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- Title
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).
- Authors
Jatoi A; Dakhil SR; Sloan JA; Kugler JW; Rowland KM Jr; Schaefer PL; Novotny PJ; Wender DB; Gross HM; Loprinzi CL; Jatoi, Aminah; Dakhil, Shaker R; Sloan, Jeff A; Kugler, John W; Rowland, Kendrith M Jr; Schaefer, Paul L; Novotny, Paul J; Wender, Donald B; Gross, Howard M; Loprinzi, Charles L
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusion: </bold>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.
- Publication
Supportive Care in Cancer, 2011, Vol 19, Issue 10, p1601
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-010-0988-5