Estimation of recurrence rates with off-label use of 5% imiquimod as an adjuvant therapy after surgery or as a monotherapy in patients with lentigo maligna.

Objectives The aim of this paper is to present the experience of off-label application and possible decrease of recurrence rates in patients with ledigo maligna, when treated only with 5% imiquimod or imiquimod 5% after surgical excision in clinical narrow margins (<5mm) or wider margins (≥5mm). Materials and Methods A multicenter analysis was performed in 7 European centers and n=149 patients were included in three groups a) those with adjuvant application of imiquimod after surgical excision in histopathologically clear margins (narrow <5mm) (group 1a) or (wider ≥5mm) (group1b), b) those with adjuvant application but with histopathologically involved margins(group2) c) those who received monotherapy with imiquimod(group3). In all patients was applied 5% imiquimod cream ,7 days/week, for 6-13 weeks. Results The recurrence rate in group 1b and group 1a were (6.2% to 5.5% respectively). Thus, the application of imiquimod before or after conventional surgery to narrow margins might result in acceptable recurrence rates, possibly comparable to those achieved with surgical techniques involving complete margin assessment, such as Mohs micrographic surgery, but this hypothesis should be assessed by a randomized trial. The recurrence rate in group 2 was 9.1% at a mean follow-up of 34 months while in group3 Imiquimod monotherapy resulted in complete clinical response in 71.4% of treated patients. Conclusions In conclusion by this study is supported surgery as the primary treatment in operable patients with ledigo maligna. In any case the experience by application of Imiquimod in combination with conservative surgery is encouraging.