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Published in: Cancer Chemotherapy and Pharmacology 2/2020

01-08-2020 | Cetuximab | Original Article

A phase I/II study of S-1 and irinotecan (IRIS) combined with cetuximab in patients with RAS wild-type metastatic colorectal cancer (KSCC1401)

Authors: Hironori Samura, Eiji Oki, Hiroshi Okumura, Takefumi Yoshida, Seiichiro Kai, Kazuma Kobayashi, Tatsuya Kinjo, Shinichiro Mori, Tetsuo Tohyama, Kippei Ohgaki, Hirofumi Kawanaka, Akitaka Makiyama, Norio Ureshino, Masahito Kotaka, Takayuki Shimose, Koji Ando, Hiroshi Saeki, Hideo Baba, Yoshihiko Maehara, Masaki Mori

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2020

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Abstract

Purpose

This study was designed to assess the tolerability, efficacy, and safety of tri-weekly irinotecan plus S-1 (IRIS) and weekly cetuximab in patients with metastatic colorectal cancer (mCRC).

Methods

The main eligibility criteria were RAS wild-type mCRC with no prior chemotherapy. S-1 was given orally at a dose of 40 mg/m2 (40–60 mg) twice for 2 weeks, followed by a 1-week rest. Irinotecan was given on day 1 of each cycle at a dose of 150 mg/m2. Cetuximab was administered on days 1 (400 mg/m2), 8 (250 mg/m2), and 15 (250 mg/m2), and then once weekly (250 mg/m2) thereafter. A standard 3 + 3 phase I dose de-escalation design was used to determine the maximum tolerated dose and the recommended dose (RD) of irinotecan. The primary end point of the Phase II study was overall response rate (ORR).

Results

Between December 2014 and September 2017, 4 and 54 patients were enrolled in phase I and phase II studies, respectively. No dose-limiting toxicity was observed in the phase I study, and the RD of irinotecan was 150 mg/m2. In the phase II study, the ORR was 56.9% (90% confidence interval 44.4%–68.7%). The safety profile revealed that the most common grade 3/4 adverse events were neutropenia (31.4%), appetite loss (27.5%), hypokalemia (11.8%), and diarrhea (11.8%). Grade 3/4 hand–foot skin syndrome occurred in nine patients (9.8%).

Conclusion

This study showed that the efficacy and safety of IRIS combined with cetuximab were comparable to those for other first-line treatments. This regimen is a good candidate for first-line treatment of RAS wild-type mCRC.
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Metadata
Title
A phase I/II study of S-1 and irinotecan (IRIS) combined with cetuximab in patients with RAS wild-type metastatic colorectal cancer (KSCC1401)
Authors
Hironori Samura
Eiji Oki
Hiroshi Okumura
Takefumi Yoshida
Seiichiro Kai
Kazuma Kobayashi
Tatsuya Kinjo
Shinichiro Mori
Tetsuo Tohyama
Kippei Ohgaki
Hirofumi Kawanaka
Akitaka Makiyama
Norio Ureshino
Masahito Kotaka
Takayuki Shimose
Koji Ando
Hiroshi Saeki
Hideo Baba
Yoshihiko Maehara
Masaki Mori
Publication date
01-08-2020
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2020
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-020-04108-x

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