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中华介入放射学电子杂志

中华介入放射学电子杂志 ›› 2024, Vol. 12 ›› Issue (03) : 212 -216. doi: 10.3877/cma.j.issn.2095-5782.2024.03.004

肿瘤介入

载药微球化疗栓塞联合多纳非尼及PD-1治疗中晚期大肝癌的疗效分析
叶禾清1, 李杰1, 张玉元1, 胡炉淇1, 吴白露1, 李鑫1, 叶书文1, 李一帆1, 高玥1, 詹鹏超2, 吕培杰2, 李臻1,†()   
  1. 1. 450052　河南郑州，郑州大学第一附属医院放射介入科；河南省肿瘤微创介入工程技术研究中心；郑州市肿瘤介入诊疗技术创新与转化重点实验室
    2. 450052　河南郑州，郑州大学第一附属医院放射介入科
  • 收稿日期:2024-05-23 出版日期:2024-08-25
  • 通信作者: 李臻
  • 基金资助:
    河南省重点研发计划项目(241111311000); 河南省自然科学基金重点科学基金项目(232300421120); 河南卫生科技攻关省部共建重点项目(SBGJ202102099); 中原科技创新领军人才项目(244200510020)

Efficacy of chemoembolization with drug-eluting bead combined with Donafenib and PD-1 in the treatment of advanced large liver cancer

Heqing Ye1, Jie Li1, Yuyuan Zhang1, Luqi Hu1, Bailu Wu1, Xin Li1, Shuwen Ye1, Yifan Li1, Yue Gao1, Pengchao Zhan2, Peijie Lv2, Zhen Li1,†()   

  1. 1. Department of Interventional Radiology, the First Affiliated Hospital of Zhengzhou University; Engineering Technology Research Center for Minimally Invasive Interventional Tumors of Henan Province; Zhengzhou City Laboratory of Technology Innovation and Translation for Oncology Interventional Diagnosis and Treatment, Henan Zhengzhou 450052, China
    2. Department of Interventional Radiology, the First Affiliated Hospital of Zhengzhou University, Henan Zhengzhou 450052, China
  • Received:2024-05-23 Published:2024-08-25
  • Corresponding author: Zhen Li
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叶禾清, 李杰, 张玉元, 胡炉淇, 吴白露, 李鑫, 叶书文, 李一帆, 高玥, 詹鹏超, 吕培杰, 李臻. 载药微球化疗栓塞联合多纳非尼及PD-1治疗中晚期大肝癌的疗效分析[J]. 中华介入放射学电子杂志, 2024, 12(03): 212-216.

Heqing Ye, Jie Li, Yuyuan Zhang, Luqi Hu, Bailu Wu, Xin Li, Shuwen Ye, Yifan Li, Yue Gao, Pengchao Zhan, Peijie Lv, Zhen Li. Efficacy of chemoembolization with drug-eluting bead combined with Donafenib and PD-1 in the treatment of advanced large liver cancer[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2024, 12(03): 212-216.

目的

探讨载药微球动脉化疗栓塞（drug-eluting beads transcatheter arterial chemoembolization，DEB-TACE）联合多纳非尼及程序性细胞死亡受体-1（programmed death-1，PD-1）治疗中晚期大肝癌的临床疗效和安全性。

方法

回顾性分析2022年3月至2023年3月在郑州大学第一附属医院就诊的15例大肝癌患者的临床资料，记录总生存期（overall survival，OS）和无进展生存期（progress free survival，PFS）。评价客观缓解率（objective response rate，ORR）、疾病控制率（disease control rate，DCR）和治疗相关不良事件（treatment-related adverse events，TRAEs）。

结果

15例患者均成功行DEB-TACE联合多纳非尼及PD-1治疗。中位DEB-TACE次数为2次，平均（2.0 ± 0.85）次。术后1个月ORR、DCR分别为73.33%、93.33%。中位随访时间16个月，中位PFS为11.0（95%CI：9.40～13.56）个月，中位OS为20.1（95%CI：16.00～22.79）个月。TRAE主要为1～2级，对症用药或减量后均缓解，无3级以上AE发生。

结论

DEB-TACE联合多纳非尼及PD-1治疗中晚期大肝癌大肝癌疗效确切，安全可耐受，可作为潜在的中晚期大肝癌的一线治疗方案。

关键词: 载药微球, 多纳非尼, 免疫抑制剂, 大肝癌, 系统治疗
Objective

To evaluate the clinical efficacy and safety of DEB-TACE combined with Donafenib and programmed cell death receptor-1 inhibitor (PD-1) in the treatment of advanced large liver cancer.

Methods

Clinical data of 15 patients with large liver cancer admitted to our hospital from March 2022 to March 2023 were retrospectively analyzed, and the overall survival (OS) and progression-free survival (PFS) were recorded. Objective response rate (ORR), disease control rate (DCR) and treatment-related adverse events (trAEs) were evaluated.

Results

All 15 patients were successfully treated with DEB-TACE combined with Donafinil and PD-1. The median number of DEB-TACE was 2, with an average of 2.0 ± 0.85. ORR and DCR were 73.33% and 93.33%, respectively, one month after TACE. The median follow-up time was 16 months, the median PFS was 11.0 (95%CI: 9.40-13.56) months, and the median OS was 20.1 (95%CI: 16.00-22.79) months. TRAE was mainly grade 1 to 2, which was alleviated after proper administration or reduction of dosage, and no AE above grade 3 occurred.

Conclusion

DEB-TACE combined with Donafinil and PD-1 has good efficacy, safety and tolerance in the treatment of middle and advanced large liver cancer, and can be used as the first-line treatment for potential middle and advanced large liver cancer.

Key words: Drug-eluting bead, Donafenib, Immunosuppressant, Large liver cancer, Systemic therapy
表1 15例患者基线资料
临床特征 年龄（岁） 性别（例） ECOG评分（分） 肿瘤数量（个） 肿瘤最大径（cm） AFP（ng/mL）
< 55 ≥55 男 女 0 1 1 > 1 5～10 > 10 < 400 ≥400
数据（例） 5 10 13 2 13 2 9 6 5 10 8 9
临床特征 是否门脉癌栓 Child-Pugh分级 BCLC分期 CNLC分期 DEB-TACE次数（次）
是 否 A级 B级 B期 C期 Ⅰb期 Ⅱa期 Ⅲa期 ≤2 > 2
数据（例） 9 6 11 4 9 6 2 4 9 10 5
图1 DEB-TACE联合多纳非尼及PD-1治疗后生存曲线1A：无进展生存率；1B：总生存率。
表2 15例患者1、3、6个月的疗效评估
疗效 1个月 3个月 6个月
CR 4 5 6
PR 7 5 3
SD 3 3 2
PD 1 2 3
ORR 73.33 66.67 60.00
DCR 93.33 86.67 73.33
表3 药物相关TRAEs （例）
不良反应 1～2级 3级
乏力 6 0
手足综合征 3 1
高血压 3 0
腹泻 3 0
肝功能异常 3 0
免疫性皮疹 0 1
免疫性肺炎 0 1
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