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RESEARCH PRODUCT

Final Analysis of Overall Survival Per Subgroups of Hcc Patients in the Prospective, Non-Interventional Insight Study Treated with Sorafenib

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ABSTRACT Aim: INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with hepatocellular carcinoma 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. Methods: This final analysis evaluated overall survival and safety data incluling 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), and overall survival time are documented. Documentation of adverse events comprises relationship with drug, seriousness, grade (CTCAE version 3.0), and outcome. Results: 791 pts have been enrolled; 788 of which are evaluable for safety and 782 for efficacy analyses. The table summarises major baseline characteristics together with median overall survival (mOS) data for relevant subpopulations. Patients recruited n, Male n (%) 782, 668 (85) ECOG PS, n (%), 0, 1, 2 243 (31); 404 (52); 192 (16) BCLC-Stage n (%), A, B, C, D 101 (13); 194 (25); 392 (50); 14 (2) Child Pugh Stage, n (%), A( 9), Missing 443 (57); 182 (23); 26 (3); 131 (17) MOS total population (Events n = 278) 14.8 months mPFS total population (Events n = 633) 4.1 months MOS according to BCLC A, B, C, D 29.1; 19.5; 13.6; 3.1 months MOS according to Child Pugh A, B, C 17.5; 8.1; 5.6 months MOS Child Pugh B: 7, 8, 9 points 8.1; 9.4; 2.4 months mOS Duration of therapy > 24 weeks (n = 352); >40 weeks (n = 209) 25.1; 31.8 months MOS according to age 16.8; 14.5 months (p = 0.5625) MOS according to etiology: Hep C, Hep B, NASH, alcohol 23.3; 10.8; 11.8; 14.3 months AEs (all grades), n (%); Drug-related AEs (all grades), n (%) 688 (87.3); 511 (64.9) SAEs (all grades), n (%); Drug-related SAEs (all grades), n (%) 394 (50); 77 (9.8) Conclusions: Results of mOS in pts with HCC treated under daily practice conditions in hospitals and private practices confirms the general efficacy of Sorafenib and gives further insight into survival of pts with CHILD B, BCLC stage A/B, age ≥65, etiology of HCC and a relevant subgroup of patients treated longer than 40 weeks. Further demographic data, efficacy and safety results will be presented. Disclosure: T.M. Ganten: - Advisor Bayer Healthcare - holding Bayer stocks - fees for Advisor and corporate; sponsored research funding from Bayer Healthcare - other fees from Novartis; R. Stauber: - Fees for Advisory Boards for Abbvie, BMS, Gilead, MSD - corporate sponsored research funding from MSD; R. Buder: - corporate sponsored research funding from Bayer Healthcare; P.R. Galle: - Advisor and Consultant for Bayer, Lilly, Jennerex and BMS; I. Bernard: - Bayer Employee. All other authors have declared no conflicts of interest.