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Imiquimod 5% Cream Appears Effective and Safe for Superficial Basal-Cell Carcinoma: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 11, 2004 -- Imiquimod 5% cream (Aldaraź) appears effective for the concurrent treatment of multiple superficial basal-cell carcinoma (sBCCs), researchers reported here on February 7^th at the American Academy of Dermatology 62^nd Annual Meeting.

"We saw that, at either 5 or 7 dosings per week, and when used on several sBCCs at one time, there was a high rate of positive outcome," said lead investigator Robin Marks, MB, MPH, Professor of Dermatology, University of Melbourne, St. Vincent's Hospital, Melbourne, Australia. "We had some concern about whether to use it with multiple lesions concurrently, but we found no significant problems…This is good news for our patients, who generally have multiple lesions."

The study was a 6-week, open-label, multicentre trial. Subjects were assigned to 2 imiquimod treatment groups: 5 times per week for 36 subjects and 7 times per week for 31 subjects. The researchers treated a total of 208 biopsy-confirmed lesions, with a median of 3 per patient.

Complete response rate was defined as the proportion of subjects with no clinical and histological evidence of sBCC at any of the target tumour sites at 12 weeks treatment. The partial and complete histological response rates were the proportion of subjects who showed histological clearance in at least 50% and 100% of tumours, respectively.

The investigators reported an overall clearance rate of 77%. For the 5x and 7x groups respectively, the partial histological response rates were 89% and 84%. Complete histological response rates were 47% and 58%, respectively, and the complete response rate was 44% and 55%, respectively.

"There were some localised site reactions, but no one left the trial for that reason or any other adverse event," stated Professor Marks.

Imiquimod is approved in the United States to treat genital and anal warts.

This study was sponsored by 3M Pharmaceuticals.


[Study title: Imiquimod 5% Cream in the Treatment of Multiple Superficial Basel Cell Carcinoma. Abstract 27]

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