OVHIPEC-1
Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer
Phase 3N = 245NCT00426257
- Population
- Stage III epithelial ovarian cancer with at least stable disease after three cycles of neoadjuvant carboplatin and paclitaxel
- Design
- Multicentre, open-label trial. Patients with stage III epithelial ovarian cancer and at least stable disease after three cycles of carboplatin (AUC 5 to 6) and paclitaxel (175 mg/m2) were randomly assigned at the time of surgery, when complete or optimal (residual tumours of 10 mm or less) cytoreduction was deemed feasible, to interval cytoreductive surgery with or without HIPEC with cisplatin (100 mg/m2). Three further cycles of carboplatin and paclitaxel followed surgery. The primary end point was recurrence-free survival. The name OVHIPEC-1 is the one used in later reports of this trial (for example PMID 35583992).
- Primary endpoint
- RFS
- Arms
- Interval surgery (control, n = 123): Interval cytoreductive surgery without HIPEC
- Interval surgery plus HIPEC (experimental, n = 122): Interval cytoreductive surgery with HIPEC with cisplatin 100 mg/m2
- People
- van Driel WJ
RFSHR 0.66 (95% CI 0.50–0.87)Δ median RFS+3.5 monthsOSHR 0.67 (95% CI 0.48–0.94)Δ median OS+11.8 monthsΔ Grade 3 or 4 adverse events, overall+2 points
Show the numbers
| Endpoint | Analysis | Interval surgery plus HIPEC | Interval surgery | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat analysis, as stated in the abstract (245 patients) | primaryvan 2018 | median 14.2 months | median 10.7 months | HR 0.66 (95% CI 0.50–0.87)P=0.003Hazard ratio for disease recurrence or death. Events in 110 of 123 patients (89%) in the surgery group and 99 of 122 (81%) in the surgery-plus-HIPEC group. |
| OSIntention-to-treat analysis, as stated in the abstract (245 patients) | primarymedian follow-up 4.7 yearsvan 2018 | median 45.7 months | median 33.9 months | HR 0.67 (95% CI 0.48–0.94)P=0.02Key secondary end point. Deaths: 76 patients (62%) in the surgery group and 61 (50%) in the surgery-plus-HIPEC group. |
| Grade 3 or 4 adverse events, overallNot stated in the abstract | primaryvan 2018 | 27% | 25% | P=0.76 |
| Endpoint | Analysis | Interval surgery plus HIPEC | Interval surgery | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat analysis, as stated in the abstract (245 patients) | primaryvan 2018 | median 14.2 months | median 10.7 months | HR 0.66 (95% CI 0.50–0.87)P=0.003Hazard ratio for disease recurrence or death. Events in 110 of 123 patients (89%) in the surgery group and 99 of 122 (81%) in the surgery-plus-HIPEC group. |
| OSIntention-to-treat analysis, as stated in the abstract (245 patients) | primarymedian follow-up 4.7 yearsvan 2018 | median 45.7 months | median 33.9 months | HR 0.67 (95% CI 0.48–0.94)P=0.02Key secondary end point. Deaths: 76 patients (62%) in the surgery group and 61 (50%) in the surgery-plus-HIPEC group. |
| Grade 3 or 4 adverse events, overallNot stated in the abstract | primaryvan 2018 | 27% | 25% | P=0.76 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| RFS | 0.66 | 0.5–0.87 |
| OS | 0.67 | 0.48–0.94 |
- Interval surgery (control)
- Interval surgery plus HIPEC (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Interval surgery | Interval surgery plus HIPEC |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 9 | 55.8% | 64.4% |
| 18 | 31.2% | 41.5% |
| 27 | 17.4% | 26.8% |
| 36 | 9.7% | 17.3% |
- Interval surgery (control)
- Interval surgery plus HIPEC (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Interval surgery | Interval surgery plus HIPEC |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 29 | 55.3% | 64.4% |
| 57 | 31.2% | 42.1% |
| 86 | 17.2% | 27.1% |
| 114 | 9.7% | 17.7% |