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阿替利珠单抗联合多纳非尼治疗晚期不可切除肝细胞癌的疗效与安全性观察
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| 篇名： | 阿替利珠单抗联合多纳非尼治疗晚期不可切除肝细胞癌的疗效与安全性观察 |
| TITLE： | Observation on the efficacy and safety of atezolizumab plus donafenib in the treatment of advanced unresectable hepatocellular carcinoma |
| 摘要： | 目的 探索阿替利珠单抗联合多纳非尼治疗晚期不可切除肝细胞癌（uHCC）的疗效与安全性。方法选取2023年5月1日至2025年4月30日于河北医科大学第一医院肝胆胰外科就诊的uHCC患者为研究对象进行回顾性研究。所有患者均接受经导管动脉化疗栓塞术（TACE）和/或肝动脉灌注化疗术（HAIC）介入治疗，在此基础上按照系统治疗方案分为对照组（阿替利珠单抗+贝伐珠单抗，n＝56）和观察组（阿替利珠单抗+多纳非尼，n＝49）。比较两组患者的近期（治疗后3个月）疗效和远期疗效；进一步将性别、年龄、乙型肝炎、肝硬化、Child-Pugh分级、巴塞罗那临床肝癌（BCLC）分期、美国东部肿瘤协作组体能状态（ECOG-PS）评分、肿瘤数目、肿瘤最大直径、门静脉癌栓及介入方式作为亚组变量对总生存期进行分析，并对亚组变量与治疗组别进行交互作用检验；比较两组患者治疗期间的不良反应。结果治疗3个月后，观察组患者的疾病控制率显著高于对照组（P＜0.05），但两组在客观缓解率上的差异无统计学意义（P＞0.05）。对照组患者的中位无进展生存期为7.53个月[95%置信区间（CI）为6.32～8.53个月]，观察组为8.06个月（95%CI为7.33～9.70个月），两组比较的差异无统计学意义（P＞0.05）；对照组患者的中位总生存期为13.56个月（95%CI为11.23～15.77个月），观察组为14.92个月（95%CI为12.93～17.11个月），观察组显著长于对照组（P＜0.05）。亚组分析结果显示，在Child-PughA级、BCLCB期及未合并门静脉癌栓患者中，观察组相对于对照组的死亡风险较低，风险比分别为0.46、0.49和0.44，交互作用的P值分别为0.035、0.008和0.013。两组患者发生的不良反应总体以1～2级为主；各项不良反应发生率比较，差异均无统计学意义（P＞0.05）。结论对于接受介入治疗的晚期uHCC患者，阿替利珠单抗联合多纳非尼方案与较高的疾病控制率和较长的总生存期相关，这种关联主要见于Child-PughA级、BCLCB期及未合并门静脉癌栓的患者。 |
| ABSTRACT： | OBJECTIVE To investigate the efficacy and safety of atezolizumab plus donafenib in patients with advanced unresectable hepatocellular carcinoma （uHCC）.METHODS Patients with uHCC treated at the Dept. of Hepatobiliary and Pancreatic Surgery， The First Hospital of Hebei Medical University， from May 1， 2023 to April 30， 2025 were selected as study subjects for a retrospective study. All patients received interventional therapy with transcatheter arterial chemoembolization （TACE） and/or hepatic arterial infusion chemotherapy （HAIC）. On this basis， patients were divided according to the systemic treatment regimen into a control group （atezolizumab plus bevacizumab， n ＝56） and an observation group （atezolizumab plus donafenib， n ＝49）. Short-term efficacy at 3 months after treatment and long-term efficacy were compared between the two groups. Subgroup analyses were further performed with sex， age， hepatitis B， liver cirrhosis， Child-Pugh class， Barcelona Clinic Liver Cancer （BCLC） stage， Eastern Cooperative Oncology Group Performance Status （ECOG-PS） score， tumor number， maximum tumor diameter， portal vein tumor thrombus， and interventional treatment modality as subgroup variables， with interaction tests conducted between subgroup variables and treatment group. Adverse reactions during treatment were compared between the two groups.RESULTS At 3 months after treatment， the disease control rate was significantly higher in the observation group than in the control group （ P ＜0.05）， whereas the difference in objective response rate between the two groups was not statistically significant （ P ＞0.05）. The median progression-free survival was 7.53 months [95% confidence interval （CI）： 6.32-8.53 months] in the control group and 8.06 months （95%CI： 7.33-9.70 months） in the observation group， with no statistically significant difference between the two groups （ P ＞0.05）. The median overall survival was 13.56 months （95%CI： 11.23-15.77 months） in the control group and 14.92 months （95%CI： 12.93-17.11 months） in the observation group， and overall survival was significantly longer in the observation group than in the control group （ P ＜0.05）. Subgroup analysis showed that among patients with Child-Pugh class A， BCLC stage B， or without portal vein tumor thrombus， the risk of death was lower in the observation group than in the control group， with hazard ratios of 0.46， 0.49 and 0.44， respectively， and interaction P values of 0.035， 0.008 and 0.013， respectively. Adverse reactions in both groups were mainly grade 1-2， and there were no statistically significant differences in the incidence of individual adverse reactions between the two groups （ P ＞0.05）.CONCLUSIONS In patients with advanced uHCC receiving interventional therapy， the atezolizumab plus donafenib regimen was associated with a higher disease control rate and longer overall survival， and this association was mainly observed in patients with Child-Pugh class A， BCLC stage B， or without portal vein tumor thrombus. |
| 期刊： | 2026年第37卷第19期 |
| 作者： | 徐晨；杨智凯；张敬坡 |
| AUTHORS： | XU Chen，YANG Zhikai，ZHANG Jingpo |
| 关键字： | 晚期不可切除肝细胞癌;阿替利珠单抗;多纳非尼;贝伐珠单抗;介入治疗;疗效 |
| KEYWORDS： | advanced unresectable hepatocellular carcinoma;Atezolizumab;donafenib;bevacizumab;interventional therapy;Efficacy |
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