Chen Jin-Hong, Lu Lu, Zhang Xiao-Yun, Xiang Bang-De, Xu Xiao, Li Xiang-Cheng, Huang Zhi-Yong, Wen Tian-Fu, Luo Liu-Ping, Huang Jing, Zhong Jian-Hong, Liu Zhi-Kun, Li Chang-Xian, Long Xin, Zhu Wen-Wei, Yang Xin, Wang Chao-Qun, Jia Hu-Liang, Zhang Ju-Bo, Zeng Yong-Yi, Lu Cai-De, Qin Lun-Xiu
Hepatobiliary Surgery Center, Department of General Surgery, Huashan Hospital & Cancer Metastasis Institute, Fudan University, Shanghai 200040, China.
Department of Liver Surgery, West China Hospital of Sichuan University, Chengdu 610041, China.
Hepatobiliary Pancreat Dis Int. 2025 Jun;24(3):277-285. doi: 10.1016/j.hbpd.2025.03.001. Epub 2025 Mar 26.
The high recurrent rate after surgery hinders the survival of patients with hepatocellular carcinoma (HCC). This prospective cohort study aimed to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) as an adjuvant therapy in HCC patients with high risk of recurrence.
Patients were enrolled from eight hepatobiliary centers in China. The primary endpoint was disease-free survival (DFS). The secondary endpoints were overall survival (OS) and safety. Additionally, propensity score matching (PSM) and other three propensity score analyses were performed to balance the potential baseline bias to validate the conclusion. The adverse events (AEs) were recorded throughout the study. The study was registered at ClinicalTrials.gov (NCT03838796).
A total of 297 patients were enrolled, with 147 in the LEN + TACE group and 150 in the TACE group. Before PSM, the LEN + TACE group achieved significantly better DFS than the TACE group (19.0 vs. 10.0 months, P = 0.011). PSM analysis identified 111 matched pairs. After PSM, the LEN + TACE group also showed better DFS (19.0 vs. 9.0 months, P = 0.018). Other three propensity score analyses yielded similar DFS benefit tendency. Furthermore, favorable OS was also obtained in the LEN + TACE group before PSM. Lenvatinib related AEs of grade 3 or 4 occurred in 28.6% of the patients in the LEN + TACE group.
Adjuvant lenvatinib plus TACE might be a promising adjuvant approach for HCC patients with high risk of recurrence, which could significantly prolong DFS and potentially OS with a manageable safety profile.
手术后的高复发率阻碍了肝细胞癌（HCC）患者的生存。这项前瞻性队列研究旨在评估乐伐替尼联合经动脉化疗栓塞术（TACE）作为复发高危HCC患者辅助治疗的疗效和安全性。
患者来自中国的8个肝胆中心。主要终点是无病生存期（DFS）。次要终点是总生存期（OS）和安全性。此外，进行了倾向评分匹配（PSM）和其他三种倾向评分分析，以平衡潜在的基线偏倚，验证结论。在整个研究过程中记录不良事件（AE）。该研究已在ClinicalTrials.gov注册（NCT03838796）。
共纳入297例患者，乐伐替尼联合TACE组147例，TACE组150例。在PSM之前，乐伐替尼联合TACE组的DFS明显优于TACE组（19.0个月对10.0个月，P = 0.011）。PSM分析确定了111对匹配对。PSM后，乐伐替尼联合TACE组的DFS也更好（19.0个月对9.0个月，P = 0.018）。其他三种倾向评分分析也得出了类似的DFS获益趋势。此外，在PSM之前，乐伐替尼联合TACE组的OS也较好。乐伐替尼联合TACE组中28.6%的患者发生了3级或4级与乐伐替尼相关的AE。
辅助使用乐伐替尼联合TACE可能是复发高危HCC患者一种有前景的辅助治疗方法，可显著延长DFS，并可能延长OS，且安全性可控。
