Itabashi Michio    Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine    Position   Professor (Fixed Term)
Article types	Original article
Language	English
Peer review	Non peer reviewed
Title	S-1 and Oxaliplatin Versus Tegafur-uracil and Leucovorin as Postoperative Adjuvant Chemotherapy in Patients With High-risk Stage III Colon Cancer (ACTS-CC 02): A Randomized, Open-label, Multicenter, Phase III Superiority Trial.
Journal	Formal name：Clinical colorectal cancer Abbreviation：Clin Colorectal Cancer ISSN code：19380674/15330028
Domestic / Foregin	Foregin
Volume, Issue, Page	19(1),pp.22-31.e6
Author and coauthor	Sunami Eiji, Kusumoto Tetsuya, Ota Mitsuyoshi, Sakamoto Yoshiyuki, Yoshida Kazuhiro, Tomita Naohiro, Maeda Atsuyuki, Teshima Jin, Okabe Michio, Tanaka Chihiro, Yamauchi Junichiro, Itabashi Michio, Kotake Kenjiro, Takahashi Keiichi, Baba Hideo, Boku Narikazu, Aiba Keisuke, Ishiguro Megumi, Morita Satoshi, Takenaka Naruhito, Okude Ryota, Sugihara Kenichi
Publication date	2020/03
Summary	BACKGROUND:The efficacy of S-1 plus oxaliplatin (SOX) as postoperative adjuvant chemotherapy for colon cancer has not been established. This randomized phase III study was designed to verify the superiority of SOX over tegafur-uracil and leucovorin (UFT/LV) in patients with high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries).PATIENTS AND METHODS:Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300 mg/m2 of UFT and 75 mg/day of LV on days 1-28, every 35 days, 5 cycles) or SOX (100 mg/m2 of oxaliplatin on day 1 and 80 mg/m2 of S-1 on days 1-14, every 21 days, 8 cycles). The primary endpoint was disease-free survival (DFS).RESULTS:A total of 478 patients in the UFT/LV group and 477 patients in the SOX group were included in the primary analysis. The 3-year DFS was 60.6% (95% confidence interval [CI], 56.0%-64.9%) in the UFT/LV group and 62.7% (95% CI, 58.1%-66.9%) in the SOX group. The stratified hazard ratio for DFS was 0.90 (95% CI, 0.74-1.09; stratified log-rank test, P = .2780). In the N2b subgroup, the 3-year DFS was 46.0% (95% CI, 37.5%-54.0%) in the UFT/LV group and 54.7% (95% CI, 45.7%-62.7%) in the SOX group (hazard ratio, 0.76; 95% CI, 0.55-1.05).CONCLUSION:As postoperative adjuvant chemotherapy, SOX was not superior to UFT/LV in terms of DFS in patients with high-risk stage III colon cancer.
DOI	10.1016/j.clcc.2019.10.002
PMID	31917122