卡瑞利珠单克隆抗体联合仑伐替尼一线治疗不可切除肝细胞癌疗效及相关因素分析  

Efficacy and related factors of camrelizumab combined with lenvatinibin first-line treatment of unresectable liver cancer

作　　者：石宁 陈志鸿 李巧 吴凡 林叶[1] 夏武政[1] 王慧玲[1] 陈振荣 殷子[1] 陈锦章[2] 金浩生[1] SHI Ning;CHEN Zhi-hong;LI Qiao(Department of Hepatobiliary Surgery,Guangdong People′s Hospital,Guangzhou 510080,China)

机构地区：[1]广东省人民医院肝胆外科,广东广州510080 [2]南方医科大学南方医院肝脏肿瘤中心,广东广州510515

出　　处：《中国实用外科杂志》2022年第11期1286-1293,共8页Chinese Journal of Practical Surgery

基　　金：国家临床重点专科建设项目(No.2022YW030009);“白求恩·肝癌研究计划”项目(No.BCFMSD-HCC-20201127-007)。

摘　　要：目的探讨卡瑞利珠单克隆抗体联合仑伐替尼一线治疗不可切除肝细胞癌的疗效及安全性,并分析影响其疗效的相关因素。方法前瞻性纳入2020年4月至2022年3月广东省人民医院(31例)和南方医科大学南方医院(8例)初治不可切除肝细胞癌病例共39例病例。入组病例均采用卡瑞利珠单克隆抗体联合仑伐替尼的治疗方案。38例进入疗效数据分析,按照实体瘤疗效评价标准(RECIST 1.1标准)分为客观反应组(n=12)和非客观反应组(n=26)。39例进入安全性分析。主要研究指标包括客观反应率(ORR),疾病控制率(DCR),总生存期,疾病无进展生存期,6个月生存率和药物不良反应。结果38例病人至少完成1次影像学评估并进入疗效数据分析。按RECIST1.1标准(最佳疗效),无完全缓解(CR)病例,部分缓解(PR)12例(31.6%),疾病稳定(SD)21例(55.3%),疾病进展(PD)5例(13.2%),ORR为31.6%(12/38),DCR为86.8%(33/38)。按改良实体瘤疗效评价标准(mRECIST)标准(最佳疗效)达CR 4例(10.5%),PR 20例(52.6%),SD 9例(23.7%),PD 5例(13.2%),ORR为63.2%(24/38),DCR为86.8%(33/38)。中位随访时间为7.1(2.2~24.2)个月,6个月生存率为95.8%。10例病人肿瘤缓解后,成功接受手术切除或者病灶消融术。Cox回归分析结果显示,合并大血管侵犯为病人无进展生存期的独立危险因素。39例进入安全性分析病人中,发生手足综合征13例(33.3%),发生高血压3例(7.7%),发生牙龈肿痛3例(7.7%),≥3级的不良反应3例(7.7%)分别为手足综合征、高血压和急性肝肾功能不全各1例。结论卡瑞利珠单克隆抗体联合仑伐替尼用于治疗不可切除肝细胞癌具有较好的协同抗肿瘤作用,肿瘤ORR较高,安全性较高,不良反应较少。大血管侵犯可能为肿瘤无进展生存期的独立危险因素。Objective To investigate the efficacy and safety of camrelizumab combined with lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma,and analyze the relevant factors affecting its efficacy.Methods Patients with newly diagnosed unresectable hepatocellular carcinoma in Guangdong Provincial People’s Hospital(31 cases)and Nanfang Hospital of Southern Medical University(8 cases)from April 2020 to March 2022 were prospectively enrolled.All cases were treated with camrelizumab combined with lenvatinib.Thirty-eight patients entered the efficacy analysis and were divided into objective response group(n=12)and non-objective response group(n=26)according to the efficacy evaluation standard of solid tumors(RECIST 1.1 standard).39 cases entered the safety analysis.Primary study measures included objective response rate(ORR),disease control rate(DCR),overall survival,progression-free survival,6-month survival rate,and adverse effects.Results Thirty-eight patients completed at least one imaging evaluation and were included in the data analysis.According to RE CIST 1.1 criteria(best efficacy),there are 0 case of complete response(CR),12(31.6%)cases of partial response(PR),21(55.3%)cases of disease stability(SD),and 5(13.2%)cases of PD(disease progression).The ORR was 31.6%(12/38);DCR was 86.8%(33/38).According to mRECIST standard(best efficacy),there were 4 cases(10.5%)of CR,20 cases(52.6%)of PR,9 cases(23.7%)of SD,4 cases(13.2%)of PD.The ORR was 63.2%(24/38);DCR was 86.8%(33/38).The median follow-up time was 7.1(2.2~24.2)months and 6-month survival rate was 95.8%.After the tumor was relieved,10 patients successfully underwent surgical resection or ablation of the lesion.Cox regression analysis showed that macro vascular invasion was an independent risk factor for progression-free survival in patients.Among the 39 patients who entered the safety analysis,13 cases(33.3%)developed hand-foot syndrome,3 cases(7.7%)developed hypertension,and 3 cases(7.7%)developed gum swelling and pain.3 cases(7.7%)of grad

关 键 词：原发性肝癌 免疫检查点抑制剂 靶向药物 系统性治疗 

分 类 号：R6[医药卫生—外科学]