0000000000379084
AUTHOR
Tom M. Ganten
Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study.
Abstract Purpose: Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months. Experimental Design: The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Results: Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor s…
Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial
International audience; BACKGROUND:We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).METHODS:In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor-free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overal…
Final Analysis of Overall Survival Per Subgroups of Hcc Patients in the Prospective, Non-Interventional Insight Study Treated with Sorafenib
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 e…
Interim Analysis of Overall Survival Per Subgroups in the Prospective, Non-Interventional Insight Study in Patients with Hepatocellular Carcinoma Treated with Sorafenib
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 sorafeni…
Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma - The SHELTER study
Background & Aims No established therapies for patients with hepatocellular carcinoma (HCC) and progression on first-line sorafenib treatment currently exist. This phase I/II trial investigated safety, pharmacokinetics and potential biomarkers of the histone deacetylase inhibitor resminostat and a combination therapy with resminostat and sorafenib. Methods Patients with HCC and radiologically confirmed progression on sorafenib were treated in an exploratory, multi-center, open-label, uncontrolled, non-randomized, parallel group phase I/II study. In the combination group (n=38) four dose levels ranged from daily 200 to 600mg resminostat plus 400 to 800mg sorafenib. The monotherapy group (n=1…