PHASE-II TRIAL OF INTRAPERITONEAL CARBOPLATIN IN OVARIAN-CARCINOMA PATIENTS WITH MACROSCOPIC RESIDUAL DISEASE AT 2ND-LOOK LAPAROTOMY

Background: Because of its antitumour activity and its pharmacological advantage when administered by the intraperitoneal route, carboplatin was studied in a phase II multicentric trial. The aim of the study wa s to determine the response rate and the toxicity of carboplatin admin istered intraperitoneally and to determine if pathological complete re sponse could be attained in women with macroscopic residual ovarian ca ncer at second-look laparotomy after intravenous cisplatin chemotherap y. Patients and methods: Twenty-nine patients with macroscopical resid ual disease after intravenous cisplatin-based chemotherapy at second-l ook laparotomy, were treated at that time with 300 mg/M2 of carboplati n administered in the abdominal cavity every four weeks for six cycles . In instances of negative findings at physical and CT scan examinatio n, laparotomy evaluation was performed and the catheter was removed. T he dose of carboplatin was increased or decreased according to hematol ogical toxicity. Results: Efficacy is evaluable in 25 pts: 2 pts had p athological complete responses and 1 pt had microscopic disease (12% r esponse rate of evaluable patients). Toxicity is evaluable for 135 cyc les in 29 patients. No grade 4 hematological toxicity was observed, 2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia; gra de 3 vomiting was observed in 11% of cycles. No peritoneal complicatio n was observed; catheter dysfunction occurred after the first cycle in one patient who refused a surgical procedure to remove the catheter a nd to pursue treatment. Conclusion: Intraperitoneal carboplatin demons trates efficacy in patients with macroscopical residual disease at sec ond-look laparotomy after first-line cisplatin chemotherapy. The recom mended dose for further studies is 300 mg/m2 administered every 4 week s. A low response rate does not favour a randomised study.