经肝动脉化疗栓塞术联合卡瑞利珠单抗及阿帕替尼治疗中晚期肝细胞癌的效果及安全性分析

Efficacy and safety of transarterial chemoembolization combined with camrelizumab and apatinib in treatment of advanced hepatocellular carcinoma

目的评估经肝动脉化疗栓塞术(TACE)联合卡瑞利珠单抗及阿帕替尼治疗中晚期肝细胞癌(HCC)的疗效和安全性。方法选取2019年7月—2021年6月在苏州大学附属第一医院诊治且符合入排标准的19例中晚期HCC患者,接受TACE联合卡瑞利珠单抗及阿帕替尼治疗,依据改良实体瘤疗效评价标准(mRECIST)评估肿瘤反应,依据通用不良事件术语5.0标准(CTCAE v5.0标准)评估不良事件。采用Kaplan-Meier法对无进展生存期、总生存期进行分析并计算95%CI。结果19例患者中位随访时间为14.0个月。截至最后一次随访,根据mRECIST标准,19例患者中有7例(36.8%)最佳反应达到完全缓解,9例(47.4%)达到部分缓解,2例(10.5%)达到疾病稳定,随访期间总客观缓解率达到84.2%,总疾病控制率达到94.7%,中位持续缓解时间达到8.0(34~13.0)个月,中位无进展生存期达到9.5(95%CI:4.7~14.3)个月,6个月生存率达到100%,12个月生存率达到789%。19例患者中发生7例(36.8%)严重不良事件。所有级别中最常见不良事件包括TACE栓塞后综合征(17例,89.5%)、肝损伤(14例,73.7%)、血液系统毒性(8例,42.1%)、蛋白尿(8例,42.1%)等。结论TACE联合卡瑞利珠单抗及阿帕替尼治疗中晚期HCC疗效肯定,不良事件可控,为中晚期HCC患者的一线治疗提供了潜在的新治疗选择。

Objective To investigate the efficacy and safety of transarterial chemoembolization(TACE) combined with camrelizumab and apatinib in the treatment of advanced hepatocellular carcinoma(HCC). Methods From July 2019 to June 2021, 19 patients with advanced HCC who met the inclusion and exclusion criteria in the First Affiliated Hospital of Soochow University were enrolled in this study. All patients received TACE combined with camrelizumab and apatinib. Tumor response was assessed according to Modified Response Evaluation Criteria in Solid Tumors(mRECIST), and adverse events were assessed according to Common Terminology Criteria for Adverse Events(v5.0). The Kaplan-Meier method was used to analyze progression-free survival and overall survival and calculate 95% confidence interval(CI). Results The median follow-up time was 14.0 months for the 19 patients. As of the last follow-up based on mRECIST, 7 patients(7/19, 36.8%) achieved complete response, 9(9/19, 47.4%) achieved partial response, and 2(2/19, 10.5%) achieved stable disease. During follow-up, overall objective response rate and overall disease control rate reached 84.2% and 94.7%, respectively;the median duration of response reached 8.0(3.4-13.0) months, and median progression-free survival reached 9.5(95%CI: 4.7-14.3) months;the 6-month survival rate reached 100%, and the 12-month survival rate reached 78.9%. Among the 19 patients, 7(36.8%) experienced serious adverse events. The most common adverse events of all grades included post-embolization syndrome after TACE(17/19, 89.5%), liver injury(14/19, 73.7%), hematologic toxicity(8/19, 42.1%), and proteinuria(8/19, 42.1%). Conclusion TACE combined with camrelizumab and apatinib has marked efficacy and controllable adverse events in the treatment of advanced HCC, which provides a potential new option for the first-line treatment of advanced HCC.