Trifluridine/tipiracil versus placebo for third or later lines of treatment in metastatic gastric cancer: an exploratory subgroup analysis from the TAGS study.

Tabernero, J; Shitara, K; Zaanan, A; Doi, T; Lorenzen, S; Van Cutsem, E; Fornaro, L; Catenacci, D V T; Fougeray, R; Moreno, S R; Azcue, P; Arkenau, H-T; Alsina, M; Ilson, D H

doi:10.1016/j.esmoop.2021.100200

journal article

Titel:: Trifluridine/tipiracil versus placebo for third or later lines of treatment in metastatic gastric cancer: an exploratory subgroup analysis from the TAGS study.
Dokumenttyp:: Journal Article; Research Support, Non-U.S. Gov't
Autor(en):: Tabernero, J; Shitara, K; Zaanan, A; Doi, T; Lorenzen, S; Van Cutsem, E; Fornaro, L; Catenacci, D V T; Fougeray, R; Moreno, S R; Azcue, P; Arkenau, H-T; Alsina, M; Ilson, D H
Abstract:: 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.
Zeitschriftentitel:: ESMO Open
Jahr:: 2021
Band / Volume:: 6
Heft / Issue:: 4
Volltext / DOI:: doi:10.1016/j.esmoop.2021.100200
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/34175675
TUM Einrichtung:: III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie (Prof. Bassermann)2021