Abstract

289 Background:The incidence of non-alcoholic fatty liver disease (NAFLD)-associated hepatocellular carcinoma (HCC) is increasing. The impact of NAFLD on overall survival (OS), treatment response and toxicity in patients with HCC treated with sorafenib is unknown. We examined the impact of NAFLD on OS and toxicity in an international cohort of patients receiving sorafenib. Methods:Clinical and demographic data were collected from patients consecutively treated at specialist centres in Europe and North America. The impact of NAFLD on OS, sorafenib-specific survival and sorafenib-related toxicity compared to other aetiologies of liver disease using multivariable Cox-proportional hazards and logistic regression modelling was assessed. Results:5201 patients were treated with sorafenib; 183 (3.6%) had NAFLD-associated HCC. NAFLD-associated HCC patients were more likely to be older women(median age 65.8 vs 63.0 years, p < 0.01 and 10.4% vs 2.3%, < 0.01), with a median BMI of 29.4. After controlling for known prognostic factors, no difference in OS in patients with or without NAFLD was observed(adjusted HR 0.94 (95% CI 0.76 -1.16), p = 0.57). NAFLD-associated patients had more advanced stage HCC when they commenced sorafenib (BCLC C/D 70.9% vs 58.9%, p < 0.01) and were more likely to be commenced on a lower starting dose of sorafenib (51.4 vs. 36.4%, p < 0.01). However, there was no difference in sorafenib-specific survival between NAFLD and other aetiologies(HR 0.99, 95% CI (0.85 – 1.16, p=0.92). Adverse events were similar between NAFLD and non-NAFLD HCC groups, including rates of ≥ grade 2 hypertension(6.3 vs. 5.8%, p = 1.00). A lower rate of severe hand foot syndrome was observed in the NAFLD population(3.8 vs. 12.4%, p = 0.03). Conclusions: OS in HCC does not appear to be influenced by the presence of NAFLD. NAFLD-associated HCC derive similar clinical benefit from sorafenib compared to other aetiologies.

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