Feasibility study of alternate-day S-1 as adjuvant chemotherapy for gastric cancer: a randomized controlled trial

Gastric Cancer. 2014;17(3):508-13. doi: 10.1007/s10120-013-0289-z. Epub 2013 Aug 15.

Abstract

Background: The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer established oral S-1 administration for 1 year as the standard postoperative adjuvant chemotherapy for gastric cancer in Japan. We conducted a multicenter cooperative prospective study comparing daily and alternate-day S-1 administration as postoperative adjuvant therapy for gastric cancer.

Methods: Patients with Stage II or III gastric cancer who underwent curative surgery were randomly assigned to receive standard daily S-1 administration [group A: 80-120 mg/day S-1 depending on body surface area (BSA); days 1-28 every 6 weeks for 1 year] or alternate-day administration (group B: 80-120 mg/day S-1 depending on BSA; alternate days for 15 months). Treatment completion rate was the primary endpoint, and relative dose intensity and safety, overall survival, and relapse-free survival (RFS) were secondary endpoints.

Results: Seventy-three patients were enrolled. The treatment completion rate was 72.2 % in group A and 91.8 % in group B; the relative dose intensity was 67.5 % in group A and 81.2 % in group B; and compliance was better in group B. Digestive system adverse effects were less frequent in group B than in group A. Median follow-up time was 2.8 years; 3-year survival rate was 69.6 % in group A and 87.3 % in group B; and 3-year RFS rate was 76.4 % in group A and 73.1 % in group B.

Conclusions: Our data show improved compliance and fewer adverse effects with alternate-day S-1 administration, which appears to be a more sustainable option for adjuvant chemotherapy for Stage II or III gastric cancer.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use
  • Chemotherapy, Adjuvant / methods
  • Disease-Free Survival
  • Drug Administration Schedule
  • Drug Combinations
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Medication Adherence*
  • Middle Aged
  • Neoplasm Staging
  • Oxonic Acid / administration & dosage*
  • Oxonic Acid / adverse effects
  • Oxonic Acid / therapeutic use
  • Prospective Studies
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery
  • Survival Rate
  • Tegafur / administration & dosage*
  • Tegafur / adverse effects
  • Tegafur / therapeutic use
  • Treatment Outcome

Substances

  • Antimetabolites, Antineoplastic
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid