Safety and efficacy of trifluridine/tipiracil in treatment of patients with advanced gastric cancer having ascites

Abstract

Background: Trifluridine/tipiracil (FTD/TPI) is an oral chemotherapy comprising a thymidine-based nucleoside analog and a thymidine phosphorylase inhibitor. The FTD/TPI versus placebo in patients with heavily pretreated metastatic gastric cancer trial showed that FTD/TPI is effective with manageable toxicity in these patients. However, data on the effect of FTD/TPI on patients with advanced gastric cancer (AGC) having ascites are limited.Methods: We retrospectively collected and analyzed the clinicopathologic data of patients with AGC who had received FTD/TPI monotherapy in our institutions from September 2019 to July 2021.Results: A total of 44 patients were included in this study. The median age was 71 (range, 37‒85) years, 22 patients were men, the numbers of patients with Eastern Cooperative Oncology Group performance status scores 0, 1, and 2 were 8, 32, and 4, respectively, and 25 patients had diffuse-type histology. A total of 25 patients had ascites, among whom 13 had massive ascites. The response rate and disease control rate (DCR) were 2% and 41%, respectively. The median progression-free survival was 2.4 months and median overall survival (OS) was 5.8 months. Patients with ascites exhibited significantly shorter OS (8.6 vs. 4.7 months, P=0.0406) than those without ascites, and DCR (68% vs. 20%, P=0.0012) was significantly worse in patients with ascites. There was no significant difference in the frequency of occurrence of adverse events of grade 3 or higher between patients with and without ascites.Conclusion: FTD/TPI has a moderate, although inadequate, effect on patients with AGC having ascites.