经动脉化疗栓塞联合仑伐替尼加或不加替雷利珠单抗作为不可切除肝细胞癌一线治疗的疗效和安全性：一项倾向评分匹配分析

Efficacy and Safety of Transarterial Chemoembolization Plus Lenvatinib with or Without Tislelizumab as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Propensity Score Matching Analysis.

作者信息

Jiang Jiayun, Zhang Hui, Lai Jiejuan, Zhang Shiyu, Ou Yanjiao, Fu Yu, Zhang Leida

机构信息

Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, People's Republic of China.

Medical Research Institute, College of Pharmaceutical Sciences, Southwest University, Chongqing, People's Republic of China.

出版信息

J Hepatocell Carcinoma. 2024 Aug 24;11:1607-1622. doi: 10.2147/JHC.S472286. eCollection 2024.

PURPOSE

To compare the efficacy and safety of transarterial chemoembolization (TACE) plus lenvatinib and tislelizumab (TACE-Len-T) versus TACE plus lenvatinib (TACE-Len) as the first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC).

PATIENTS AND METHODS

This retrospective study included 136 uHCC patients treated with TACE-Len-T or TACE-Len from January 1, 2021, to June 30, 2023. Clinical outcomes including overall survival (OS), progression-free survival (PFS), tumor response and adverse events (AEs) were compared between the two groups. The risk factors affecting OS and PFS were also analyzed.

RESULTS

The median OS and PFS of the TACE-Len-T group were significantly longer than those of the TACE-Len group (Median OS: not reached vs 13.8 months, P<0.001; Median PFS: 13.0 months vs 2.7 months, P<0.001). The best overall objective response rate (ORR) was also better with TACE-Len-T treatment (ORR: 72.1% vs 29.4%, P<0.001), and the disease control rate (DCR) significantly increased in the TACE-Len-T group (88.2% vs 48.5%, P<0.001). Multivariate analyses revealed that TACE-Len treatment, tumor number >3, and cTACE were independent risk factors for OS, whereas TACE-Len treatment was the only independent risk factor for PFS. The frequency and severity of AEs in the TACE-Len-T group were comparable to those in the TACE-Len group (any grade: 92.6% vs 91.2%, P=0.753; grade 3 or 4: 33.8% vs 32.3%, P=0.855).

CONCLUSION

TACE-Len-T treatment significantly improved OS, PFS, ORR, and DCR over TACE-Len treatment, with a manageable safety profile in uHCC.

目的

比较经动脉化疗栓塞术（TACE）联合乐伐替尼和替雷利珠单抗（TACE-Len-T）与TACE联合乐伐替尼（TACE-Len）作为不可切除肝细胞癌（uHCC）患者一线治疗的疗效和安全性。

患者与方法

这项回顾性研究纳入了2021年1月1日至2023年6月30日期间接受TACE-Len-T或TACE-Len治疗的136例uHCC患者。比较了两组的临床结局，包括总生存期（OS）、无进展生存期（PFS）、肿瘤反应和不良事件（AE）。还分析了影响OS和PFS的危险因素。

结果

TACE-Len-T组的中位OS和PFS显著长于TACE-Len组（中位OS：未达到 vs 13.8个月，P<0.001；中位PFS：13.0个月 vs 2.7个月，P<0.001）。TACE-Len-T治疗的最佳总体客观缓解率（ORR）也更高（ORR：72.1% vs 29.4%，P<0.001），且TACE-Len-T组的疾病控制率（DCR）显著提高（88.2% vs 48.5%，P<0.001）。多因素分析显示，TACE-Len治疗、肿瘤数量>3和cTACE是OS的独立危险因素，而TACE-Len治疗是PFS的唯一独立危险因素。TACE-Len-T组AE的发生频率和严重程度与TACE-Len组相当（任何级别：92.6% vs 91.2%，P=0.753；3级或4级：33.8% vs 32.3%，P=0.855）。