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

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

目的探讨小粒径载药微球(70~150μm)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)<150μm(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 and 5 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 gradeⅢafter combination therapy,with postoperative pain being the most significant.No gradeⅤor 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.