARPi: 382 Control: 375 | PARPi: Carboplatin (AUC6, q21) + Paclitaxel (175 mg/m2 q21 or 80 mg/m2 q7) + oral Veliparib (150 mg twice daily) × 6 cycles followed by oral Veliparib 300 mg twice daily for 14 days and then oral Veliparib 400 mg twice daily until PD Control: Carboplatin (AUC6, q21) + Paclitaxel (175 mg/m2 q21 or 80 mg/m2 q7) + Placebo × 6 cycles + Placebo maintenance | 0.68 | 0.56–0.83 | < 0.001 | PARPi: 332/377 Control: 285/371 |
BRCAm cohort (stage III: 79.5%, stage IV: 20.5%) | PARPi: 108 Control: 90 | 0.44 | 0.28–0.68 | < 0.001 | ||||
HRD cohort (stage III: 77.7%, stage IV: 22.3%) | PARPi: 214 Control: 207 | 0.57 | 0.43–0.76 | < 0.001 |