Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens.
OBJECTIVE
To establish a safe and efficacious dosing regimen for the treatment of primary nodular basal cell carcinoma (BCC) using 5% imiquimod cream.


METHODS
Two phase 2 studies were conducted: a 6-week, randomized, open-label, dose-response study evaluating 4 dosing regimens and a 12-week, randomized, vehicle-controlled, double-blind, dose-response study evaluating 4 dosing regimens.


METHODS
Twenty-four public and private dermatology clinics in Australia and New Zealand (6-week study) and the United States (12-week study) participated.


METHODS
The study populations comprised 99 patients enrolled in the 6-week study and 92 patients in the 12-week study. Patients were at least 18 years old and had a biopsy-confirmed diagnosis of nodular BCC.


METHODS
In the 6-week study, imiquimod was applied once daily for 3 or 7 days per week or twice daily for 3 or 7 days per week. In the 12-week study, imiquimod or placebo cream (vehicle) was applied once daily for 3, 5, or 7 days per week, or twice daily for 7 days per week. The entire tumor area was excised 6 weeks after treatment and examined histologically for evidence of remaining BCC.


METHODS
The proportion of patients having no histologic evidence of BCC in the posttreatment excision specimen.


RESULTS
Dosing once daily for 7 days per week resulted in the highest clearance rate, with 25 (71%) of 35 and 16 (76%) of 21 patients showing clearance of their tumor in the 6- and 12-week studies, respectively.


CONCLUSIONS
Topical 5% imiquimod cream is well tolerated and most effective in treating nodular BCC when applied once daily for 7 days per week for either 12 or 6 weeks.
Shumack
Stephen
S
St George Dermatology and Skin Cancer Center, Level 3, 22 Belgrave St, Kogarah, Australia 2217. sshumack@bigpond.com
Robinson
June
J
Kossard
Steven
S
Golitz
Loren
L
Greenway
Hubert
H
Schroeter
Arnold
A
Andres
Kara
K
Amies
Mark
M
Owens
Mary
M
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001315:Australia; D001707:Biopsy, Needle; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod