title: Intralesional recombinant interferon beta-1a in the treatment of basal cell carcinoma: results of an open-label multicentre study.
abstract: Although effective conventional therapies are available to treat basal cell carcinoma (BCC), undesirable side effects, including scarring, and in some cases permanent damage, often occur in problematic areas of the body, especially around the eyes, mouth, and cartilage of the nose and ears. In previous studies, intratumoural injection of recombinant interferon beta-1a (rIFN-beta-1a) has been shown to result in complete remission (CR) in 47% to 86% of patients with BETACC. The primary objective of the study was to determine the response rate to rIFN-beta-1a, in a larger BETACC patient population. Secondary objectives included evaluating the effect of tumour type/size on response as well as residues, cosmetic results, and relapse rate after CR. The safety profile of intratumoural rIFN-beta-1a in BETACC patients was also evaluated. This was an open-label, multicentre study involving 139 patients with BETACC (diameter between 5.0 and 20 mm). Intratumoural injections of rIFN-beta-1a (1.0 x 106 IU) were administered three times a week for 3 weeks. The response was determined 16 weeks after start of treatment and the status of patients was followed for up to 5 years. At 16 weeks, the response rate to intratumoural rIFN-beta-1a was 66.9% (95% CI, range 58.2-74.8%). There was no significant difference between the response rates for patients with solid or other BETACC tumour types. Similarly, tumour size did not significantly affect the response rate. The cosmetic result of treatment was rated as good or very good in 83% of responders. The relapse rate after CR was 4.5% (median follow-up 2 years). All patients showed local inflammatory reactions, which were generally considered to be the adverse drug reactions (ADRs). Systemic ADRs mostly consisted of flu-like symptoms and occurred in 32/139 patients. No ADRs were considered to be the serious. These results show that intratumoural injections of rIFN-beta-1a are effective in the treatment of BETACC in the majority of patients. In addition, rIFN-beta-1a is safe and generally well tolerated. rIFN-beta-1a represents an effective alternative treatment for BETACC.
authors.affiliation: Department of Dermatology and Allergy, Municipal Hospital Plauen, Box 100153, Germany. l.kowalzick@vogtland-klinikum-plauen.de
authors.forename: Lutz
authors.initials: L
authors.lastname: Kowalzick
authors.forename: Thomas
authors.initials: T
authors.lastname: Rogozinski
authors.forename: Rolf
authors.initials: R
authors.lastname: Wimheuer
authors.forename: Josef
authors.initials: J
authors.lastname: Pilz
authors.forename: Uwe
authors.initials: U
authors.lastname: Manske
authors.forename: Albrecht
authors.initials: A
authors.lastname: Scholz
authors.forename: Gerhard
authors.initials: G
authors.lastname: Fierlbeck
authors.forename: Peter
authors.initials: P
authors.lastname: Mohr
authors.forename: Falk
authors.initials: F
authors.lastname: Ochsendorf
authors.forename: Gunnar
authors.initials: G
authors.lastname: Wagner
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Gaus
authors.forename: Joseph
authors.initials: J
authors.lastname: Brzoska
authors.forename: Stefania
authors.initials: S
authors.lastname: Jablonska
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001707:Biopsy, Needle; D002280:Basal Cell Carcinoma / Q000175:diagnosis* / Q000188:drug therapy*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D007279:Injections, Subcutaneous; D007370:Interferon Type I / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D007370:Interferon Type I; D011994:Recombinant Proteins