Objective: To compare the outcomes of transarterial chemoembolization (TACE) combined with sorafenib versus TACE alone for treating patients with unresectable hepatocellular carcinoma (HCC). Methods: This retrospective analysis included all patients receiving either TACE plus sorafenib therapy or TACE alone for unresectable HCC between February 2008 and August 2015 at the First Affiliated Hospital of Soochow University, China. Propensity score matching (PSM) was carried out to reduce bias due to confounding variables. The primary outcome was overall survival (OS), calculated from the date of the first TACE treatment until the date of death of any cause. A multivariate Cox proportional hazards analysis was conducted to examine determinants of OS. Results: A total of 308 patients were included in the study: 61 receiving TACE plus sorafenib treatment and 247 receiving TACE monotherapy. The PSM cohort included 61 subjects receiving TACE plus sorafenib and 122 subjects receiving TACE alone. In the overall analysis that included all patients, the median OS in the combination group was significantly longer than that in the monotherapy group (29.0 ± 7.2 vs. 14.9 ± 1.1 months; P = 0.008). In the PCM cohort, the median OS was also significantly longer in the combination group (29.0 ± 7.2 vs. 14.9 ± 1.5 months; P = 0.018). Subgroup analysis revealed longer OS in patients receiving combination treatment in both the BCLC-B and BCLC-C subgroups (P < 0.05 for both). Multivariate analyses in the PSM cohort revealed that treatment methods (P = 0.003), number of nodules (P = 0.010), tumor size (P = 0.012), vascular invasion (P = 0.005), and number of TACE (P = 0.029) were independent prognostic factors of OS. The most common adverse events were hand-foot skin reaction (75.4%) and diarrhea (47.5%) in the combination group, and fatigue (19.0%) and liver dysfunction (18.2%) in the monotherapy group. There were no treatment-related deaths in either group. Conclusion: The combined use of TACE and sorafenib is generally well tolerated and could significantly increase OS of patients with unresectable HCC.

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