Evidence map›Paper›PMID 20820817›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2011

Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB).

Aminah Jatoi, Shaker R Dakhil, Jeff A Sloan, John W Kugler, Kendrith M Rowland, Paul L Schaefer, Paul J Novotny, Donald B Wender, Howard M Gross, Charles L Loprinzi and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00091247 (An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

NCT00091247 nacompletednot on this map

An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2004 to 2009Enrolled130ConditionsUnspecified Adult Solid Tumor, Protocol SpecificArmstetracycline hydrochloride, placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
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  11. Article
  12. Dermatologic events from EGFR inhibitors: the issue of the missing patient voice.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Review
  13. Article
  14. Review
  15. Article
  16. Management of egfr tki-induced dermatologic adverse events.Current oncology (Toronto, Ont.) · 2015
    Review
  17. Article
  18. Review
  19. Article
  20. 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

11 authors at 6 institutions in 1 country.

Aminah JatoiMayo Clinic, 200 First Street, SW, Rochester, MN 55905, USA. Jatoi.aminah@mayo.edu
Shaker R Dakhil
Jeff A Sloan
John W Kugler
Kendrith M Rowland
Paul L Schaefer
Paul J Novotny
Donald B Wender
Howard M Gross
Charles L Loprinzi
North Central Cancer Treatment Group
Mayo Clinic · USCommunity Hospital · USHematology Oncology Associates · USIowa Oncology Research Association · USMichigan Cancer Research Consortium · USWichita Clinic · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
SIOUX COMMUNITY CANCER CONSORTIUMU10CA035103 · NCI · UNIVERSITY OF SOUTH DAKOTA · PI MAZURCZAK, MIROSLAW · 1985 to 2014
$11.6M
MISSOURI VALLEY CANCER CONSORTIUM CCOPU10CA063849 · NCI · MISSOURI VALLEY CANCER CONSORTIUM, INC. · PI SOORI, GAMINI · 1994 to 2014
$11.3M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035195 · NCI · CARLE FOUNDATION HOSPITAL (URBANA, IL) · PI ROWLAND, KENDRITH MARTIN · 1985 to 2014
$11.3M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
DULUTH COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035269 · NCI · ESSENTIA INSTITUTE OF RURAL HEALTH · PI NIKCEVICH, DANIEL A · 1985 to 2014
$10.7M
IOWA ONCOLOGY RESEARCH ASSOCIATION CCOPU10CA035101 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI BEHRENS, ROBERT J. · 1985 to 2014
$10.1M
NCI NIH HHS CA-25224NCI NIH HHS CA-35090NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35195NCI NIH HHS CA-35267NCI NIH HHS CA-35269NCI NIH HHS CA-35415NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS K24 CA131099NCI NIH HHS N01 CA035431NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035269NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037417NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849
6 · The paper itself

Abstract

purposePrevious studies suggest tetracycline and other antibiotics lessen the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash. This study sought to confirm such findings.

methodsPatients starting an EGFR inhibitor were eligible for this randomized, double-blinded, placebo-controlled study and had to be rash-free. They were then randomly assigned to tetracycline 500 mg orally twice a day for 28 days versus a placebo. Rash development and severity (monthly physician assessment and weekly patient-reported questionnaires), quality of life (SKINDEX-16), and adverse events were monitored during the 4-week intervention and then for an additional 4 weeks. The primary objective was to compare the incidence of grade 2 or worse rash between study arms; 32 patients per group provided a 90% probability of detecting a 40% difference in incidence with a type I error rate of 0.05 (two-sided).

resultsSixty-five patients were enrolled, and groups were balanced on baseline characteristics. During the first 4 weeks, healthcare provider-reported data found that 27 tetracycline-treated patients (82%) and 24 placebo-exposed patients (75%) developed a rash. This rash was a grade 2+ in 17 (52%) and 14 (44%), respectively (p = 0.62). Comparable grade 2+ rash rates were observed during weeks 5 through 8 as well as with patient-reported rash data throughout the study period. Quality of life was comparable across study arms, and tetracycline was well tolerated.

conclusionAlthough previous studies suggest otherwise, this randomized, double-blinded, placebo-controlled study did not find that tetracycline lessened rash incidence or severity in patients who were taking EGFR inhibitors.

Indexed as

AdultAgedAged, 80 and overAnti-Bacterial AgentsAntineoplastic AgentsDouble-Blind MethodDrug EruptionsErbB ReceptorsFemaleHumansIncidenceMaleMiddle AgedQuality of LifeSeverity of Illness IndexTetracyclineAnti-Bacterial AgentsAntineoplastic AgentsErbB ReceptorsTetracycline

Identifiers

PMID20820817
PMCPMC3935797
OpenAlexW2088397090

What OpenQuestion holds

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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.