Evidence map›Paper›PMID 19879702›Full record

ArticleInternational journal of radiation oncology, biology, physics2010

Molecular and clinical responses in a pilot study of gefitinib with paclitaxel and radiation in locally advanced head-and-neck cancer.

Carter Van Waes, Clint T Allen, Deborah Citrin, David Gius, A Dimetrios Colevas, Nancy A Harold, Susan Rudy, Liesl Nottingham, Christine Muir, Zhong Chen and 3 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00083057 (A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.1field-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.

NCT00083057 phase1completednot on this map

A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

TypeinterventionalSponsorNational Institutes of Health Clinical Center (CC)Ran2004 to 2010Enrolled30ConditionsHead and Neck CancerArmsgefitinib, paclitaxel, radiation therapy
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 37 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. A phase I trial of erlotinib and concurrent chemoradiotherapy for stage III and IV (M0) squamous cell carcinoma of the head and neck.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Article
  10. Early tumor progression associated with enhanced EGFR signaling with bortezomib, cetuximab, and radiotherapy for head and neck cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011
    Article
  11. 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

13 authors at 4 institutions in 1 country.

Carter Van WaesHead and Neck Surgery Branch, National Institute of Deafness and Communication Disorders, National Institutes of Health, Bethesda, MD, USA.
Clint T Allen
Deborah Citrin
David Gius
A Dimetrios Colevas
Nancy A Harold
Susan Rudy
Liesl Nottingham
Christine Muir
Zhong Chen
Anurag K Singh
Janet Dancey
John C Morris
Center for Cancer Research · USNational Cancer Institute · USNational Institutes of Health · USNational Institute on Deafness and Other Communication Disorders · US

Funding

Mechanisms of Normal Tissue Toxicity From IrradiationZIABC010850 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2009 to 2025
$19.4M
NF-kappaB in pathogenesis and therapy of head and neck cancerZ01DC000016 · NIDCD · NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS · PI VAN WAES, CARTER · 1994 to 2008
$2.9M
Signal and Transcription Factor Network interactions in Head and Neck CancerZ01DC000073 · NIDCD · NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS · PI VAN WAES, CARTER · 2008 to 2008
$607k
Intramural NIH HHS NIH0010047277Intramural NIH HHS Z01 DC000016Intramural NIH HHS Z01 DC000073NIDCD NIH HHS Z01-DC-000016NIDCD NIH HHS Z01-DC-000073PHS HHS NIH0010047277
6 · The paper itself

Abstract

purposeEpidermal growth factor receptor (EGFR) overexpression in head-and-neck squamous cell carcinoma (HNSCC) stimulates tumor cell proliferation, inhibits apoptosis, and increases chemotherapy and radiation resistance. We examined the toxicity, safety and the effects on EGFR signaling in tumor biopsy samples from patients with locally advanced HNSCC treated with the EGFR signaling inhibitor gefitinib (GEF) combined with weekly intravenous paclitaxel (PAC) and radiation therapy (RT). METHODS AND MATERIALS: This was a pilot Phase I dose-escalation study. Eligibility included Stage III to IVB HNSCC, age >or=18 years, no prior RT or chemotherapy, adequate organ function, and informed consent. Endpoints included determination of maximum tolerated dose (MTD) and analysis of treatment effect on EGFR signaling, tumor cell proliferation, and apoptosis in biopsy samples.

resultsTen patients were treated. The MTD of this combination was GEF 250 mg/d with PAC 36 mg/m(2) intravenously weekly x 6 with concurrent RT. Grade 3/4 toxicities included prolonged (>8 weeks) stomatitis (7 patients), infection (2 patients), and interstitial pneumonitis (1 patient). There were five complete responses (CR) and two partial responses (PR). Of 7 patients undergoing serial biopsies, only 1 patient demonstrated a reduction in phosphorylated EGFR, decreased downstream signaling, and reduced cellular proliferation after initiating GEF.

conclusionsInhibition of EGFR by GEF was observed in only one of seven tumors studied. The addition of GEF to PAC and RT did not appear to improve the response of locally advanced HNSCC compared with our prior experience with PAC and RT alone. This treatment appeared to delay recovery from stomatitis.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsApoptosisCarcinoma, Squamous CellCell ProliferationCombined Modality TherapyDrug Administration ScheduleDrug Resistance, NeoplasmErbB ReceptorsFemaleGefitinibHead and Neck NeoplasmsHumansInfectionsErbB ReceptorsGefitinibNeoplasm ProteinsPaclitaxelQuinazolines

Identifiers

PMID19879702
PMCPMC2868084
OpenAlexW2133370964

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.