Vulvar Paget's disease: outcomes of 51 patients treated with imiquimod cream

Background: Vulvar Paget's disease (VPD) is a rare neoplasm with high recurrence rates even after surgical treatment.Imiquimod topical cream is a promising therapy; however, experience with it is limited to small series or case reports.This study aims to analyze the effectiveness and safety of topical imiquimod in a large cohort of patients with VPD.Methods: Fifty-five cases of histologically proven-VPD treated with topical imiquimod at the Gynecologic and Obstetric Division 1 U, S. Anna Hospital, University of Turin were retrospectively reviewed.We investigated the potential factors related to clinico-pathological response to imiquimod using univariate and multivariate logistic regression to estimate odds ratios (ORs).Results: Four women discontinued the treatment due to side-effects. Of the remaining 51 (42 in situ tumors, and 9 micro-invasive tumors) who completed treatment, 22 (43%) achieved a complete clinico-pathological response. Among the women who had a complete response, there were no cases of recurrence (mean follow-up: 66 months).Symptomatic lesions (burning: OR 0.15, CI 0.03-0.67; itching: OR 0.07, CI 0.008-0.64), smaller tumors <60 mm (OR 0.15, CI 0.006-0.43), non-recurrent VPD (OR 0.19, CI 0.04-0.43) and treatment frequency of three application per week (OR 0.13, CI 0.04-0.50) were associated with a lower risk of persistence. Perianal involvement was associated with treatment failure (OR 7.79, CI 1.88-32.2). Multivariate analysis confirmed a predictive role for smaller tumors, non-recurrent VPD, and a treatment frequency of three applications per week. Conclusion: Imiquimod can be safely used for the treatment of VPD, even for micro-invasive tumors. Furthermore, we report some potential predictors of treatment response.