Evidence map›Paper›PMID 37213030›Full record

Trial reportJournal of cancer research and clinical oncology2023

Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS).

Kohei Shitara, Ben George, Julien Taieb, Raghav Sundar, Marwan G Fakih, Lukas Makris, Karim A Benhadji, Michele Ghidini

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02500043 (Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

NCT02500043 phase3completednot on this map

Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments

TypeinterventionalSponsorTaiho Oncology, Inc.Ran2016 to 2019Enrolled507ConditionsRefractory Metastatic Gastric CancerArmsTAS-102, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

8 authors at 8 institutions in 5 countries.

Kohei ShitaraNational Cancer Center Hospital East, Kashiwa-Shi, Chiba, 277-8577, Japan. kshitara@east.ncc.go.jp.
Ben GeorgeMedical College of Wisconsin, Milwaukee, WI, USA.
Julien TaiebHôpital Européen Georges Pompidou, Université Paris-Cité, SIRIC CARPEM, Paris, France.
Raghav SundarNational University Health System, Singapore, Singapore.
Marwan G FakihCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Lukas MakrisStathmi, Inc., New Hope, PA, USA.
Karim A BenhadjiTaiho Oncology, Inc., Princeton, NJ, USA.
Michele GhidiniAzienda Ospedaliera di Cremona, Cremona, Italy.
City of Hope · USHope Foundation · USHôpital Européen Georges-Pompidou · FRIstituti Ospitalieri di Cremona · ITMedical College of Wisconsin · USNational Cancer Center Hospital East · JPNational University Health System · SGTaiho Oncology (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase III TAGS trial, trifluridine/tipiracil showed survival benefit versus placebo in patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. This post hoc exploratory analysis assessed the impact of prior therapy type on outcomes.

methodsBased on prior treatment, patients in TAGS (N = 507) were categorized into overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel sequentially or in combination (n = 154), neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival, time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2, and safety were assessed.

resultsBaseline characteristics and prior therapy patterns were generally well balanced between trifluridine/tipiracil and placebo arms across subgroups. Trifluridine/tipiracil was associated with survival benefits versus placebo regardless of prior treatment: across subgroups, median overall survival was 4.6-6.1 versus 3.0-3.8 months (hazard ratios, 0.47-0.88), median progression-free survival was 1.9-2.3 versus 1.7-1.8 months (hazard ratios, 0.49-0.67), and median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months (hazard ratios, 0.56-0.88). Among trifluridine/tipiracil-randomized patients, median overall and progression-free survival trended longer in those who had not received ramucirumab, paclitaxel and ramucirumab, or irinotecan (6.0-6.1 and 2.1-2.3 months, respectively) than in those who previously received these agents (4.6-5.7 and 1.9 months). The trifluridine/tipiracil safety profile was consistent across subgroups, with similar overall incidences of grade ≥ 3 adverse events. Minor variations in hematologic toxicities were noted.

conclusionsIn TAGS, third- or later-line trifluridine/tipiracil treatment demonstrated overall and progression-free survival and functioning benefits versus placebo and a consistent safety profile in patients with metastatic gastric/gastroesophageal junction cancer, regardless of prior treatment type. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT02500043.

Indexed as

Colorectal NeoplasmsStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsEsophagogastric JunctionHumansIrinotecanPaclitaxelPyrrolidinesThymineTrifluridineDrug CombinationsIrinotecanPaclitaxelPyrrolidinesThyminetipiracilTrifluridineAntineoplastic protocolsGastric cancerGastroesophageal junction cancerThird- or later-line therapyTrifluridine tipiracil

Identifiers

PMID37213030
PMCPMC10374776
OpenAlexW4377220970

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.