Evidence map›Paper›PMID 34175675›Full record

ArticleESMO open2021

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

J Tabernero, K Shitara, A Zaanan, T Doi, S Lorenzen, E Van Cutsem, L Fornaro, D V T Catenacci, R Fougeray, S R Moreno and 4 more

Open access · goldAbstract read
In one paragraph

Article in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. German, Austrian, and Swiss guidelines for systemic treatment of gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Article
  4. Article
  5. HTA and Gastric Cancer: Evaluating Alternatives in Third- and Fourth-Line Patients.International journal of environmental research and public health · 2023
    Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. 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

14 authors at 11 institutions in 8 countries.

J TaberneroDepartment of Medical Oncology, Vall d'Hebron Hospital Campus and Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain. Electronic address: jtabernero@vhio.net.
K ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
A ZaananDepartment of Gastrointestinal Oncology, European Georges Pompidou Hospital, AP-HP Centre, University of Paris, Paris, France.
T DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
S LorenzenThird Department of Internal Medicine (Hematology/Medical Oncology), Klinikum Rechts der Isar, Technische Universitaet München, München, Germany.
E Van CutsemDepartment of Gastroenterology and Digestive Oncology, University Hospital Gasthuisberg and University of Leuven, Leuven, Belgium.
L FornaroDivision of Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
D V T CatenacciGastrointestinal Oncology Program, University of Chicago Medical Center, Chicago, USA.
R FougerayCentre of EXcellence Methodology and Valorization of Data (CentEX MVD), Institut de Recherches Internationales Servier, Suresnes, France.
S R MorenoGlobal Medical and Patient Affairs, Les Laboratoires Servier SAS, Suresnes, France.
P AzcueGlobal Medical and Patient Affairs, Les Laboratoires Servier SAS, Suresnes, France.
H-T ArkenauDrug Development Unit, Sarah Cannon Research Institute UK Limited, London, UK.
M AlsinaDepartment of Medical Oncology, Vall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Barcelona, Spain.
D H IlsonGastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, USA.
National Cancer Center Hospital East · JPServier (France) · FRAssistance Publique – Hôpitaux de Paris · FRAzienda Ospedaliera Universitaria Pisana · ITKU Leuven · BEMemorial Sloan Kettering Cancer Center · USSarah Cannon Research Institute · GBTUM Klinikum · DEUniversitat de Vic - Universitat Central de Catalunya · ESUniversity of Chicago Medical Center · USVall d'Hebron Hospital Universitari · ES

Funding

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

Abstract

backgroundMetastatic 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

methodsPatients 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.

resultsBaseline 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.

conclusionsThis 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.

Indexed as

Colorectal NeoplasmsStomach NeoplasmsHumansPyrrolidinesThymineTrifluridineUracilPyrrolidinesThyminetipiracilTrifluridineUracilcancer of the esophagogastric junctionfourth linemetastatic gastric canceroverall survivalthird linetrifluridine/tipiracil

Identifiers

PMID34175675
PMCPMC8253956
OpenAlexW3176415106

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.