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RESEARCH PRODUCT

Interim Analysis of Overall Survival Per Subgroups in the Prospective, Non-Interventional Insight Study in Patients with Hepatocellular Carcinoma Treated with Sorafenib

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ABSTRACT Background The efficacy of Sorafenib in patients (pts) with hepatocellular carcinoma (HCC) has been proven in randomized, controlled trials. INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with HCC. The objectives of this study are the evaluation of safety and efficacy under practice conditions in both hospitals and private practices. Enrollment into INSIGHT is not restricted to a particular tumor stage. Recruitment into the study is ongoing. Methods The second interim analysis (data cut-off 23 FEB 2012) evaluated overall survival and safety data in relevant subgroups. All patients with HCC were observed for the duration of their sorafenib therapy. In addition to baseline data the performance status, tumor status (clinical and/or radiological), time to progression and overall survival time are documented. Documentation of adverse events comprises relationship with drug, seriousness, grade (CTCAE version 3.0), and outcome. Results Until the data cut-off 623 pts have been enrolled; 618 of which are evaluable for safety and efficacy analyses. The table summarises major baseline characteristics together with median overall survival (mOS) data for relevant subpopulations. Patients recruited n, Male n (%) 618, 528 (85) ECOG PS, n (%), 0, 1, 2 203 (33); 310 (50); 98 (16) BCLC-Stage n (%), A, B, C, D 80 (13); 149 (24); 319 (52); 12 (2) Child Pugh Stage, n (%), A( 9), Missing 264 (43); 99 (16); 12 (2); 243 (39) Months mOS total population (Events n = 164) 17,1 mPFS total population (Events n = 408) 4,1 mOS according to BCLC A, B, C, D 29,2; 19,6; 14,5; 4,0 mOS according to Child Pugh A, B, C n.r.; 7,2; 4,0 mOS Child Pugh B: 7, 8, 9 points 11,5; 9,5; 2,5 mOS Duration of therapy > 24 weeks (n = 176); >40 weeks (n = 91) 19,8; 26,7 n.r.-not reached Conclusions Results of mOS in pts with HCC treated under daily practice conditions in hospitals and private practices confirm the general efficacy of Sorafenib known from registration trials and gives further insight into pts with Child B/C cirrhosis and BCLC stage A/B. Further demographic data and efficacy and safety results will be presented. Disclosure T. Ganten: Advisory Boards and Cooperate-sponsored research (Bayer HealthCare Germany). E. Schott: ES has received lecture fees and travel support from Bayer and has acted as an advisor to Bayer. P. Galle: Advisory Boards, Speaker for Bayer. P. Malfertheiner: - Anstellungsverhaltnis, Fuhrungsposition: Klinikdirektor - Beratungs- bzw. Gutachtertatigkeit: Aptalis, Novartis - Honorare: Aptalis, Falk Foundation, Abbott, AstraZeneca - Finanzierung wissenschaftlicher Untersuchungen: Bayer, Novartis. K. Achilles: I am employee of Bayer Vital. All other authors have declared no conflicts of interest.