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.
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The authors have no conflicts of interest.
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This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35195, CA-35090, CA-35113, CA-35103, CA-35415, CA-35431, CA-35103, CA-35269, CA-35101, CA-37417, CA-63848, CA-63849, and CA-35267.
Iowa Oncology Research Association CCOP, Des Moines, IA 50309-1014 (Roscoe F. Morton, M.D.); Meritcare Hospital CCOP, Fargo, ND 58122 (Preston D. Steen, M.D.); Missouri Valley Cancer Consortium, Omaha, NE 68106 (Gamini S. Soori, M.D.); Medcenter One Health Systems, Bismarck, ND 58506 (Edward J. Wos, M.D.); Rapid City Regional Oncology Group, Rapid City, SD 57709 (Richard C. Tenglin, M.D.); Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, MN 55416 (Patrick J. Flynn, M.D.); Montana Cancer Consortium, Billings, MT 59101 (Benjamin T. Marchello, M.D.) Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA 52403 (Martin Wiesenfeld, M.D.); Duluth CCOP, Duluth, MN 55805 (Daniel A. Nikcevich, M.D.); Hematology & Oncology of Dayton, Inc., Dayton, OH 45415 (Howard M. Gross, M.D.)
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Jatoi, A., Dakhil, S.R., Sloan, J.A. et al. 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). Support Care Cancer 19, 1601–1607 (2011). https://doi.org/10.1007/s00520-010-0988-5
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DOI: https://doi.org/10.1007/s00520-010-0988-5