Evidence map›Paper›PMID 20921459›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Immunologic escape after prolonged progression-free survival with epidermal growth factor receptor variant III peptide vaccination in patients with newly diagnosed glioblastoma.

John H Sampson, Amy B Heimberger, Gary E Archer, Kenneth D Aldape, Allan H Friedman, Henry S Friedman, Mark R Gilbert, James E Herndon, Roger E McLendon, Duane A Mitchell and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical 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 NCT00643097 (A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII), which is not on this map. Cited by 463 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
463citing papers in PubMed, 11 pooled it
22.2field-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.

NCT00643097 phase2completednot on this map

A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII

TypeinterventionalSponsorJohn SampsonRan2007 to 2016Enrolled40ConditionsMalignant Neoplasms of BrainArmsPEP-3 vaccine, sargramostim, Temozolomide
3 · Its place in the literature

Who cites it

463 citing papers in PubMed, 11 syntheses or guidelines pooled it, 803 citations in OpenAlex.

  1. Pooled it
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  4. A systematic review of immunotherapy in high-grade glioma: learning from the past to shape future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
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  10. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
    Pooled it
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  12. Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  13. Glioblastoma-mediated Immune Dysfunction Limits CMV-specific T Cells and Therapeutic Responses: Results from a Phase I/II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
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403 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

John H SampsonDuke University Medical Center, Durham, NC 27710, USA.
Amy B Heimberger
Gary E Archer
Kenneth D Aldape
Allan H Friedman
Henry S Friedman
Mark R Gilbert
James E Herndon
Roger E McLendon
Duane A Mitchell
David A Reardon
Raymond Sawaya
Robert J Schmittling
Weiming Shi
James J Vredenburgh
Darell D Bigner
The University of Texas MD Anderson Cancer Center · US

Funding

TUMOR SUPPRESSOR GENES IN HUMAN MEDULLOBLASTOMAP50NS020023 · NINDS · DUKE UNIVERSITY · PI ZALUTSKY, MICHAEL ROD · 1985 to 2013
$17.3M
TEMODAR RESISTANCE IN CENTRAL NERVOUS SYSTEMP50CA108786 · NCI · DUKE UNIVERSITY · PI BIGNER, DARELL D · 2004 to 2009
$12.3M
BRAIN TUMORS: IMMUNOLOGICAL AND BIOLOGICAL STUDIESR37CA011898 · NCI · DUKE UNIVERSITY · PI BIGNER, DARELL D · 1988 to 2012
$8.1M
Modulation of Microglia and T Cell Interactions in Malignant GliomaR01CA120813 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HEIMBERGER, AMY BETH, RAO, GANESH · 2007 to 2025
$4.7M
Dendritic Cell Immunotherapy of Malignant GliomasR01CA097222 · NCI · DUKE UNIVERSITY · PI SAMPSON, JOHN H · 2002 to 2006
$1.5M
NCI NIH HHS 5P50 CA108786NCI NIH HHS P50 CA108786NCI NIH HHS R01 CA097222NCI NIH HHS R01 CA120813NCI NIH HHS R01-CA97222-05NCI NIH HHS R37 CA011898NINDS NIH HHS 5P50 NS20023NINDS NIH HHS P50 NS020023
6 · The paper itself

Abstract

purposeImmunologic targeting of tumor-specific gene mutations may allow precise eradication of neoplastic cells without toxicity. Epidermal growth factor receptor variant III (EGFRvIII) is a constitutively activated and immunogenic mutation not expressed in normal tissues but widely expressed in glioblastoma multiforme (GBM) and other neoplasms. PATIENTS AND

methodsA phase II, multicenter trial was undertaken to assess the immunogenicity of an EGFRvIII-targeted peptide vaccine and to estimate the progression-free survival (PFS) and overall survival (OS) of vaccinated patients with newly diagnosed EGFRvIII-expressing GBM with minimal residual disease. Intradermal vaccinations were given until toxicity or tumor progression was observed. Sample size was calculated to differentiate between PFS rates of 20% and 40% 6 months after vaccination.

resultsThere were no symptomatic autoimmune reactions. The 6-month PFS rate after vaccination was 67% (95% CI, 40% to 83%) and after diagnosis was 94% (95% CI, 67% to 99%; n = 18). The median OS was 26.0 months (95% CI, 21.0 to 47.7 months). After adjustment for age and Karnofsky performance status, the OS of vaccinated patients was greater than that observed in a control group matched for eligibility criteria, prognostic factors, and temozolomide treatment (hazard ratio, 5.3; P = .0013; n = 17). The development of specific antibody (P = .025) or delayed-type hypersensitivity (P = .03) responses to EGFRvIII had a significant effect on OS. At recurrence, 82% (95% CI, 48% to 97%) of patients had lost EGFRvIII expression (P < .001).

conclusionEGFRvIII-targeted vaccination in patients with GBM warrants investigation in a phase III, randomized trial.

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingBrain NeoplasmsCancer VaccinesChemotherapy, AdjuvantDacarbazineDisease-Free SurvivalDNA MethylationDNA Modification MethylasesDNA Repair EnzymesDrug Administration ScheduleEnzyme-Linked Immunosorbent AssayErbB ReceptorsFemaleGene Expression Regulation, NeoplasticAntineoplastic Agents, AlkylatingCancer VaccinesDacarbazineDNA Modification MethylasesDNA Repair Enzymesepidermal growth factor receptor VIIIErbB ReceptorsMGMT protein, humanTemozolomideTumor Suppressor Proteins

Identifiers

PMID20921459
PMCPMC3020702
OpenAlexW2137605317

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.