Trifluridine/tipiracil (FTD/TPI) in advanced gastric cancer-a retrospective cohort study providing real-world survival and safety data from the United Kingdom

Journal article

BackgroundIn advanced gastric adenocarcinoma (aGC), the TAGS study demonstrated a survival advantage of trifluridine/tipiracil (FTD/TPI) over placebo in ≥3rd line setting. This led to approval in the United Kingdom (UK). Clinical trial and real-world patients often differ in age, fitness and comorbidity, which has implications for safety and survival. Real-world data can inform clinical practice. This study sought to define the UK patient population who have received FTD/TPI and compare outcomes to TAGS.MethodsThis was a retrospective study. Patients with aGC commenced on FTD/TPI prior to 1st February 2024 were eligible. Patients were identified from electronic health records. Data on baseline demographics and cancer outcome, including survival and toxicity, were collected.ResultsData was collected for 58 patients from 12 centres in England, Scotland and Northern Ireland. Median age was 68.5 (range, 40-85) years, 44 (75.9%) were male and 10 (17.2%), 35 (60.3%) and 13 (22.4%) were Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1, and ≥2, respectively. Most primary tumours were gastroesophageal junctional (70.7%) and 24.1% were human epidermal growth factor receptor 2 (HER2) positive. FTD/TPI was given in 3rd line for 44 (75.9%) patients, 48 (82.8%) were commenced on full dose and on progression 6 (10.3%) received subsequent therapy. Median number of cycles received was 3 (range, 1-11). Median overall survival (mOS) in the whole population was 4.0 months [95% confidence interval (CI): 3.5-5.4], with mOS 5.9 vs. 4.0 vs. 2.5 months for ECOG PS 0, 1, and ≥2 respectively. On cox-regression analysis, with age, sex, ECOG PS, HER2 status, primary site and albumin as variables, ECOG PS ≥2 [hazard ratio (HR) =3.00; 95% CI: 1.07-8.35; P=0.04] and albumin ≥35 g/L (HR =0.47; 95% CI: 0.25-0.89; P=0.02) were prognostic; 29 (50%) and 16 (27.6%) patients required dose delay and reduction respectively, most commonly due to neutropenia. Grade ≥3 toxicity, attributed to FTD/TPI, was observed in 17 (29.3%) patients; 14 (82.4%) due to neutropenia and 3 (17.6%) anaemia. One (1.7%) patient stopped due to toxicity.ConclusionsWe present UK real-world data regarding use of FTD/TPI for aGC. Compared to TAGS, the patient population differed and mOS was lower than the reported 5.7 months, but long-term survivors are observed. Pre-treatment ECOG PS and albumin appear prognostic. Toxicity is in line with that reported previously. Our data support the use of FTD/TPI in selected populations with aGC.

Authors: Salf, J; Cunningham, A; Shah, D; Kunene, V; Karanam, S

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: AME Publishing
• Journal: Journal of Gastrointestinal Oncology
• Volume: 16
• Issue: 6
• Pages: 2584-2591
• Publication date: 2025-12-26
• Acceptance date: 2025-06-25
• DOI: 10.21037/jgo-2025-119
• EISSN: 2219-679X
• ISSN: 2078-6891
• Pmid: 41522763
• Language: English
• Keywords: Gastric cancer; Survival; Toxicity; Real-world Data; Trifluridine/tipiracil (Ftd/tpi)