Treatment of Cervical Intraepithelial Neoplasia With Topical Imiquimod

• DOI: 10.1097/ogx.0b013e31826f7c35
• Publication Date: 2012-10-31T06:38:20Z
• Authors: Christoph Grimm; Stephan Polterauer; Camilla Natter; Jasmin Rahhal; Lukas Hefler; Clemens B. Tempfer; Georg Heinze; Georg Stary; Alexander Reintha...; Paul Speiser
• Keywords: Imiquimod

Cervical intraepithelial neoplasia (CIN) is a common disease among women of reproductive age. High-grade CIN lesions (CIN 2–3) are precancerous and can progress to cervical cancer. The most important risk factor for the development progression cancer persistent high-risk human papillomavirus (HPV) infection. preferred treatment in countries surgical excision using conization. There high need medical alternative therapy 2–3 largely because preterm birth other long-term sequelae conization future pregnancies. No has been established clinical practice patients with 2–3. In 2008, study reported on efficacy imiquimod, topical immune response modulator, against HPV-related vulvar neoplasia. Earlier this year, randomized controlled trial found that combined use imiquimod did not improve recurrence rates compared alone. However, had number design flaws. A major problem was application only 5 times before surgery, an uncommon short regimen. aim present randomized, double-blind, placebo-controlled phase 2 estimate therapeutic vaginal, self-applied HPV-positive Study subjects were 59 untreated, histologically proven, high-risk, HPV-positive, newly diagnosed Eligible receive either vaginal suppositories containing or placebo 16 weeks. primary outcome efficacy, defined as histologic regression 1 less following treatment. Secondary outcomes included complete remission, HPV clearance, tolerability. sample size 24 per group calculated detect 35% absolute increase (imiquimod vs. placebo), assuming 2-sided 5% significance level power 80%. All tested positive at baseline. After weeks treatment, achieved 73% 39% (P = 0.009). higher remission (47%) than (14%) 0.008). Human clearance after 60% 14% < 0.001). Complete HPV-16 infection 47% 0% 0.003). Three (5%), all within group, have microinvasive Topical no high-grade adverse effects; well tolerated. These findings suggest efficacious, feasible, well-tolerated