Sorafenib in Patients with Hepatocellular Carcinoma—Results of the Observational INSIGHT Study

Abstract

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. The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor stage (A: 29.2, B: 19.6, C: 13.6, D: 3.1 and A: 6.0, B: 5.5, C: 3.9, and D: 1.7 months, respectively), Child-Pugh liver function (A: 17.6, B: 8.1, C: 5.6 and A: 5.3, B: 3.3, C: 2.5 months, respectively), and performance status of the patient; however, age did not affect prognosis. Sorafenib-related adverse events at any grade occurred in 64.9% of patients, with diarrhea (35.4%), hand-foot-skin reaction (16.6%), nausea (10.3%), and fatigue (11.2%) occurring most frequently. Sorafenib treatment was shown to be effective in a real-life setting, in agreement with previously reported clinical trial data. The therapy was found to have an acceptable safety profile, with predominantly mild to moderate side effects. .

The prognostic factors between different viral etiologies among advanced hepatocellular carcinoma patients receiving sorafenib treatment

“…A recent multicenter study from the United Kingdom also demonstrated Child‐Pugh class, performance status, and albumin‐bilirubin grade as prognostic factors in sorafenib‐treated patients . Other multicenter observational studies have recently demonstrated similar results of Child‐Pugh class as the main determining factor of overall survival . PVT was another frequently reported prognostic factor .…”

7‐Deoxynarciclasine shows promising antitumor efficacy by targeting Akt against hepatocellular carcinoma

“…Among the chemotherapeutic agents, sorafenib, a small molecule multikinase inhibitor, is considered as a standard treatment for patients with advanced HCC. However, the survival time of patients with advanced HCC is only extended by approximately 2–3 months . Therefore, there is an urgent need to develop novel and promising strategies against advanced HCC.…”

New Systemic Treatments in Advanced Hepatocellular Carcinoma

“…Sorafenib was the first systemic treatment approved in HCC, and its effectiveness and safety were externally validated in prospective randomized studies and in cohort studies . This manuscript reviews the available data regarding systemic treatment after LT in this special population.…”