肝动脉灌注化疗联合免疫靶向新辅助治疗单发CNLCⅠb期肝细胞癌的安全性与疗效分析  

Safety and efficacy analysis of hepatic artery infusion chemotherapy combined with immune targeted therapy for single CNLCⅠb hepatocellular carcinoma

作　　者：谢海翔 韩创业 彭凯 叶新平[1] 朱广志[1] 曾智明[2] 胡凯[3] 杨红[4] 龙莉玲[5] 陶霖[6] 吕自力[7] 彭涛[1] Xie Haixiang;Han Chuangye;Peng Kai;Ye Xinping;Zhu Guangzhi;Zeng Zhiming;Hu Kai;Yang Hong;Long Liling;Tao Lin;Lyu Zili;Peng Tao(Department of Hepatobiliary Surgery,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Oncology,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Ultrasound,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Radiology,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Gastroenterology,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Pathology,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China)

机构地区：[1]广西医科大学第一附属医院肝胆外科,南宁530021 [2]广西医科大学第一附属医院肿瘤内科,南宁530021 [3]广西医科大学第一附属医院放疗科,南宁530021 [4]广西医科大学第一附属医院超声科,南宁530021 [5]广西医科大学第一附属医院放射科,南宁530021 [6]广西医科大学第一附属医院消化内科,南宁530021 [7]广西医科大学第一附属医院病理科,南宁530021

出　　处：《中华肝胆外科杂志》2023年第1期28-33,共6页Chinese Journal of Hepatobiliary Surgery

摘　　要：目的探讨5-氟尿嘧啶+亚叶酸钙+奥沙利铂(FOLFOX)-肝动脉灌注化疗(HAIC)联合免疫靶向新辅助治疗单发中国肝癌分期(CNLC)Ⅰb期肝细胞癌患者的安全性及有效性。方法回顾性分析2021年10月至2022年8月在广西医科大学第一附属医院接受FOLFOX-HAIC联合免疫靶向新辅助治疗的20例单发CNLCⅠb期肝细胞癌患者的临床资料,其中男性18例,女性2例,年龄(55.1±9.9)岁。实体瘤临床疗效评价标准(RECIST)1.1和改良实体瘤临床疗效评价标准(mRECIST)评估FOLFOX-HAIC联合免疫靶向治疗的疗效,同时不良事件评价标准4.0版评估安全性。结果治疗2个周期(1次FOLFOX-HAIC+程序性死亡蛋白-1抗体治疗为1个周期)后依据RECIST 1.1评估疗效,20例患者客观缓解率70.0%(14/20),疾病控制率100.0%(20/20)。依据mRECIST评估疗效,20例患者客观缓解率90.0%(18/20),疾病控制率100.0%(20/20)。经过治疗后有12例(60.0%)患者接受了肝肿瘤手术切除,均达到R0切除,2例(10.0%)进行放射治疗,3例(15.0%)停药待手术,2例(10.0%)拒绝手术,1例(5.0%)因免疫性肝炎导致多器官功能衰竭死亡。根据病理结果,3例(25.0%)获得病理学完全缓解,4例(33.3%)获得主要病理学缓解。在安全性评估中,总的不良事件发生率为100.0%(20/20),其中7例(35.0%)发生3级不良事件,1例(5.0%)因5级免疫性肝炎导致多器官功能衰竭死亡,1~3级不良事件予以对症处理后可缓解。结论FOLFOX-HAIC联合免疫靶向新辅助治疗是安全的,具有较高的肿瘤客观缓解率和疾病控制率,为肝癌新辅助治疗提供新的策略,但患者术后的长期生存获益,有待后续研究证实。Objective To investigate the safety and efficacy of FOLFOX(5-fluorouracil+calcium folinate+oxaliplatin)hepatic arterial infusion chemotherapy(FOLFOX-HAIC)combined with immune and targeted therapy as triple combination therapy for patients with single China Liver Cancer Staging(CNLC)Ⅰb hepatocellular carcinoma.Methods A total of 20 patients with single CNLCⅠb hepatocellular carcinoma who received FOLFOX-HAIC combined with immune and targeted therapy as triple combination therapy in the First Affiliated Hospital of Guangxi Medical University from October 2021 to August 2022 were included.The clinical data of all patients was retrospectively analyzed.There were 18 males and 2 females,with the age of(55.1±9.9)years.Response Evaluation Criteria in Solid Tumors(RECIST)1.1 and Modified Response Evaluation Criteria in Solid Tumors(mRECIST)were used to evaluate the efficacy of FOLFOX-HAIC combined with immune and targeted therapy,and the clinical safety of triple combination therapy was evaluated by common terminology criteria for adverse events 4.0.Results According to RECIST 1.1,objective response rate of 20 patients was 70.0%(14/20)and disease control rate was 100.0%(20/20)after 2 cycles of treatment(one cycle of FOLFOX-HAIC plus programmed death-1 antibody).According to mRECIST,objective response rate was 90.0%(18/20)and the disease control rate was 100.0%(20/20)after 2 cycles of treatment.Following the treatment,12 patients(60.0%)received liver tumor resection,and all of them achieved R0 resection,2 patients(10.0%)received radiotherapy,3 patients(15.0%)stopped drug treatment for surgery,2 patients(10.0%)refused surgery,and 1 patient(5.0%)died of multiple organ failure caused by immune hepatitis.According to pathological results,3 patients(25.0%,3/12)achieved pathological complete response,and 4 patients(33.3%,4/12)achieved major pathological response.In the safety evaluation,the overall incidence of adverse events was 100.0%(20/20).Seven patients(35.0%)had grade 3 adverse events and 1 patient(5.0%)died of multip

关 键 词：癌 肝细胞 肝动脉灌注化疗 新辅助治疗 临床疗效 安全性 

分 类 号：R735.7[医药卫生—肿瘤]