| Trial ID # | ISRCTN10356387; ICON8B |
| Phase | III |
| Drug Class | Angiogenesis Inhibitors: VEGF |
| Drug Name | Bevacizumab |
| Alternate Drug Names | immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin |
| Drugs in Trial | Bevacizumab, Carboplatin, Paclitaxel |
| Eligible Participant | Newly diagnosed high-risk stage III/IV ovarian cancer |
| Patients Enrolled | 707; 53% stage IIIC, 40% stage IV, 91% HGSOC. 14% PDS, 84% IDS, 2% no surgery |
| Therapy Setting | First-line |
| Study Design | Double Blind, Randomized |
| Endpoints | PFS, OS, evaluated per RECIST |
| Biomarkers | High risk: stage IIIA1(ii), stage IIIA2 with positive retroperitoneal lymph nodes >1cm in diameter, stage IIIB or IIIC disease with >1cm residual disease following immediate primary surgery (IPS) or those receiving primary chemotherapy with or without delayed primary surgery (DPS), and all stage IV disease |
| Efficacy | Standard of Care (SoC): CarboPt AUC5 or AUC6+Pac 175mg/m2 every 3 weeks+Bev SoC+Bev (n=292) vs CarboPt q3w+Pac qw+Bev (n=286): PFS: 16.7 vs 22.2 months, HR: 0.75 (0.62-0.90, p=0.002) |
| Clinically Significant Adverse Events | SoC+Bev vs CarboPt q3w+Pac qw+Bev: |
| Conclusion | In primary treatment of high-risk stage IIIC/IV ovarian cancer, bevacizumab with weekly taxol and carboplatin improves PFS and OS compared to bevacizumab with standard three weekly chemotherapy |
| Reference | Clamp A et al. ICON8B: GCIG phase III randomised trial comparing weekly dose-dense chemotherapy + bevacizumab to three-weekly chemotherapy+ bevacizumab in first-line high-risk stage III-IV epithelial ovarian cancer treatment: primary progression-free survival analysis. ESGO (2023) abstract 159 |