Evidence map›Paper›PMID 30782343›Full record

Trial reportLancet (London, England)2019

Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial.

Ulrich Herrlinger, Theophilos Tzaridis, Frederic Mack, Joachim Peter Steinbach, Uwe Schlegel, Michael Sabel, Peter Hau, Rolf-Dieter Kortmann, Dietmar Krex, Oliver Grauer and 39 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06419946 (Phase III Trial of Temozolomide/Lomustine), which is not on this map. Cited by 343 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
343citing papers in PubMed, 4 pooled it
45.1field-weighted citation impact, top 1% 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.

NCT06419946 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)

TypeinterventionalSponsorVastra Gotaland RegionRan2025 to 2033Enrolled200ConditionsGlioblastoma, IDH-wildtype, MGMT-Methylated GlioblastomaArmsTemozolomide, Lomustine
3 · Its place in the literature

Who cites it

343 citing papers in PubMed, 4 syntheses or guidelines pooled it, 568 citations in OpenAlex.

  1. Pooled it
  2. Multidisciplinary treatment is necessary in glioblastoma with extracerebral metastases.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
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  15. Anatomical-molecular interaction in glioblastoma: subventricular zone involvement and MGMT-related survival benefit.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
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283 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

49 authors at 20 institutions in 2 countries.

Ulrich HerrlingerDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany. Electronic address: ulrich.herrlinger@ukbonn.de.
Theophilos TzaridisDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Frederic MackDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Joachim Peter SteinbachDr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
Uwe SchlegelDepartment of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.
Michael SabelDepartment of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany.
Peter HauDepartment of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.
Rolf-Dieter KortmannDepartment of Radiation Oncology, University of Leipzig, Leipzig, Germany.
Dietmar KrexDepartment of Neurosurgery, University of Dresden, Dresden, Germany.
Oliver GrauerDepartment of Neurology, University of Münster, Münster, Germany.
Roland GoldbrunnerDepartment of Neurosurgery, University of Cologne, Cologne, Germany.
Oliver SchnellDepartment of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany; Department of Neurosurgery, University of Freiburg, Freiburg, Germany.
Oliver BährDr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
Martin UhlDepartment of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.
Clemens SeidelDepartment of Radiation Oncology, University of Leipzig, Leipzig, Germany.
Ghazaleh TabatabaiInterdisciplinary Division of Neurooncology, University of Tübingen, Tübingen, Germany.
Thomas KowalskiDepartment of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.
Florian RingelDepartment of Neurosurgery, Technical University of Munich, Munich, Germany; Department of Neurosurgery, University of Mainz, Mainz, Germany.
Friederike Schmidt-GrafDepartment of Neurology, Technical University of Munich, Munich, Germany.
Bogdana SuchorskaDepartment of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany.
Stefanie BrehmerDepartment of Neurosurgery, University of Mannheim, Mannheim, Germany.
Astrid WeyerbrockDepartment of Neurosurgery, University of Freiburg, Freiburg, Germany.
Miriam RenovanzDepartment of Neurosurgery, University of Mainz, Mainz, Germany.
Lars BullingerDepartment of Internal Medicine, University of Ulm, Ulm, Germany.
Norbert GalldiksDepartment of Neurology, University of Cologne, Cologne, Germany; Institute of Neuroscience and Medicine (INM-3), Juelich, Germany.
Peter VajkoczyDepartment of Neurosurgery, Charité University of Berlin, Berlin, Germany.
Martin MischDepartment of Neurosurgery, Charité University of Berlin, Berlin, Germany.
Hartmut VatterDepartment of Neurosurgery, University Hospital Bonn, Bonn, Germany.
Moritz StuplichDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Niklas SchäferDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Sied KebirDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Johannes WellerDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Christina SchaubDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.
Walter StummerDepartment of Neurosurgery, University of Münster, Münster, Germany.
Jörg-Christian TonnDepartment of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany.
Matthias SimonDepartment of Neurosurgery, University Hospital Bonn, Bonn, Germany.
Vera C KeilDepartment of Neuroradiology, University Hospital Bonn, Bonn, Germany.
Michael NellesDepartment of Neuroradiology, University Hospital Bonn, Bonn, Germany.
Horst UrbachDepartment of Neuroradiology, University Hospital Bonn, Bonn, Germany; Department of Neuroradiology, University of Freiburg, Freiburg, Germany.
Martin CoenenStudy Centre Bonn, University Hospital Bonn, Bonn, Germany.
Wolfgang WickDepartment of Neurology, University of Heidelberg and German Cancer Research Center, Heidelberg, Germany.
Michael WellerDepartment of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.
Rolf FimmersInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
Matthias SchmidInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
Elke HattingenDepartment of Neuroradiology, University Hospital Bonn, Bonn, Germany.
Torsten PietschInstitute of Neuropathology and DGNN Brain Tumor Reference Centre, University Hospital Bonn, Bonn, Germany.
Christoph CochStudy Centre Bonn, University Hospital Bonn, Bonn, Germany.
Martin GlasDivision of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany; Division of Clinical Neurooncology, Department of Neurology and West German Cancer Center, German Cancer Consortium, Partner Site Essen, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Neurooncology Working Group of the German Cancer Society
University Hospital Bonn · DEUniversity of Freiburg · DECharité - Universitätsmedizin Berlin · DEDeutschen Konsortium für Translationale Krebsforschung · DEGoethe University Frankfurt · DEJohannes Gutenberg University Mainz · DELeipzig University · DERuhr University Bochum · DEUniversity Hospital Regensburg · DEUniversity of Münster · DEEssen University Hospital · DEForschungszentrum Jülich · DEHeidelberg University · DEHeinrich Heine University Düsseldorf · DETechnical University of Munich · DETechnische Universität Dresden · DEUniversität Ulm · DEUniversity Hospital of Zurich · CHUniversity of Cologne · DEUniversity of Mannheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is an urgent need for more effective therapies for glioblastoma. Data from a previous unrandomised phase 2 trial suggested that lomustine-temozolomide plus radiotherapy might be superior to temozolomide chemoradiotherapy in newly diagnosed glioblastoma with methylation of the MGMT promoter. In the CeTeG/NOA-09 trial, we aimed to further investigate the effect of lomustine-temozolomide therapy in the setting of a randomised phase 3 trial.

