新辅助联合辅助治疗在肝内胆管癌疗效的多中心回顾性分析  

Multicenter retrospective analysis of the efficacy of neoadjuvant combined with adjuvant therapy in intrahepatic cholangiocarcinoma

作　　者：宋祥林 施晓冬 刘红枝 曾建兴 周伟平 程张军[3] 楼健颖[4] 郑树国 毕新宇 王剑明[7] 郭伟[8] 李富宇[9] 王坚[10] 郑亚民[11] 李敬东[12] 程石[13] 黄尧 曾永毅 SONG Xianglin;SHI Xiaodong;LIU Hongzhi;ZENG Jianxing;ZHOU Weiping;CHENG Zhangjun;LOU Jianying;ZHENG Shuguo;BI Xinyu;WANG Jianming;GUO Wei;LI Fuyu;WANG Jian;ZHENG Yamin;LI Jingdong;CHENG Shi;HUANG Yao;ZENG Yongyi(Department of Hepatobiliary Surgery,Mengchao Hepatobiliary Hospital of Fujian Medical University,Fuzhou 350025,China;Department of Liver SurgeryⅢ,the Third Affiliated Hospital of Naval Medical University,Shanghai 200438,China;Department of Hepatobiliary and Pancreatic Surgery,Zhongda Hospital,Southeast University,Nanjing 210009,China;Department of Hepatobiliary and Pancreatic Surgery,the Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310009,China;Department of Biliary Surgery,the Southwest Hospital of Army Medical University,Chongqing 400038,China;Department of Hepatobiliary Surgery,Cancer Hospital,Peking Union Medical University,Chinese Academy of Medical Sciences,Beijing 100021,China;Department of Biliary and Pancreatic Surgery,Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China;Department of General Surgery,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing 100050,China;Department of Biliary Surgery,West China Hospital,Sichuan University,Chengdu 610041,China;Department of Biliary and Pancreatic Surgery,Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine,Shanghai 200127,China;Department of General Surgery,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Department of Hepatobiliary Surgery,Affiliated Hospital of North Sichuan Medical College,Nanchong,Sichuan 637000,China;Department of General Surgery,Tiantan Hospital Affiliated to Capital Medical University,Beijing 100070,China)

机构地区：[1]福建医科大学孟超肝胆医院肝胆外科,福建福州350025 [2]中国人民解放军海军军医大学第三医院肝外三科,上海200438 [3]东南大学附属中大医院肝胆胰外科,江苏南京210009 [4]浙江大学医学院附属第二医院肝胆胰外科,浙江杭州310009 [5]中国人民解放军陆军军医大学西南医院胆道外科,重庆400038 [6]中国医学科学院北京协和医学院肿瘤医院肝胆外科,北京100021 [7]华中科技大学同济医学院附属同济医院胆胰外科,湖北武汉430030 [8]首都医科大学附属北京友谊医院普通外科,北京100050 [9]四川大学华西医院胆道外科,四川成都610041 [10]上海交通大学医学院附属仁济医院胆胰外科,上海200127 [11]首都医科大学宣武医院普通外科,北京100053 [12]川北医学院附属医院肝胆外科,四川南充637000 [13]首都医科大学附属北京天坛医院普通外科,北京100070

