Evidence map›Paper›PMID 20716591›Full record

Trial reportNeuro-oncology2010

Phase II trial of bevacizumab and erlotinib in patients with recurrent malignant glioma.

Sith Sathornsumetee, Annick Desjardins, James J Vredenburgh, Roger E McLendon, Jennifer Marcello, James E Herndon, Alyssa Mathe, Marta Hamilton, Jeremy N Rich, Julie A Norfleet and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00671970 (Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma), which is not on this map. Cited by 119 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 6 pooled it
–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.

NCT00671970 phase2completednot on this map

Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma

TypeinterventionalSponsorDuke UniversityRan2007 to 2010Enrolled57ConditionsGlioblastoma, GliosarcomaArmsBevacizumab and Erlotinib
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Incorporation of biomarkers in phase II studies of recurrent glioblastoma.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
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  4. Guideline
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  6. Safety of bevacizumab in patients with malignant gliomas: a systematic review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2014
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59 more citing papers are in PubMed but not listed here.

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

13 authors.

Sith SathornsumeteeThe Preston Robert Tisch Brain Tumor Center, Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
Annick Desjardins
James J Vredenburgh
Roger E McLendon
Jennifer Marcello
James E Herndon
Alyssa Mathe
Marta Hamilton
Jeremy N Rich
Julie A Norfleet
Sridharan Gururangan
Henry S Friedman
David A Reardon

Funding

TUMOR SUPPRESSOR GENES IN HUMAN MEDULLOBLASTOMAP50NS020023 · NINDS · DUKE UNIVERSITY · PI BIGNER, DARELL D · 1985 to 2013
$17.3M
TEMODAR RESISTANCE IN CENTRAL NERVOUS SYSTEMP50CA108786 · NCI · DUKE UNIVERSITY · PI BIGNER, DARELL D · 2004 to 2009
$12.3M
NCI NIH HHS P50 CA 108786NCI NIH HHS P50 CA108786NINDS NIH HHS P50 NS020023NINDS NIH HHS P50-NS-020023
6 · The paper itself

Abstract

Vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) signaling are established contributors to malignant glioma (MG) biology. We, therefore, evaluated bevacizumab, a humanized anti-VEGF monoclonal antibody, in combination with the EGFR tyrosine kinase inhibitor erlotinib, in this phase 2 study for recurrent MG patients (www.ClinicalTrials.gov, NCT00671970). Fifty-seven patients (n = 25, glioblastoma [GBM]; n = 32, anaplastic glioma [AG]) were enrolled. The primary endpoint was 6-month progression-free survival (PFS-6). Overall survival (OS), radiographic response, pharmacokinetics, and correlative biomarkers were the secondary endpoints. Patients were stratified based on the concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs). Bevacizumab (10 mg/kg) was given intravenously every 2 weeks. Erlotinib was orally administered daily at 200 mg/day for patients not on EIAEDs and 500 mg/day for patients on EIAEDs. PFS-6 and median OS were 28% and 42 weeks for GBM patients and 44% and 71 weeks for AG patients, respectively. Twelve (48%) GBM patients and 10 (31%) AG patients achieved a radiographic response. Erlotinib pharmacokinetic exposures were comparable between EIAED and non-EIAED groups. Rash, mucositis, diarrhea, and fatigue were common but mostly grades 1 and 2. Among GBM patients, grade 3 rash, observed in 32%, was associated with survival benefit, whereas elevated hypoxia-inducible factor-2 alpha and VEGF receptor-2 levels were associated with poor survival. Bevacizumab plus erlotinib was adequately tolerated in recurrent MG patients. However, this regimen was associated with similar PFS benefit and radiographic response when compared with other historical bevacizumab-containing regimens.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticonvulsantsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBrain NeoplasmsDrug Therapy, CombinationErlotinib HydrochlorideFemaleGliomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticonvulsantsBevacizumabErlotinib HydrochlorideQuinazolines

Identifiers

PMID20716591
PMCPMC3018944

What OpenQuestion holds

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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.