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Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study.

OBJECTIVE
To investigate the efficacy of topical treatment with imiquimod 5% cream, an immune response modifier, in patients with vulvar intraepithelial neoplasia (VIN) 2/3.


STUDY DESIGN
Fifteen women (aged 35-51) with histologically proven multifocal VIN 2/3 without invasion, were entered into a prospective, observational, pilot study. Imiquimod 5% cream was applied by the patient to the vulvar lesions one to three times a week at night. Clinical response was analyzed by macroscopic examination and categorized as complete (CR) or partial (PR).


RESULTS
Four patients achieved CR (27%) and nine patients, PR (60%) after 6-34 weeks of treatment. Two patients discontinued medication. CR was reached after 6, 7, 11 and 30 weeks of treatment.


CONCLUSION
This pilot study showed the potential beneficial effect of imiquimod 5% cream in multifocal VIN 2/3. In contrast to current surgical treatment, imiquimod focuses on the cause of VIN and preserves the anatomy and function of the vulva. Therefore, imiquimod may prove to be the treatment of choice in multifocal, high grade VIN.