Efficacy of 5% imiquimod cream on vulvar intraepithelial neoplasia in Korea: pilot study.

Background: Various therapeutic options, including surgery, electrocautery, cryotherapy, 5-fluorouracil treatment, laser therapy, radiotherapy, photodynamic therapy, and interferon-α/γ injection, have been employed to treat vulvar intraepithelial neoplasia (VIN) with varying degrees of success. To truly cure VIN, human papillomavirus elimination is considered important.

Objective: To investigate the efficacy of 5% imiquimod cream used to treat VIN in Korean patients.

Methods: We performed a prospective, uncontrolled, observational study. Nine patients with histologically confirmed VIN applied 5% imiquimod cream to their vulvar lesions three to five times a week until a clinical response was apparent. All lesions were photo-documented, and therapeutic efficacy was assessed in terms of local adverse effects lesion number, size, and hyperpigmentation.

Results: The mean treatment duration was 30.2 months, and the median follow-up period after therapy completion was 30 months. Of the nine patients recruited, six (66.6%) experienced complete responses (CR) or partial responses (PR). Hyperpigmented patches in the VIN lesions were evident in five subjects (55.6%), and all experienced either CR or PR. Only three patients (33.3%) suffered from local adverse effects, which were relieved after temporary suspension of therapy, and better outcomes were attained ultimately.

Conclusion: The imiquimod cream was more efficacious when used to treat VIN of the hyperpigmented type compared with lesions lacking pigmentation. The unifocal nature of a lesion and the development of local adverse effects are useful factors when imiquimod cream is prescribed. However, although the cream is convenient and effective, regional resistance may develop, and close follow-up is essential because VIN may become malignant.