S-1 and oxaliplatin versus tegafur-uracil and leucovorin as post-operative adjuvant chemotherapy in patients with high-risk stage III colon cancer: updated 5-year survival of the phase III ACTS-CC 02 trial.

The ACTS-CC 02 trial demonstrated that S-1 plus oxaliplatin (SOX) was not superior to tegafur-uracil and leucovorin (UFT/LV) in terms of disease-free survival (DFS) as adjuvant chemotherapy for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries). We now report the final overall survival (OS) and subgroup analysis according to the pathological stage (TNM 7th edition) for treatment efficacy. Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300 mg/m A total of 478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis. With a median follow-up time of 74.3 months, the 5-year DFS rate was 55.2% in the UFT/LV group and 58.1% in the SOX group [stratified hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.76-1.11; P = 0.3973], and the 5-year OS rates were 78.3% and 79.1%, respectively (stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175). In the subgroup analysis, the 5-year OS rates in patients with T4N2b disease were 51.0% and 64.1% in the UFT/LV and SOX groups, respectively (HR 0.72; 95% CI 0.40-1.31). Our final analysis reconfirmed that SOX as adjuvant chemotherapy is not superior to UFT/LV in terms of DFS in patients with high-risk stage III colon cancer. The 5-year OS rate was similar in the UFT/LV and SOX groups.

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Disclosure JW reports personal fees from Johnson and Johnson and Medtronic Co., Ltd., outside the submitted work. KY reports personal fees and research grants from Asahi Kasei, Chugai Pharmaceutical Co., Ltd., Covidien, Daiichi Sankyo, Eli Lilly Japan K.K., Johnson & Johnson, Merc Serono, MSD K.K., Nippon Kayaku, Novartis, Ono Pharmaceutical Co., Ltd., Sanofi, Taiho Pharmaceutical Co., Ltd., Takeda, Tsumura, Yakult Honsha Co., Ltd., Eisai, and Otsuka outside the submitted work. NTo reports personal fees from Taiho Pharmaceutical Co., Ltd., and Chugai Pharmaceutical Co., Ltd., and research grants from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., and Sysmex outside the submitted work. HU reports personal fees from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Takeda, Daiichi Sankyo, and Bayer. MI reports research grants from Taiho Pharmaceutical Co., Ltd., Pfizer, Astellas Pharma, Chugai Pharmaceutical Co., Ltd., and Takeda outside the submitted work. KT reports personal fees from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K. outside the submitted work. HB reports personal fees from Taiho Pharmaceutical Co., Ltd., and research grants from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., and Shin Nippon Biomedical outside the submitted work. NB reports personal fees from Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, and research grants from Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, and Takeda outside the submitted work. SM reports personal fees from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Yakult Honsha Co., Ltd., Eli Lilly Japan K.K., and Ono Pharmaceutical Co., Ltd. outside the submitted work. NTa reports personal fees from Taiho Pharmaceutical Co., Ltd. during the conduct of the study and outside the submitted work, and is an employee of Taiho Pharmaceutical Co., Ltd., the manufacturer of UFT/LV and S-1. KS reports personal fees and research grants from Taiho Pharmaceutical Co., Ltd. and Chugai Pharmaceutical Co., Ltd. outside the submitted work. All other authors have declared no conflicts of interest.