A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption

J Am Acad Dermatol. 2009 Oct;61(4):614-20. doi: 10.1016/j.jaad.2009.03.046. Epub 2009 Jul 31.

Abstract

Background: Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking.

Objective: We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash.

Methods: In all, 24 patients with metastatic colorectal cancer with cetuximab facial rash received twice daily pimecrolimus application for 5 weeks to half of the face. At baseline, week 2, and week 5, a dermatologist performed facial lesion counts, patients reported perceived severity of rash-related symptoms, and standardized facial photographs were obtained for blinded evaluation of global rash severity.

Results: Treatment sides had greater decrease in lesion counts than observation sides of face at weeks 2 (P < .001) and 5 (P = .02). However, there were no significant differences in patients' assessment of symptoms and in review of facial photographs for rash severity between treatment and observation sides.

Limitations: This study was not placebo controlled.

Conclusions: Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acneiform Eruptions / chemically induced*
  • Acneiform Eruptions / drug therapy*
  • Administration, Topical
  • Adult
  • Aged
  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents / adverse effects
  • Cetuximab
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / secondary
  • Dermatologic Agents / administration & dosage*
  • Drug Eruptions / drug therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Tacrolimus / administration & dosage
  • Tacrolimus / analogs & derivatives*
  • Treatment Failure
  • Young Adult

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Dermatologic Agents
  • pimecrolimus
  • Cetuximab
  • Tacrolimus