Zie inmiddels publicaties van Fase III studies waarin deze resultaten worden bevestigd en de FDA het bedrijf 3M Pharmaceuticals toestemming geeft om Aldarazalf - Imiquimod te gebruiken als medicijn bij niet-melanome huidkankers in Amerika.

De resultaten van deze fase II studie, gerandomiseerd en dubbelblind uitgevoerd geven bijzonder goede resultaten bij een behandeling van huidkankertumoren, althans dat meldt de producent van deze Imiquimodzalf. Wel waren er nog al wat bijwerkingen als jeuk, brandende pijn enz.

-- PRESS RELEASE: 3M Reports Results Of Topical Cream Study --

ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 1, 2002--A clinical study, published today in the Journal of American Academy of Dermatology, shows effects of Imiquimod 5% cream in the treatment of superficial basal cell carcinoma (sBCC)(1).
This phase II, randomized, double-blind, vehicle-controlled, dose-response study was conducted in 13 study centers in the US involving 128 patients. The patients were applied imiquimod 5% cream twice daily, once daily, 5 times per week, or 3 times per week for 12 weeks with the control group receiving vehicle only. All patients were 18 years of age or older and had biopsy-confirmed primary basal cell carcinomas.
The study showed that a complete response (defined as no histological evidence of tumor after 12 weeks of treatment) was seen in 100% of the twice daily group, which included 10 patients. This regimen was discontinued, however, because it was not well tolerated.
A complete response was also seen in 87% of the 31 patients on the once daily regimen. Among those who used the cream five times per week, 81% of 26 patients had complete responses, as did 52% of the 29 patients applying imiquimod three times each week. A complete response was also seen in 19% of the 32 patients given vehicle only.
A total of 13 patients discontinued treatment because of adverse effects, 3 from the twice daily group, 7 from the once daily group and 3 from the five times per week group.
The results confirmed the findings of previous studies conducted in Australia and New Zealand(2), which showed that 88% of patients who applied imiquimod daily for six weeks achieved total clearance of sBCC tumour cells, determined by a post-treatment biopsy.
Basal cell carcinoma is the most common cancer in the US, with approximately 1 million new cases estimated per year.(1) There has been an increasing incidence in recent years in the US and other parts of the world such as Australia where there are high levels of ultraviolet B radiation.(3)
Superficial BCCs are slow-growing, locally invasive malignant skin tumors that are commonly seen on the trunk and limbs. It tends to mainly affect Caucasians and are currently treated by destructive procedures (eg surgery, cryotherapy, electrodessication), or the application of topical 5-fluorouracil.
Imiquimod 5% cream is manufactured by 3M Pharmaceuticals and is currently indicated for treatment of external genital and perianal warts. Imiquimod is first in a new class of drugs known as Immune Response Modifiers (IRMs), which work by stimulating the body to produce cytokines, naturally occurring proteins used by cells of the immune system to communicate with each other. The cytokines induced by IRMs enhance cell-mediated immunity, a natural process by which the body controls or eliminates virus infected cells and tumor cells.
Phase III studies of imiquimod 5% cream for basal cell carcinoma are on-going.

Note to editors: Labeling for imiquimod cream, 5% for external genital and perianal warts:

Most local skin reactions were mild to moderate and included erythema, erosion, flaking, edema, scabbing, and induration at the wart site. Most common application-site reactions were itching (26%), burning (16%), and pain (4%) at the wart site. Application site pigmentation changes have also been reported. New warts may develop during treatment. The effect of ALDARA cream on the transmission of genital warts is unknown. Aldara cream may weaken condoms and diaphragms. Sexual contact should be avoided while the cream is on the skin.(4)

References

(1). Geisse JK, Rich P, Pandya A, Gross K, et al. Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: A double-blind, randomized, vehicle-controlled study. J Am Acad Dermatol 2002;47:390-8.

(2). Marks R, Gebauer K, Shumack S, et al. Imiquimod 5% cream in the treatment of superficial basal cell carcinoma. Results of a multicenter 6-week dose-response trial. J Am Acad Dermatol 2001;44:807-13.

(3). Leman, J. Basal cell carcinoma: still an enigma. Arch Dermatol 2001;137:1239-1240.

(4). Edwards L, Ferenczy A, Eron L, et al. Self-administered topical 5% imiquimod cream for external anogenital warts. Arch Dermatol 1998;134(1):25-30


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