CEASE HCC: Comparative Effectiveness Analysis of Sorafenib and Embolization for Hepatocellular Carcinoma

Abstract

Background: Transarterial embolization and sorafenib are the two main first-line therapeutic options for patients with hepatocellular carcinoma (HCC) who are not candidates for curative treatments. As no prospective trials or comparative studies exist on the relative effectiveness of these two treatment strategies, this study aimed to compare the clinical effectiveness of embolization and sorafenib as practiced in real-world settings. Materials and Methods: Using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database, patients aged ≥65 diagnosed with primary liver cancer between 2007-2011 who received embolization or sorafenib were identified. Patients were excluded if they had insufficient claims records, a diagnosis of intrahepatic cholangiocarcinoma, other primary cancers, liver transplantation, or combination therapy. The primary outcome of interest was overall survival. Inverse-propensity for treatment weighted (IPW) models were used to control for selection bias. Results: 1,017 patients met inclusion and exclusion criteria. IPW models showed good balance between treatment groups. Compared to those who underwent embolization, patients who received sorafenib had significantly higher hazard of earlier death from time of treatment (HR=1.87, 95% CI 1.46, 2.37; p<0.0001) and from time of cancer diagnosis (HR=1.87, 95% CI 1.46, 2.39; p<0.0001). The survival advantage after embolization was seen in both intermediate and advanced stage disease. Conclusion: This comparative effectiveness study of Medicare patients with HCC demonstrated significantly longer overall survival following treatment with embolization when compared with sorafenib. As these findings conflict with expert opinion-based guidelines for treatment in advanced stage disease, prospective randomized comparative trials in this subpopulation would be justified.