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


CONCLUSIONS
This study was not placebo controlled.


CONCLUSIONS
Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.
Scope
Alon
A
Dermatology Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10022, USA.
Lieb
Jocelyn A
JA
Dusza
Stephen W
SW
Phelan
Deborah L
DL
Myskowski
Patricia L
PL
Saltz
Leonard
L
Halpern
Allan C
AC
D017486:Acneiform Eruptions / Q000139:chemically induced* / Q000188:drug therapy*; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003879:Dermatologic Agents / Q000008:administration & dosage*; D003875:Drug Eruptions / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017211:Treatment Failure; D055815:Young Adult
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D003879:Dermatologic Agents; C117268:pimecrolimus; D000068818:Cetuximab; D016559:Tacrolimus