DI-020 Effectiveness of sorafenib in advanced hepatocellular carcinoma in real-life conditions

Background Sorafenib is an oral multikinase inhibitor used for the treatment of hepatocellular carcinoma (HCC). It is the only systemic treatment indicated for advanced HCC and was included in our Hospital´s formulary in 2007. Purpose To assess the characteristics of the patients receiving sorafenib for the treatment of HCC in our hospital and to describe the treatment effectiveness in real-life conditions. Material and methods Retrospective observational study. We included all patients who had started treatment with sorafenib for HCC in our hospital between 1st January 2007 and 31st December 2013. Demographic and clinical variables (tumour stage according to BCLC, ECOG PS, Child Pugh, presence of macroscopic vascular invasion and/or extrahepatic spread) were recorded. The main outcomes were time to progression and overall survival, assessed by Kaplan-Meier plots. Results were also analysed with the log-rank test stratified by BCLC stage. Results 72 patients were included. They had predominantly BCLC stage C HCC (77.8%), PS between 0–1 (88.9%) and compensated cirrhosis. At the end of the study, 53 patients had discontinued the treatment. The most common reasons for treatment discontinuation were clinical worsening (35.1%) and occurrence of uncontrollable adverse events (24.6%). The median time to progression was 4.8 months (95% CI 3.8, 5.9). The median time to progression was 3.1 months (95% CI 2.5, 3.7) in the BCLC B group, as compared with 5.3 months in the BCLC C group (95% CI 4.4, 6.1), p = 0.024. At the end of the study, 44 deaths had occurred. Median overall survival (OS) was 15.2 months (95% CI 11.2, 19.3). There was no significant difference between the two groups in the median OS:19.5 months (95% CI 9.6, 29.4) in the BCLC B group vs. 14.2 months (95% CI 8.9, 19.5) in the BCLC C group, p = 0.75. Conclusion The effectiveness of sorafenib in the treatment of advanced HCC under real-life conditions is consistent with the data from the clinical trials. Our results seem to indicate that in patients with BCLC stage C, sorafenib is more likely to delay disease progression. Nevertheless, overall survival was longer in the patients with BCLC stage B carcinoma. References and/or acknowledgements No conflict of interest.