Phase i study of s-1 plus fractional cisplatin as adjuvant chemotherapy for advanced gastric cancer in an outpatient setting (KOGC-03)

Tsunehiro Takahashi, Yoshiro Saikawa, Kazumasa Fukuda, Rieko Nakamura, Norihito Wada, Hirofumi Kawakubo, Hiroya Takeuchi, Hiromasa Takaishi, Yuko Kitagawa

Research output: Contribution to journalArticle


Aim: The aim of this phase I study was to adjust the dose of cisplatin as adjuvant combination chemotherapy with S-1 in an outpatient setting for gastric cancer.

Patients and Methods: The first course was initiated with S-1 monotherapy on days 1-28. From the second to the sixth course, S-1 was administered on days 1-28 and cisplatin was added on days 1, 15, and 29. The dose level of cisplatin was escalated as follows: 20 mg/m2 (level 1); 25 mg/m2 (level 2); 30 mg/m2 (level 3). Dose-limiting toxicity was a delay factor of the start of the next course due to incomplete recovery.

Results: The maximum tolerated and recommended doses were confirmed as level 3 and level 2, respectively.

Conclusion: Although further clinical trials are recommended to evaluate efficacy, this combination of S-1 plus cisplatin regimen is expected to become a standard adjuvant treatment for gastric cancer in the outpatient setting.

Original languageEnglish
Pages (from-to)467-472
Number of pages6
JournalAnticancer research
Issue number1
Publication statusPublished - 2015 Jan 1



  • Adjuvant chemotherapy
  • Cisplatin
  • Gastric cancer
  • Outpatient setting
  • S-1

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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