Imiquimod: new indication. Basal cell carcinoma: inferior to other treatments

(1) Basal cell carcinoma is a common malignancy that is rarely life-threatening. The aim of treatment is to remove the tumour and prevent local recurrences. Surgical excision is the standard treatment, with a mean relapse rate of about 5% at 5 years. The main alternative is radiotherapy. (2) The Indications section of the Summary of Product Characteristics (SPC) for imiquimod cream in Europe now includes "topical treatment of small superficial basal cell carcinomas in adults". (3) Imiquimod cream was primarily evaluated in 2 double-blind randomised controlled trials versus excipient, in a total of 724 patients. In these trials, small basal cell tumours (maximum 2 cm in diameter) disappeared in three-quarters of patients after imiquimod application 5 or 7 days a week for six weeks. (4) A non comparative trial involving 143 patients showed a relapse rate of 21% at 2 years. Indirect comparisons show that this is a much higher relapse rate than after other well-assessed treatments for basal cell cancer. (5) During clinical trials, nearly one-third of patients who used imiquimod 5 times a week complained of pruritus, a burning sensation, or local pain. Nearly one-half of patients experienced these problems with daily use. (6) Imiquimod cream is relatively inconvenient to use: it has to be applied in the evening; residual cream must be removed the following morning; and baths, showers and direct sunlight must be avoided during treatment.