671P - Dose finding study of oxaliplatin, irinotecan, and S-1 for patients with metastatic or recurrent gastrointestinal cancer

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Gastrointestinal Cancers
Presenter Boram Han
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors B. Han1, H.Y. Kim2, H.J. Kim3, H.S. Kim1, J.H. Kim1, D.R. Choi1, G. Jang4, J.H. Kwon3, H.H. Song3, J.Y. Jung3, J.H. Jeong3, H. Ha3, M. Kim3, D.Y. Zang1
  • 1Internal Medicine, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 2Department Of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang - Anyang/KR
  • 3Department Of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang/KR
  • 4Internal Medicine, Hallym University Medical Center, Halllym University College of Medicine, 431-070 - Anyang/KR

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.