Evidence map›Paper›PMID 30226855›Full record

Observational studyPloS one2018

EPIGIST: An observational real-life study on patients with metastatic gastrointestinal stromal tumors receiving imatinib.

Olivier Bouché, Axel Le Cesne, Maria Rios, Loic Chaigneau, Antoine Italiano, Florence Duffaud, Thierry Lecomte, Dominique Arsène, Sylvain Manfredi, Thomas Aparicio and 10 more

Abstract readObservational Study
In one paragraph

Observational study in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

20 authors.

Olivier BouchéDepartment of Digestive Oncology, University Hospital, Reims, France.ORCID 0000-0002-8284-3743
Axel Le CesneDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, France.
Maria RiosDepartment of Medical Oncology, Institut de Cancérologie de Lorraine-Alexis Vautrin, Nancy, France.
Loic ChaigneauDepartment of Medical Oncology, Centre J. Minjoz Universitary Hospital Center, Besançon, France.
Antoine ItalianoDepartment of Medical Oncology, Institut Bergonié, Bordeaux, France.
Florence DuffaudDepartment of Medical Oncology, La Timone University Hospital, Marseille and Aix -Marseille University (AMU), Marseille, France.
Thierry LecomteDepartment of Hepato-Gastroenterology and Digestive Oncology, University Hospital Trousseau, Tours, France.
Dominique ArsèneDepartment of Hepato-Gastroenterology and Digestive Oncology, University Hospital Caen Normandy, Caen, France.
Sylvain ManfrediDepartment of Gastroenterology Oncology, University Hospital Dijon, Dijon, France.
Thomas AparicioDepartment of Medical Oncology, University Hospital Saint Louis, Paris, France.
Stéphane RemyDepartment of Medical Oncology, Clinique Paulmy, Bayonne, France.
Nicolas IsambertDepartment of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.
Olivier CollardDepartment of Medical Oncology, Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, France.
Frank PriouDepartment of Medical Oncology, Les Oudairies hospital CHD Vendée, La Roche sur Yon, France.
François BertucciDepartment of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.
Roland SambucDepartment of Public Health, La Conception Hospital, Marseille, France.
Ségolene Bisot-LocardOncology Business Unit, Novartis Pharma S.A.S., Rueil-Malmaison, France.
Olivier BourgesOncology Business Unit, Novartis Pharma S.A.S., Rueil-Malmaison, France.
Sylvie ChabaudBiostatistics Unit, Centre Léon Bérard, Lyon, France.
Jean-Yves BlayDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGastrointestinal stromal tumors (GISTs) are rare, but represent the most common mesenchymal neoplasms of the gastrointestinal tract. EPIdemiology GIST, is an observational multicenter longitudinal follow-up cohort study reporting the prescribing patterns of imatinib in patients with GIST and the impact of the treatment in a real-world (standard clinical) setting.

methodsEligible patients had a confirmed diagnosis of unresectable or metastatic KIT-positive GIST and started treatment with imatinib for the first time between May 24, 2002, and June 30, 2010. During routine visits, annual collection of clinical characteristics was requested, i.e., age, GIST stage at diagnosis, history, imatinib treatment duration and dosage, adherence, and concomitant medications. Survival outcomes were estimated using the Kaplan-Meier method. Other data were analyzed using descriptive statistics.

resultsOf 151 patients enrolled, imatinib was initiated for 126 patients before enrollment and for 25 patients on the day of enrollment or soon after. The patient characteristics were similar to those in published prospective trials. The estimated 1-, 2-, 3-, and 4-year overall survival rates were 90.4% (95% confidence interval [CI; 84.8%-94.0%]), 84.7% (95% CI [78.1%-89.4%]), 73.0% (95% CI [65.0%-79.4%]), and 60.7% (95% CI [51.4%-68.8%]), respectively. The most common adverse events (AEs) were diarrhea (39%), asthenia (39%), eyelid or periorbital edema (32%), abdominal pain (23%), and anemia (21%). Eight of 126 serious AEs were possibly related to the treatment as assessed by investigators.

conclusionsStudy results showed that patients in real-life populations are generally treated in accordance with national and international clinical recommendations and have outcomes comparable to those of patients in clinical trials.

Indexed as

AdultAgedDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsEdemaFemaleFollow-Up StudiesGastrointestinal Stromal TumorsHumansImatinib MesylateMaleMiddle AgedMutationNeoplasm MetastasisProto-Oncogene Proteins c-kitTreatment OutcomeImatinib MesylateProto-Oncogene Proteins c-kit

Identifiers

PMID30226855
PMCPMC6143255

What OpenQuestion holds

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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.