Send to:

Choose Destination
See comment in PubMed Commons below
Ann Oncol. 2014 Sep;25(9):1743-9. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18.

S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).

Author information

  • 1Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka.
  • 2Department of Translational Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo.
  • 3Department of Surgery, Center of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka.
  • 4Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Iwate.
  • 5Department of Surgery, Kobe City Medical Center West Hospital, Hyogo.
  • 6Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka.
  • 7Department of Surgery, Hakodate Goryoukaku Hospital, Hokkaido.
  • 8Department of Colorectal Surgery, Japanese Red Cross Medical Center, Tokyo.
  • 9Department of Surgery, Saiseikai Utsunomiya Hospital, Tochigi.
  • 10Department of Surgery, Niigata Cancer Center Hospital, Niigata.
  • 11Department of Surgery, National Defense Medical College, Saitama.
  • 12Department of Surgery, Tochigi Cancer Center, Tochigi.
  • 13Department of Surgery II, Tokyo Women's Medical University, Tokyo.
  • 14Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo.
  • 15Department of Surgical Oncology and Vascular Surgery, The University of Tokyo, Graduate School of Medicine, Tokyo.
  • 16Department of Surgery, Kitasato University School of Medicine, Kanagawa.
  • 17Department of Clinical Oncology, St Marianna University, Kanagawa.
  • 18Department of Surgery, Hyogo College of Medicine, Hyogo.
  • 19Department of Statistical Analysis, Translational Research Informatics Center, Hyogo.
  • 20Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo, Japan



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).


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.


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.


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.



© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.


S-1; UFT/LV; adjuvant chemotherapy; colon cancer

[PubMed - indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire Icon for PubMed Central
    Loading ...
    Write to the Help Desk