title: S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).
abstract: BACKGROUND
  S-1 is an oral fluoropyrimidine whose antitumor effects have been demonstrated in treating various gastrointestinal cancers, including metastatic colon cancer, when administered as monotherapy or in combination chemotherapy. We conducted a randomized phase III study investigating the efficacy of S-1 as adjuvant chemotherapy for colon cancer by evaluating its noninferiority to tegafur-uracil plus leucovorin (UFT/LV).
  
  
  METHODS
  Patients aged 20-80 years with curatively resected stage III colon cancer were randomly assigned to receive S-1 (80-120 mg/day on days 1-28 every 42 days; four courses) or UFT/LV (UFT: 300-600 mg/day and LV: 75 mg/day on days 1-28 every 35 days; five courses). The primary end point was disease-free survival (DFS) at 3 years.
  
  
  RESULTS
  A total of 1518 patients (758 and 760 in the S-1 and UFT/LV group, respectively) were included in the full analysis set. The 3-year DFS rate was 75.5% and 72.5% in the S-1 and UFT/LV group, respectively. The stratified hazard ratio for DFS in the S-1 group compared with the UFT/LV group was 0.85 (95% confidence interval: 0.70-1.03), demonstrating the noninferiority of S-1 (noninferiority stratified log-rank test, P < 0.001). In the subgroup analysis, no significant interactions were identified between the major baseline characteristics and the treatment groups.
  
  
  CONCLUSIONS
  Adjuvant chemotherapy using S-1 for stage III colon cancer was confirmed to be noninferior in DFS compared with UFT/LV. S-1 could be a new treatment option as adjuvant chemotherapy for colon cancer.
  
  
  BACKGROUND
  NCT00660894.
authors.affiliation: Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka.
authors.forename: M
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Translational Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo.
authors.forename: M
authors.initials: M
authors.lastname: Ishiguro
authors.affiliation: Department of Surgery, Center of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka.
authors.forename: K
authors.initials: K
authors.lastname: Ikejiri
authors.affiliation: Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Iwate.
authors.forename: I
authors.initials: I
authors.lastname: Mochizuki
authors.affiliation: Department of Surgery, Kobe City Medical Center West Hospital, Hyogo.
authors.forename: Y
authors.initials: Y
authors.lastname: Nakamoto
authors.affiliation: Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka.
authors.forename: Y
authors.initials: Y
authors.lastname: Kinugasa
authors.affiliation: Department of Surgery, Hakodate Goryoukaku Hospital, Hokkaido.
authors.forename: A
authors.initials: A
authors.lastname: Takagane
authors.affiliation: Department of Colorectal Surgery, Japanese Red Cross Medical Center, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Endo
authors.affiliation: Department of Surgery, Saiseikai Utsunomiya Hospital, Tochigi.
authors.forename: H
authors.initials: H
authors.lastname: Shinozaki
authors.affiliation: Department of Surgery, Niigata Cancer Center Hospital, Niigata.
authors.forename: Y
authors.initials: Y
authors.lastname: Takii
authors.affiliation: Department of Surgery, National Defense Medical College, Saitama.
authors.forename: H
authors.initials: H
authors.lastname: Mochizuki
authors.affiliation: Department of Surgery, Tochigi Cancer Center, Tochigi.
authors.forename: K
authors.initials: K
authors.lastname: Kotake
authors.affiliation: Department of Surgery II, Tokyo Women's Medical University, Tokyo.
authors.forename: S
authors.initials: S
authors.lastname: Kameoka
authors.affiliation: Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo.
authors.forename: K
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: Department of Surgical Oncology and Vascular Surgery, The University of Tokyo, Graduate School of Medicine, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Watanabe
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Kanagawa.
authors.forename: M
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Department of Clinical Oncology, St Marianna University, Kanagawa.
authors.forename: N
authors.initials: N
authors.lastname: Boku
authors.affiliation: Department of Surgery, Hyogo College of Medicine, Hyogo.
authors.forename: N
authors.initials: N
authors.lastname: Tomita
authors.affiliation: Department of Statistical Analysis, Translational Research Informatics Center, Hyogo.
authors.forename: E
authors.initials: E
authors.lastname: Nakatani
authors.affiliation: Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo, Japan. Electronic address: k-sugi.srg2@tmd.ac.jp.
authors.forename: K
authors.initials: K
authors.lastname: Sugihara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D014498:Uracil / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D014498:Uracil; D010094:Oxonic Acid; D002955:Leucovorin
keywords: S-1; UFT/LV; adjuvant chemotherapy; colon cancer