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 intermediate metabolite of capecitabine (XELODA), in gastric cancer patients after curative resection, we conducted a phase III randomized controlled study to compare oral 5'-DFUR and oral 5-fluorouracil (5-FU). 485 gastric cancer patients with Stage II or III operative findings at curative resection were registered and administered 5'-DFUR (460 mg/m2/day, daily, for two years) or 5-FU (115 mg/m2/day, daily, for the same period). Although no differences in overall survival or disease-free survival were detected, subset analysis showed 5'-DFUR was more effective in reducing peritoneal recurrence than 5-FU (p = 0.047), and in patients with Stage III or stage IIIb (histologic findings) in the 5'-DFUR group had more favorable disease-free survival curves and survival curves than the 5-FU group with similar stages.
Takiguchi
N
N
1st Department of Surgery, Chiba University, School of Medicine, Chuo-ku, Chiba-city 260-8677, Japan.
Nakajima
N
N
Saitoh
N
N
Fujimoto
S
S
Nakazato
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005467:Floxuridine / Q000627:therapeutic use*; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D013997:Time Factors
D005467:Floxuridine; D005472:Fluorouracil; C025034:doxifluridine