Evidence map›Paper›PMID 27212198›Full record

Trial reportInternational journal of radiation oncology, biology, physics2016

Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience.

Voichita Bar-Ad, Qiang Ed Zhang, Paul M Harari, Rita Axelrod, David I Rosenthal, Andy Trotti, Christopher U Jones, Adam S Garden, Guobin Song, Robert L Foote and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Cutaneous Squamous Cell Carcinoma: From Biology to Therapy.International journal of molecular sciences · 2020
    Review
  11. Affibody-Based PET Imaging to Guide EGFR-Targeted Cancer Therapy in Head and Neck Squamous Cell Cancer Models.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2019
    Article
  12. Article
  13. Article
  14. Activity of weekly paclitaxel-cetuximab chemotherapy in unselected patients with recurrent/metastatic head and neck squamous cell carcinoma: prognostic factors.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2017
    Article
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Voichita Bar-AdJefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania. Electronic address: voichita.bar-ad@jefferson.edu.
Qiang Ed ZhangNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Paul M HarariUniversity of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Rita AxelrodJefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
David I RosenthalUniversity of Texas M. D. Anderson Cancer Center, Houston, Texas.
Andy TrottiH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
Christopher U JonesRadiological Associates of Sacramento, Sacramento, California.
Adam S GardenUniversity of Texas M. D. Anderson Cancer Center, Houston, Texas.
Guobin SongVirginia Mason Medical Center, Seattle, Washington.
Robert L FooteMayo Clinic, Rochester, Minnesota.
David RabenUniversity of Colorado Comprehensive Cancer Center, Denver, Colorado.
George ShenoudaMcGill University, Montreal, Quebec, Canada.
Sharon A SpencerUniversity of Alabama at Birmingham, Birmingham, Alabama.
Jonathan HarrisNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Quynh-Thu LeStanford University Medical Center, Stanford, California.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeTo evaluate the severity of cetuximab-induced skin rash and its correlation with clinical outcome and late skin toxicity in patients with head and neck squamous cell carcinoma treated with chemoradiation therapy and cetuximab. METHODS AND MATERIALS: Analysis included patients who received loading dose and ≥1 cetuximab dose concurrent with definitive chemoradiation therapy (70 Gy + cisplatin) or postoperative chemoradiation therapy (60-66 Gy + docetaxel or cisplatin).

resultsSix hundred two patients were analyzed; 383 (63.6%) developed grade 2 to 4 cetuximab rash. Patients manifesting grade 2 to 4 rash had younger age (P<.001), fewer pack-years smoking history (P<.001), were more likely to be males (P=.04), and had p16-negative (P=.04) oropharyngeal tumors (P=.003). In univariate analysis, grade 2 to 4 rash was associated with better overall survival (hazard ratio [HR] 0.58, P<.001) and progression-free survival (HR 0.75, P=.02), and reduced distant metastasis rate (HR 0.61, P=.03), but not local-regional failure (HR 0.79, P=.16) relative to grade 0 to 1 rash. In multivariable analysis, HRs for overall survival, progression-free survival, distant metastasis, and local-regional failure were, respectively, 0.68 (P=.008), 0.85 (P=.21), 0.64 (P=.06), and 0.89 (P=.48). Grade ≥2 rash was associated with improved survival in p16-negative patients (HR 0.28 [95% confidence interval 0.11-0.74]) but not in p16-positive patients (HR 1.10 [0.42-2.89]) (P=.05 for interaction). Twenty-five percent of patients with grade 2 to 4 acute in-field radiation dermatitis experienced grade 2 to 4 late skin fibrosis, versus 14% of patients with grade 0 to 1 acute in-field radiation dermatitis (P=.002).

conclusionGrade 2 to 4 cetuximab rash was associated with better survival, possibly due to reduction of distant metastasis. This observation was noted mainly in p16-negative patients. Grade 2 to 4 acute in-field radiation dermatitis was associated with higher rate of late grade 2 to 4 skin fibrosis.

Indexed as

AdultAgedAntineoplastic AgentsCarcinoma, Squamous CellCausalityCetuximabChemoradiotherapyComorbidityDisease-Free SurvivalDrug EruptionsFemaleHead and Neck NeoplasmsHumansIncidenceMaleMiddle AgedAntineoplastic AgentsCetuximab

Identifiers

PMID27212198
PMCPMC5199017

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Registered trials

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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.