Evidence map›Paper›PMID 19204207›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034.

Martin J van den Bent, Alba A Brandes, Roy Rampling, Mathilde C M Kouwenhoven, Johan M Kros, Antoine F Carpentier, Paul M Clement, Marc Frenay, Mario Campone, Jean-Francois Baurain and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00086879 (Randomized Phase II of TARCEVA™), which is not on this map. Cited by 283 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
283citing papers in PubMed, 8 pooled it
26.7field-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.

NCT00086879 phase2completednot on this map

Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan2004 to 2011Enrolled110ConditionsBrain and Central Nervous System TumorsArmscarmustine, erlotinib hydrochloride, temozolomide
3 · Its place in the literature

Who cites it

283 citing papers in PubMed, 8 syntheses or guidelines pooled it, 563 citations in OpenAlex.

  1. Pooled it
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  5. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Guideline
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  8. Temozolomide for high grade glioma.The Cochrane database of systematic reviews · 2013
    Pooled it
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223 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

17 authors at 1 institution in 1 country.

Martin J van den BentNeuro-Oncology Unit, Daniel den Hoed Cancer Center, PO Box 5201, 3008AE Rotterdam, the Netherlands. m.vandenbent@erasmusmc.nl
Alba A Brandes
Roy Rampling
Mathilde C M Kouwenhoven
Johan M Kros
Antoine F Carpentier
Paul M Clement
Marc Frenay
Mario Campone
Jean-Francois Baurain
Jean-Paul Armand
Martin J B Taphoorn
Alicia Tosoni
Heidemarie Kletzl
Barbara Klughammer
Denis Lacombe
Thierry Gorlia
Neurology, Inc · US

Funding

EORTC HEADQUARTERSU10CA011488 · NCI · EUROPEAN ORG/RES/TREATMENT/CANCER · PI LACOMBE, DENIS · 1985 to 2015
$6.6M
NCI NIH HHS 2U10 CA11488-36NCI NIH HHS 5U10CA11488-34NCI NIH HHS 5U10 CA11488-38NCI NIH HHS U10 CA011488
6 · The paper itself

Abstract

purposeApproximately 50% of glioblastomas (GBMs) are characterized by overexpression of the epidermal growth factor receptor (EGFR) and EGFR gene amplification. In approximately 25% of instances, constitutively activated EGFR mutants are present. These observations make EGFR-inhibiting drugs a logical approach for trials in recurrent GBM. PATIENTS AND

methodsIn a randomized, controlled, phase II trial, 110 patients with progressive GBM after prior radiotherapy were randomly assigned to either erlotinib or a control arm that received treatment with either temozolomide or carmustine (BCNU). The primary end point was 6-month progression-free survival (PFS). Tumor specimens obtained at first surgery were investigated for EGFR expression; EGFRvIII mutants; EGFR amplification; EGFR mutations in exons 18, 19, and 21; and pAkt. These results were correlated with outcome. Pharmacokinetic analysis was part of the study. RESULTS; Treatment was well tolerated in general; skin toxicity was the most frequent adverse effect of erlotinib. The 6-month PFS rate in the erlotinib arm was 11.4% (95% CI, 4.6% to 21.5%), and it was 24% in the control arm. Of all explored biomarkers, only low pAkt expression appeared to be of borderline significance to an improved outcome. None of the eight patients who had tumors with EGFRvIII mutant presence and PTEN expression had 6-month PFS. The use of enzyme-inducing anticonvulsants significantly increased erlotinib clearance, but pharmacokinetic findings were not related to outcome.

conclusionErlotinib has insufficient single-agent activity in unselected GBM. No clear biomarker associated with improved outcome to erlotinib was identified.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBrain NeoplasmsCarmustineDacarbazineErbB ReceptorsErlotinib HydrochlorideFemaleGlioblastomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalPTEN PhosphohydrolaseAntineoplastic AgentsCarmustineDacarbazineepidermal growth factor receptor VIIIErbB ReceptorsErlotinib HydrochloridePTEN PhosphohydrolasePTEN protein, humanQuinazolinesTemozolomide

Identifiers

PMID19204207
PMCPMC2667826
OpenAlexW2086216067

What OpenQuestion holds

Textmetadata
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.