Abstract
PURPOSE: To compare the efficacy and safety of postoperative adjuvant therapy with transarterial chemoembolization (TACE) plus tyrosine kinase inhibitor (TKI) (TPT) versus TACE alone in hepatocellular carcinoma (HCC) patients at high risks of recurrence after radical hepatectomy. PATIENTS AND METHODS: We retrospectively analyzed 264 HCC patients who underwent radical hepatectomy (R0 resection) between August 2016 and August 2023. To mitigate selection bias, propensity score matching (PSM) was employed. The primary endpoints were recurrence-free survival (RFS) and overall survival (OS), analyzed using Kaplan-Meier curves and Log rank tests. Treatment-related adverse events (TRAEs) were graded according to CTCAE v4.0. Prognostic factors were evaluated via Cox proportional hazards regression. RESULTS: Before PSM, the cohort comprised 141 patients receiving TPT and 123 patients treated with TACE alone. After PSM, 81 well-balanced patients were selected per group (all p > 0.05). The TPT group exhibited significantly prolonged median recurrence-free survival (mRFS: 37.1 vs 27.7 months; p < 0.05) and median overall survival (mOS: 41.3 vs 38.3 months; p < 0.05) compared to the TACE alone group. The 1-, 2-, and 3-year RFS rates in the TPT group were 95.1%, 67.9%, and 48.1%, respectively, significantly higher than those in the TACE alone group (76.5%, 55.6%, and 40.7%; all p < 0.05). Similarly, the corresponding OS rates were 95.1%, 75.3%, and 54.3% (TPT) versus 81.5%, 66.7%, and 53.1% (TACE alone; all p < 0.05). Multivariable Cox regression analyses confirmed TPT as an independent protective factor for both RFS and OS. No significant increase in treatment-related adverse events (TRAEs) was observed with the TPT regimen compared to TACE alone. The overall TRAE rate was 51.8% in the TPT group, with grade ≥3 events occurring in 14.8% of patients, indicating an acceptable safety profile.