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Off-label study: short-course imiquimod for VAIN treatment.

LAKE BUENA VISTA, FLA. -- Initial clinical experience in treating vaginal intraepithelial neoplasia with topical imiquimod has shown short-course therapy to have a high degree of efficacy, simplicity of use, and a relative absence of associated adverse events. Dr. Henry W. Buck reported.

A series of 84 patients from a student health service now has been treated for vaginal intraepithelial neoplasia (VAIN) with the topical immune response modifier, Dr. Buck said at a meeting of the American Society for Colposcopy and Cervical Pathology.

The treatment course involves the internal application of one sachet of imiquimod 5% cream (250 mg) once weekly for three doses. The first dose is given in the office, and patients administer the subsequent doses themselves, said Dr. Buck of the University of Kansas, Lawrence.

Of 67 who completed the treatment with imiquimod (Aldara) and were available for follow-up, 54 (81%) cleared with one course of therapy.

Of the remaining 13, 10 cleared after two courses.

Most (79) patients had low-grade disease (VAIN-1). Three had diagnoses of VAIN-2, and two had VAIN-3.

One VAIN-2 patient cleared after a single course, another after three courses, and the third was lost to follow-up. Both of the two VAIN-3 patients cleared after one course.

Dr. Buck said when he first began prescribing imiquimod for vaginal use, patients were told to use it twice a week. That was the regimen in another study in which imiquimod was being evaluated for use in cervical intraepithelial neoplasia. But after one patient experienced excoriation, the once-weekly regimen was instituted. There has been only one more excoriation, he said.

In comparison, 5-FU cream "tears up the vagina" markedly, Dr. Buck said at the meeting.

Recurrence rates also were low. Of the 42 who were followed for at least 6 months, only 2 had recurrences. The remaining 95% remained clear.

The package insert for Aldara states that vaginal use is considered internal and should be avoided. But Dr. Buck said he has been prescribing it for 3 years and is "comfortable" prescribing it for vaginal use.

"I didn't begin this study as a research project--I simply wanted to treat patients. I had done a lot of lasering in the past and that just doesn't sell in the college setting," he said.

"I did want to keep some statistics, though, to see if it was working or not. When I began to evaluate the data I was quite impressed--it looked like we had found something that was really working," he said.


New York Bureau
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Author:Walsh, Nancy
Publication:OB GYN News
Date:May 1, 2004
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