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Trifluridine/tipiracil versus placebo for third or later lines of treatment in metastatic gastric cancer: an exploratory subgroup analysis from the TAGS study Tabernero Caturla, Josep Zaanan, Aziz Doi, Toshihiko Lorenzen, S. Van Cutsem, Eric Alsina Maqueda, Maria Shitara, Kohei Institut Català de la Salut [Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB-Quiron, UVic-UCC, Barcelona, Spain. [Shitara K] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. [Zaanan A] Department of Gastrointestinal Oncology, European Georges Pompidou Hospital, AP-HP Centre, University of Paris, Paris, France. [Doi T] Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. [Lorenzen S] Third Department of Internal Medicine (Hematology/Medical Oncology), Klinikum Rechts der Isar, Technische Universitaet München, München, Germany. [Van Cutsem E] Department of Gastroenterology and Digestive Oncology, University Hospital Gasthuisberg and University of Leuven, Leuven, Belgium. [Alsina M] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Estómac - Càncer - Tractament Metàstasi DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Stomach Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias gástricas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica Metastatic gastric cancer; Overall survival; Trifluridine/tipiracil Càncer gàstric metastàtic; Supervivència global; Trifluridina/tipiracil Cáncer gástrico metastásico; Supervivencia global; Trifluridina/tipiracilo Background Metastatic gastric cancer and cancer of the esophagogastric junction (GC/EGJ) is an aggressive disease with poor prognosis. In the TAGS study, trifluridine/tipiracil (FTD/TPI) improved overall survival (OS) compared with placebo in heavily pre-treated patients. This unplanned, exploratory subgroup analysis of the TAGS study aimed to clarify outcomes when FTD/TPI was used as third-line (3L) treatment and fourth- or later-line (4L+) treatment. Patients and methods Patients were divided into a 3L group (126 and 64 in FTD/TPI and placebo arms, respectively) and 4L+ group (211 and 106 in FTD/TPI and placebo arms, respectively). Endpoints included OS, progression-free survival (PFS), time to Eastern Cooperative Oncology Group performance status (ECOG PS) deterioration to ≥2, and safety. Results Baseline characteristics were generally well balanced between FTD/TPI and placebo for 3L and 4L+ treatment. Median OS (mOS) for FTD/TPI versus placebo was: 6.8 versus 3.2 months {hazard ratio (HR) [95% confidence interval (CI)] = 0.68 (0.47-0.97), P = 0.0318} in the 3L group; and 5.2 versus 3.7 months [0.73 (0.55-0.95), P = 0.0192] in the 4L+ group. Median PFS for FTD/TPI versus placebo was 3.1 versus 1.9 months [0.54 (0.38-0.77), P = 0.0004] in the 3L group; and 1.9 versus 1.8 months [0.57 (0.44-0.74), P < 0.0001] in the 4L+ group. Time to deterioration of ECOG PS to ≥2 for FTD/TPI versus placebo was 4.8 versus 2.0 months [HR (95% CI) = 0.60 (0.42-0.86), P = 0.0049] in the 3L group; and 4.0 versus 2.5 months [0.75 (0.57-0.98), P = 0.0329] in the 4L+ group. The safety of FTD/TPI was consistent in all subgroups. Conclusions This analysis confirms the efficacy and safety of FTD/TPI in patients with GC/EGJ in third and later lines with a survival benefit that seems slightly superior in 3L treatment. When FTD/TPI is taken in 3L as recommended in the international guidelines, physicians can expect to provide patients with an mOS of 6.8 months. The TAGS study was funded by Taiho Oncology and Taiho Pharmaceutical (no grant number). This exploratory subgroup analysis was funded by Servier (no grant number). 2022-04-06T06:50:47Z 2022-04-06T06:50:47Z 2021-08 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Tabernero J, Shitara K, Zaanan A, Doi T, Lorenzen S, Van Cutsem E, et al. Trifluridine/tipiracil versus placebo for third or later lines of treatment in metastatic gastric cancer: an exploratory subgroup analysis from the TAGS study. ESMO Open. 2021 Aug;6(4):100200. 2059-7029 https://hdl.handle.net/11351/7307 10.1016/j.esmoop.2021.100200 34175675 000703610200021 eng ESMO Open;6(4) https://doi.org/10.1016/j.esmoop.2021.100200 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia