Meeting
2019 Gastrointestinal Cancers Symposium
A randomized phase III trial of S-1/oxaliplatin (SOX) versus UFT/leucovorin as adjuvant chemotherapy for high-risk stage III colon cancer: The ACTS-CC 02 trial.
Authors
Takao Takahashi
Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan
Takao Takahashi , Eiji Sunami , Tetsuya Kusumoto , Mitsuyoshi Ota , Yoshiyuki Sakamoto , Naohiro Tomita , Atsuyuki Maeda , Jin Tejima , Michio Okabe , Chihiro Tanaka , Junichiro Yamauchi , Michio Itabashi , Kenjiro Kotake , Keiichi Takahashi , Hideo Baba , Narikazu Boku , Keisuke Aiba , Megumi Ishiguro , Satoshi Morita , Kenichi Sugihara
Organizations
Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan, Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan, Department of Gastrointestinal Surgery and Clinical Research Center Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan, Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori, 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 Prefectual 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 Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan, Department of Surgery, Tochigi Cancer Center, Tochigi, Japan, Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan, Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan, Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, Department of Internal Medicine, Division of Clinical Oncology/Hematology, The Tokyo Jikei University School of Medicine, Tokyo, Japan, Department of Translational Oncology, Tokyo Medical and Dental University, Tokyo, Japan, Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Tokyo Medical and Dental University, Tokyo, Japan
Research Funding
Pharmaceutical/Biotech Company
Background: The ACTS-CC 02 trial was designed to verify the superiority of postoperative adjuvant chemotherapy with S-1/oxaliplatin (SOX) over UFT/leucovorin (LV), one of the standard oral fluoropyrimidine regimens in Japan, in terms of disease-free survival (DFS) in patients (pts) with high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries). The results of the safety analysis have been reported previously (Clin Colorectal Cancer, 2018). We now present the 3-year DFS results as the primary endpoint. Methods: Pts who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300–600 mg/day of UFT according to body surface area [BSA] and 75 mg/day of LV on days 1-28, every 35 days, 5 courses) or SOX (100 mg/m2 of oxaliplatin on day 1 and 80–120 mg/day of S-1 according to BSA on days 1-14, every 21 days, 8 courses). The primary endpoint was DFS. Results: From April 2010 through October 2014, a total of 966 pts were enrolled at 260 institutions. The full analysis set, excluding pts who withdrew informed consent before protocol treatment, comprised 478 and 477 pts in the UFT/LV group and SOX group, respectively. The median age was 65.0 years. The ECOG PS was 0 in 94.0%, and the disease stage was IIIA/IIIB/IIIC in 1.3%/50.2%/48.6%. The 3-year DFS rate was 60.6% in the UFT/LV group and 62.7% in the SOX group (HR: 0.90; 95% CI: 0.74-1.09; p = 0.28); the superiority of SOX was not demonstrated. In stage IIIB, the 3-year DFS rate was 69.3% and 68.5% in the UFT/LV group and SOX group, respectively (HR: 1.01; 95% CI: 0.74-1.37; p = 0.95). In Stage IIIC, the 3-year DFS rate was 50.6% and 55.8% in the UFT/LV group and SOX group, respectively (HR: 0.82, 95% CI: 0.63-1.06; p = 0.12). Notably, in the N2b subgroup, the 3-year DFS rate was 46.0% and 54.7% in the UFT/LV group and SOX group, respectively (HR: 0.76, 95% CI: 0.55-1.05; p = 0.10). Conclusions: SOX was not shown to be superior to UFT/LV in pts with high-risk stage III colon cancer. However, the oxaliplatin-based regimen was suggested to be more effective in advanced disease, such as stage IIIC and N2b. Clinical trial information: JapicCTI-101073.
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Abstract Details
Session Type
Rapid Oral Abstract Session
Session Title
Rapid Abstract Session C: Cancers of the Colon, Rectum, and Anus
Track
Cancers of the Colon, Rectum, and Anus
Sub Track
Multidisciplinary Treatment
Clinical Trial Registration Number
JapicCTI-101073
Citation
J Clin Oncol 37, 2019 (suppl 4; abstr 484)
DOI
10.1200/JCO.2019.37.4_suppl.484
Abstract #
484
Abstract Disclosures
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