Phase II trial of weekly irinotecan and carboplatin for relapsed ovarian cancer: A Kansai Clinical Oncology Group study.

Abstract

5089 Background: Irinotecan has shown favorable activities in combination with carboplatin for patients with advanced or recurrent epithelial ovarian cancer (EOC). Thus a multicenter phase II trial was conducted to evaluate the activity and toxicity. Methods: Intravenous administrations of 60 mg/m2 of irinotecan (Days 1 and 8 ) and carboplatin at AUC of 5 mg-min/mL (Day 1), repeated every 21 days, were given to patients with either radiological or serological recurrent EOC. The primary endpoint was response rate (RR) determined by RECIST and GCIG criteria, while the secondary endpoints were adverse events (AEs; NCI-CTCAE ver 2.0) and progression-free survival (PFS). Results: From 2005 to 2009, 40 patients were enrolled in the trial. Their median age was 59 years old (range, 33-78) and histological findings were serous (68%), endometrioid (17%), and others (15%). The number of previous regimens were 1 in 45%, 2 in 30%, and 3 or 4 in 20%. 35 patients (88%) had measurable disease. Overall RR was 31% and median PFS was 5.5 months (range, 1-15) in patients with TFI <6 months, while those were 56% and 10 months (range: 3-16), respectively, in patients with TFI ≥6 months. Grade 3 or 4 toxicities encountered during the first cycle included G3/G4 neutropenia in 14/13 (68%), G3/G4 thrombocytepenia in 17/0 (43%), G3 febrile neutropenia in 2, G3 fatigue in 2, G3 nausea in 1, and G2 diarrhea in 1. Delay of the second cycle in 28 (70%), and the actual dose intensity (DI) of irinotecan and carboplatin during the first 12 weeks were 30.5 mg/m2/week (range,15-40) and 1.4 AUC of 1.4 (range 1.1-1.7), respectively. Conclusions: Our results showed that combination chemotherapy with irinotecan and carboplatin was efficacious in regard to RR and PFS. Severe hematologic toxicity was often observed, but was controllable. We concluded that the regimen was useful as second-line chemotherapy, while the recommended regimen is 60 mg/m2 of irinotecan (Days 1 and 8 ) and carboplatin at an AUC of 5 (Day 1), repeated every 28 days.