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01-07-2018 | Original Paper

A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer

Authors: Kei Saito, Hiroyuki Isayama, Yoshihiro Sakamoto, Yousuke Nakai, Kazunaga Ishigaki, Mariko Tanaka, Takeyuki Watadani, Junichi Arita, Naminatsu Takahara, Suguru Mizuno, Hirofumi Kogure, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada, Kiyoshi Hasegawa, Masashi Fukayama, Norihiro Kokudo, Kazuhiko Koike

Published in: Medical Oncology | Issue 7/2018

Abstract

There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m² by 30-min infusion on day 1, S-1 40 mg/m² orally twice daily, and LV 25 mg orally twice daily on days 1–7 every 2 weeks were provided, and evaluation by CT every 2 courses was performed. The primary end point was R0 resection rate, and the secondary endpoints were resection rate, response rate, adverse events, surgical outcomes, and survival. Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.

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Title: A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer
Authors: Kei Saito
Hiroyuki Isayama
Yoshihiro Sakamoto
Yousuke Nakai
Kazunaga Ishigaki
Mariko Tanaka
Takeyuki Watadani
Junichi Arita
Naminatsu Takahara
Suguru Mizuno
Hirofumi Kogure
Hideaki Ijichi
Keisuke Tateishi
Minoru Tada
Kiyoshi Hasegawa
Masashi Fukayama
Norihiro Kokudo
Kazuhiko Koike
Publication date: 01-07-2018
Publisher: Springer US
Published in: Medical Oncology / Issue 7/2018
Print ISSN: 1357-0560
Electronic ISSN: 1559-131X
DOI: https://doi.org/10.1007/s12032-018-1158-8

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