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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 5/2016

01-11-2016 | Original Article

A dose-finding study for oxaliplatin, irinotecan, and S-1 (OIS) in patients with metastatic or recurrent gastrointestinal cancer

Authors: Boram Han, Joo Young Jung, Hyeong Su Kim, Ji Woong Cho, Kab Choong Kim, Hyun Lim, Ho Suk Kang, Hong Il Ha, Min-Jeong Kim, Jung Hoon Kim, Dae Ro Choi, Geundoo Jang, Jung Han Kim, Hunho Song, Dae Young Zang

Published in: Cancer Chemotherapy and Pharmacology | Issue 5/2016

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Abstract

Purposes

To determine the maximum tolerated dose (MTD), recommended dose (RD), and activity of combined oxaliplatin, irinotecan, and S-1 chemotherapy for 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, every 2 weeks. This phase I study used the following dose levels for oxaliplatin/irinotecan/S-1: 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; and level 5, 85/180/100 mg/m2. Treatment was repeated for a maximum of 12 cycles, until disease progression, or until unacceptable toxicity.

Results

Twenty-four patients were enrolled between October 2012 and February 2014 (median age 59 years). During the first cycle, one of the six patients in levels 1, 3, and 4 developed a dose-limiting toxicity (grade 3 febrile neutropenia), and none of the three patients in level 5 developed a dose-limiting toxicity. As the planned maximum dose did not reach the MTD, the level 5 dose was defined as the RD. Twenty-one patients were evaluated for response, which included 2 cases of complete response and 8 cases of partial response, with an overall response rate of 47.6 %.

Conclusions

The combination of oxaliplatin, irinotecan, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced GI cancer. The RD was 85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan, and 100 mg/m2 of S-1 every 2 weeks.
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Metadata
Title
A dose-finding study for oxaliplatin, irinotecan, and S-1 (OIS) in patients with metastatic or recurrent gastrointestinal cancer
Authors
Boram Han
Joo Young Jung
Hyeong Su Kim
Ji Woong Cho
Kab Choong Kim
Hyun Lim
Ho Suk Kang
Hong Il Ha
Min-Jeong Kim
Jung Hoon Kim
Dae Ro Choi
Geundoo Jang
Jung Han Kim
Hunho Song
Dae Young Zang
Publication date
01-11-2016
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 5/2016
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-016-3147-y

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