Randomized Controlled Trial of Adjuvant Chemotherapy with Fluoropyrimidines Versus Surgery-alone for Gastric Cancer

Anticancer Res. 2017 Jun;37(6):3061-3067. doi: 10.21873/anticanres.11661.

Abstract

Aim: This prospective randomized study compared the survival of patients with stage IB-IIIA gastric cancer treated with surgery alone or surgery followed by adjuvant chemotherapy.

Patients and methods: Patients with pathological stage IB-IIIA disease were randomly assigned to the following groups: surgery alone (n=116), or surgery followed by adjuvant chemotherapy with 5-fluorouracil, doxifluridine, or uracil-tegafur for 12 months (n=113).

Results: The overall survival rate was 86.1% in the adjuvant group and 78.5% in the surgery-alone group. The overall survival rate did not significantly differ between the adjuvant-chemotherapy and surgery-only groups (p=0.163). In the subgroup analyses, patients with stage II disease and those receiving uracil-tegafur treatment in the adjuvant group showed significantly better prognosis than those in the surgery-alone group (p=0.036 and 0.005, respectively).

Conclusion: This study did not find a significant survival benefit to be associated with adjuvant chemotherapy with fluoropyrimidines in patients with stage IB-IIIA gastric cancer. However, it may be effective for patients with stage II disease. Additionally, uracil-tegafur is a promising agent for adjuvant chemotherapy of gastric cancer if S-1 is not available because of its toxicity.

Keywords: 5-FU; 5’-DFUR; Gastric cancer; UFT; adjuvant chemotherapy; fluoropyrimidine.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Chemotherapy, Adjuvant / adverse effects
  • Female
  • Floxuridine / adverse effects
  • Floxuridine / therapeutic use*
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery*
  • Survival Analysis
  • Tegafur / adverse effects
  • Tegafur / therapeutic use*
  • Uracil / adverse effects
  • Uracil / therapeutic use*

Substances

  • Antineoplastic Agents
  • Floxuridine
  • Tegafur
  • Uracil
  • Fluorouracil
  • doxifluridine