Evidence map›Paper›PMID 22271880›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012

A phase I trial of erlotinib and concurrent chemoradiotherapy for stage III and IV (M0) squamous cell carcinoma of the head and neck.

Jill Gilbert, Michelle A Rudek, Michaela J Higgins, Ming Zhao, Sara Bienvenu, Nancy Tsottles, Muhammad A Chaudhry, Richard Wahl, Arlene Forastiere, Maura Gillison

Erratum issuedAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

  • Erratum issued
    Chaudhry, Muhammad A]
5 · Who and what money

Authors and funding

10 authors.

Jill GilbertVanderbilt University School of Medicine, Nashville, TN, USA. jill.gilbert@vanderbilt.edu
Michelle A Rudek
Michaela J Higgins
Ming Zhao
Sara Bienvenu
Nancy Tsottles
Muhammad A Chaudhry
Richard Wahl
Arlene Forastiere
Maura Gillison

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
PLANNING A PROGRAM OF RESEARCH IN PROSTATE CANCERR21CA069773 · NCI · DUKE UNIVERSITY · PI WALTER, PHILIP JOHN · 1995 to 1998
–
NCI NIH HHS 5P30CA006973NCI NIH HHS CA-70095NCI NIH HHS P30 CA006973NCI NIH HHS P30CA069773NCI NIH HHS U01 CA070095
6 · The paper itself

Abstract

purposeErlotinib, an orally active selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, has synergistic activity with radiation and with cisplatin. The EGFR is overexpressed in the majority of head and neck cancers. The primary objective of this phase I study was to determine the maximum-tolerated dose (MTD) of erlotinib in combination with low-dose daily cisplatin and radiotherapy. We also sought evidence of biologic activity of erlotinib alone using serial 18-FDG positron emission tomography (PET) imaging. EXPERIMENTAL

designOral erlotinib was taken daily starting with a 14-day run-in and continued until radiation therapy (RT) was completed. Low-dose daily cisplatin, 6 mg/m(2) i.v. was given concurrently with standard fractionation RT to a total dose of 66 to 70 Gy. Dose escalation followed a modified Fibonacci dose escalation design.

resultsTwenty-two patients were enrolled and 18 patients received therapy on protocol. MTD of the combination of erlotinib, cisplatin, and RT was not reached. The recommended phase II dose of erlotinib is 150 mg per day in combination with cisplatin and RT, the highest dose of erlotinib evaluated in this study. 18F-FDG PET showed evidence for metabolic response to single-agent erlotinib. Per PERCIST criteria, the overall metabolic response rate at day 14 was 38.8% (95% CI: 17.3-64.3). On completion of concurrent chemoradiotherapy, overall response rate derived from tumor measurements based on imaging studies was 83% for all dose levels combined.

conclusionsErlotinib in combination with low-dose daily cisplatin and RT is well tolerated and shows evidence of clinical efficacy. The combination should be evaluated further.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyCisplatinDose Fractionation, RadiationErlotinib HydrochlorideHead and Neck NeoplasmsHumansMaleMaximum Tolerated DoseMiddle AgedQuinazolinesCisplatinErlotinib HydrochlorideQuinazolines

Identifiers

PMID22271880
PMCPMC3306472

What OpenQuestion holds

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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.