Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer : a subgroup analysis from the phase 3 TAGS study
Mansoor, Wasat (The Christie NHS Foundation Trust)
Arkenau, Hendrik-Tobias (University College London)
Alsina, Maria (Vall d'Hebron Institut d'Oncologia)
Shitara, Kohei (National Cancer Center Hospital East)
Thuss-Patience, Peter (Charité - Universitätsmedizin Berlin)
Cuffe, Sinead (St. James's Hospital ( Dublín, Irlanda))
Dvorkin, Mikhail (Omsk Regional Clinical Centre of Oncology)
Park, David (St, Joseph Heritage Healthcare)
Ando, Takayuki (University of Toyama)
Van Den Eynde, Marc (UCL Cliniques Universitaires Saint-Luc)
Beretta, Giordano D. (Humanitas Gavazzeni)
Zaniboni, Alberto (Fondazione Poliambulanza-Istituto Ospedaliero)
Doi, Toshihiko (National Cancer Center Hospital East)
Tabernero, Josep (Vall d'Hebron Institut d'Oncologia)
Ilson, David H. (Memorial Sloan Kettering Cancer Center)
Makris, Lukas (Stathmi, Inc, New Hope, PA USA)
Benhadji, Karim A. (Taiho Oncology)
Van Cutsem, Eric (University Hospitals Gasthuisberg (Leuven, Bélgica))
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	Patients with advanced gastroesophageal junction cancer (GEJC) have poor survival outcomes, and GEJC-specific data from trials evaluating agents in gastric cancers (GCs) as a whole are lacking. Trifluridine/tipiracil (FTD/TPI) was approved for previously treated metastatic GC or GEJC (mGC/mGEJC) based on results of the phase 3 TAGS trial. Subgroup analyses by primary tumor type (GC or GEJC) in TAGS are reported here. Pa tients with mGC/mGEJC treated with ≥ 2 prior chemotherapy regimens were randomized (2:1) to receive FTD/TPI or placebo, plus best supportive care. A pre-planned sub-analysis was performed to evaluate efficacy and safety outcomes by primary tumor type (GEJC or GC). Of 507 randomized patients, 145 (29%) had GEJC and 360 (71%) had GC as the primary disease site. Baseline characteristics were generally similar between the GEJC and GC subgroups, except that more patients in the GEJC subgroup had received ≥ 3 prior regimens (72 vs. 59% in the GC subgroup). Survival benefit with FTD/TPI was observed in both subgroups. The overall survival hazard ratio for FTD/TPI vs placebo was 0. 75 (95% CI 0. 50-1. 11) and 0. 67 (95% CI 0. 52-0. 87) in the GEJC and GC subgroups, respectively. Grade ≥ 3 adverse events of any cause were reported in 75 (77%) and 192 (81%) FTD/TPI-treated patients in the GEJC and GC subgroups, respectively. No new safety concerns were noted with FTD/TPI. As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile. The online version contains supplementary material available at 10. 1007/s10120-021-01156-x.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Trifluridine/tipiracil ; Gastroesophageal junction cancer ; TAGS ; Phase 3 ; Subgroup analysis
Published in:	Gastric Cancer, Vol. 24 (march 2021) , p. 970-977, ISSN 1436-3305

DOI: 10.1007/s10120-021-01156-x
PMID: 33713215

8 p, 1.6 MB

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