Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption Journal Article

Authors: Scope, A.; Agero, A. L. C.; Dusza, S. W.; Myskowski, P. L.; Lieb, J. A.; Saltz, L.; Kemeny, N. E.; Halpern, A. C.
Article Title: Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption
Abstract: 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. © 2007 by the American Society of Clinical Oncology.
Keywords: adult; cancer chemotherapy; clinical article; controlled study; aged; aged, 80 and over; middle aged; antibiotic agent; clinical trial; placebo; drug withdrawal; antineoplastic agents; colorectal cancer; metastasis; controlled clinical trial; randomized controlled trial; bedtime dosage; administration, topical; receptor, epidermal growth factor; cetuximab; nail disease; rash; colorectal neoplasms; antibodies, monoclonal; disease severity; evening dosage; morning dosage; prophylaxis; acne; double blind procedure; double-blind method; administration, oral; dry skin; minocycline; mucosal disease; placebos; acneiform eruptions; dermatologic agents; tazarotene; cefalexin; skin irritation; nicotinic acids
Journal Title: Journal of Clinical Oncology
Volume: 25
Issue: 34
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2007-12-01
Start Page: 5390
End Page: 5396
Language: English
DOI: 10.1200/jco.2007.12.6987
PUBMED: 18048820
PROVIDER: scopus
Notes: --- - "Cited By (since 1996): 84" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Anna Liza C Agero
    34 Agero
  2. Leonard B Saltz
    580 Saltz
  3. Allan C Halpern
    299 Halpern
  4. Jocelyn Ann Lieb
    12 Lieb
  5. Stephen Dusza
    162 Dusza
  6. Alon Scope
    112 Scope
  7. Patricia Myskowski
    133 Myskowski
  8. Nancy Kemeny
    347 Kemeny