title: Recurrence rate of superficial basal cell carcinoma following successful treatment with imiquimod 5% cream: interim 2-year results from an ongoing 5-year follow-up study in Europe.
abstract: Imiquimod is an immune response modifier that acts through Toll-like receptor 7 to induce innate and cell-mediated immune responses. This ongoing phase III, open-label study conducted in Europe is evaluating the long-term (5 year) clinical efficacy and safety of imiquimod 5% cream applied once daily 5 times per week (5 x/week) for 6 weeks for the treatment of superficial basal cell carcinoma (sBCC). A total of 182 subjects were enrolled. The initial sBCC clearance rate was 90% (12-week post treatment), whereas the proportion of subjects who were clinically clear at 2 years (current time point) was estimated to be 79.4%. Local skin/application site reactions were the most frequently reported safety findings. Initial efficacy rates of imiquimod applied 5 x/week for 6 weeks demonstrate its clinical utility as an alternative approach to the treatment of sBCC. The recurrence rate seen to date supports ongoing follow up of subjects treated with imiquimod.
authors.affiliation: Universitätsklinik für Dermatologie und Venerologie, Otto-von-Guericke-Universität Magdeburg,Leipziger Str. 44, 39120 Magdeburg, Germany. harald.gollnick@medizin.uni-magdeburg.de
authors.forename: Harald
authors.initials: H
authors.lastname: Gollnick
authors.forename: Carlos Guillén
authors.initials: CG
authors.lastname: Barona
authors.forename: Ronald G J
authors.initials: RG
authors.lastname: Frank
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruzicka
authors.forename: Mosaad
authors.initials: M
authors.lastname: Megahed
authors.forename: Veronica
authors.initials: V
authors.lastname: Tebbs
authors.forename: Mary
authors.initials: M
authors.lastname: Owens
authors.forename: Patti
authors.initials: P
authors.lastname: Stampone
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009824:Ointments; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000970:Antineoplastic Agents; D009824:Ointments; D000077271:Imiquimod