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

• Published in: Journal of clinical oncology Vol. 25; no. 34; pp. 5390 - 5396
• Main Authors: SCOPE, Alon, AGERO, Anna Liza C, DUSZA, Stephen W, MYSKOWSKI, Patricia L, LIEB, Jocelyn A, SALTZ, Leonard, KEMENY, Nancy E, HALPERN, Allan C
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01.12.2007; Lippincott Williams & Wilkins
• Subjects: Acneiform Eruptions - chemically induced; Acneiform Eruptions - prevention & control; Administration, Oral; Administration, Topical; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Cetuximab; Colorectal Neoplasms - drug therapy; Dermatologic Agents - administration & dosage; Dermatology; Double-Blind Method; Female; Humans; Male; Medical sciences; Middle Aged; Minocycline - administration & dosage; Nicotinic Acids - administration & dosage; Placebos; Receptor, Epidermal Growth Factor - antagonists & inhibitors; Skin involvement in other diseases. Miscellaneous. General aspects; Tumors; Antineoplastic agent; Skin disease; Tetracycline derivatives; Acne; Retinoid; Monoclonal antibody; Epidermal growth factor receptor; Prevention; Local administration; Randomization; Cancerology; Tazarotene; Minocycline; Clinical trial; Protein synthesis inhibitor; Cetuximab
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2007.12.6987

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. 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. 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. 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.