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

Int J Oncol. 2000 May;16(5):1021-7. doi: 10.3892/ijo.16.5.1021.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Female
  • Floxuridine / therapeutic use*
  • Fluorouracil / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Stomach Neoplasms / drug therapy
  • Stomach Neoplasms / surgery
  • Stomach Neoplasms / therapy*
  • Time Factors

Substances

  • Floxuridine
  • Fluorouracil
  • doxifluridine