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中华介入放射学电子杂志 ›› 2024, Vol. 12 ›› Issue (01) : 45 -50. doi: 10.3877/cma.j.issn.2095-5782.2024.01.008

肿瘤介入

小粒径载药微球联合信迪利单抗及贝伐珠单抗治疗不可切除肝癌的安全性及疗效分析
曹耿飞1, 任伟新1,(), 张海潇1, 顾俊鹏1, 阿斯哈尔·哈斯木1   
  1. 1. 830054 新疆乌鲁木齐,新疆医科大学第一附属医院介入放射科
  • 收稿日期:2023-08-09 出版日期:2024-02-25
  • 通信作者: 任伟新
  • 基金资助:
    新疆维吾尔自治区科技支疆项目(指令性)(2021E02074)

Safety and efficacy of small drug-eluting bead chemoembolization combined with sintilimab plus bevacizumab in treatment of unresectable liver cancer

Gengfei Cao1, Weixin Ren1,(), Haixiao Zhang1, Junpeng Gu1, Hasimu Asihaer·1   

  1. 1. Department of Interventional Radiology, the First Affiliated Hospital of Xinjiang Medical University, Xinjiang Urumqi 830045, China
  • Received:2023-08-09 Published:2024-02-25
  • Corresponding author: Weixin Ren
引用本文:

曹耿飞, 任伟新, 张海潇, 顾俊鹏, 阿斯哈尔·哈斯木. 小粒径载药微球联合信迪利单抗及贝伐珠单抗治疗不可切除肝癌的安全性及疗效分析[J]. 中华介入放射学电子杂志, 2024, 12(01): 45-50.

Gengfei Cao, Weixin Ren, Haixiao Zhang, Junpeng Gu, Hasimu Asihaer·. Safety and efficacy of small drug-eluting bead chemoembolization combined with sintilimab plus bevacizumab in treatment of unresectable liver cancer[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2024, 12(01): 45-50.

目的

探讨小粒径载药微球(70~150 μm)栓塞联合信迪利单抗及贝伐珠单抗治疗不可切除中晚期原发性肝癌的安全性及疗效。

方法

回顾性分析2021年4月至2022年10月新疆医科大学第一附属医院采用小粒径载药微球联合信迪利单抗及贝伐珠单抗治疗的34例不可切除中晚期肝癌患者临床资料。根据改良版实体瘤疗效评价标准(modified response evaluation criteria in solid tumors,mRECIST)评价标准评估肿瘤反应,观察小粒径载药微球联合信迪利单抗及贝伐珠单抗的不良反应情况,同时分析患者无疾病进展生存期、客观缓解率等情况。

结果

术后所有患者均经历了Ⅰ~Ⅲ级不同程度的不良反应,以术后疼痛最为显著;无Ⅴ级以上及致死性不良事件发生。本组随访时间3~18个月,中位随访时间15个月。中位无疾病进展期为15个月。术后1、3、6、12个月的客观缓解率分别为70.6%、76.5%、61.8%、50.0%;疾病控制率分别为100%、94.1%、82.4%、67.7%。

结论

小粒径载药微球联合信迪利单抗及贝伐珠单抗治疗不可切除中晚期肝癌显示出良好的安全性、耐受性,同时具有较长的无疾病进展生存期及更高的客观缓解率。

Objective

To evaluate the safety and efficacy of transarterial chemoembolization using drug eluting bead (DEB) <150 μm (DCBeadM1®) combined with sintilimab and bevacizumab in the treatment of unresectable middle/advanced-stage hepatocellular carcinoma (HCC).

Methods

Clinical data of 34 patients with unresectable middle/advanced-stage HCC treated with DC Bead M1 combined with sintilimab and bevacizumab in the First Affiliated Hospital of Xinjiang Medical University from April 2021 to October 2022 were retrospectively analyzed. Among them, 29 patients were male and5 female, aged from 33 to 72 years with a median age of 59 years. The informed consents of all patients were obtained and the local ethical committee approval was received. According to the modified response evaluation criteria in solid tumors (mRECIST), the tumor response was evaluated. The adverse events of the combined therapy were observed. The progression-free survival and objective response rate of patients were analyzed.

Results

All patients experienced varying degrees of adverse event ranging from gradeⅠto grade Ⅲafter combination therapy, with postoperative pain being the most significant. No grade Ⅴor fatal adverse events occurred. The follow-up time ranged from 3 to 18 months, with a median of 15 months. The median progression-free survival time were 15 months. The objective response rate at postoperative 1, 3, 6, 12 months were 70.6%, 76.5%, 61.8%, 50.0% and disease control rate were 100%, 94.1%, 82.4%, 67.7%, respectively.

Conclusion

DC Bead M1 combined with sintilimab and bevacizumab shows good safety and tolerance in the treatment of unresectable middle/advanced-stage HCC, which can bring favorable objective response rate and progression-free survival.

表1 入组患者基线资料
表2 联合治疗不良反应发生情况[例(%)]
图1 患者无疾病进展生存期的Kaplan-Meier生存曲线分析
图2 患者,男性,42岁,既往乙肝病史,间断发热伴体质量减轻1个月入院2A:肝动脉造影可见典型HCC血管染色,同期行DSA引导下肿瘤穿刺活检;2B:栓塞完成后造影可见肿瘤染色消失,肿瘤内部可见"肿瘤湖征";2C:术前CT动脉期影像,肿瘤明显强化;2D:术后15个月CT提示肿瘤明显缩小,且未见明确强化。(AFP为11.32 ng/mL,术中行穿刺活检,术后病理结果为肝细胞肝癌。栓塞完成后造影可见肿瘤内"肿瘤湖征",仅行1次M1-TACE栓塞后,系统性治疗维持,目前评估为CR)
图3 术后3个月入组患者肿瘤疗效评价瀑布图
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