卡瑞利珠单抗联合仑伐替尼治疗晚期原发性肝癌患者疗效和安全性分析*

doi:10.3969/j.issn.1672-5069.2024.04.026

摘要/Abstract

摘要： 目的探讨应用卡瑞利珠单抗联合仑伐替尼治疗晚期原发性肝癌(PLC)患者的疗效及安全性。方法 2019年4月～2021年4月我院收治的晚期PLC患者78例,被随机分为对照组39例和观察组39例,分别给予仑伐替尼或卡瑞利珠单抗联合仑伐替尼治疗。复查影像学检查,评估客观缓解率(ORR)和疾病控制率(DCR)。采用化学发光免疫分析法检测血清甲胎蛋白(AFP)、癌胚抗原(CEA)和糖链抗原199(CA199)水平。采用Kaplan-Meier法进行生存分析。结果在治疗后,观察组ORR和DCR分别为56.4%和92.3%,显著高于对照组的33.3%和74.4%(P<0.05);观察组血清AFP水平为(78.9±17.4) ng/ml,显著低于对照组【(152.6±31.5)ng/ml,P<0.05】;在随访两年末,观察组和对照组中位无进展生存期(PFS)分别为16.2个月和12.3个月,无进展生存率分别为38.5%和25.6%(P＞0.05),观察组中位总生存期(OS)为20.3个月,对照组为16.0个月,观察组总生存率显著高于对照组(61.5%对38.5%,P<0.05);在治疗期间,观察组皮疹、乏力、食欲下降、高血压和蛋白尿等不良反应发生率分别为12.8%、17.9%、10.3%、7.7%和7.7%,与对照组的10.3%、20.5%、7.7%、7.7%和5.1%比,差异无统计学意义(P＞0.05),但反应性毛细血管增生发生率为12.8%,而对照组无这种不良反应。结论应用卡瑞利珠单抗联合仑伐替尼治疗晚期PLC患者近远期疗效较好,不良反应可控,值得深入探讨。

关键词: 原发性肝癌, 晚期, 卡瑞利珠单抗, 仑伐替尼, 治疗

Abstract: Objective The aim of this study was to explore the efficacy and safety of camrelizumab and lenvatinib combination in the treatment of patients with advanced primary liver cancer (aPLC). Methods 78 patients with aPLC were enrolled in our hospital between April 2019 and April 2021, and were randomly divided into control (n=39) and observation group (n=39), receiving camrelizumab or camrelizumab and lenvatinib combination therapy until progression of the disease or death. The Objective response rate (ORR) and disease control rate (DCR) were recorded. Serum alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA) and carbohydrate antigen 199 (CA199) levels were detected by chemiluminescence immunoassay. The survival analysis was conducted by Kaplan-Meier method. Results After treatment, the ORR and DCR in the observation group were 56.4% and 92.3%, much higher than 33.3% and 74.4%(P<0.05)in the control; serum AFP level in the observation group was (78.9±17.4) ng/ml, much lower than [(152.6±31.5)ng/ml, P<0.05] in the control; at the end of two-year follow-up, the mean progression free survival(PFS) in the observation and control groups were 16.2 mon and 12.3 mon, the PFS rates were 38.5% and 25.6%(P＞0.05), and the mean overall survival (OS) were 20.3 mon and 16.0 mon, with the OS rates of 61.5% in the observation, much greater than 38.5% (P<0.05) in the control; during the treatment period, the incidence rates of rash, fatigue, anorexia, hypertension and urinary protein positive in the observation group were 12.8%, 17.9%, 10.3%, 7.7% and 7.7%, all not significantly different compared to 10.3%, 20.5%, 7.7%, 7.7% and 5.1% (P＞0.05), while the incidence of reactive capillary hyperplasia in the observation group was 12.8%, which didn’t occurred in the control group. Conclusion The administration of camrelizumab and lenvatinib combination in the treatment of patients with unresectable PLC has to some extent a short-term and long-term efficacy, and the adverse reactions are endurable.

Key words: Hepatoma, Advanced, Camrelizumab, Lenvatinib, Therapy

黄英, 杨志勇, 罗明. 卡瑞利珠单抗联合仑伐替尼治疗晚期原发性肝癌患者疗效和安全性分析^*[J]. 实用肝脏病杂志, 2024, 27(4): 595-598.

Huang Ying, Yang Zhiyong, Luo Ming. Should the patients with advanced primary liver cancer get benefit from camrelizumab and lenvatinib combination treatment?[J]. Journal of Practical Hepatology, 2024, 27(4): 595-598.

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卡瑞利珠单抗联合仑伐替尼治疗晚期原发性肝癌患者疗效和安全性分析^*

Should the patients with advanced primary liver cancer get benefit from camrelizumab and lenvatinib combination treatment?

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