Treatment of cervical intraepithelial neoplasia with topical imiquimod.

5041 Background: Alternatives to surgical therapy are needed for the treatment of high-grade cervical intraepithelial neoplasia (CIN). We investigated the effectiveness of a treatment with imiquimod (IMQ), a topical immune-response modulator, for patients with CIN 2 and 3. METHODS In this placebo-controlled trial 59 patients with CIN 2 and 3 were randomized to receive either a 16-week treatment with topical IMQ or placebo. The main outcome was effectiveness, defined as histologic regression (to CIN1 or less) four weeks after end of treatment; secondary outcomes were complete histologic remission, human papillomavirus (HPV) clearance and treatment tolerability. RESULTS Of the patients 27 (46%) and 32 (54%) presented with CIN 2 and 3, respectively. Histologic regression was significantly increased in the IMQ group (75%) compared to the placebo group (41%) (P=0.01). Complete histologic remission was significantly increased in the IMQ group (46%) as compared with the placebo group (15%) (P=0.02). At baseline, all 59 patients (100%) were tested positive for HPV DNA. HPV clearance rate was increased in the IMQ group (61%), as compared with the placebo group (15%) (P<0.001). The lesion progressed to micro-invasive cancer in 2 of 59 patients (3%)-both within the placebo group. Topical IMQ treatment was well tolerated. Due to local and/or systemic side effects, eight patients (27%) within the IMQ group switched to 50%-dose medication and one patient (3%) prematurely quit the treatment. CONCLUSIONS Topical IMQ is an effective treatment for high-grade CIN and is well tolerated.