Evidence map›Paper›PMID 19960228›Full record

Trial reportJournal of neuro-oncology2010

Phase II trial of erlotinib with temozolomide and radiation in patients with newly diagnosed glioblastoma multiforme.

David M Peereboom, Dale R Shepard, Manmeet S Ahluwalia, Cathy J Brewer, Neeraj Agarwal, Glen H J Stevens, John H Suh, Steven A Toms, Michael A Vogelbaum, Robert J Weil and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 3 pooled it
7.8field-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

114 citing papers in PubMed, 3 syntheses or guidelines pooled it, 197 citations in OpenAlex.

  1. Pooled it
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  17. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
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  20. Review

54 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

12 authors at 3 institutions in 1 country.

David M PeereboomBrain Tumor and Neuro-Oncology Center, Neurological Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA. peerebd@ccf.org
Dale R Shepard
Manmeet S Ahluwalia
Cathy J Brewer
Neeraj Agarwal
Glen H J Stevens
John H Suh
Steven A Toms
Michael A Vogelbaum
Robert J Weil
Paul Elson
Gene H Barnett
Cleveland Clinic · USThe Neurological Institute · USGeisinger Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Approximately 40-50% of glioblastomas (GBM) overexpress epidermal growth factor receptor (EGFR). Erlotinib is a specific and potent EGFR tyrosine kinase inhibitor active against refractory GBM. Patients with non-small cell lung cancer and > or =grade 2 erlotinib-induced rash have improved survival. This phase 2 study assessed the efficacy and safety of concurrent radiation therapy (RT) and temozolomide with pharmacodynamic dose escalation of erlotinib in patients with newly diagnosed GBM. Patients received RT 60 Gy in 30 fractions with concurrent temozolomide 75 mg/m(2)/day x 42 days, followed in four weeks by temozolomide 150-200 mg/m(2)/day x 5, every 28 days for 12 cycles. Patients received erlotinib, 50 mg/day and increased by 50 mg/day every 2 weeks until the occurrence of grade 2 rash or to a maximum dose of 150 mg/day, from day 1 until disease progression. Twenty-seven patients were treated in this study. Twenty-two (81%) patients came off study for progressive disease (18 [67%]) or adverse events (4 [15%]). Eighteen patients (67%) have died. Median progression-free survival was 2.8 months, and the median overall survival was 8.6 months. Five patients remain on study with a median follow-up of 16 months. Grade 3/4 toxicities included thrombocytopenia, anemia, lymphopenia, fatigue, and febrile neutropenia. There were four deaths on study, three definitely treatment-related; therefore, the trial was terminated after accrual of 27 of 30 planned patients. Erlotinib co administered with RT and temozolomide was not efficacious and had an unacceptable toxicity.

Indexed as

AdolescentAdultAgedAntineoplastic Agents, AlkylatingAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDacarbazineDisease-Free SurvivalDNA Modification MethylasesDNA Repair EnzymesErlotinib HydrochlorideFemaleGlioblastomaHumansKarnofsky Performance StatusMagnetic Resonance ImagingAntineoplastic Agents, AlkylatingDacarbazineDNA Modification MethylasesDNA Repair EnzymesErlotinib HydrochlorideMGMT protein, humanProtein Kinase InhibitorsQuinazolinesTemozolomideTumor Suppressor Proteins

Identifiers

PMID19960228
OpenAlexW2038657036

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.