671P - Dose Finding Study of Oxaliplatin, Irinotecan, and S-1 for Patients with Metastatic or Recurrent Gastrointestinal Cancer

Abstract

ABSTRACT Aim: To determine the maximum tolerated dose (MTD), recommended dose (RD), and activity of combined oxaliplatin, irinotecan and S-1 chemotherapy on metastatic or recurrent gastrointestinal (GI) cancer Methods: Oxaliplatin and irinotecan were administered intravenously on day 1 and S-1 was administered orally on days 1-7 of every 2-week cycle. The doses of oxaliplatin/irinotecan/S-1 in phase I study were level 1, 85/120/60 mg/m2; level 2, 85/120/80 mg/m2; level 3, 85/120/100 mg/m2; level 4, 85/150/100 mg/m2; level 5, 85/180/100 mg/m2. Treatment was repeated until disease progression, unacceptable toxicity, or for a maximum of 12 cycles. Results: Twenty-two patients were enrolled in this study between October 2012 and February 2014 (median age, 59). One of six patients at level 1, 3 and 4 developed dose-limiting toxicity (febrile neutropenia) and none of three at level 5 did during the first cycle. As the planned maximum dose did not reach the MTD, the dose used at level 5 was defined as RD. Nineteen patients were evaluated for response. Two complete responses, seven partial responses were noted, and the overall response rate was 47.7%. Conclusions: The triple combination of oxaliplatin, irinotecan, and S-1 showed satisfactory toxicity profile and modest clinical benefit in patient with advanced GI cancer. The RD of oxaliplatin, irinotecan, and S-1 were 85 mg/m2, 180 mg/m2, and 100 mg/m2 every two weeks. Disclosure: All authors have declared no conflicts of interest.