Published in:
01-02-2014 | Original Article
A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer
Authors:
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
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 2/2014
Login to get access
Abstract
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.