经动脉化疗栓塞联合多纳非尼加或不加免疫检查点抑制剂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 Donafenib with or without Immune Checkpoint Inhibitors as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Propensity Score Matching Analysis.
作者信息
Deng Liwei, Sun Yanyuan, Wang Haiqing, Liao Changli, Li Deshan, Xu Guohui, Yang Xuegang
机构信息
School of Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.
Department of Interventional Therapy, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, Chengdu, People's Republic of China.
出版信息
J Hepatocell Carcinoma. 2024 Jan 9;11:29-38. doi: 10.2147/JHC.S443779. eCollection 2024.
PURPOSE
To compare the efficacy and safety of transarterial chemoembolization (TACE) plus donafenib with immune checkpoint inhibitors (ICIs) (T+D+I) versus TACE plus donafenib (T+D) as the first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).
METHODS
This retrospective study included patients with unresectable HCC who received T+D+I or T+D between June 2021 and February 2023. The tumor response was analyzed according to the modified Response Evaluation Criteria in Solid Tumors. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) in the two groups were compared before and after propensity score matching (PSM). Cox's proportional-hazards regression model was used to analyze factors affecting PFS and OS.
RESULTS
This study included 69 patients: 41 patients in the T+D group and 28 patients in the T+D+I group. After PSM, 26 patients in each group were analyzed. Patients in the T+D+I group had a higher DCR (96.2% vs 73.1%, = 0.021), longer median PFS (13.1 vs 7.2 months, = 0.017), and longer median OS (23.1 vs 14.7 months, = 0.021) than those in the T+D group. The ORR in the two groups was similar (53.8% vs 50.0%, = 0.781). Multivariate analyses revealed that T+D+I treatment and total bilirubin levels of <20 μmol/L were independent prognostic factors for long PFS. T+D+I treatment, Child-Pugh class A, and single-lobe tumor distribution were independent prognostic factors for long OS. The incidence of TRAEs in the two groups was similar ( > 0.05).
CONCLUSION
In comparison with TACE plus donafenib, TACE plus donafenib with ICIs could significantly improve DCR, PFS, and OS as a potential first-line treatment for unresectable HCC with an acceptable safety profile.
目的
比较经动脉化疗栓塞术（TACE）联合多纳非尼与免疫检查点抑制剂（ICI）（T+D+I）对比TACE联合多纳非尼（T+D）作为不可切除肝细胞癌（HCC）患者一线治疗的疗效和安全性。
方法
这项回顾性研究纳入了2021年6月至2023年2月期间接受T+D+I或T+D治疗的不可切除HCC患者。根据改良的实体瘤疗效评价标准分析肿瘤反应。在倾向评分匹配（PSM）前后比较两组的客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和治疗相关不良事件（TRAEs）。采用Cox比例风险回归模型分析影响PFS和OS的因素。
结果
本研究共纳入69例患者：T+D组41例，T+D+I组28例。PSM后，每组分析26例患者。T+D+I组患者的DCR更高（96.2%对73.1%，P = 0.021），中位PFS更长（13.1个月对7.2个月，P = 0.017），中位OS更长（23.1个月对14.7个月，P = 0.021），均高于T+D组。两组的ORR相似（53.8%对50.0%，P = 0.781）。多因素分析显示，T+D+I治疗和总胆红素水平<20 μmol/L是PFS延长的独立预后因素。T+D+I治疗、Child-Pugh A级和单叶肿瘤分布是OS延长的独立预后因素。两组TRAEs的发生率相似（P>0.05）。
结论
与TACE联合多纳非尼相比，TACE联合多纳非尼与ICI作为不可切除HCC的潜在一线治疗方案，可显著提高DCR、PFS和OS，且安全性可接受。
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