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 Anticancer agents
Gastrointestinal Cancers
Therapy
Biological therapy
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.