Source: Blood  |  Posted 5 years ago

By Bruce Sylvester

WASHINGTON, DC -- February 5, 2007 -- A 36-month follow-up study of patients treated for superficial intraepithelial squamous cell carcinomas with curettage and imiquimod (Aldara) 5% cream shows a 97% cure rate.

Researchers reported this finding here on February 3[^]rd[] at the 65[^]th[] annual meeting of the American Academy of Dermatology (AAD). The research was highlighted by the AAD in a special session of distinguished research poster presentations.

"We not only saw this very significant overall 95% clearance rate over 36 months, but the treatment was also well tolerated with no systemic side effects," said presenter and lead investigator Donald Tillman, DO, of Great Plains Dermatology P.A., Hays, Kansas.

Dr. Tillman and colleagues treated and followed 100 subjects with a mean age of 74 years (range 49-96 yrs, 62% men and 38% women) with biopsy-proven squamous cell carcinomas. Lesions ranged from 0.3 cm to 2.4 cm (mean 1.06 cm). The majority of lesions were superficial, well-differentiated intraepithelial squamous cell carcinomas.

All patients reported at least 1 prior squamous cell carcinoma (mean number of 5.5 prior tumors).

The investigators used curettage to treat all tumors and to remove the entire tumor, if possible. They used electrodessication primarily for hemostasis.

Ten days following curettage, the researchers applied imiquimod 5% cream (once daily) to the treated area, 5 days a week for 6 weeks. At each clinic visit in the 6-week period, the investigators evaluated subjects for reaction to the imiquimod 5% cream and graded reactions as mild, moderate, or severe. They allowed rest periods from treatment for patients with moderate or severe reactions.

The researchers examined and photographed each subject at their first visit, at weeks 2 and 6, and (on average) every 3 months thereafter. They rebiopsied suspicious lesions at the month-3 visit, and at any other time during follow-up.

All subjects except 1 had some reaction to imiquimod 5% cream, but the most common reactions were mild burning and itching at the application site.

Among the 27 subjects who were assessed at the 3-month visit, 3 biopsies were positive and received alternative treatment. One patient showed recurrence during the remainder of the 36-month follow-up.

"[Imiquimod] was well tolerated and provided an apparent long-term cure for these superficial tumors. A longer-term follow-up is necessary before more definite conclusions can be determined," the authors stated in their poster.

"Even though cosmetic results were not studied specifically, we saw no evidence of hypertrophic scarring," Dr. Tillman said.

Aldara is FDA-approved to treat actinic keratosis (AK), superficial basal cell carcinoma and external genital and anal warts.

3-M Pharmaceuticals provided support for the publication of the poster presentation.

[Presentation title: Effectiveness of Curettage and Imiquimod 5% Cream in the Treatment of Superficial Intraepithelial Squamous Cell Carcinomas: a 36-Month Clinical Experience Reported. Poster 7]