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Randomized Double-Blind Trial of Prophylactic Oral Minocycline and Topical Tazarotene for Cetuximab-Associated Acne-Like Eruption

Alon Scope, Anna Liza C. Agero, Stephen W. Dusza, Patricia L. Myskowski, Jocelyn A. Lieb, Leonard Saltz, Nancy E. Kemeny, Allan C. Halpern

From the Dermatology Service and Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY

Address reprint requests to Allan C. Halpern, MD, Dermatology Service, Memorial Sloan-Kettering Cancer Center, 160 East 53rd St, New York, NY 10022; e-mail: halperna{at}mskcc.org

Purpose To evaluate the ability of either oral minocycline, topical tazarotene or both, to reduce or prevent cetuximab-related acneiform rash when administered starting on day 1 of cetuximab therapy.

Patients and Methods Metastatic colorectal cancer patients preparing to initiate cetuximab were randomly assigned to receive daily oral minocycline or placebo, and to receive topical tazarotene application to either left or right side of the face. Both therapies were administered for 8 weeks.

Results Forty-eight eligible patients were randomly assigned to minocycline (n = 24) or placebo (n = 24). Total facial lesion counts were significantly lower in patients receiving minocycline at weeks 1 through 4. At week 4, a lower proportion of patients in the minocycline arm reported moderate to severe itch than in the placebo arm (20% v 50%, P = .05). Facial photographs, obtained at week 4, were reviewed for rash global severity. Patients in the minocycline arm trended toward lower frequency of moderate to severe rash than patients receiving placebo (20% v 42%, P = .13). The differences in total facial lesion counts and subjectively assessed itch were diminished by week 8. Cetuximab treatment was interrupted because of grade 3 skin rash in four patients in the placebo arm, and none in the minocycline arm. There was no observed clinical benefit to tazarotene application. Tazarotene treatment was associated with significant irritation, causing its discontinuation in one third of patients.

Conclusion Prophylaxis with oral minocycline may be useful in decreasing the severity of the acneiform rash during the first month of cetuximab treatment. Topical tazarotene is not recommended for management of cetuximab-related rash.

Supported by an investigator-initiated grant from Bristol-Myers Squibb and ImClone Systems Inc.

Presented in part as poster and oral presentation at the 65th Annual Meeting of the American Academy of Dermatology, February 2-6, 2007, Washington, DC.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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