Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group

Abstract

Purpose This phase II trial assessed the tolerability and eYcacy of a triplet of oxaliplatin, irinotecan, and Xuorouracil/folinic acid in advanced gastric cancer. Methods Patients with unresectable or metastatic gastric cancer, unexposed to palliative chemotherapy, received oxaliplatin 85 mg/m 2 iv and irinotecan 150 mg/m 2 iv on day 1, 6S-folinic acid 250 mg/m 2 iv and Xuorouracil 750 mg/m 2 iv on day 2, every 2 weeks. Response rate (RR) was assessed after a minimum of four cycles, and treatment continued up to 12 cycles. Results Sixty-three patients were treated, with a median of eight (range 1-12) cycles/patient. Two complete and 19 partial responses were registered (RR 33% [95% CI, 22-46%]). Median progression-free survival was 7.5 (95% CI, 5.6-9.4) months, and median overall survival was 12.1 (95% CI, 10.8-13.4) months. Most common grade ¸3 toxicities were neutropenia (59%), febrile neutropenia (7%), vomiting (20%), and diarrhoea (10%). All-grade neurotoxicity aVected 33% of patients. Conclusions Oxaliplatin, irinotecan, and Xuorouracil/folinic acid administered every 2 weeks are safe and active in advanced gastric cancer. Keywords

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