Evidence map›Paper›PMID 34672349›Full record

Trial reportNeuro-oncology2022

Trabectedin for recurrent WHO grade 2 or 3 meningioma: A randomized phase II study of the EORTC Brain Tumor Group (EORTC-1320-BTG).

Matthias Preusser, Antonio Silvani, Emilie Le Rhun, Riccardo Soffietti, Giuseppe Lombardi, Juan Manuel Sepulveda, Petter Brandal, Lucy Brazil, Alice Bonneville-Levard, Veronique Lorgis and 28 more

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

Trial report in Neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 4 pooled it
7.4field-weighted citation impact, top 2% 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

53 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Trial
  6. Trial
  7. Alliance A071401: Phase II Trial of Focal Adhesion Kinase Inhibition in Meningiomas With SomaticJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  15. Rational Radionuclide Therapy for Recurrent Meningioma.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  16. Combined SSTR2-targeted Analogue withFrontiers in oncology · 2026
    Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 20 institutions in 10 countries.

Matthias PreusserDepartment of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0003-3541-2315
Antonio SilvaniDepartment of Neuro-Oncology, IRCCS Fondazione Istituto Neurologico Carlo Besta, Milan, Italy.
Emilie Le RhunUniversity of Lille, U-1192, Lille, France.
Riccardo SoffiettiDepartment of Neuro-Oncology, University and City of Health and Science Hospital, Turin, Italy.
Giuseppe LombardiDepartment of Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0003-1316-2132
Juan Manuel SepulvedaNeurooncology Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.
Petter BrandalDepartment of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway.
Lucy BrazilSt Thomas' Hospital, London, UK.
Alice Bonneville-LevardCentre Leon Berard, Lyon, France.
Veronique LorgisDepartment of Medical Oncology, Centre Georges François Leclerc, Dijon, France.
Elodie VauleonDepartment of Medical Oncology, Centre Eugene Marquis, Rennes, France.
Jacoline BrombergDepartment of Neuro-Oncology, Erasmus MC University Medical Center Cancer Center, Rotterdam, the Netherlands.
Sara ErridgeEdinburgh Cancer Centre, Western General Hospital, Edinburgh, UK.
Alison CameronBristol Cancer Institute, University Hospitals Bristol, Bristol, UK.
Florence LefrancDepartment of Neurosurgery, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Paul M ClementDepartment of Oncology, KU Leuven, Leuven, Belgium.
Sarah DumontMedical Oncology Department, Institut Gustave-Roussy, Université Paris-Saclay, Villejuif, France.
Marc SansonSorbonne Université, Inserm, CNRS, UMR S 1127, Institut du Cerveau et de la Moelle épinière, ICM, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, Paris, France.
Charlotte BronnimannDepartment of Medical Oncology, Bordeaux University Hospital-CHU, Bordeaux, France.
Carmen BalanáDepartment of Medical Oncology, Catalan Institute of Oncology, Badalona, Barcelona, Spain.
Niklas ThonDepartment of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.
Joanne LewisFreeman Hospital, Newcastle, UK.
Maximilian J MairDepartment of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.
Philipp SieversDepartment of Neuropathology, Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.
Julia FurtnerDepartment of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
Josef PichlerDepartment of Internal Medicine and Neurooncology, Neuromed Campus, Kepler University Hospital, Johannes Kepler University of Linz, Linz, Austria.
Jordi BrunaUnit of Neuro-Oncology, Hospital Universitari de Bellvitge-Institut Català D'Oncologia L'Hospitalet, Barcelona, Spain.
Francois DucrayUnit of Neuro-Oncology, Hospices Civils de Lyon, Lyon, France.
Jaap C ReijneveldBrain Tumor Center, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.
Christian MawrinDepartment of Neuropathology, Otto-von-Guericke-University, Magdeburg, Germany.
Martin BendszusDepartment of Neuroradiology, University of Heidelberg, Heidelberg, Germany.
Christine MarosiDepartment of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.
Vassilis GolfinopoulosEuropean Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Corneel CoensEuropean Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Thierry GorliaEuropean Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Michael WellerDepartment of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.ORCID 0000-0002-1748-174X
Felix SahmDepartment of Neuropathology, Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.
Wolfgang WickNeurology Clinic, Heidelberg University Medical Center, Clinical Cooperation Unit, Neurooncology, German Cancer Research Center, Heidelberg, Germany.ORCID 0000-0002-6171-634X
Medical University of Vienna · ATEuropean Organisation for Research and Treatment of Cancer · BEGerman Cancer Research Center · DEAmsterdam University Medical Centers · NLBellvitge University Hospital · ESCentre Eugène Marquis · FRCentre Georges François Leclerc · FRCentre Léon Bérard · FRCentre National de la Recherche Scientifique · FRErasmus MC · NLFondazione IRCCS Istituto Neurologico Carlo Besta · ITFreeman Hospital · GBHeidelberg University · DEHospital Universitario 12 De Octubre · ESInserm · FRInstitut Català d'Ornitologia · ESIstituto Oncologico Veneto · ITJohannes Kepler University of Linz · ATLMU Klinikum · DEOslo University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo systemic treatment has been established for meningioma progressing after local therapies.

methodsThis randomized, multicenter, open-label, phase II study included adult patients with recurrent WHO grade 2 or 3 meningioma. Patients were 2:1 randomly assigned to intravenous trabectedin (1.5 mg/m2 every 3 weeks) or local standard of care (LOC). The primary endpoint was progression-free survival (PFS). Secondary endpoints comprised overall survival (OS), objective radiological response, safety, quality of life (QoL) assessment using the QLQ-C30 and QLQ-BN20 questionnaires, and we performed tissue-based exploratory molecular analyses.

resultsNinety patients were randomized (n = 29 in LOC, n = 61 in trabectedin arm). With 71 events, median PFS was 4.17 months in the LOC and 2.43 months in the trabectedin arm (hazard ratio [HR] = 1.42; 80% CI, 1.00-2.03; P = .294) with a PFS-6 rate of 29.1% (95% CI, 11.9%-48.8%) and 21.1% (95% CI, 11.3%-32.9%), respectively. Median OS was 10.61 months in the LOC and 11.37 months in the trabectedin arm (HR = 0.98; 95% CI, 0.54-1.76; P = .94). Grade ≥3 adverse events occurred in 44.4% of patients in the LOC and 59% of patients in the trabectedin arm. Enrolled patients had impeded global QoL and overall functionality and high fatigue before initiation of systemic therapy. DNA methylation class, performance status, presence of a relevant co-morbidity, steroid use, and right hemisphere involvement at baseline were independently associated with OS.

conclusionsTrabectedin did not improve PFS and OS and was associated with higher toxicity than LOC treatment in patients with non-benign meningioma. Tumor DNA methylation class is an independent prognostic factor for OS.

Indexed as

Brain NeoplasmsMeningeal NeoplasmsMeningiomaAdultDisease-Free SurvivalHumansQuality of LifeTrabectedinWorld Health OrganizationTrabectedinclinical trialDNA methylation classmeningiomaquality of lifetrabectedin

Identifiers

PMID34672349
PMCPMC9071312
OpenAlexW2971441574

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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.