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01-01-2014 | Original Article

Phase II clinical study of alternate-day oral therapy with S-1 as first-line chemotherapy for locally advanced and metastatic pancreatic cancer

Authors: Hiroki Yamaue, Sohei Satoi, Takamasa Kanbe, Motoki Miyazawa, Masaji Tani, Manabu Kawai, Seiko Hirono, Kenichi Okada, Hiroaki Yanagimoto, A-Hon Kwon, Tomoyuki Mukouyama, Hiroaki Tsunoda, Kazuo Chijiiwa, Jiro Ohuchida, Jun Kato, Kazuki Ueda, Taketo Yamaguchi, Shinichi Egawa, Kazuhiko Hayashi, Tetsuhiko Shirasaka

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2014

Abstract

Purpose

Based on the results of first-line chemotherapy for advanced pancreatic cancer, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration followed by 2 weeks of drug withdrawal frequently causes adverse effects. On the other hand, we experienced in clinical practice that alternate-day administration of S-1 reduced adverse effects and were tolerable for advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multicenter cooperative prospective study to compare daily with alternate-day administration of S-1 for advanced pancreatic cancer.

Methods

Patients with advanced pancreatic cancer were eligible for enrollment in this trial. S-1 was administered at a dose of 40–60 mg twice daily, calculated according to body surface area, on Monday, Wednesday, Friday, and Sunday. Each treatment cycle was 42 days. The primary end point was overall survival (OS). Secondary end points were safety, response rate (RR), progression-free survival (PFS), and time to treatment failure (TTF).

Results

Forty-eight patients were evaluable for response. OS as the primary end point was 8.4 months (95 % CI 5.4–10.8), and the 1-year survival rate was 29.2 %. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4 %, and the disease control rate was 79.2 %. Grade 3/4 hematological and non-hematological toxicities were minor. All of these adverse reactions were tolerable and reversible.

Conclusions

The current data demonstrate the mitigation of adverse effects with alternate-day administration of S-1, and this appears to be a more sustainable option for advanced pancreatic cancer.

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Title: Phase II clinical study of alternate-day oral therapy with S-1 as first-line chemotherapy for locally advanced and metastatic pancreatic cancer
Authors: Hiroki Yamaue
Sohei Satoi
Takamasa Kanbe
Motoki Miyazawa
Masaji Tani
Manabu Kawai
Seiko Hirono
Kenichi Okada
Hiroaki Yanagimoto
A-Hon Kwon
Tomoyuki Mukouyama
Hiroaki Tsunoda
Kazuo Chijiiwa
Jiro Ohuchida
Jun Kato
Kazuki Ueda
Taketo Yamaguchi
Shinichi Egawa
Kazuhiko Hayashi
Tetsuhiko Shirasaka
Publication date: 01-01-2014
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 1/2014
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-013-2323-6

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Abstract

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