A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer

Hidetoshi Eguchi, Hiroaki Nagano, Shogo Kobayashi, Koichi Kawamoto, Hiroshi Wada, Naoki Hama, Yoshito Tomimaru, Hirofumi Akita, Daisuke Sakai, Taroh Satoh, Toshihiro Kudo, Fumiaki Isohashi, Masaki Mori, Yuichiro Doki

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22 Citations (Scopus)


Purpose: Use of the fourth-generation oral fluoropyrimidine S-1 together with gemcitabine has shown striking anticancer effects. In this single-arm phase I trial of preoperative combination therapy using gemcitabine and S-1 concurrently with radiotherapy, we verified the safety and feasibility and determined the maximum-tolerated dose of each drug in patients with resectable pancreatic cancer. Methods: A standard 3+3 dose escalation scheme was used. Patients with cytologically or histologically proven resectable pancreatic ductal adenocarcinoma were administered 30-min intravenous gemcitabine infusions on days 1, 8, 22, and 29 and S-1 orally on days 1-5, 8-12, 22-26, and 29-33. A total radiation dose of 50.4 Gy (1.8 Gy/day, 5 times per week, 28 fractions) was concurrently delivered. Surgical exploration was scheduled 4-7 weeks after the final radiation fraction. Results: Twenty-one patients were enrolled. No treatment-related deaths occurred during this study. Recommended doses were determined to be 80 mg/m2 of S-1 daily and 1,000 mg/m2 of gemcitabine. CA19-9 was reduced to <50 % of baseline values in 12 (75 %) of 16 measurable patients. Nineteen of 21 enrolled patients successfully underwent surgical resection. Conclusions: Preoperative chemoradiotherapy consisting of gemcitabine and S-1 concurrent with full-dose radiation is feasible and well tolerated.

Original languageEnglish
Pages (from-to)309-315
Number of pages7
JournalCancer chemotherapy and pharmacology
Issue number2
Publication statusPublished - Feb 2014


All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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