Concentration‐Based Short‐Course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Cytoreductive Surgery (iCRS) for Advanced Ovarian Cancer: Final Analysis of Overall Survival in a Phase 2 Trial
Thales Paulo Batista, Ana Beatriz Diniz de Barros, Vandré Cabral Gomes Carneiro, Rodrigo Tancredi, Levon Badiglian‐Filho, Ronaldo Lúcio Rangel Costa, André Lopes, Bruno José de Queiroz Sarmento, Cristiano Souza LeãoABSTRACT
Background
The optimal regimen for Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) remains controversial. We aim to present long‐term overall survival results from our phase 2 trial evaluating a concentration‐based short‐course regimen for ovarian cancer at the time of interval CytoReductive Surgery (iCRS).
Methods
This was a multicenter, single‐arm, phase 2 trial including patients with advanced ovarian cancer undergoing iCRS after neoadjuvant chemotherapy (NACT). HIPEC was administered via the closed‐abdomen technique for 30 min at 41°C–43°C, comprising the use of cisplatin (25 mg/L of perfusate/m 2 , total limit 240 mg) alone, or in combination with doxorubicin (15 mg/L, total limit 90 mg).
Results
Between February 2015 and July 2019, fifteen patients were enrolled and followed for a median of 110.6 months (95% CI, 85.2 – not reached). Median overall survival was 83.9 months (95% CI, 31.3 – not reached), with a 5‐year survival rate of 53.3% (95% CI, 33.2–85.6) and a restricted mean survival time truncated at 5 years of 45·6 months (95% CI, 37.2–54.0). At the time of this analysis, 13.3% were alive without disease, 13.3% remained on systemic therapy, and 73.3% had died.
Conclusion
Concentration‐based short‐course HIPEC is a feasible and safe regimen for ovarian cancer patients. This approach is associated with favorable long‐term overall survival, highlighting the need for head‐to‐head comparisons of different HIPEC regimens.