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

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

Purpose: Previous 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. Methods: Patients 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). Results: Sixty-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. Conclusion: Although 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.

Original languageEnglish (US)
Pages (from-to)1601-1607
Number of pages7
JournalSupportive Care in Cancer
Volume19
Issue number10
DOIs
StatePublished - Oct 1 2011

Keywords

  • EGFR inhibitor
  • EGFR inhibitor-induced rash
  • Rash
  • Tetracycline

ASJC Scopus subject areas

  • Oncology

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