Abstract
BACKGROUND: Trifluridine (FTD)/tipiracil (TPI) is a standard salvage treatment for advanced gastric cancer (AGC). This study aimed to assess the efficacy and safety of FTD/TPI in heavily pretreated patients with AGC in clinical practice. MATERIALS AND METHODS: This retrospective cohort study conducted at a single Japanese institute between November 2019 and May 2022 included patients with inoperable advanced or recurrent gastric cancer (GC) who received FTD/TPI with or without ramucirumab (RAM) in the third-line or later setting. Univariate and multivariate analyses were carried out to examine the clinical factors associated with disease progression and survival. RESULTS: A total of 98 consecutive patients, including 2 patients treated with RAM, were enrolled. Eighty-five patients had prior immune checkpoint inhibitor administration before FTD/TPI and 86 patients were treated with FTD/FPI as the fourth or later line of treatment. Objective response rate was 2.3% (2/87), and disease control rate was 40.2% (35/87). Nausea, anorexia, and diarrhea were the observed adverse events (AEs) in 45, 24, and 19 patients, respectively. The most common grade 3 or 4 AE was neutropenia. Multivariate analysis revealed that performance status (PS) ≥1, elevated serum carcinoembryonic antigen (CEA) and/or carbohydrate antigen 19-9 (CA19-9) levels, and primary tumor location were independently associated with shorter progression-free survival. In terms of overall survival, PS ≥1, elevated serum CEA and/or CA19-9, and the presence of moderate to severe ascites demonstrated statistically significant associations with poorer survival. CONCLUSIONS: FTD/TPI could be a therapeutic option for AGC patients previously treated with nivolumab in clinical practice. AEs associated with FTD/TPI were manageable in heavily pretreated patients with AGC.