title: Phase I study of S-1 plus fractional cisplatin as adjuvant chemotherapy for advanced gastric cancer in an outpatient setting (KOGC-03).
abstract: OBJECTIVE
  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.
  
  
  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/m(2) (level 1); 25 mg/m(2) (level 2); 30 mg/m(2) (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Keio Cancer Center, Keio University Hospital, Shinjuku, Tokyo, Japan tsunehiro-t@a8.keio.jp.
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Saikawa
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fukuda
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Rieko
authors.initials: R
authors.lastname: Nakamura
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Norihito
authors.initials: N
authors.lastname: Wada
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kawakubo
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takeuchi
authors.affiliation: Keio Cancer Center, Keio University Hospital, Shinjuku, Tokyo, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Takaishi
authors.affiliation: Department of Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D055118:Medication Adherence; D008875:Middle Aged; D010045:Outpatients; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: Gastric cancer; S-1; adjuvant chemotherapy; cisplatin; outpatient setting