Evidence map›Paper›PMID 33713215›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2021

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

Wasat Mansoor, Hendrik-Tobias Arkenau, Maria Alsina, Kohei Shitara, Peter Thuss-Patience, Sinead Cuffe, Mikhail Dvorkin, David Park, Takayuki Ando, Marc Van Den Eynde and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Does immunotherapy change the treatment paradigm in metastatic gastric cancer?Medical oncology (Northwood, London, England) · 2022
    Review
  5. Biomarkers of Trifluridine-Tipiracil Efficacy.Journal of clinical medicine · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 17 institutions in 9 countries.

Wasat MansoorThe Christie NHS Foundation Trust, Manchester, UK. was.mansoor@nhs.net.ORCID 0000-0002-1477-4934
Hendrik-Tobias ArkenauSarah Cannon Research Institute, Cancer Institute, University College London, London, UK.
Maria AlsinaVall D, Institute of Oncology (VHIO), Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Kohei ShitaraNational Cancer Center Hospital East, Chiba, Japan.
Peter Thuss-PatienceCharité-Universitätsmedizin Berlin, Medizinische Klinik M.S. Hämatologie, Onkologie Und Tumorimmunologie, Berlin, Germany.
Sinead CuffeSt. James's Hospital, Dublin, Republic of Ireland.
Mikhail DvorkinOmsk Regional Clinical Centre of Oncology, Omsk, Russian Federation.
David ParkSt. Jude Crosson Cancer Institute/St, Joseph Heritage Healthcare, Fullerton, CA, USA.
Takayuki AndoUniversity of Toyama, Toyama, Japan.
Marc Van Den EyndeUCL Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Giordano D BerettaHumanitas Gavazzeni, Bergamo, Italy.
Alberto ZaniboniFondazione Poliambulanza-Istituto Ospedaliero, Brescia, Italy.
Toshihiko DoiNational Cancer Center Hospital East, Chiba, Japan.
Josep TaberneroInstitute of Oncology (VHIO), Vall D'Hebron University Hospital, UVic-UCC, IOB-Quiron, Barcelona, Spain.
David H IlsonMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Lukas MakrisStathmi, Inc, New Hope, PA, USA.
Karim A BenhadjiTaiho Oncology, Inc, Princeton, NJ, USA.
Eric Van CutsemUniversity Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.
National Cancer Center Hospital East · JPBudgetary Health Care Institution of the Omsk Region "Clinical Oncology Center" · RUCharité - Universitätsmedizin Berlin · DECliniques Universitaires Saint-Luc · BEFondazione Poliambulanza Istituto Ospedaliero · ITHope Foundation · USHumanitas Gavazzeni · ITMemorial Sloan Kettering Cancer Center · USSarah Cannon Research Institute · GBSt. James's Hospital · IESt. Jude Medical Center · USTaiho Oncology (United States) · USThe Christie NHS Foundation Trust · GBUniversitair Ziekenhuis Leuven · BEUniversitat Autònoma de Barcelona · ESUniversitat de Vic - Universitat Central de Catalunya · ESUniversity of Toyama · JP

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients 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.

methodsPa 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).

resultsOf 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.

conclusionAs 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.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsEsophagogastric JunctionFemaleHumansMaleMiddle AgedNeoplasm MetastasisProportional Hazards ModelsPyrrolidinesStomach NeoplasmsSurvival RateThymineDrug CombinationsPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationGastroesophageal junction cancerPhase 3Subgroup analysisTAGSTrifluridine/tipiracil

Identifiers

PMID33713215
PMCPMC8205879
OpenAlexW3135442446

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.