A phase I study of gemcitabine and S-1 concurrent radiotherapy in patients with locally advanced pancreatic cancer

• Published in: Suizo Vol. 25; no. 2; pp. 109 - 116
• Main Authors: MATSUMURA, Yuji, SUYAMA, Masafumi, SAI, Jinkan, KUBOKAWA, Yoshihiro, KAMIYA, Takayoshi, WATANABE, Sumio
• Format: Journal Article
• Language: Japanese
• Published: Japan Pancreas Society 2010
• Subjects: Chemoradiotherapy; Gemcitabine; Locally advanced pancreatic cancer; S-1
• ISSN: 0913-0071; 1881-2805
• DOI: 10.2958/suizo.25.109

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/m2) 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/m2/day. Results: Fifteen patients were enrolled in this study. Three patients received S-1 at 50mg/m2/day, 3 at 60mg/m2/day, 3 at 70mg/m2/day, and 6 at 80mg/m2/day. Though 1 patient at the final dose level (80mg/m2/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/m2/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.