Evidence map›Paper›PMID 36609807›Full record

Trial reportJournal of neuro-oncology2023

Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial.

J Weller, N Schäfer, C Schaub, T Tzaridis, T Zeyen, M Schneider, A L Potthoff, F A Giordano, J P Steinbach, P S Zeiner and 18 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01149109 (Phase III Trial of CCNU/Temozolomide), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.0field-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.

NCT01149109 phase3completednot on this map

Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients

TypeinterventionalSponsorUniversity Hospital, BonnRan2010 to 2017Enrolled141ConditionsGlioblastomaArmsTemozolomide and lomustine, Temozolomide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 7 citations in OpenAlex.

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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

28 authors at 18 institutions in 1 country.

J WellerDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany. johannes.weller@ukbonn.de.ORCID http://orcid.org/0000-0001-5818-5392
N SchäferDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
C SchaubDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
T TzaridisDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.ORCID http://orcid.org/0000-0001-9651-1144
T ZeyenDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
M SchneiderDepartment of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.ORCID http://orcid.org/0000-0002-6025-7479
A L PotthoffDepartment of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.ORCID http://orcid.org/0000-0002-5710-6557
F A GiordanoDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
J P SteinbachDr. Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
P S ZeinerDr. Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
T KowalskiDepartment of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.
M SabelDepartment of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany.
P HauDepartment of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Regensburg, Germany.
D KrexDepartment of Neurosurgery, University of Dresden, Dresden, Germany.
O GrauerDepartment of Neurology, University of Münster, Münster, Germany.
R GoldbrunnerDepartment of General Neurosurgery, Center of Neurosurgery, University of Cologne, Cologne, Germany.
O SchnellDepartment of Neurosurgery, University of Freiburg, Freiburg, Germany.
G TabatabaiDepartment of Neurology and Interdisciplinary Neurooncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research, Center for Neuro-Oncology, Comprehensive Cancer Center Tübingen-Stuttgart, German Cancer Consortium (DKTK), Partner site Tübingen, Eberhard Karls University, Tübingen, Germany.ORCID http://orcid.org/0000-0002-3542-8782
F RingelDepartment of Neurosurgery, University of Mainz, Mainz, Germany.ORCID http://orcid.org/0000-0003-3132-7543
F Schmidt-GrafDepartment of Neurology, Technical University of Munich, Munich, Germany.
S BrehmerDepartment of Neurosurgery, University of Mannheim, Mannheim, Germany.
J C TonnDepartment of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany.
L BullingerDepartment of Hematology, Oncology and Tumorimmunology, Charité University of Berlin, Berlin, Germany.
P VajkoczyDepartment of Neurosurgery, Charité University of Berlin, Berlin, Germany.
M GlasDivision of Clinical Neurooncology, Department of Neurology and West German Cancer Center (WTZ), German Cancer Consortium, Partner Site Essen, University Hospital Essen, Essen, Germany.
H VatterDepartment of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.
U HerrlingerDivision of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
C SeidelDepartment of Radiation Oncology, University of Leipzig, Leipzig, Germany.
University Hospital Bonn · DECharité - Universitätsmedizin Berlin · DEGoethe University Frankfurt · DEDeutschen Konsortium für Translationale Krebsforschung · DEEssen University Hospital · DEHeidelberg University · DEHeinrich Heine University Düsseldorf · DEHertie Institute for Clinical Brain Research · DEJohannes Gutenberg University Mainz · DELeipzig University · DETechnical University of Munich · DETechnische Universität Dresden · DEUniversitätsklinikum Knappschaftskrankenhaus Bochum · DEUniversity Hospital Regensburg · DEUniversity of Cologne · DEUniversity of Freiburg · DEUniversity of Mannheim · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the randomized phase III trial CeTeG/NOA-09, temozolomide (TMZ)/lomustine (CCNU) combination therapy was superior to TMZ in newly diagnosed MGMT methylated glioblastoma, albeit reporting more frequent hematotoxicity. Here, we analyze high grade hematotoxicity and its prognostic relevance in the trial population.

methodsDescriptive and comparative analysis of hematotoxicity adverse events ≥ grade 3 (HAE) according to the Common Terminology of Clinical Adverse Events, version 4.0 was performed. The association of HAE with survival was assessed in a landmark analysis. Logistic regression analysis was performed to predict HAE during the concomitant phase of chemotherapy.

resultsHAE occurred in 36.4% and 28.6% of patients under CCNU/TMZ and TMZ treatment, respectively. The median onset of the first HAE was during concomitant chemotherapy (i.e. first CCNU/TMZ course or daily TMZ therapy), and 42.9% of patients with HAE receiving further courses experienced repeat HAE. Median HAE duration was similar between treatment arms (CCNU/TMZ 11.5; TMZ 13 days). Chemotherapy was more often discontinued due to HAE in CCNU/TMZ than in TMZ (19.7 vs. 6.3%, p = 0.036). The occurrence of HAE was not associated with survival differences (p = 0.76). Regression analysis confirmed older age (OR 1.08) and female sex (OR 2.47), but not treatment arm, as predictors of HAE.

conclusionOlder age and female sex are associated with higher incidence of HAE. Although occurrence of HAE was not associated with shorter survival, reliable prediction of patients at risk might be beneficial to allow optimal management of therapy and allocation of supportive measures.

trial registrationNCT01149109.

Indexed as

Brain NeoplasmsGlioblastomaAntineoplastic Agents, AlkylatingDacarbazineFemaleHumansLomustinePrognosisTemozolomideAntineoplastic Agents, AlkylatingDacarbazineLomustineTemozolomideGlioblastomaHematotoxicityLomustineMGMTTemozolomide

Identifiers

PMID36609807
PMCPMC9886607
OpenAlexW4313656783

What OpenQuestion holds

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LicenceCC BY
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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.