methodsIn this open-label, randomised, phase 3 trial, we enrolled patients from 17 German university hospitals who were aged 18-70 years, with newly diagnosed glioblastoma with methylated MGMT promoter, and a Karnofsky Performance Score of 70% and higher. Patients were randomly assigned (1:1) with a predefined SAS-generated randomisation list to standard temozolomide chemoradiotherapy (75 mg/m

findingsBetween June 17, 2011, and April 8, 2014, 141 patients were randomly assigned to the treatment groups; 129 patients (63 in the temozolomide and 66 in the lomustine-temozolomide group) constituted the modified intention-to-treat population. Median overall survival was improved from 31·4 months (95% CI 27·7-47·1) with temozolomide to 48·1 months (32·6 months-not assessable) with lomustine-temozolomide (hazard ratio [HR] 0·60, 95% CI 0·35-1·03; p=0·0492 for log-rank analysis). A significant overall survival difference between groups was also found in a secondary analysis of the intention-to-treat population (n=141, HR 0·60, 95% CI 0·35-1·03; p=0·0432 for log-rank analysis). Adverse events of grade 3 or higher were observed in 32 (51%) of 63 patients in the temozolomide group and 39 (59%) of 66 patients in the lomustine-temozolomide group. There were no treatment-related deaths.

interpretationOur results suggest that lomustine-temozolomide chemotherapy might improve survival compared with temozolomide standard therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter. The findings should be interpreted with caution, owing to the small size of the trial.

fundingGerman Federal Ministry of Education and Research.

Indexed as

Combined Modality TherapyAdultAgedAntineoplastic Agents, AlkylatingFemaleGlioblastomaHumansLomustineMaleMiddle AgedTemozolomideAntineoplastic Agents, AlkylatingLomustineTemozolomide

Identifiers

PMID30782343
OpenAlexW2914199948

What OpenQuestion holds

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Read underepoch 390

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.