Gynecologic oncology · 2026
The role of hyperthermic intraperitoneal chemotherapy in newly diagnosed and recurrent ovarian cancer: A time-to-event meta-analysis of randomized trials.
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Altayf Alhasan, Nelson Gregg, Chiva Luis M, Restaino Stefano, Fadeli Loubna, Nounou Mohamedhen Vall, Abuasaker Husam, Elgazzar Mohamed, Shoulkamy Tasneem, Elhadi Muhammed
Аннотация
BACKGROUND: The role of hyperthermic intraperitoneal chemotherapy (HIPEC) in epithelial ovarian cancer remains debated, with inconsistent results across clinical settings. This meta-analysis used reconstructed time-to-event data from randomized trials to provide a time-sensitive evaluation of HIPEC's therapeutic impact.
METHODS: A systematic search of PubMed, Scopus, Web of Science, CENTRAL, and ClinicalTrials.gov (through June 2025) identified randomized controlled trials (RCTs) comparing cytoreductive surgery (CRS) with or without HIPEC in newly diagnosed or recurrent ovarian cancer. Time-to-event data were reconstructed from published Kaplan-Meier curves to generate pooled analyses for progression-free survival (PFS) and overall survival (OS), supplemented by restricted mean survival time (RMST) estimates. Subgroup analyses were performed by disease setting and HIPEC duration, and safety outcomes were synthesized using a random-effects model.
RESULTS: Seven RCTs comprising 1300 patients (CRS alone, n = 653; CRS + HIPEC, n = 647) met the inclusion criteria. In newly diagnosed ovarian cancer treated with interval CRS after neoadjuvant chemotherapy, HIPEC conferred a significant survival advantage, improving both PFS (HR = 0.65, 95% CI 0.52-0.82, p < 0.001) and OS (HR = 0.68, 95% CI 0.54-0.86, p = 0.001). In contrast, no statistically significant benefit was detected in the recurrent setting (OS: HR = 0.85, 95% CI 0.69-1.03, p = 0.10; PFS: HR = 0.95, 95% CI 0.81-1.12, p = 0.52). For recurrent disease, the RMST for PFS was 2.25 years (95% CI 1.95-2.55) with HIPEC versus 2.27 years (95% CI 1.94-2.60) with CRS alone, yielding a ΔRMST of -0.02 years (95% CI -0.46 to 0.43, p = 0.94). Subgroup analyses suggested the most pronounced effect with 90-min HIPEC protocols. Grade ≥ 3 adverse events occurred in 45.7% of patients receiving HIPEC compared with 36.4% in the control arm (RR = 1.17, 95% CI 0.87-1.58, p = 0.29). The most frequent toxicities were electrolyte disturbances and renal dysfunction, both typically mild and reversible.
CONCLUSIONS: HIPEC significantly improves PFS and OS when integrated with interval CRS for newly diagnosed ovarian cancer, particularly with a 90-min perfusion, without a meaningful rise in severe toxicity. Its value in recurrent disease remains uncertain and requires further investigations.
PROTOCOL REGISTRATION: This meta-analysis was prospectively registered in PROSPERO (registration number: CRD420251152447).
METHODS: A systematic search of PubMed, Scopus, Web of Science, CENTRAL, and ClinicalTrials.gov (through June 2025) identified randomized controlled trials (RCTs) comparing cytoreductive surgery (CRS) with or without HIPEC in newly diagnosed or recurrent ovarian cancer. Time-to-event data were reconstructed from published Kaplan-Meier curves to generate pooled analyses for progression-free survival (PFS) and overall survival (OS), supplemented by restricted mean survival time (RMST) estimates. Subgroup analyses were performed by disease setting and HIPEC duration, and safety outcomes were synthesized using a random-effects model.
RESULTS: Seven RCTs comprising 1300 patients (CRS alone, n = 653; CRS + HIPEC, n = 647) met the inclusion criteria. In newly diagnosed ovarian cancer treated with interval CRS after neoadjuvant chemotherapy, HIPEC conferred a significant survival advantage, improving both PFS (HR = 0.65, 95% CI 0.52-0.82, p < 0.001) and OS (HR = 0.68, 95% CI 0.54-0.86, p = 0.001). In contrast, no statistically significant benefit was detected in the recurrent setting (OS: HR = 0.85, 95% CI 0.69-1.03, p = 0.10; PFS: HR = 0.95, 95% CI 0.81-1.12, p = 0.52). For recurrent disease, the RMST for PFS was 2.25 years (95% CI 1.95-2.55) with HIPEC versus 2.27 years (95% CI 1.94-2.60) with CRS alone, yielding a ΔRMST of -0.02 years (95% CI -0.46 to 0.43, p = 0.94). Subgroup analyses suggested the most pronounced effect with 90-min HIPEC protocols. Grade ≥ 3 adverse events occurred in 45.7% of patients receiving HIPEC compared with 36.4% in the control arm (RR = 1.17, 95% CI 0.87-1.58, p = 0.29). The most frequent toxicities were electrolyte disturbances and renal dysfunction, both typically mild and reversible.
CONCLUSIONS: HIPEC significantly improves PFS and OS when integrated with interval CRS for newly diagnosed ovarian cancer, particularly with a 90-min perfusion, without a meaningful rise in severe toxicity. Its value in recurrent disease remains uncertain and requires further investigations.
PROTOCOL REGISTRATION: This meta-analysis was prospectively registered in PROSPERO (registration number: CRD420251152447).