Evaluating the efficacy and safety of Sorafenib versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients

Abstract

Introduction: Sorafenib is the standard first-line treatment forhepatocellular carcinoma(HCC). No sufficient data exists regarding its efficacy in the Egyptian population as it is a costly medication that is not endorsed by insurance and hence is not used in most institutions. Aim:This study aimed to evaluate the overall survival [OS], progression-free survival [PFS] and quality of life [QOL] of Egyptian HCC patients receiving sorafenib versus best supportive care[BSC]. Patients and Methods:A multi-center prospective controlled study. A hundred and tenHCC patients were assessed for eligibility. Eligible HCC patients were stratified into one of two groups based on institutions’ protocols for HCC treatment. The first group received best supportive care [n= 20] and the second group received sorafenib [n=35]; the patients follow up were continued for one year after diagnosis. Results: Out of 110 enrolled patients, only 55 completed the trial; Sorafenib [n=35], BSC [n= 20]. The one-year OS was 0.0% versus 75.5% [p= 0.008] in BSC and Sorafenib respectively. Median PFS was 5 months versus 12 months in BSC group and Sorafenib respectively [p= 0.008]. Sorafenib group hazard ratio for developing progression was 2.35; [95% [Confidence Interval], 1.19 to 4.62; P=0.014]. QOL scores was significantly different between the 2 groups [p= 0.047]. Most observed side effects of Sorafenib were; Diarrhea [n=15] and hand-foot syndrome [n= 12]. Conclusion:Sorafenib was an effective therapy in Egyptian HCC patients with a superior QOL, OS and PFS than those receiving supportive care. Clinicaltrials.gov, registration number is NCT02971696.