Evidence map›Paper›PMID 34997449›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2022

Efficacy and safety of trifluridine/tipiracil in older and younger patients with metastatic gastric or gastroesophageal junction cancer: subgroup analysis of a randomized phase 3 study (TAGS).

Kohei Shitara, Toshihiko Doi, Hisashi Hosaka, Peter Thuss-Patience, Armando Santoro, Federico Longo, Ozgur Ozyilkan, Irfan Cicin, David Park, Aziz Zaanan and 6 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Efficacy and safety of irinotecan-based therapy in elderly patients with advanced gastric cancer receiving third-line or later chemotherapy: post-hoc age-subgroup analysis of the rindberg trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Trial
  2. Review
  3. Age is not destiny: what RINDBeRG tells us-and what it does not-about Irinotecan in older adults.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. 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

16 authors at 15 institutions in 7 countries.

Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, 277-8577, Japan. kshitara@east.ncc.go.jp.ORCID 0000-0001-5196-3630
Toshihiko DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, 277-8577, Japan.
Hisashi HosakaDepartment of Gastroenterology, Gunma Prefectural Cancer Center, Ota, Gunma, Japan.
Peter Thuss-PatienceMedizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20072, Milan, Italy.
Federico LongoMedical Oncology, Hospital Universitario Ramon y Cajal, IRYCIS, CIBERONC, Madrid, Spain.
Ozgur OzyilkanMedical Oncology, Baskent University Adana Practice and Research Centre Kisla, Adana, Turkey.
Irfan CicinDepartment of Internal Medicine, Division of Medical Oncology, School of Medicine, Trakya University, Edirne, Turkey.
David ParkHematology and Oncology, St. Jude Crosson Cancer Institute/St. Joseph Heritage Healthcare, Fullerton, CA, USA.
Aziz ZaananDepartment of Gastrointestinal Oncology, European Georges Pompidou Hospital, AP-HP Centre, University of Paris, Paris, France.
Carles PericayMedical Oncology, Corporación Sanitaria Parc Tauli, Barcelona, Spain.
Mustafa ÖzgüroğluDepartment of Internal Medicine, Division of Medical Oncology, Clinical Trial Unit, Cerrahpaşa School of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey.
Maria AlsinaMedical Oncology Department, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Lukas MakrisStathmi, Inc., New Hope, PA, USA.
Karim A BenhadjiClinical Development, Taiho Oncology, Inc., Princeton, NJ, USA.
David H IlsonGastrointestinal Oncology Service in the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
National Cancer Center Hospital East · JPAssistance Publique – Hôpitaux de Paris · FRBaşkent University · TRCharité - Universitätsmedizin Berlin · DECorporació Sanitària Parc Taulí · ESHope Foundation · USHumanitas University · ITHyogo Prefectural Cancer Center · JPInstituto Ramón y Cajal de Investigación Sanitaria · ESIstanbul University-Cerrahpaşa · TRMemorial Sloan Kettering Cancer Center · USSt. Jude Medical Center · USTaiho Oncology (United States) · USTrakya University · TRVall d'Hebron Hospital Universitari · ES

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

backgroundTrifluridine and tipiracil (FTD/TPI) demonstrated survival benefit vs placebo and manageable safety in previously treated patients with metastatic gastric/gastroesophageal junction cancer (mGC/GEJC) in the randomized, placebo-controlled, phase 3 TAGS study. This subgroup analysis of TAGS examined efficacy/safety outcomes by age.

methodsIn TAGS, patients with mGC/GEJC and ≥ 2 prior therapies were randomized (2:1) to receive FTD/TPI 35 mg/m

resultsAmong 507 randomized patients (n = 337 FTD/TPI; n = 170 placebo), 55%, 45%, and 14% were aged < 65, ≥ 65, and ≥ 75 years, respectively. Overall survival hazard ratios for FTD/TPI vs placebo were 0.67 (95% CI 0.51-0.89), 0.73 (95% CI 0.52-1.02), and 0.67 (95% CI 0.33-1.37) in patients aged < 65, ≥ 65, and ≥ 75 years, respectively. Regardless of age, patients receiving FTD/TPI experienced improved progression-free survival and stayed longer on treatment than those receiving placebo. Among FTD/TPI-treated patients, frequencies of any-cause grade ≥ 3 adverse events (AEs) were similar across age subgroups (80% each), although grade ≥ 3 neutropenia was more frequent in older patients [40% (≥ 65 and ≥ 75 years); 29% (< 65 years)]; AE-related discontinuation rates did not increase with age [14% (< 65 years), 12% (≥ 65 years), and 12% (≥ 75 years)].

conclusionsThe results of this subgroup analysis show the efficacy and tolerability of FTD/TPI treatment regardless of age in patients with mGC/GEJC who had received 2 or more prior treatments.

Indexed as

Colorectal NeoplasmsEsophageal NeoplasmsFrontotemporal DementiaStomach NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsEsophagogastric JunctionHumansPyrrolidinesThymineTrifluridineDrug CombinationsPyrrolidinesThyminetipiracilTrifluridinetrifluridine tipiracil drug combinationAgedAge groupsGastrointestinal neoplasmsRandomized controlled trialStomach neoplasmsTrifluridine tipiracil

Identifiers

PMID34997449
PMCPMC9013328
OpenAlexW4205756108

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.