A phase III randomized study comparing oral doxifluridine and oral 5-fluorouracil after curative resection of gastric cancer

To investigate the usefulness of oral doxifluridine (5'-DFUR), an active in termediate metabolite of capecitabine (XELODA), in gastric cancer patients after curative resection, we conducted a phase III randomized controlled st udy to compare oral 5'-DFUR and oral 5-fluorouracil (5-FU). 485 gastric can cer patients with Stage II or III operative findings at curative resection were registered and administered 5'-DFUR (460 mg/m(2)/day, daily, for two y ears) or 5-FU (115 mg/m(2)/ day, daily, for the same period). Although no d ifferences in overall survival or disease-free survival were detected, subs et analysis showed 5'-DFUR was more effective in reducing peritoneal recurr ence than 5-FU (P=0.047), and in patients with Stage III or stage IIIb (his tologic findings) in the 5'-DFUR group had more favorable disease-free surv ival curves and survival curves than the 5-FU group with similar stages.