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

article

J. Tabernero¹  K. Shitara²  A. Zaanan³  T. Doi⁴  S. Lorenzen⁵  E. Van Cutsem⁶  L. Fornaro⁷  D.V.T. Catenacci⁸  R. Fougeray⁹  S.R. Moreno^1,10  P. Azcue^1,10  H.-T. Arkenau^1,11  M. Alsina¹  D.H. Ilson^1,12 

[1] Department of Medical Oncology, Vall d’Hebron Hospital Campus and Institute of Oncology;Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East;Department of Gastrointestinal Oncology, European Georges Pompidou Hospital, AP-HP Centre, University of Paris;Department of Gastrointestinal Oncology, National Cancer Center Hospital East;Third Department of Internal Medicine ,(Hematology/Medical Oncology), Klinikum Rechts der Isar, Technische Universitaet München;Department of Gastroenterology and Digestive Oncology, University Hospital Gasthuisberg and University of Leuven;Division of Oncology, Azienda Ospedaliero-Universitaria Pisana;Gastrointestinal Oncology Program, University of Chicago Medical Center;Centre of EXcellence Methodology and Valorization of Data ,(CentEX MVD), Institut de Recherches Internationales Servier;Global Medical and Patient Affairs, Les Laboratoires Servier SAS;Drug Development Unit, Sarah Cannon Research Institute UK Limited;Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center

关键词: metastatic gastric cancer;    cancer of the esophagogastric junction;    trifluridine/tipiracil;    third line;    fourth line;    overall survival;   

DOI  :  10.1016/j.esmoop.2021.100200

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

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.

【 授权许可】

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