Survival Benefits and Safety Profile of T ransarterial C hemoembolization (TACE) B ased  Monotherapy or Multi-modal Therapies in Locally Advanced Stage Hepatocellular Carcinoma: an Observational Study from Real-World Setting

Abstract Background : Majority of patients with locally advanced hepatocellular carcinoma (HCC) in Asian-Pacific regions underwent transarterial chemoembolization (TACE) or TACE-based muti-modal treatments instead of molecular target therapy in clinical practice. We aimed to evaluate the treatment outcomes and safety of transarterial chemoembolization based multi-modal treatments in locally advanced HCC from a real-world setting. Methods: From January 2008 to December 2015, 552 patients with locally advanced HCC who received TACE based monotherapy or multi-modal treatments at Liver Cancer Institute, Zhongshan Hospital, Fudan University were retrospectively enrolled. The clinical outcome of these patients were evaluated among these treatment groups. Propensity score matching analysis was performed to reduce potential bias for comparing treatment modalities. Results: Of all the patients, 375 patients received TACE treatment, 83 patients received TACE followed Sorafenib treatment (TACE+Sorafenib), 30 patients received TACE followed local ablation treatment (TACE+LAT), and 64 patients received TACE followed radiotherapy (TACE+Radiotherapy). 1-, 3-, 5-year OS rates in TACE group were 50.5%, 29.8% and 24.5% vs. 74.3%, 46.6% and 37.6% in TACE+multi-modal treatment group (P<0.001). The median survival time was 7.5 months, 13.0 months, 16.5 months, 10.0 months for TACE alone group, TACE+Sorafenib group, TACE+LAT group, and TACE+Radiotherapy group respectively. After propensity score matching, survival benefits were verified in TACE+Sorafenib and TACE+LAT treatments group. Safety analysis showed the major adverse events rates was 3.6% in TACE alone group and 3.9% in TACE+multi-modal treatment group with no statistic difference (P=1.0). Conclusions: TACE+Sorafenib treatment or TACE+local ablation treatment could achieve superior survival benefits to TACE alone in the management of locally advanced HCC.