Phase 3 non-inferiority trial of topical imiquimod versus surgery for vulvar intraepithelial neoplasia

The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Topical imiquimod may be an effective alternative. A multicenter, phase 3, non-inferiority trial in Austria compared imiquimod to surgery. Complete clinical response at six months after imiquimod treatment was seen in 80% of patients, compared with 79% of patients after one surgical intervention. The authors conclude that topical imiquimod was a safe, effective, and well accepted alternative to surgery.