卡瑞利珠单抗联合仑伐替尼治疗不可切除肝细胞癌的疗效和安全性  

The efficacy and safety of carrilizumab combined with ramvaritinib in the treatment of unresectable hepatocellular carcinoma

作　　者：钱厚龙[1] 李阳[2] 朱翔 路逵[2] QIAN Hou-long;LI Yang;ZHU Xiang;LU Kui(Department of Interventional Radiology,Taizhou Second People’s Hospital,Jiangsu 225500,China;Department of Oncology,Taizhou Second People’s Hospital,Jiangsu 225500,China)

机构地区：[1]泰州市第二人民医院介入科,江苏225500 [2]泰州市第二人民医院肿瘤科,江苏225500

出　　处：《肝脏》2023年第4期452-456,共5页Chinese Hepatology

摘　　要：目的探讨卡瑞利珠单抗联合仑伐替尼治疗不可切除肝细胞癌(HCC)的效果和安全性。方法将26例不可切除的HCC患者分成两组,对照组11例采用仑伐替尼治疗,观察组15例加用卡瑞利珠单抗治疗。观察两组肿瘤标志物变化,临床疗效、随访和生存指标,主要药物不良反应。结果治疗1个月和3个月时,观察组的血清甲胎蛋白(AFP)和异常凝血酶原(PIVKA-Ⅱ)水平为(502.18±135.90)ng/mL、(436.57±124.63)ng/mL、(634.35±167.18)mAU/mL、(546.07±145.96)mAU/mL,低于对照组的(541.73±156.87)ng/mL、(497.81±136.52)ng/mL、(687.49±185.24)mAU/mL、(604.75±163.28)mAU/mL,差异有统计学意义(t=7.429、6.834、8.182、7.761,均P<0.05)。观察组的客观缓解率(ORR)、局部控制率(DCR)、转化切除率和缓解持续时间(mDR)为46.67%、73.33%、20.0%、6.2(2.1,9.8)个月,高于对照组的27.27%、54.55%,9.091%、4.3(2.1,6.2)个月,差异有统计学意义(χ^(2)=3.826、3.275、3.417,Z=12.738,均P<0.05);观察组应答时间(mRT)为2.6(2.0,3.9)个月,低于对照组的3.7(2.8,4.1)个月,差异有统计学意义(Z=3.265,P<0.05)。观察组的随访时间(mFUP)、总体生存期(mOS)、无进展生存期(mPFS)和靶病灶长径缩小程度为13.4(2.3,24.6)个月、10.7(5.1,16.4)个月、6.7(3.2,9.6)个月、(16.72±4.78)mm,低于对照组的10.9(1.9,20.5)个月、7.4(3.7,12.3)个月、4.4(2.1,7.3)个月、(13.36±4.01)mm,差异有统计学意义(Z=11.752、15.627、17.284,t=8.273,均P<0.05);观察组的病死率为46.67%,低于对照组的63.64%,差异有统计学意义(χ^(2)=9.582,P<0.05)。两组未出现5级不良反应,3~4级不良反应发生率差异无统计学意义(P>0.05)。结论卡瑞丽珠单抗联合仑伐替尼能提高不可切除HCC患者的临床疗效,延长生存时间,使患者获益,安全性较高。Objective To investigate the efficacy and safety of carrelizumab combined with ramvaritinib in the treatment of unresectable hepatocellular carcinoma(HCC).Methods Twenty-six unresectable HCC patients were divided into a control group and an observation group.The control group was treated with ramvaritinib,and the observation group was treated with carrelizumab.The changes of tumor markers,clinical efficacy,follow-up time,survival indexes and major adverse drug reactions were observed.Results After 1 and 3 months of treatment,the levels of serum alpha-fetoprotein(AFP)and abnormal prothrombin(PIVKA-II)in both groups were decreased compared with those before treatment,and the decrease range in observation group was higher than that in control group(P<0.05).The objective response rate(ORR),local control rate(DCR)and conversion rate in the observation group were significantly higher than those in the control group,and the median response time(mRT)was shorter and the median duration of response(mDR)was longer than that in the control group(P<0.05).The median follow-up time(mFUP),median overall survival(mOS),median progression-free survival(mPFS)and the extent of long diameter reduction of target lesions in the observation group were significantly higher than those in the control group,and the mortality was lower than that in the control group(P<0.05).There was no grade 5 adverse reactions between the two groups,and there was no significant difference in the incidence of grade 3-4 reactions between the two groups(P>0.05).Conclusion The combination of Caririzumab with ramvaritinib may improve the clinical efficacy of ramvartinib on unresectable HCC patients,prolong the patients’survival with high safety.

关 键 词：肝细胞癌 不可切除 卡瑞利珠单抗 仑伐替尼 转化率 生存时间 

分 类 号：R735.7[医药卫生—肿瘤]