Thumbnail Image
Publication

Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer: a subgroup analysis from the phase 3 TAGS study.

Mansoor, Wasat
; 
Arkenau, Hendrik-Tobias
; 
Alsina, Maria
; 
Shitara, Kohei
; 
Thuss-Patience, Peter
; 
Cuffe, Sinead
; 
Dvorkin, Mikhail
; 
Park, David
; 
Ando, Takayuki
; 
Van Den Eynde, Marc
... show 8 more
Author
Mansoor, Wasat
 Arkenau, Hendrik-Tobias
 Alsina, Maria
 Shitara, Kohei
 Thuss-Patience, Peter
 Cuffe, Sinead
 Dvorkin, Mikhail
 Park, David
 Ando, Takayuki
 Van Den Eynde, Marc
 Beretta, Giordano D
 Zaniboni, Alberto
 Doi, Toshihiko
 Tabernero, Josep
 Ilson, David H
 Makris, Lukas
 Benhadji, Karim A
 Van Cutsem, Eric
Advisors
Editors
Other Contributors
Departments
Date
2021-03-13
Date Submitted
Keywords
Gastroesophageal junction cancer
Phase 3
Subgroup analysis
TAGS
Trifluridine/tipiracil
Other Subjects
Subject Mesh
Planned Date
Start Date
Collaborators
Principal Investigators
Files
Thumbnail Image
Mansoor2021_Article_TrifluridineTipiracilInPatient.pdf
Adobe PDF, 1.57 MB
Alternative Titles
Publisher
URI
https://hdl.handle.net/10147/631326
Abstract
Background: 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. Methods: 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). Results: 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. Conclusion: 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.
Language
en
Citation
ISSN
eISSN
1436-3305
ISBN
DOI
10.1007/s10120-021-01156-x
PMID
33713215
PMCID
Sponsorships
Funding Sources
Funding Amounts
Grant Identifiers
Methodology
Duration
Ethical Approval