Evidence map›Paper›PMID 20708924›Full record

ArticleEuropean journal of cancer (Oxford, England : 1990)2010

A phase I and biology study of gefitinib and radiation in children with newly diagnosed brain stem gliomas or supratentorial malignant gliomas.

J Russell Geyer, Clinton F Stewart, Mehmet Kocak, Alberto Broniscer, Peter Phillips, James G Douglas, Susan M Blaney, Roger J Packer, Sri Gururangan, Anu Banerjee and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in European journal of cancer (Oxford, England : 1990), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03620032 (Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
3.3field-weighted citation impact, top 8% 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.

NCT03620032 phase2unknown statusnot on this mapstarted 2015, after this paper: background citation

Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2015 to 2024Enrolled54ConditionsDiffuse Intrinsic Pontine GliomaArmsNimotuzumab, Vinorelbine, Radiotherapy
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 62 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Nimotuzumab-vinorelbine combination therapy versus other regimens in the treatment of pediatric diffuse intrinsic pontine glioma.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Article
  4. Review
  5. Review
  6. Advances in Treatment of Diffuse Midline Gliomas.Current neurology and neuroscience reports · 2023
    Review
  7. Review
  8. Review
  9. Review
  10. Neurotoxic Effects of Childhood Cancer Therapy and Its Potential Neurocognitive Impact.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review
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

14 authors at 9 institutions in 1 country.

J Russell GeyerSeattle Children's Hospital, Seattle, WA, USA.
Clinton F Stewart
Mehmet Kocak
Alberto Broniscer
Peter Phillips
James G Douglas
Susan M Blaney
Roger J Packer
Sri Gururangan
Anu Banerjee
Mark W Kieran
Larry E Kun
Richard J Gilbertson
James M Boyett
St. Jude Children's Research Hospital · USPediatric Brain Tumor Consortium · USSeattle Children's Hospital · USBaylor College of Medicine · USChildren's Hospital of Philadelphia · USChildren's National · USDana-Farber Cancer Institute · USDuke Medical Center · USUniversity of San Francisco · US

Funding

ZOLENDRONIC ACID IN CHILDREN W/ SEVERE OSTEOGENESIS IMPERFECTAM01RR000188 · NCRR · BAYLOR COLLEGE OF MEDICINE · PI LOUIS, CHRYSTAL U · 1985 to 2011
$30.6M
The Pediatric Brain Tumor Consortium (PBTC)U01CA081457 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI BOYETT, JAMES MILFORD · 1999 to 2013
$29.2M
An Investigation of Radial Glia as the Source of Ependymoma Stem CellsR01CA129541 · NCI · UNIVERSITY OF CAMBRIDGE · PI GILBERTSON, RICHARD · 2007 to 2016
$3.0M
NCI NIH HHS R01 CA129541NCI NIH HHS U01 CA081457NCI NIH HHS U01 CA81457NCRR NIH HHS 5M01RR000188NCRR NIH HHS M01 RR000188
6 · The paper itself

Abstract

purposeTo estimate the maximum-tolerated dose (MTD); study the pharmacology of escalating doses of gefitinib combined with radiation therapy in patients ⩽21 years with newly diagnosed intrinsic brainstem gliomas (BSG) and incompletely resected supratentorial malignant gliomas (STMG); and to investigate epidermal growth factor receptor (EGFR) amplification and expression in STMG. PATIENTS AND

methodsThree strata were identified: stratum 1A--BSG; stratum IB--incompletely resected STMG not receiving enzyme-inducing anticonvulsant drugs (EIACD); and stratum II--incompletely resected STMG receiving EIACD. Dose escalation using a modified 3+3 cohort design was performed in strata IA and II. The initial gefitinib dosage was 100mg/m(2)/d commencing with radiation therapy and the dose-finding period extended until 2 weeks post-radiation. Pharmacokinetics (PK) and biology studies were performed in consenting patients.

resultsOf the 23 eligible patients, 20 were evaluable for dose-finding. MTDs for strata IA and II were not established as accrual was halted due to four patients experiencing symptomatic intratumoral haemorrhage (ITH); two during and two post dose-finding. ITH was observed in 0 of 11 patients treated at 100mg/m(2)/d, 1 of 10 at 250 mg/m(2)/d and 3 of 12 at 375 mg/m(2)/d. Subsequently a second patient at 250 mg/m(2)/d experienced ITH. PK analysis showed that the median gefitinib systemic exposure increased with dosage (p = 0.04). EGFR was over-expressed in 5 of 11 STMG and amplified in 4 (36%) samples.

conclusionThis trial provides clear evidence of EGFR amplification in a significant proportion of paediatric STMG and 250 mg/m(2)/d was selected for the phase II trial.

Indexed as

AdolescentAntineoplastic AgentsBrain Stem NeoplasmsChildChild, PreschoolCombined Modality TherapyErbB ReceptorsFemaleGefitinibGliomaHumansMaleMaximum Tolerated DoseQuinazolinesSupratentorial NeoplasmsYoung AdultAntineoplastic AgentsErbB ReceptorsGefitinibQuinazolines

Identifiers

PMID20708924
PMCPMC2988095
OpenAlexW1971465436

What OpenQuestion holds

Textmetadata
LicenceTDM
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.