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

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

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13 Citations (Scopus)

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.

Original languageEnglish
Article number100
JournalMedical Oncology
Volume35
Issue number7
DOIs
Publication statusPublished - 1 Jul 2018
Externally publishedYes

Keywords

  • Gemcitabine
  • Leucovorin
  • Neoadjuvant chemotherapy
  • Pancreatic cancer
  • S-1

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