Imiquimod: Promising treatment for vulvar intraepithelial neoplasia

Topical 5% imiquimod cream is an effective alternative to surgery for vulvar intraepithelial neoplasia, according to the results of a small placebo-controlled trial from the Netherlands.

Researchers randomized 52 women with grade 2 or 3 vulvar intraepithelial neoplasia to either imiquimod or placebo cream applied twice weekly for 16 weeks.

At 20 weeks, one-third (35%) of the women in the imiquimod group and none given placebo had a complete response and remained disease free at 1 year. In addition, 81% of the women treated with imiquimod and none of the women who received placebo had at least a 25% reduction in lesion size, and 69% of the treated women experienced regression from grade 2 or 3 disease to a lower grade. More than half (58%) of the women who initially tested positive for HPV DNA (96%) had HPV cleared from their lesions, as compared with 8% in the placebo group (P<0.001). Imiquimod also reduced pruritus and pain at 20 weeks (P=0.008 and P=0.004, respectively) and at 12 months (P=0.04 and P=0.02, respectively) as compared with placebo. Of the women followed for 1 year, lesions progressed to invasion in one of the women in the treatment group and in two of the women receiving placebo.

van Seters M, van Beurden M, ten Kate FJ, et al. Treatment of vulvar intraepithelial neoplasia with topical imiquimod. N Engl J Med. 2008;358:1465-1473.