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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

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

KEYWORDS:

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

PMID:
24942277
PMCID:
PMC4143094
DOI:
10.1093/annonc/mdu232
[Indexed for MEDLINE]
Free PMC Article

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