Adjuvant Lenvatinib in Combination with Transarterial Chemoembolization for Hepatocellular Carcinoma Patients with High-Risk of Postoperative Recurrence (LANCE): A Multicenter Prospective Cohort Study

Purpose: To evaluate the efficacy and safety of lenvatinib in combination with transarterial chemoembolization (TACE) as an adjuvant therapy in HCC patients with high-risk of postoperative recurrence. Methods: This study was a prospective cohort study. Patients who met the eligible criteria were recruited between November 2018 to May 2021 from 8 hepatobiliary centers in China. The primary endpoint was disease-free survival (DFS). The secondary endpoints were overall survival (OS) and safety. The treatment-related adverse events (AEs) were recorded throughout the entire study period. Results: A total of 297 patients were enrolled, with 147 patients in the TACE + Lenvatinib (Len) group and 150 patients in the TACE group. The baseline characteristics were well balanced between the two groups. Patients in the TACE + Len group achieved significantly better DFS. The median DFS was 19.0 months [95% confidence interval (CI), 14.0-25.0] and 10.0 months [95% CI, 8.0-13.0] in the TACE + Len and TACE group, respectively (log-rank test p= 0.011). The adjusted hazard ratio (HR) of disease recurrence for baseline prognostic variables between the two groups was 0.68 (95% CI, 0.50–0.91, p = 0.009). Lenvatinib treatment-related AEs of grade 3 or 4 occurred in 28.6% of the patients in TACE + Len group. Conclusions: This study suggested that adjuvantTACE plus lenvatinib a promising approach for HCC patients with high-risk of postoperative recurrence, which could significantly reduce postoperative recurrence and prolong survival with a manageable safety profile.