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肝动脉灌注化疗联合乐伐替尼和替雷利珠单抗治疗高肿瘤负荷晚期肝细胞癌的有效性和安全性:一项多中心倾向评分匹配分析

Efficiency and safety of HAIC combined with lenvatinib and tislelizumab for advanced hepatocellular carcinoma with high tumor burden: a multicenter propensity score matching analysis.

作者信息

Zhao Zhonghua, Jiang Xiongying, Wen Shiping, Hao Yanzhang

机构信息

Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.

Department of Interventional Radiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.

出版信息

Front Pharmacol. 2025 Jan 7;15:1499269. doi: 10.3389/fphar.2024.1499269. eCollection 2024.

Abstract

PURPOSE

The present work focused on assessing whether hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and tislelizumab was safe and effective on advanced hepatocellular carcinoma (HCC) showing high tumor burden.

METHODS

In the present multicenter retrospective study, treatment-naive advanced HCC patients (BCLC stage C) showing high tumor burden (maximum diameter of intrahepatic lesion beyond 7 cm) treated with lenvatinib and tislelizumab with or without HAIC were reviewed for eligibility from June 2020 to June 2023. Baseline differences between groups were mitigated by propensity score matching (PSM). Our primary endpoint was overall survival (OS); and secondary endpoints included adverse events (AEs), progression-free survival (PFS), disease control rate (DCR) and objective response rate (ORR) according to RECIST 1.1 criteria, respectively.

RESULTS

After eligibility reviewed, total 162 patients treated with lenvatinib and tislelizumab were enrolled: 63 patients with HAIC (HTP group), and the remaining 99 patients without HAIC (TP group). After PSM 1:1, 47 cases were evenly divided into each group. Of them, HTP group showed significant prolonged median OS compared with TP group (16.6 versus 21.0 months; hazard ratio [HR]: 0.26, 95% confidence interval [CI]: 0.35-0.98; = 0.039), and median PFS of HTP group was also prolonged (8.9 versus 11.6 months; HR: 0.55, 95% CI: 0.34-0.87; = 0.010). Higher DCR and ORR could be observed in HTP relative to TP groups (ORR: 53.2% versus 17.0%, < 0.001; DCR: 87.2% versus 61.7%, = 0.004). The severe AEs (grade 3/4) and all grades were comparable between the groups, while all of these AEs could be controlled, and AEs of grade 5 were not reported.

CONCLUSION

HAIC combined with lenvatinib and tislelizumab is the candidate treatment for advanced HCC patients because of its improved prognosis and acceptable safety.

摘要

目的

本研究旨在评估肝动脉灌注化疗(HAIC)联合乐伐替尼和替雷利珠单抗治疗高肿瘤负荷的晚期肝细胞癌(HCC)是否安全有效。

方法

在本多中心回顾性研究中,对2020年6月至2023年6月期间接受乐伐替尼和替雷利珠单抗治疗、未接受过其他治疗的高肿瘤负荷(肝内病变最大直径超过7 cm)晚期HCC患者(BCLC C期)进行评估,这些患者接受或未接受HAIC治疗。通过倾向评分匹配(PSM)减少组间基线差异。我们的主要终点是总生存期(OS);次要终点分别包括不良事件(AE)、无进展生存期(PFS)、疾病控制率(DCR)和根据RECIST 1.1标准的客观缓解率(ORR)。

结果

经过资格审查,共有162例接受乐伐替尼和替雷利珠单抗治疗的患者入组:63例接受HAIC治疗(HTP组),其余99例未接受HAIC治疗(TP组)。经过1:1的PSM后,每组平均分为47例。其中,HTP组的中位OS显著长于TP组(16.6个月对21.0个月;风险比[HR]:0.26,95%置信区间[CI]:0.35 - 0.98;P = 0.039),HTP组的中位PFS也延长(8.9个月对11.6个月;HR:0.55,95% CI:0.34 - 0.87;P = 0.010)。与TP组相比,HTP组的DCR和ORR更高(ORR:53.2%对17.0%,P < 0.001;DCR:87.2%对61.7%,P = 0.004)。两组之间的严重AE(3/4级)和所有级别的AE相当,而所有这些AE都可以得到控制,未报告5级AE。

结论

HAIC联合乐伐替尼和替雷利珠单抗因其改善的预后和可接受的安全性,是晚期HCC患者的候选治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18a1/11747745/e63f8b106039/fphar-15-1499269-g001.jpg

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