191P - Assessment of efficacy and safety of sorafenib versus no treatment in Egyptian hepatocellular carcinoma patients

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-treatment control group [n = 20]. The one year OS was 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 showed a better outcome OS, PFS and QOL as compared to no-treatment in Egyptian patients with advanced Hepatocellular Carcinoma.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.