CHICAGO — Clearance of superficial basal cell carcinoma following successful treatment with imiquimod 5% cream was sustained in a high proportion of patients during 5 years of an open-label study.
The initial clinical clearance rate in the European study was about 90% (163 of 182 patients) 12 weeks after treatment with once-daily imiquimod 5% cream (Aldara) five times a week for 6 weeks.
The sustained clearance rate among 162 patients who initially cleared was estimated at 87% at 5 years of follow-up, Dr. Harald Gollnick and associates reported in a poster at the Academy of Dermatology's Academy 2008 meeting. (One patient who cleared at the 12-week visit died prior to entering follow-up.) The estimated probability of treatment success at the end of year 5 was 78% among all 182 patients.
The proportion of patients who were clinically clear at 2 years was estimated to be 79%, according to previously published results (Eur. J. Dermatol. 2005;15:374-81).
The study, funded by 3M Pharmaceuticals and Meda Pharmaceuticals, included patients (mean age 65 years) with a primary, biopsy-confirmed tumor at least 0.5 cm
Overall, 18 patients had a clinical recurrence of the target lesion, with most recurrences (14) occurring during the first 2 years of follow-up. Fourteen recurrences (78%) were confirmed on biopsy, according to the investigators, who have been consultants to, and received honoraria from, Meda.
In all, 36 patients had 74 serious adverse events, all of which were considered probably not related to imiquimod. Most local skin reactions resolved by 3 months, but in some patients, erythema took several years to resolve, reported Dr. Gollnick of Otto von Guericke University of Magdeburg (Germany) and associates.