出　　处：《中国普通外科杂志》2025年第2期284-297,共14页China Journal of General Surgery

基　　金：福建省福州市临床重点专科建设基金资助项目(20230101)。

摘　　要：背景与目的:肝内胆管癌(ICC)是一种高度恶性的肝脏肿瘤,发病率在全球范围内呈上升趋势,尤其在亚洲地区增长显著。尽管根治性手术切除是目前唯一可能实现治愈的治疗手段,但ICC的高复发率和术后总生存(OS)率低仍是临床治疗中的主要挑战。术后辅助治疗(AT)和新辅助治疗(NAT)作为降低术后复发风险、延长患者OS的重要手段,已在多项研究中显示出一定的疗效。然而,NAT和AT联合应用在ICC治疗中的具体疗效和安全性仍需进一步验证。本研究通过多中心回顾性分析,评估NAT联合AT在改善ICC患者疗效方面的价值,为优化治疗策略提供科学依据。方法:回顾性收集2011年12月—2017年12月全国13家医疗单位576例接受根治性切除且术后病理证实为ICC患者的临床病理学资料。根据治疗方式不同,将患者分为NAT+AT组、AT组和非NAT/AT组。对三组患者进行两两1∶1倾向评分匹配(PSM),平衡患者基线资料,使用Kaplan-Meier方法分析OS和无病生存期(DFS),并根据第8版美国癌症联合委员会(AJCC) TNM分期系统进行亚组分析。结果:研究最终共纳入395例ICC患者,其中NAT+AT组42例(10.6%),AT组62例(15.7%),非NAT/AT组291例(73.7%)。PSM前,组间CA19-9、肝功能Child-Pugh分级、术中出血量、手术切缘、分化程度、血管侵犯、ECOG评分、淋巴结清扫比例差异有统计学意义(均P<0.05),PSM后,组间所有基线资料差异均无统计学意义(均P>0.05)。PSM后的分析结果显示,NAT+AT组的中位OS和DFS明显优于AT组与非NAT/AT组(均P<0.05),而AT组和非NAT/AT组的OS和DFS差异均无统计学意义(均P>0.05)。亚组分析结果显示,TNMⅠ期患者中,NAT+AT组的DFS明显优于非NAT/AT组(P<0.05),但两组OS差异无统计学意义(P>0.05);TNMⅡ期和Ⅲ期患者中,NAT+AT组和AT组的OS和DFS均明显优于非NAT/AT组(均P<0.05),且NAT+AT组的DFS在TNMⅢ期患者中明显优于AT组(P<0.05)。结论:NAT联合AT能为局部晚期ICC患�Background and Aims:Intrahepatic cholangiocarcinoma(ICC)is a highly malignant liver tumor,with an increasing incidence worldwide,particularly in Asia.Although radical surgical resection is currently the only potentially curative treatment,the high recurrence rate and low postoperative overall survival(OS)rate of ICC remain major clinical challenges.Adjuvant therapy(AT)and neoadjuvant therapy(NAT)are important strategies to reduce postoperative recurrence and prolong OS.Several studies have shown certain efficacy of these treatments.However,the specific efficacy and safety of combined NAT and AT in ICC treatment require further validation.This study was conducted to evaluate the value of combining NAT and AT in improving the therapeutic outcomes of ICC patients through a multicenter retrospective analysis,so as to provide scientific evidence for optimizing treatment strategies.Methods:The clinicopathologic data of 576 patients with ICC who underwent radical resection and were pathologically confirmed from 13 hospitals in China between December 2011 and December 2017 were retrospectively collected.Patients were grouped based on their treatment modality:NAT+AT group,AT group,and non-NAT/AT group.The three patient groups were matched pairwise in a 1∶1 ratio using propensity score matching(PSM)to balance baseline data.The Kaplan-Meier method was used to analyze OS and disease-free survival(DFS),and subgroup analyses were conducted according to the 8th edition of the AJCC TNM staging system.Results:A total of 395 ICC patients were included in the final analysis,with 42 patients(10.6%)in the NAT+AT group,62 patients(15.7%)in the AT group,and 291 patients(73.7%)in the non-NAT/AT group.Before PSM,significant differences were observed between groups in terms of CA19-9,liver function Child-Pugh classification,intraoperative blood loss,surgical margin,differentiation grade,vascular invasion,ECOG score,and lymph node dissection ratio(all P<0.05).After PSM,there were no significant differences in baseline characteristics bet

关 键 词：胆管肿瘤 胆管 肝内 放化疗 辅助 多中心研究 预后 

分 类 号：R735.8[医药卫生—肿瘤]