A pharmaceutical treatment may offer patients an alternative to the usual surgical removal of basal cell carcinomas, according to a presentation at the annual meeting of the American Academy of Dermatology in New Orleans. The results of a pilot study show that imiquimod(Drug information on imiquimod) 5% cream (Aldara) is an effective treatment for basal cell carcinoma.
“Surgical treatments work well, but there should be a place for medical treatments, and dermatologists need to be at the forefront in using them,” said lead investigator Karl Beutner, MD, PhD, of Solano Dermatology Associates in Vallejo, California.
The study of 35 patients with basal cell carcinoma found that 100% of patients who were treated either twice daily, once daily, or three times per week with imiquimod cream experienced complete clearance of the tumor after 10, 13, and 14.5 weeks of therapy, respectively. Overall, taking into account all five arms of the trial, 83% of those treated with imiquimod cream experienced complete clearance of the tumor.
Drug Stimulates Cytokine Production
Most current treatments for basal cell carcinoma involve surgical removal, which causes scarring. Imiquimod uses the body’s own immune system to fight disease and infection at the cellular level by stimulating the production of cytokines, such as interferon-alpha. The exact mechanism of action of imiquimod is unknown. It is currently marketed as a topical treatment for external genital and perianal warts.
“These results show great promise for imiquimod as a topical treatment for basal cell carcinoma, especially on the extremities and trunk, where scarring from surgery is more profound,” said Dr. Beutner. “Products such as imiquimod can help physicians move away from surgical approaches to medical treatments, which have the potential to achieve better cosmetic results,” he said.
About the Trial
The randomized, double-blind study compared the effects of imiquimod cream with the effects of a placebo in 35 patients with a primary basal cell carcinoma of defined size (median, 0.8 cm2) and confirmed by biopsy to be either nodular or superficial.
A total of 24 patients received imiquimod cream and 11 received a placebo cream in one of five dosing regimens: twice daily, once daily, three times weekly, twice weekly, and once per week; all regimens were continued for up to 2 weeks after visible clearance of the tumor or for 16 weeks, whichever came first. After 6 weeks of therapy, the treated sites were surgically removed and tested for evidence of tumor.
All 15 of the patients in the twice-daily, once-daily, and thrice-weekly dose groups achieved complete clearance of the basal cell carcinoma. Complete tumor clearance was documented in 60% and 50% of the patients in the twice-weekly and once-weekly imiquimod groups, respectively, and in 9% of the placebo group.
“Although the results of the pilot trial are encouraging,” said Dr. Beutner, “Large, well-controlled trials will be necessary to confirm efficacy and establish optimal dosing regimens for imiquimod before it can be used in more routine practice.” The study was supported by a grant from 3M Pharmaceuticals.
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