晚期肝内胆管癌免疫治疗联合化疗的临床价值研究  

A study on the clinical value of immunotherapy combined with chemotherapy for advanced intrahepatic cholangiocarcinoma

作　　者：盛芳 徐芳 谢梦忆 丁媛 王琛 游川[2] 李敬东[2,3] 周芳 赵云 SHENG Fang;XU Fang;XIE Mengyi;DING Yuan;WANG Chen;YOU Chuan;LI Jingdong;ZHOU Fang;ZHAO Yun(Department of Infectious Diseases,Zhangjiagang Hospital Affiliated to Soochow University,Suzhou 215600,China;Sichuan Clinical Research Center of Digestive Diseases,Affiliated Hospital of North Sichuan Medical College,Nanchong 617000,China;Department of Hepato Surgery,Affiliated Hospital of North Sichuan Medical College,Nanchong 617000,China;Department of Oncology,Zhangjiagang Hospital Affiliated to Soochow University,Suzhou 215600,China)

机构地区：[1]苏州大学附属张家港医院感染性疾病科,江苏苏州215600 [2]川北医学院附属医院四川省消化系统疾病临床医学研究中心,四川南充617000 [3]川北医学院附属医院肝外一科,四川南充617000 [4]苏州大学附属张家港医院肿瘤科,江苏苏州215600

出　　处：《中国肿瘤外科杂志》2024年第5期509-513,共5页Chinese Journal of Surgical Oncology

基　　金：南充市科技研发计划项目(23JCYJPT0038);川北医学院附属医院科研发展计划项目(2022PTZK009)。

摘　　要：目的评估晚期肝内胆管癌(ICC)免疫治疗联合化疗的临床价值。方法回顾性收集2019年1月至2022年4月在苏州大学附属张家港医院或川北医学院附属医院收治的80例晚期ICC的临床及病理学资料。患者中男性50例,女性30例,年龄29~77岁(58±11)岁。根据化疗是否联合免疫治疗,将患者分为仅化疗组(A组,n=26)和免疫联合化疗组(B组,n=54)。比较两组患者的一般资料、临床病理特征、总体生存情况、无进展生存情况和治疗相关不良事件。采用RECIST评价标准对整体疗效进行评价,比较两组患者的客观缓解率(ORR)和疾病控制率(DCR)。结果67.5%的患者接受了免疫治疗联合化疗,A组接受治疗的周期数低于B组(4±2个周期vs.5±3个周期)(P<0.05),其他临床病理特征的比较差异无统计学意义(均P>0.05)。A组和B组患者ORR(15.4%vs.22.2%)比较差异无统计学意义(P>0.05),但是B组的DCR显著高于A组(76%vs.50%,P<0.05)。A组患者的中位总体生存时间和1、2、3年总体生存率分别为10个月和39%、20%、7%,明显低于B组的24个月和72%、49%、35%,P<0.05;但中位无进展生存时间和1、2年总体生存率的比较差异无统计学意义(P>0.05)。两组1/2和3/4级不良事件的比较差异无统计学意义(P>0.05)。胃肠道毒性(腹泻、腹痛)和皮肤不良反应(皮疹、瘙痒)是免疫联合化疗最常见的治疗相关不良事件。结论ICC患者可能从免疫联合化疗中获益,但临床证据有限。针对这一联合策略,未来仍需加大研究力度。Objective To assess the clinical value of immunotherapy combined with chemotherapy in the treatment of advanced intrahepatic cholangiocarcinoma(ICC).Methods The clinical and pathological data of 80 patients with advanced ICC,who were treated at two tertiary hospitals from January 2019 to April 2022,were retrospectively collected.There were 50 males and 30 females,aged(58±11)years old(range:29-77 years old).According to whether chemotherapy was combined with immunotherapy,the patients were divided into a chemotherapy-only group(group A,n=26)and an immunotherapy combined with chemotherapy group(group B,n=54).The demographic characteristics,clinicopathological profiles,overall survival rates,progression-free survival rates and treatment-related adverse events were compared between the two groups.The overall curative effect was evaluated by RECIST evaluation criteria,and the objective response rate(ORR)and disease control rate(DCR)were compared between the two groups.Results Among the patients,67.5%received a combination of immunotherapy and chemotherapy.The number of treatment cycles in group A(4±2)was found to be lower than that in group B(5±3)(P<0.05).However,there were no significant differences observed in other clinicopathological characteristics(all P>0.05).There was no statistically significant difference in ORR between group A(15.4%)and group B(22.2%)(P>0.05).However,the DCR in group B was significantly higher than that in group A(76%vs 50%;P<0.05).The median overall survival time(10 vs.24 months)and the one-,two-,and three-year overall survival rates(39%,20%,7%vs.72%,49%,35%)of patients in group A were significantly lower than those in group B(P<0.05).However,there was no significant difference between the median progression-free survival time and the one-or two-year overall survival rates(P>0.05).There was no statistically significant difference in the incidence of grade 1-2 and grade 3-4 adverse events between the two groups(P>0.05).Gastrointestinal toxicity(diarrhea,abdominal pain)and skin adverse rea

关 键 词：肝内胆管癌 免疫治疗 免疫检查点抑制剂 化疗 

分 类 号：R735.8[医药卫生—肿瘤]