Evidence map›Paper›PMID 41071419›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2025

Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.

Andrew J Martin, Yu Yang Soon, Katrin Marie Sjoquist, Nick Pavlakis, David Goldstein, Kohei Shitara, John R Simes

Abstract readClinical Trial, Phase IIIClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Andrew J MartinULTRA The University of Queensland's Clinical Trials Capability, Herston Brisbane, Brisbane, QLD, 4006, Australia. andrew.martin@uq.edu.au.ORCID 0000-0001-5804-2295
Yu Yang SoonNHMRC Clinical, Trials Centre, University of Sydney, Sydney, NSW, Australia.
Katrin Marie SjoquistNHMRC Clinical, Trials Centre, University of Sydney, Sydney, NSW, Australia.
Nick PavlakisDepartment of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia.
David GoldsteinNelune Comprehensive Cancer Centre, Prince of Wales Hospital, Sydney, NSW, Australia.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Centre Hospital East, Kashiwa City, Japan.
John R SimesNHMRC Clinical, Trials Centre, University of Sydney, Sydney, NSW, Australia.

Funding

Bayer unrestricted research grant to AGITG
6 · The paper itself

Abstract

backgroundThe INTEGRATE trials evaluated regorafenib in advanced gastric and esophagogastric junction cancer (AGOC), a poor prognosis population. In INTEGRATE 1 (I1, phase 2), regorafenib improved progression-free survival (PFS) without a clear excess decline in health-related quality of life (HRQoL). INTEGRATE 2a (I2a, phase 3) demonstrated an overall survival (OS) benefit, alone and in a pre-specified pooled analysis with I1.

aimTo evaluate HRQoL outcomes from I2a and the pooled analysis with I1.

methodsHRQoL was assessed at baseline, day 1 of each cycle, and every 8 weeks until progression, using EORTC QLQ-C30, EORTC STO22, and the participant Disease and Treatment Assessment (PtDATA). The primary endpoint was deterioration-free survival (DetFS), defined as time to a ≥ 10-point decline in QLQ-C30 physical function (DetFSPF) or global health status (DetFSGHS), progression, or death. Secondary analyses used linear mixed models (LMM). Tertiary analyses used logistic regression to evaluate symptom and side-effect prevalence (PtDATA). Pooled analyses adjusted for trial effects.

resultsOf 251 I2a participants, 240 contributed HRQoL data. Regorafenib was superior on DetFSPF (HR = 0.75, 95% CI 0.58-0.99, p = 0.03) and DetFSGHS (HR = 0.68, 95% CI 0.52-0.89, p = 0.004). LMM showed no appreciable differences in HRQoL trajectories. Rash, hand-foot syndrome, numbness, and coping difficulties were more frequent with regorafenib. Pooled analyses confirmed these findings.

conclusionRegorafenib modestly prolonged survival in AGOC without clear HRQoL deterioration. Despite more frequent toxicities, overall HRQoL was preserved. Regorafenib may offer a net clinical benefit when survival and HRQoL preferences are considered.

Indexed as

Antineoplastic AgentsEsophageal NeoplasmsEsophagogastric JunctionPhenylurea CompoundsPyridinesQuality of LifeStomach NeoplasmsAgedFemaleHumansMaleMiddle AgedSurvival RateAntineoplastic AgentsPhenylurea CompoundsPyridinesregorafenibAdvanced gastric and esophagogastric junction cancerHealth-related quality of lifePhase III trialRegorafenib

Identifiers

PMID41071419

What OpenQuestion holds

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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.