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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 k-sugi.srg2@tmd.ac.jp.

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).

PATIENTS AND 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.

CONCLUSION:

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.

CLINICALTRIALSGOV:

NCT00660894.

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

KEYWORDS:

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

PMID:
24942277
[PubMed - indexed for MEDLINE]
PMCID:
PMC4143094
Free PMC Article
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