Effectiveness and satisfaction with imiquimod for the treatment of superficial basal cell carcinoma in daily dermatological practice.

BACKGROUND The use of imiquimod for the treatment of superficial basal cell carcinoma (sBCC) in actual conditions of the daily practice has been poorly studied. OBJECTIVE A prospective, observational and multicentre study was designed to gather information on the effectiveness and safety of imiquimod therapy in patients with sBCC in daily practice. Patient's satisfaction with imiquimod was also assessed. METHODS A total of 370 adult patients with sBCC were included in the study. Patients were treated with imiquimod 5% cream five times per week for 6 weeks. A maximum of three lesions per patient were treated. Patients were requested to complete diary cards to register treatment-related events and had a final visit within 16 weeks after the end of treatment. RESULTS Target sBCCs included 471 tumours, with a mean (SD) 1.3 (0.6) lesions per patient. Most sBCC were primary tumours (92.6%). Tumours were clinically diagnosed in 63.2% of cases and histologically confirmed in 36.8%. Previous sBCC had occurred in 42% of the patients. The mean number of daily applications of imiquimod was 1.0 (0.1) for a mean of 4.9 (0.5) days per week. The mean duration of treatment was 6.0 (1.0) weeks. In 13 patients (14 target sBCCs), rest periods were indicated with a mean of 5.0 (2.8) rest days. The clearance rate was 83.2%. Clearance rate was independent of the tumour size. Local skin reactions (mostly erythema) occurred in 85% of cases (mild 37%, moderate 39% and severe 24%). Nine patients discontinued imiquimod treatment because of severity of application site reactions. Most patients (82.1%) were very satisfied or satisfied with imiquimod. CONCLUSIONS The present data from a prospective study carried out in a community setting adds evidence of the usefulness and favourable clinical profile of imiquimod 5% cream when administered for treating sBCC.