clinical outcome of topical interferon alpha-2b cream in phase ii trial for lsilcin 1 patients在二期临床结果的局部干扰素alpha-2b奶油审判lsilcin 1患者.pdfVIP

Journal of Cancer Therapy, 2011, 2, 203-208 203 doi:10.4236/jct.2011.22026 Published Online June 2011 (http://www.SciRP.org/journal/jct) Clinical Outcome of Topical Interferon Alpha-2b Cream in Phase II Trial for LSIL/CIN 1 Patients 1 2 1* Roberto Kurzeja , Gerd Böhmer , Achim Schneider 1Department of Gynecology, Charite Universitätsmedizin, Berlin, Germany; 2Gynecologic Practice, Wagner and Stibbe, Bad Münder, Germany. Email: {Roberto.kurzeja, achim.Schneider}@charite.de, Gboehmer@ nd st th Received January 22 , 2011; revised March 31 , 2011; accepted April 7 , 2011. ABSTRACT Objectives: Interferon alpha-2b possesses variable activity against human papillomavirus (HPV) associated cervical intraepithelial neoplasia (CIN). No topical therapy is currently available for treatment of early stage CIN. We evalu- ated a new patented drug delivery technology in order to achieve topical efficacy. Methods : Two separate studies were conducted in parallel. IFN002 (treatment group) was an open label study. Twenty patients with Pap IIW, III and IIID (CIN1) were treated with intravaginal application of Interferon alpha-2b cream (5 g, 2 MIU/g) three times a week (al- ternate days) for 6 weeks with 6 weeks of follow up to determine its effect on cytologic and colposcopic assessment. HPV001 (control group) was a 12 week observational study. Both studies had similar inclusion/exclusion criteria and patient population. Results : In IFN002, 8 of 20 patients (40%) in the ITT population showed resolution of abnormal Pap smear during the 12 weeks following start of treatment (responders). In HPV001, 7 of 21 patients (33.3%) were regressors (p = 0.45, one-sided FET). In the PP population, 7 of 12 (58.3%) patients in I