Cytoreductive surgery followed by intraperitoneal hyperthermic perfusion in the treatment of recurrent epithelial ovarian cancer: A phase II clinicalstudy

Aims and background: The optimal salvage therapy for recurrent ovarian carc inoma has not been clearly established. Response to second-line chemotherap y is low, with a short median survival (8.8-15 months). We investigated the effect of an aggressive approach consisting of surgery followed by intrape ritoneal drug delivery and local hyperthermia. Patients and methods: In a phase II clinical study, 27 patients with advanc ed/recurrent ovarian carcinoma were treated with cytoreductive surgery and intraperitoneal hyperthermic perfusion. Median patient age was 53 years (ra nge, 30-67) and mean follow-up was 17.4 months (range, 0.3-36.0). Patients had been surgically staged and heavily pretreated with cisplatin-based, tax ol-based or taxol/platinum-containing regimens. Nineteen (70%) patients wer e cytoreduced to minimal residual disease <2.5 mm. The intraperitoneal hype rthermic perfusion was performed with the closed abdomen technique, using a preheated polysaline perfusate containing cisplatin (25 mg/m(2)/L) + mitom ycin C (3.3 mg/m(2)/L) through a heart-lung pump (mean flow of 700 mL/min) for 60 min in the hyperthermic phase (42.5 <degrees>C). Results: Two-year overall survival was 55%. Median times to overall progres sion and local progression were 16 months and 21.8 months, respectively. Va riables that affected the overall survival or time to progression were as f ollows: residual disease (P = 0.00025), patient age (P = 0.04), and lag tim e between diagnosis and cytoreductive surgery + intraperitoneal hyperthermi c perfusion (P= 0.04). treatment-related morbidity, mortality and acute tox icity (grade II-III) rates were 11%, 4% and 11%, respectively. Eight (89%) of 9 patients had ascites resolution. Conclusion: Our results suggest that cytoreductive surgery + intraperitonea l hyperthermic perfusion is a well-tolerated, feasible and promising altern ative in the management of selected patients with recurrent ovarian cancer, but further randomized controlled studies are needed in order to confirm o ur findings.