Treating Advanced Hepatocellular Carcinoma with Sorafenib: A 10-Year Single Center Experience

Abstract

<b><i>Introduction:</i></b> Sorafenib was the first therapy used for systemic treatment of unresectable hepatocellular carcinoma (HCC). Multiple prognosis factors associated with sorafenib therapy have been described. <b><i>Objectives:</i></b> The aim of this work was to evaluate survival and time to progression (TTP) on HCC patients treated with sorafenib, and check for predictive factors of sorafenib benefit. <b><i>Materials and Methods:</i></b> Retrospectively, data from all HCC patients treated with sorafenib in a Liver Unit from 2008 to 2018 were collected and analyzed. <b><i>Results:</i></b> Sixty-eight patients were included; 80.9% were male, the median age was 64.5 years, 57.4% had Child-Pugh A cirrhosis and 77.9% were BCLC stage C. Macrovascular invasion (MVI) was present in 25% of the patients and 25% of the subjects had other extrahepatic metastasis. The median survival was 10 months (IQR 6.0–14.8) and median TTP was 5 months (IQR 2.0–7.0). Survival and TTP were similar between Child-Pugh A and B patients: 11.0 months (IQR 6.0–18.0) for Child-Pugh A and 9.0 months (IQR 5.0–14.0) for Child-Pugh B (<i>p</i> = 0.336). In univariate analysis, larger lesion size (LS &#x3e;5 cm), higher alpha-fetoprotein (AFP &#x3e;50 ng/mL), and no history of locoregional therapy were statistically associated with mortality (HR 2.17, 95% CI 1.24–3.81; HR 3.49, 95% CI 1.90–6.42; HR 0.54, 95% CI 0.32–0.93, respectively), but only LS and AFP were independent predictive factors, as shown in multivariate analysis (LS: HR 2.08, 95% CI 1.10–3.96; AFP: HR 3.13, 95% CI 1.59–6.16). MVI and LS &#x3e;5 cm were associated with TTP shorter than 5 months in univariate analysis (MVI: HR 2.80, 95% CI 1.47–5.35; LS: HR 2.1, 95% CI 1.08–4.11), but only MVI was an independent predictive factor of TTP shorter than 5 months (HR 3.42, 95% CI 1.72–6.81). Regarding safety data, 76.5% of patients reported at least one side effect (any grade), and 19.1% presented grade III–IV adverse effects leading to treatment discontinuation. <b><i>Conclusions:</i></b> We observed no significant difference in survival or TTP in Child-Pugh A or Child-Pugh B patients treated with sorafenib, as compared to more recent real-life studies. Lower primary LS and AFP were associated with a better outcome, and lower AFP was the main predictor of survival. The reality of systemic treatment for advanced HCC has recently changed and continues to evolve, but sorafenib remains a viable therapeutic option.