Evidence map›Paper›PMID 20498391›Full record

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

Epidermal growth factor receptor inhibitor gefitinib added to chemoradiotherapy in locally advanced head and neck cancer.

Ezra E W Cohen, Daniel J Haraf, Rangesh Kunnavakkam, Kerstin M Stenson, Elizabeth A Blair, Bruce Brockstein, Eric P Lester, Joseph K Salama, Allison Dekker, Rosalyn Williams and 6 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
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. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
11.5field-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.

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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
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  4. A phase II study of gefitinib for aggressive cutaneous squamous cell carcinoma of the head and neck.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

Ezra E W CohenDepartment of Medicine, University of Chicago, Chicago, IL, USA. ecohen@medicine.bsd.uchicago.edu
Daniel J Haraf
Rangesh Kunnavakkam
Kerstin M Stenson
Elizabeth A Blair
Bruce Brockstein
Eric P Lester
Joseph K Salama
Allison Dekker
Rosalyn Williams
Mary Ellyn Witt
Tatyana A Grushko
James J Dignam
Mark W Lingen
Olufunmilayo I Olopade
Everett E Vokes
NorthShore University HealthSystem · US

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI MARK W. LINGEN · 1985 to 2026
$122.1M
NCI NIH HHS P30 CA014599NCI NIH HHS P30 CA14599
6 · The paper itself

Abstract

purposeAssess efficacy and toxicity of gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, added to, and in maintenance after, concurrent chemoradiotherapy (CCRT) in locally advanced head and neck cancer (LA-HNC) and correlate outcomes with EGFR gene copy number alterations. PATIENTS AND

methodsPatients with stage III to IV LA-HNC received two cycles of carboplatin/paclitaxel induction chemotherapy (IC) followed by split-course CCRT with fluorouracil, hydroxyurea, twice daily radiotherapy (FHX), and gefitinib (250 mg daily) followed by continued gefitinib for 2 years total. The primary end point was complete response (CR) rate after CCRT. EGFR gene copy number was assessed by fluorescent in situ hybridization.

resultsSixty-nine patients (66 with stage IV disease, 37 with oropharynx primary tumors, and 67 with performance status 0 to 1) were enrolled with a median age of 55 years. Predominant grade 3 or 4 toxicities during IC and CCRT were neutropenia (n = 20) and in-field mucositis (n = 59) and dermatitis (n = 23), respectively. CR rate after CCRT was 90%. After median follow-up of 3.5 years, 4-year overall, progression-free, and disease-specific survival rates were 74%, 72%, and 89%, respectively. To date, one patient has developed a second primary tumor in the aerodigestive tract. In 31 patients with available tissue, high EGFR gene copy number was associated with worse overall survival (P = .02).

conclusionGefitinib can be administered with FHX and as maintenance therapy for at least 2 years, demonstrating CR and survival rates that compare favorably with prior experience. High EGFR gene copy number may be associated with poor outcome in patients with LA-HNC treated with this regimen.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyDisease-Free SurvivalDrug Administration ScheduleErbB ReceptorsFemaleGefitinibHead and Neck NeoplasmsHumansMaleMiddle AgedQuinazolinesErbB ReceptorsGefitinibQuinazolines

Identifiers

PMID20498391
PMCPMC2903330
OpenAlexW2127421486

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.