| Trial ID # | NCT01654146; ICON8 |
| Phase | III |
| Drug Class | Chemotherapy |
| Drug Name | Carboplatin |
| Alternate Drug Names | Paraplatin, Novoplatinum |
| Drugs in Trial | Carboplatin, Paclitaxel |
| Eligible Participant | Newly diagnosed stage IC-IV epithelial ovarian cancer |
| Patients Enrolled | 1566 (20% stage IC-II, 60% stage III, 20% stage IV) |
| Therapy Setting | First-line |
| Study Design | Open-Label, Randomized |
| Endpoints | PFS, OS, evaluated per RECIST |
| Efficacy | Standard of Care (SoC): CarboPt AUC5 or AUC6+Pac 175mg/m2 every 3 weeks SoC (n=522) vs CarboPt q3w+Pac qw (n=523) vs CarboPt+Pac qw (n=521): PFS: 25 vs 25.8 vs 25.9 months Exploratory analysis, patients planned for neoadjuvant chemotherapy followed by IDS w/ RECIST and/or GCIG CA125-evaluable disease: |
| Clinically Significant Adverse Events | SoC vs CarboPt q3w+Pac qw vs CarboPt+Pac qw: |
| Conclusion | Weekly dose-dense chemotherapy can be delivered successfully as first-line treatment for epithelial ovarian cancer but does not significantly improve PFS compared with standard chemotherapy every 3 weeks |
| Reference | Clamp AR et al. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment (ICON8): primary progression free survival analysis results from a GCIG phase 3 randomised controlled trial. Lancet (2019) 394(10214):2084-2095 Morgan RD et al. Objective responses to first-line neoadjuvant carboplatin-paclitaxel regimens for ovarian, fallopian tube, or primary peritoneal carcinoma (ICON8): post-hoc exploratory analysis of a randomised, phase 3 trial. Lancet Oncol (2021) 22(2):277-288 Clamp AR et al. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet (2022) 23(7):919-930 |