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

Abstract

ObjectiveAdjuvant 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 analysisMethodsA 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)ResultsThe 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.ConclusionsAdjuvant 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 numberNCT00660894.

A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01)

“…One reported the completion rate was 51.4% (the rate for those without recurrence was not available) for BTC after major hepatectomy [13] and the other reported a complete rate of 75.8% (the rate for those without recurrence, 86.0%) [16]. Regarding other types of cancer, a 6-month administration of S-1 was completed in 76.5% of cases (rate for non-recurrence, not available) in colon cancer [20] and 72.2% (rate for those without recurrence, 75.8%) in pancreatic cancer [11]. Compared to other regimens for BTC, the BILCAP trial that evaluated a 6-month administration of capecitabine and the BCAT trial that evaluated a 6-month administration of gemcitabine showed the complete rates were 54.7 and 52.1%, respectively [9,21].…”

A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01)

“…One reported the completion rate was 51.4% (the rate for those without recurrence was not available) for BTC after major hepatectomy (13) and the other reported a complete rate of 75.8% (the rate for those without recurrence, 86.0%). (16) Regarding other types of cancer, a 6-month administration of S-1 was completed in 76.5% of cases (rate for non-recurrence, not available) in colon cancer (20) and 72.2% (rate for those without recurrence, 75.8%) in pancreatic cancer. (11) Compared to other regimens for BTC, the BILCAP trial that evaluated a 6-month administration of capecitabine and the BCAT trial that evaluated a 6-month administration of gemcitabine showed the complete rates were 54.7% and 52.1%, respectively.…”

Long-term outcomes of living donor liver transplantation in patients with a prior history of nonhepatic malignancy

“…The intervals from PTM treatment to LT in the patients with advanced-stage colon cancer and breast cancer was 19 months and 9 years, and neither has experienced recurrence during the follow-up period. 5-year disease free survival rate in the patients with Stage IIIA colon cancer which was curatively resected and received chemotherapy was over 70% in the literature (31,32). We accepted the patient with advanced colon cancer as the candidate of transplant recipient.…”