Phase I/II study of S-1 with concurrent radiotherapy for unresectable locally advanced pancreatic cancer

S-1 is a new oral fluoropyrimidine anticancer agent and has shown a good efficacy for pancreatic cancer. There are few published data regarding the efficacy of combination therapy of S-1 and radiation in patients with pancreatic cancer. Phase I/II study was conducted to evaluate the efficacy and toxicity of S-1 combined with radiotherapy. The phase I study determined the recommended of S-1 for the phase II chemoradiotherapy trial to be 80 mg/m2/day given on days 1-21. Median survival and 1-year survival rate were 15 months and 70% in the phase II study. Combination therapy of S-1 and radiation was a promising and well-tolerated approach in patients with unresectable locally advanced pancreatic cancer. (author)