Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase III trial: ACTS-CC trial

Abstract

Background:The Adjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC) is a phase III trial designed to validate the non-inferiority of S-1 to UFT/leucovorin (LV) as postoperative adjuvant chemotherapy for stage III colon cancer. We report the results of a planned safety analysis.Methods:Patients aged 20–80 years with curatively resected stage III colon cancer were randomly assigned to receive UFT/LV (UFT, 300 mg m−2 per day as tegafur; LV, 75 mg per day on days 1–28, every 35 days, 5 courses) or S-1 (80, 100, or 120 mg per day on days 1–28, every 42 days, 4 courses). Treatment status and safety were evaluated.Results:Of 1535 enrolled patients, a total of 1504 (756 allocated to S-1 and 748 to UFT/LV) were analysed. The completion rate of protocol treatment was 77% in the S-1 group and 73% in the UFT/LV group. The overall incidence of adverse events (AEs) were 80% in S-1 and 74% in UFT/LV. Stomatitis, anorexia, hyperpigmentation, and haematological toxicities were common in S-1, whereas increased alanine aminotransferase and aspartate aminotransferase were common in UFT/LV. The incidences of ⩾grade 3 AEs were 16% and 14%, respectively.Conclusion:Although AE profiles differed between the groups, feasibility of the protocol treatment was good. Both S-1 and UFT/LV could be safely used as adjuvant chemotherapy.

S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial)

“…As we previously reported [10], though the profile of toxicities differed, no significant difference was observed in terms of safety and feasibility between S-1 and UFT/LV.…”

“…The results of safety analysis have been previously reported [10]. This paper focuses on disease-free survival (DFS) as the primary end point.…”

A combination of oral uracil-tegafur plus leucovorin (UFT + LV) is a safe regimen for adjuvant chemotherapy after hepatectomy in patients with colorectal cancer: Safety report of the UFT/LV study

“…NCT00660894), a phase III controlled study designed to verify the noninferiority of S-1 to UFT/LV, a total of 1,535 patients have been enrolled, among whom 748 received UFT/LV therapy. Mochizuki et al have reported on safety in the ACTS-CC trial (20). In the UFT/LV group, the incidence of adverse events was 73.7% for all grades and 14.4% for grades 3 or higher.…”

Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis: survival analysis of N-SOG 01 trial

“…As for colon cancer, a large randomized phase III trial compared S-1 with UFT/LV as adjuvant chemotherapy for patients with stage III disease (ACTS-CC trial: NCT00660894). This trial demonstrated the safety and efficacy of both regimens with the result that 3-year disease-free survival (DFS) was 75.5 % in the S-1 arm and 72.5 % in the UFT/LV arm [12,13]. Additionally, recent randomized phase III trial (UFT/LV trial: UMIN CTR; C000000013) showed that adjuvant UFT/LV therapy could significantly prevent recurrence after curative resection in the patients with colorectal liver metastasis (HR 0.56, p = 0.003) [14].…”