Assessment of efficacy and safety of sorafenib versus no treatment in Egyptian hepatocellular carcinoma patients

Abstract

Background: Hepatocellular carcinoma [HCC] is the third leading cause of death from cancer worldwide. In Egypt, HCC accounts for about 4.7% of chronic liver disease. To date, no controlled studies have evaluated the Sorafenib efficacy in comparison to no treatment in HCC patients whose etiology of HCV genotype 4 (The most prevalent hepatitis C virus genotype in Egypt). Methods: A multicenter prospective controlled interventional study. 110 Patients were evaluated for overall survival [OS], Progression‐free survival [PFS], safety and quality of life [QOL] using FACT Hepatobiliary Symptom Index [FHSI‐8] questionnaire. NCT02971696. Results: Out of 110 patients enrolled, only 55 completed the trial; sorafenib [n = 35], no‐treatmentcontrol group[n=20]. The one year OSwas 0.0% versus 75.5% [p =0.008] in control and sorafenib respectively. Median PFS was 5 months versus 12 months in control group and sorafenib respectively [p = 0.008]. Sorafenib group HR for developing progression was 2.35; [95% [CI], 1.19 to 4.62; P = 0.014]. QOL scores [FHSI‐8] was significantly different between the 2 groups [F =4.455, p= 0.047]. Most observed side effects of sorafenib were; Diarrhea [n = 15] and hand‐foot syndrome [n=12]. Conclusions: Sorafenib treatment showeda better outcome OS, PFS and QOL ascom‐pared to no‐treatment in Egyptian patients with advanced Hepatocellular Carcinoma.