KOV-HIPEC-01
Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial
N = 184NCT01091636
- Population
- Stage III or IV ovarian cancer with residual tumour under 1 cm after primary or interval cytoreductive surgery
- Design
- Single-blind randomised trial at 2 institutions in South Korea (March 2010 to January 2016). Patients with stage III or IV ovarian cancer and residual tumour size under 1 cm after primary or interval cytoreductive surgery were randomised 1:1 to HIPEC (41.5 degrees C, cisplatin 75 mg/m2, 90 minutes) or a control group. The primary end point was progression-free survival. The name KOV-HIPEC-01 is not in this paper's abstract; follow-up reports of the same trial (for example PMID 35712968, quality of life, citing NCT01091636 and 184 randomised patients) use it.
- Primary endpoint
- PFS
- Arms
- Cytoreductive surgery (control, n = 92): Cytoreductive surgery without HIPEC
- Surgery plus HIPEC (experimental, n = 92): Cytoreductive surgery with HIPEC (cisplatin 75 mg/m2, 90 minutes)
- People
- Lim MC
Δ median PFS+1 monthsΔ median OS+8.2 monthsPFSHR 0.60 (95% CI 0.37–0.99)Δ median PFS+2 monthsOSHR 0.53 (95% CI 0.29–0.96)Δ median OS+13.6 months
Show the numbers
| Endpoint | Analysis | Surgery plus HIPEC | Cytoreductive surgery | Effect |
|---|---|---|---|---|
| PFSAll randomised patients (184); the full text refers to the intention-to-treat population (median follow-up 69.4 months) | primarymedian follow-up 69.4 monthsLim 2022 | median 19.8 months | median 18.8 months | P=0.43Medians as published; the abstract gives interquartile ranges (13.0 to 43.2 months control, 13.7 to 55.4 months HIPEC), not confidence intervals. Median follow-up 69.4 months (IQR 54.4 to 86.3). No hazard ratio is given for the overall comparison. |
| OSAll randomised patients (184); the full text refers to the intention-to-treat population (median follow-up 69.4 months) | primarymedian follow-up 69.4 monthsLim 2022 | median 69.5 months | median 61.3 months | P=0.52Secondary end point. Interquartile ranges in the abstract: 34.3 months to not reported (control) and 45.6 months to not reported (HIPEC). |
| PFSSubgroup: interval cytoreductive surgery after neoadjuvant chemotherapy (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 17.4 months | median 15.4 months | HR 0.60 (95% CI 0.37–0.99)P=0.04Subgroup analysis; the abstract states that the benefit was seen in this subgroup and that the overall result was not significant. |
| OSSubgroup: interval cytoreductive surgery after neoadjuvant chemotherapy (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 61.8 months | median 48.2 months | HR 0.53 (95% CI 0.29–0.96)P=0.04Subgroup analysis. |
| PFSSubgroup: primary cytoreductive surgery (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 23.9 months | median 29.7 months | Subgroup analysis without a reported test. Median overall survival in this subgroup was not reached in the control group and was 71.3 months in the HIPEC group. |
| Endpoint | Analysis | Surgery plus HIPEC | Cytoreductive surgery | Effect |
|---|---|---|---|---|
| PFSAll randomised patients (184); the full text refers to the intention-to-treat population (median follow-up 69.4 months) | primarymedian follow-up 69.4 monthsLim 2022 | median 19.8 months | median 18.8 months | P=0.43Medians as published; the abstract gives interquartile ranges (13.0 to 43.2 months control, 13.7 to 55.4 months HIPEC), not confidence intervals. Median follow-up 69.4 months (IQR 54.4 to 86.3). No hazard ratio is given for the overall comparison. |
| OSAll randomised patients (184); the full text refers to the intention-to-treat population (median follow-up 69.4 months) | primarymedian follow-up 69.4 monthsLim 2022 | median 69.5 months | median 61.3 months | P=0.52Secondary end point. Interquartile ranges in the abstract: 34.3 months to not reported (control) and 45.6 months to not reported (HIPEC). |
| PFSSubgroup: interval cytoreductive surgery after neoadjuvant chemotherapy (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 17.4 months | median 15.4 months | HR 0.60 (95% CI 0.37–0.99)P=0.04Subgroup analysis; the abstract states that the benefit was seen in this subgroup and that the overall result was not significant. |
| OSSubgroup: interval cytoreductive surgery after neoadjuvant chemotherapy (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 61.8 months | median 48.2 months | HR 0.53 (95% CI 0.29–0.96)P=0.04Subgroup analysis. |
| PFSSubgroup: primary cytoreductive surgery (subgroup size not stated in the abstract) | exploratoryLim 2022 | median 23.9 months | median 29.7 months | Subgroup analysis without a reported test. Median overall survival in this subgroup was not reached in the control group and was 71.3 months in the HIPEC group. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.6 | 0.37–0.99 |
| OS | 0.53 | 0.29–0.96 |
- Cytoreductive surgery (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)
| Months | Cytoreductive surgery | Surgery plus HIPEC |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 12 | 64.2% | 65.7% |
| 25 | 39.8% | 41.7% |
| 37 | 25.6% | 27.4% |
| 50 | 15.8% | 17.4% |
- Cytoreductive surgery (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)
| Months | Cytoreductive surgery | Surgery plus HIPEC |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 43 | 61.5% | 65.1% |
| 87 | 37.4% | 42.0% |
| 130 | 23.0% | 27.3% |
| 174 | 14.0% | 17.6% |