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.

J Watanabe, S Sasaki, T Kusumoto, Y Sakamoto, K Yoshida, N Tomita, A Maeda, J Teshima, M Yokota, C Tanaka, J Yamauchi, H Uetake, M Itabashi, K Takahashi, H Baba, K Kotake, N Boku, K Aiba, S Morita, N Takenaka, K Sugihara

Journal: ESMO open 2021;6(2):100077

PMID: 33714860

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Abstract

BACKGROUND

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 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/m of UFT and 75 mg/day of LV on days 1-28, every 35 days, five cycles) or SOX (100 mg/m of oxaliplatin on day 1 and 80 mg/m/day of S-1 on days 1-14, every 21 days, eight cycles). The primary endpoint was DFS and the patients' data were updated in February 2020.

RESULTS

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).

CONCLUSION

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.

Address: Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan. Electronic address: [email protected].; Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.; Department of Gastrointestinal Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.; Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori, Japan.; Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.; Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.; Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan.; Department of Gastrointestinal Surgery, Iwate Prefectural Central Hospital, Iwate, Japan.; Department of General Surgery, Kurashiki Central Hospital, Okayama, Japan.; Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.; Department of Surgery, Sendai Kousei Hospital, Miyagi, Japan.; Department of Specialized Surgeries, Tokyo Medical and Dental University, Tokyo, Japan.; Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.; Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.; Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.; Department of Surgery, Sano City Hospital, Tochigi, Japan.; Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.; Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Tokyo Jikei University School of Medicine, Tokyo, Japan.; Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.; Clinical Research & Pharmacoepidemiology Department, Medical Affairs Division, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.; Tokyo Medical and Dental University, Tokyo, Japan.

DOI: 10.1016/j.esmoop.2021.100077

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MeSH Terms: Antineoplastic Combined Chemotherapy Protocols, Chemotherapy, Adjuvant, Colonic Neoplasms, Humans, Leucovorin, Neoplasm Staging, Oxaliplatin, Tegafur, Uracil