Evidence map›Paper›PMID 26686755›Full record

Trial reportOral oncology2016

Cetuximab activity in dysplastic lesions of the upper aerodigestive tract.

Zubair Khan, Joel B Epstein, Shanthi Marur, M Boyd Gillespie, Lawrence Feldman, Hua-Ling Tsai, Zhe Zhang, Hao Wang, James Sciubba, Robert Ferris and 9 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oral oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Signaling pathways and targeted interventions for precancers.Signal transduction and targeted therapy · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 1 country.

Zubair KhanDepartment of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Joel B EpsteinUniversity of Illinois Cancer Center, Chicago, IL, USA.
Shanthi MarurOncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
M Boyd GillespieMedical University of South Carolina, Charleston, SC, USA.
Lawrence FeldmanUniversity of Illinois Cancer Center, Chicago, IL, USA.
Hua-Ling TsaiDepartment of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Zhe ZhangDivision of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Hao WangDivision of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
James SciubbaMilton J Dance Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD, USA.
Robert FerrisUniversity of Pittsburg Medical Center, Pittsburgh, PA, USA.
Jennifer R GrandisUniversity of Pittsburg Medical Center, Pittsburgh, PA, USA.
Michael GibsonUniversity of Pittsburg Medical Center, Pittsburgh, PA, USA.
Wayne KochDepartment of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Ralph TufanoDepartment of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
William WestraOncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Nancy TsottlesOncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Hiroyuki OzawaOncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Christine ChungOncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Joseph A CalifanoDepartment of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA; Milton J Dance Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD, USA. Electronic address: jcalifano@ucsd.edu.
Johns Hopkins University · USPittsburg State University · USGreater Baltimore Medical Center · USUniversity of Illinois Chicago · USMedical University of South Carolina · US

Funding

Cetuximab for Treatment of High-risk Pre-malignant Upper Aerodigestive LesionsR21CA126055 · NCI · JOHNS HOPKINS UNIVERSITY · PI CALIFANO, JOSEPH A · 2008 to 2009
$738k
NCI NIH HHS R21 CA126055
6 · The paper itself

Abstract

backgroundHigh risk head and neck mucosal premalignancy has a malignant conversion rate of up to 40%, despite adequate surgical therapy. Epidermal Growth Factor Receptor (EGFR) blocking agents, including cetuximab, have shown activity in head and neck squamous cell carcinoma (HNSCC) and have potential for therapy in high risk premalignancy.

methodsWe conducted a randomized, prospective, phase II clinical trial to determine the effects of cetuximab on patients with high risk premalignancy. Patients were randomized to treatment with cetuximab 400mg/m(2) on week one followed by 250mg/m(2) on week 2-8 or observation, with the option for crossover to cetuximab therapy for patients originally randomized to the observation arm.

resultsTwo of 19 enrolled patients did not complete therapy due to treatment toxicity. Analysis of 17 patients who completed the trial regimen show a trend toward a larger mean decrease in grade of dysplasia in the cetuximab treated group (-1.0) vs. the observation group (-0.2) (P=0.082, one-sided exact Wilcoxon rank sum test). However, in the observation group, none of the 5 patients (0%) achieved complete resolution of dysplasia; while 4 of 12 (33.3%) cetuximab treated patients had no remaining dysplasia after therapy.

conclusionsTreatment of high risk premalignancy of the upper aerodigestive tract with cetuximab alone may result in significant, durable, and complete clinical and histological resolution of moderate to severe dysplasia in at least a subset of high risk patients. These results warrant further investigation in larger studies with increased statistical power.

Indexed as

Antineoplastic AgentsCetuximabDisease-Free SurvivalFemaleHumansLaryngeal DiseasesMaleMouth DiseasesPharyngeal DiseasesPrecancerous ConditionsProspective StudiesTreatment OutcomeAntineoplastic AgentsCetuximabHead and neck cancerHead and neck premalignancyOral dysplasia

Identifiers

PMID26686755
PMCPMC7751887
OpenAlexW2196062918

What OpenQuestion holds

Textmetadata
LicenceTDM
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.