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CHIPOR

Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial

Phase 3N = 415NCT01376752

Population
First relapse of epithelial ovarian cancer at least 6 months after platinum-based chemotherapy, amenable to complete cytoreductive surgery after six cycles of platinum-based chemotherapy
Design
Multicentre, open-label trial at 31 sites in France, Belgium, Spain and Canada. Patients with a first relapse of epithelial ovarian cancer at least 6 months after platinum-based chemotherapy received six cycles of platinum-based chemotherapy (optional bevacizumab); those amenable to complete cytoreductive surgery were randomly assigned during surgery 1:1 to HIPEC (cisplatin 75 mg/m2 in 2 L/m2 at 41 degrees C for 60 minutes) or no HIPEC. The primary endpoint was overall survival.
Primary endpoint
OS
Arms
  • Surgery without HIPEC (control, n = 208): Cytoreductive surgery without HIPEC
  • Surgery plus HIPEC (experimental, n = 207): Cytoreductive surgery with HIPEC (cisplatin 75 mg/m2)
People
Classe JM
OSHR 0.73 (95% CI 0.56–0.96)Δ median OS+8.5 monthsΔ Grade 3 or worse adverse events within 60 days of surgery+22 points
Show the numbers
Results reported for CHIPOR
EndpointAnalysisSurgery plus HIPECSurgery without HIPECEffect
OSIntention-to-treat population, as stated in the abstract (415 patients)primarymedian follow-up 6.2 yearsClasse 2024median 54.3 months (41.9–61.7)median 45.8 months (38.9–54.2)HR 0.73 (95% CI 0.56–0.96)P=0.024Stratified hazard ratio. 268 patients (65%) had died at the primary analysis: 126 of 207 with HIPEC and 142 of 208 without.
Grade 3 or worse adverse events within 60 days of surgeryNot stated in the abstractprimaryClasse 202449%27%102 of 207 patients with HIPEC versus 56 of 208 without. Three deaths within 60 days of surgery, all in the no-HIPEC group.
Results reported for CHIPOR
EndpointAnalysisSurgery plus HIPECSurgery without HIPECEffect
OSIntention-to-treat population, as stated in the abstract (415 patients)primarymedian follow-up 6.2 yearsClasse 2024median 54.3 months (41.9–61.7)median 45.8 months (38.9–54.2)HR 0.73 (95% CI 0.56–0.96)P=0.024Stratified hazard ratio. 268 patients (65%) had died at the primary analysis: 126 of 207 with HIPEC and 142 of 208 without.
Grade 3 or worse adverse events within 60 days of surgeryNot stated in the abstractprimaryClasse 202449%27%102 of 207 patients with HIPEC versus 56 of 208 without. Three deaths within 60 days of surgery, all in the no-HIPEC group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.730.56–0.96
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100120Months (modelled)
  • Surgery without HIPEC (control)
  • 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)
MonthsSurgery without HIPECSurgery plus HIPEC
0100.0%100.0%
3459.8%64.8%
6835.7%42.0%
10221.4%27.2%
13612.8%17.6%
Primary publication: Classe JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, et al. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024;25(12):1551-1562. PubMedDOI

Appears in

Sources

  1. Classe JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, et al. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024;25(12):1551-1562.

    PubMedDOI