ICON8
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
Phase 3N = 1,566NCT01654146
- Population
- Women with newly diagnosed FIGO stage IC-IV epithelial ovarian, fallopian tube or primary peritoneal cancer, predominantly European
- Design
- Phase 3 trial. Women with newly diagnosed FIGO stage IC-IV epithelial ovarian cancer were randomly assigned to group 1 (carboplatin AUC 5 or 6 plus paclitaxel 175 mg/m2 every 3 weeks), group 2 (carboplatin AUC 5 or 6 every 3 weeks plus paclitaxel 80 mg/m2 weekly) or group 3 (carboplatin AUC 2 plus paclitaxel 80 mg/m2 weekly), after immediate primary surgery or before neoadjuvant chemotherapy with delayed primary surgery. Co-primary outcomes progression-free survival and overall survival, powered to detect a hazard ratio of 0.75 in PFS. 1566 women were randomly assigned between 6 June 2011 and 28 November 2014; analyses by intention to treat. Arm sizes are from the open-access full text. ClinicalTrials.gov lists an estimated enrolment of 1485. Overall survival was a co-primary outcome; this primary PFS paper reports preliminary overall survival only.
- Primary endpoint
- PFS, OS
- Arms
- Group 1: 3-weekly carboplatin and paclitaxel (control, n = 522): Carboplatin AUC 5 or 6 plus paclitaxel 175 mg/m2 every 3 weeks
- Group 2: 3-weekly carboplatin and weekly paclitaxel (experimental, n = 523): Carboplatin AUC 5 or 6 every 3 weeks plus paclitaxel 80 mg/m2 weekly
- Group 3: weekly carboplatin and weekly paclitaxel (experimental, n = 521): Carboplatin AUC 2 plus paclitaxel 80 mg/m2 weekly
- People
- Clamp AR, GCIG
Δ median PFS+3.1 months
Show the numbers
| Endpoint | Analysis | Group 2: 3-weekly carboplatin and weekly paclitaxel / Group 3: weekly carboplatin and weekly paclitaxel | Group 1: 3-weekly carboplatin and paclitaxel | Effect |
|---|---|---|---|---|
| PFS | primaryClamp 2019 | median 20.8 months | median 17.7 months | P=0.35 (group 2 vs 1); 0.51 (group 3 vs 1)The abstract gives medians with interquartile ranges (IQR 10.6 to not reached, 11.9 to 59.0 and 12.0 to 54.0 months), not confidence intervals. The abstract's primary comparison used restricted mean survival time: 24.4 months (97.5% CI 23.0 to 26.0) in group 1, 24.9 (24.0 to 25.9) in group 2 and 25.3 (23.9 to 26.9) in group 3. Data analysed by February 2017, when 1018 (65%) patients had progressed. |
| Endpoint | Analysis | Group 2: 3-weekly carboplatin and weekly paclitaxel / Group 3: weekly carboplatin and weekly paclitaxel | Group 1: 3-weekly carboplatin and paclitaxel | Effect |
|---|---|---|---|---|
| PFS | primaryClamp 2019 | median 20.8 months | median 17.7 months | P=0.35 (group 2 vs 1); 0.51 (group 3 vs 1)The abstract gives medians with interquartile ranges (IQR 10.6 to not reached, 11.9 to 59.0 and 12.0 to 54.0 months), not confidence intervals. The abstract's primary comparison used restricted mean survival time: 24.4 months (97.5% CI 23.0 to 26.0) in group 1, 24.9 (24.0 to 25.9) in group 2 and 25.3 (23.9 to 26.9) in group 3. Data analysed by February 2017, when 1018 (65%) patients had progressed. |
- Group 1: 3-weekly carboplatin and paclitaxel (control)
- Group 2: 3-weekly carboplatin and weekly paclitaxel (experimental)
- Group 3: weekly carboplatin and weekly paclitaxel (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Group 1: 3-weekly carboplatin and paclitaxel | Group 2: 3-weekly carboplatin and weekly paclitaxel | Group 3: weekly carboplatin and weekly paclitaxel |
|---|---|---|---|
| 0 | 100.0% | 100.0% | 100.0% |
| 13 | 60.1% | 64.8% | 65.1% |
| 26 | 36.1% | 42.0% | 42.4% |
| 39 | 21.7% | 27.3% | 27.6% |
| 53 | 12.5% | 17.1% | 17.4% |
Appears in
Sources
Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, 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.