Evidence map›Paper›PMID 28815316›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2018

Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma.

Andrew J Martin, Emma Gibbs, Katrin Sjoquist, Nick Pavlakis, John Simes, Tim Price, Jenny Shannon, Sanjeev Gill, Vikram Jain, Geoffrey Liu and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
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

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Health utility book: A systematic review and meta-analysis of health utilities in gastric cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Trial
  5. Trial
  6. Trial
  7. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2020
    Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Optimal assessment of quality of life for patients with prostate cancer.Therapeutic advances in medical oncology · 2022
    Review
  13. Article
  14. Observational
  15. Review
  16. 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

15 authors at 7 institutions in 3 countries.

Andrew J MartinNHMRC Clinical Trials Centre University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia. andrew.martin@ctc.usyd.edu.au.ORCID http://orcid.org/0000-0001-5804-2295
Emma GibbsNHMRC Clinical Trials Centre University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia.
Katrin SjoquistNHMRC Clinical Trials Centre University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia.
Nick PavlakisAustralasian Gastro-Intestinal Trials Group, Camperdown, Australia.
John SimesNHMRC Clinical Trials Centre University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia.
Tim PriceAustralasian Gastro-Intestinal Trials Group, Camperdown, Australia.
Jenny ShannonAustralasian Gastro-Intestinal Trials Group, Camperdown, Australia.
Sanjeev GillThe Alfred Hospital, Melbourne, Australia.
Vikram JainICON Cancercare, South Brisbane, Australia.
Geoffrey LiuUniversity Health Network, Princess Margaret Hospital, Toronto, Canada.
George KannourakisBallarat Oncology and Haematology Services, Wendouree, Australia.
Yeul Hong KimKorea University Anam Hospital, Seoul, South Korea.
Jin Won KimSeoul National University Bundang Hospital, Seongnam, South Korea.
David GoldsteinAustralasian Gastro-Intestinal Trials Group, Camperdown, Australia.
INTEGRATE I investigators
The University of Sydney · AUCooperative Trials Group for Neuro-Oncology · AUKorea University Medical Center · KRUniversity Health Network · CANepean Hospital · AUSeoul National University Bundang Hospital · KRThe Alfred Hospital · AU

Funding

Bayer Unrestricted research grant to Australasian Gastro-Intestinal Trials GroupNational Health and Medical Research Council Program Grant No. 1037786 to the NHMRC Clinical Trials Centre
6 · The paper itself

Abstract

backgroundThe INTEGRATE phase II multinational randomized controlled trial demonstrated the activity of regorafenib on progression-free survival (PFS) in patients with refractory advanced gastric adenocarcinoma. We sought to evaluate whether these PFS gains had the potential to be offset by quality of life (QoL) impacts from treatment side effects and to thereby determine the appropriateness of continuing development to phase III.

methodsQoL was assessed in INTEGRATE at baseline and at each 4 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30, STO22, and EQ-5D questionnaires. The patient disease and treatment assessment (PTDATA) form was also provided to English-speaking participants. Randomized groups were compared on the QLQ-C30, STO22, and EQ-5D scales using a repeated-measures model; the frequency of troublesome symptoms and side effects measured by the PTDATA form; and deterioration-free survival (DFS). The prognostic value of baseline QoL information was also evaluated.

resultsOf the 147 eligible randomized patients, 142 consented to participate in the QoL substudy, 136 completed a baseline QoL assessment, and 95 completed at least one post-baseline QoL assessment. The DFS rate was significantly improved with regorafenib, and there was no compelling statistical evidence that regorafenib had a broad negative effect across the spectrum of QoL indices evaluated. Fatigue, anxiety, appetite loss, and pain were among the issues most commonly reported for both randomized groups. Baseline levels of pain, appetite, constipation, and physical functioning were prognostic factors for survival.

conclusionsRegorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.

Indexed as

Quality of LifeAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalFemaleHumansMaleMiddle AgedPhenylurea CompoundsProportional Hazards ModelsPyridinesStomach NeoplasmsAntineoplastic AgentsPhenylurea CompoundsPyridinesregorafenibAntineoplastic agents/therapeutic useProtein kinase inhibitors/therapeutic useQuality of lifeStomach neoplasms

Identifiers

PMID28815316
OpenAlexW2746676535

What OpenQuestion holds

Textmetadata
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.