Nonsurgical Treatment of Vulvar Intraepithelial Neoplasia

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Summary and Comment

Nonsurgical Treatment of Vulvar Intraepithelial Neoplasia

Topical imiquimod was effective in treating VIN.

Vulvar intraepithelial neoplasia (VIN) is a frustrating and painful complication of human papillomavirus (HPV) infection. Surgical treatments are accompanied by risk for pain or vulvar disfigurement and do not prevent the possibility of recurrence or progression. Now, Dutch researchers have conducted a double-blind, randomized, controlled trial to determine whether VIN can be ameliorated or eliminated with 5% imiquimod cream (Aldara; provided by the manufacturer), an immune-response modifier currently used for treatment of genital warts. Participants were 18 or older and had histologically confirmed multifocal grade 2 or 3 VIN without microinvasion; lesions were tested for HPV DNA. Imiquimod (n=26) or placebo cream (n=26) was applied by participants and left overnight twice a week for 16 weeks; 5% sulfur precipitate in zinc oxide cream was used to prevent superinfection.

At 20 weeks, lesion size was reduced by more than 25% in 81% of women in the imiquimod group and in none of those in the placebo group; lesions were reduced by at least three quarters in 19% and completely disappeared in 35% of imiquimod-treated women. The placebo group showed no such response. Treatment was associated with reduced pruritus and pain at 20 weeks and at 12 months; the most common side effects during treatment were vulvar pain or pruritus, erythema, and mild-to-moderate erosion. DNA testing showed that HPV was cleared from lesions in 58% of imiquimod-treated women, compared with 8% of those who received placebo (P<0.001). Four of the nine patients with complete responses previously had undergone surgery for their condition.

Comment: These promising data suggest that patient-applied imiquimod is a beneficial alternative for treating vulvar intraepithelial neoplasia, even among patients who have relapsed after surgical intervention. Moreover, the medication seems to promote clearance of HPV and to enhance immunologic activity at lesion sites. Clinical trials often do not parallel standard clinical practice; thus, although the authors cannot estimate imiquimod’s long-term effectiveness, address its potency against different severities of disease, or predict patient response, their findings should encourage clinicians to consider imiquimod in treating VIN.

— Sandra Ann Carson, MD

Published in Journal Watch Women's Health April 3, 2008