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Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer
| Content Provider | Semantic Scholar |
|---|---|
| Author | Kusumoto, Tosiharu Ishiguro, Megumi Nakatani, Eiji Yoshida, Motoki Inoue, Tsukasa Nakamoto, Yoshihiko Shiomi, Akio Takagane, Akinori Sunami, Eiji Shinozaki, Hiroharu Takii, Yasumasa Atsuyuki Ojima, Hitoshi Hashida, Hiroki Mukaiya, Mitsuhiro Yokoyama, Toshiaki Nakamura, Masayuki Munemoto, Yoshinori Sugihara, Kenichi |
| Copyright Year | 2018 |
| Abstract | Objective Adjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC), a randomised phase III trial, demonstrated that adjuvant therapy with S-1 for stage III colon cancer was non-inferior in 3-year disease-free survival (DFS) to that of tegafur-uracil plus leucovorin (UFT/LV). We updated DFS and overall survival (OS) and performed T x N subset analysis. Methods A total of 1518 patients 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). Results The 5-year DFS rates of the S-1 and UFT/LV group were 70.2 % and 66.9 %, respectively (HR 0.88; 95% CI 0.74 to 1.06; p=0.177), and non-inferiority of DFS was reconfirmed with a median of 63.5-month follow-up. The similarity of OS was also confirmed (HR 0.92; 95% CI 0.72 to 1.17; p=0.488); 5-year OS rates of the S-1 and UFT/LV group were 86.0 % and 84.4 %, respectively. No significant interactions were identified between the major baseline characteristics and DFS of the S-1 and UFT/LV groups, except for histological type; S-1 was more favourable in patients with poorly differentiated adenocarcinoma. Patient outcomes were well separated by TNM-substages (IIIA/IIIB/IIIC). With the patients divided into 20 subsets by T and N factors, the DFS and OS rates of T3 and N1 subset, which accounted for 62 % of stage IIIB patients and 44 % of all studied subjects, were significantly better than those of the other subsets in stage IIIB and similar to those of stage IIIA. Conclusions Adjuvant therapy of S-1 for stage III colon cancer was reconfirmed to be non-inferior in DFS to those of UFT/LV after long follow-up. No difference in OS was also demonstrated. T3N1 patients might be considered separately from other patients included in stage IIIB because of its favourable outcome. Trial registration number NCT00660894. |
| Starting Page | 30 |
| Ending Page | 32 |
| Page Count | 3 |
| File Format | PDF HTM / HTML |
| PubMed reference number | 30425843v1 |
| Alternate Webpage(s) | https://doi.org/10.1136/esmoopen-2018-000428 |
| DOI | 10.1136/esmoopen-2018-000428 |
| Journal | ESMO open |
| Volume Number | 3 |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Adenocarcinoma Chemotherapy, Adjuvant Clomiphene Colon Carcinoma Eighty Follow-Up Report Freund's Adjuvant Leucovorin Overall Survival Patients PersonNameUse - assigned Pharmaceutical Adjuvants Stage 3B Stage III Colon Cancer Stage level 3 Subgroup TNM Staging System TS-1 titanium silicide Tegafur Uracil milligram/day stage II bladder cancer tegafur-uracil |
| Content Type | Text |
| Resource Type | Article |
