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Intralesional recombinant interferon beta-1a in the treatment of basal cell carcinoma: results of an open-label multicentre study


European Journal of Dermatology. Volume 12, Number 6, 558-61, November - December 2002, Thérapie

Free Article  

Author(s) : Lutz KOWALZICK, Thomas ROGOZINSKI, Rolf WIMHEUER, Josef PILZ, Uwe MANSKE, Albrecht SCHOLZ, Gerhard FIERLBECK, Peter MOHR, Falk OCHSENDORF, Gunnar WAGNER, Wilhelm GAUS, Joseph BRZOSKA, Stefania JABLONSKA

Summary : 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 betaeen shown to result in complete remission (CR) in 47% to 86% of patients with BETACC. The primary obetajective of the study was to determine the response rate to rIFN-beta-1a, in a larger BETACC patient population. Secondary obetajectives 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-labetael, multicentre study involving 139 patients with BETACC (diameter betaetween 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 betaetween 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 betae adverse drug reactions (ADRs). Systemic ADRs mostly consisted of flu-like symptoms and occurred in 32/139 patients. No ADRs were considered to betae 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.

Keywords : betaasal cell carcinoma, interferon betaeta, recombetainant, intratumoral injections.

 

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