Objective: The aim of this study was to determine the maximum-tolerated dose (MTD) of S-1, an oral fluoropyrimidine derivative, with concurrent gemcitabine and radiotherapy in patients with unresectable locally advanced pancreatic cancer.
Methods: Patients with histopathologically-confirmed unresectable locally advanced pancreatic cancer were eligible. Radiotherapy was delivered in 1.8Gy daily fractions to a total dose of 50.4Gy over 5.5 weeks. Gemcitabine (200mg/m
2) was given once a week for 6 weeks. S-1 was administered orally twice a day from Day 1 to 14 and 22 to 35 at an escalating dose from 50 to 80mg/m
2/day.
Results: Fifteen patients were enrolled in this study. Three patients received S-1 at 50mg/m
2/day, 3 at 60mg/m
2/day, 3 at 70mg/m
2/day, and 6 at 80mg/m
2/day. Though 1 patient at the final dose level (80mg/m
2/day) experienced a dose limiting toxicity (Grade 3 thrombocytopenia), an MTD was not reached in this study.
Conclusion: The recommended dose of S-1 with concurrent gemcitabine and radiotherapy was determined to be 80mg/m
2/day from Day 1 to 14 and 22 to 35 in patients with locally advanced pancreatic cancer. Oral S-1, gemcitabine, and radiotherapy are well tolerated and feasible and should be further investigated.
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