基于多中心真实世界数据的胃癌围手术期化疗患者生存分析  

A multi-center retrospective study of perioperative chemotherapy for gastric cancer based on real-world data

作　　者：丁学伟 郑志超[2] 赵群[3] 翟刚[4] 梁寒 吴欣[5] 朱正纲[6] 王海江[7] 何庆泗[8] 何显力 杜义安[10] 陈路川[11] 花亚伟[12] 黄昌明[13] 薛英威[14] 周烨[15] 周岩冰[16] 吴丹[17] 房学东[18] 代佑果[19] 张洪伟 曹家庆[21] 李乐平 柴杰 陶凯雄[24] 李国立 揭志刚[26] 葛杰[27] 徐忠法 张文斌[29] 李其云[30] 赵平[31] 马志强[32] 严志龙[33] 郑国良[2] 晏阳[5] 汤小龙 周祥[31] Ding Xuewei;Zheng Zhichao;Zhao Qun;Zhai Gang;Liang Han;Wu Xin;Zhu Zhenggang;Wang Haijiang;He Qingsi;He Xianli;Du Yif an;Chen Luchuan;Hua Yawei;Huang Changming;Xue Yingwei;Zhou Ye;Zhou Yanbing;Wu Dan;Fang Xuedong;Dai Youguo;Zhang Hongwei;Cao Jiaqing;Li Leping;Chai Jie;Tao Kaixiong;Li Guoli;Jie Zhigang;Ge Jie;Xu Zhongfa;Zhang Wenbin;Li Qiyun;Zhao Ping;Ma Zhiqiang;Yan Zhilong;Zheng Guoliang;Yan Yang;Tang Xiaolong;Zhou Xiang(Department of Gastric surgery,Tianjin Medical University Cancer Institute&Hospital,National Clinical Research Center for Cancer Prevention and Therapy,Tianjin 300060,China;Department of Gastric Surgery,Cancer Hospital of China Medical University(Liaoning Cancer Hospital and Institute),Shenyang 110042,China;The Third Department of Surgery,The Fourth Hospital,Hebei Medical University,Shijiazhuang 050011,China;Department of General Surgery,Shanxi Provincial Tumor Hospital,Taiyuan 030013,China;Department of General Surgery,The First Medical Center,Chinese PLA General Hospital,Beijing 100853,China;Department of Surgery,Ruijin Hospital,Shanghai JiaoTong University School of Medicine,Shanghai Institute of Digestive Surgery,Shanghai Key Laboratory of Gastric Neoplasms,Shanghai 2000251 China;Department of Gastrointestinal Surgery,Affiliated Tumor Hospital,Xinjiang Medical Universityy Urumqi 830011,China;Department of General Surgery,Qilu Hospital of Shandong University,Jinan 250012,China;Department of General Surgery,Tangdu Hospital,The Air Force Medical University,Xi,an 710038,China;Department of Gastric Surgery,Zhejiang Cancer Hospital,Hangzhou 310022,China;Department of Gastrointestinal Surgery,Fujian Provincial Cancer Hospital,Fujian Medical University Cancer Hospital,Fuzhou 350014,China;Department of General Surgery,The Affiliated Tumor Hospital of Zhengzhou University,Zhengzhou 450008,China;Department of Gastric Surgery,Fujian Medical University Union Hospital,Fuzhou 350004,China;Department of Gastrointestinal Surgery,Harbin Medical University Cancer Hospital,Harbin 150081,China;Department of Gastic

机构地区：[1]天津医科大学肿瘤医院胃部肿瘤科,国家肿瘤临床医学研究中心,天津市肿瘤防治重点实验室,天津市恶性肿瘤临床医学研究中心,300060 [2]辽宁省肿瘤医院胃外科,沈阳110042 [3]河北医科大学第四医院外三科,石家庄050011 [4]山西省肿瘤医院普通外一科,太原030013 [5]解放军总医院第一医学中心普通外科医学部,北京100853 [6]上海交通大学医学院附属瑞金医院普通外科,上海消化外科研究所,上海市胃肿瘤重点实验室,200025 [7]新疆医科大学附属肿瘤医院胃肠外科,乌鲁木齐830011 [8]山东大学齐鲁医院胃肠外科,济南250012 [9]空军军医大学唐都医院普通外科,西安710038 [10]浙江省肿瘤医院胃外科,杭州310022 [11]福建省肿瘤医院胃肠肿瘤外科,福州350014 [12]河南省肿瘤医院普通外科,郑州450008 [13]福建医科大学附属协和医院胃外科,福州350004 [14]哈尔滨医科大学附属肿瘤医院胃肠外科,150081 [15]复旦大学附属肿瘤医院胃外科,上海200032 [16]青岛大学附属医院胃肠外科,266003 [17]浙江大学医学院附属第二医院外科,杭州310009 [18]吉林大学中日联谊医院胃肠结直肠肛门外科,长春130033 [19]云南省肿瘤医院胃与小肠外科,昆明650118 [20]江苏省无锡明慈心血管病医院消化病诊疗中心,214101 [21]南昌大学第二附属医院胃肠外科,330006 [22]山东第一医科大学附属省立医院胃肠外科,济南250021 [23]山东大学附属山东省肿瘤医院胃外科,济南250117 [24]华中科技大学同济医学院附属协和医院胃肠外科,武汉430022 [25]东部战区总医院普通外科,南京210002 [26]南昌大学第一附属医院胃肠外科,330006 [27]中南大学湘雅医院胃肠外科,长沙410008 [28]山东第一医科大学第三附属医院普通外科,济南250031 [29]新疆医科大学第一附属医院普通外科,乌鲁木齐830000 [30]江西省肿瘤医院腹部肿瘤外一科,南昌330029 [31]四川省肿瘤医院胃肠外�

出　　处：《中华胃肠外科杂志》2021年第5期403-412,共10页Chinese Journal of Gastrointestinal Surgery

基　　金：国家重点研发计划资助(2016YFC1303200)。

摘　　要：目的探索真实世界中,围手术期化疗对胃癌患者预后的影响。方法采用回顾性队列研究方法,收集2014年1月1日至2016年1月31日期间辽宁省肿瘤医院、天津医科大学肿瘤医院等全国33家医院胃癌围手术期化疗及手术+辅助化疗病例的真实世界资料。病例纳入标准:(1)经病理组织学确诊的胃腺癌,临床分期cT_(2~4)aN_(0-3)M_(0)(AJCC第8版);(2)行D2胃癌根治手术;(3)至少完成1周期的新辅助化疗;(4)至少完成4周期辅助化疗[SOX(替吉奥+奥沙利铂)或CapeOX(卡培他滨+奥沙利铂)]。排除标准:(1)合并其他恶性肿瘤;(2)接受过放疗;(3)资料数据不全者。将入组患者中接受了新辅助化疗和辅助化疗者纳入围手术期化疗组,将单纯接受术后辅助化疗的患者纳入手术+辅助化疗组。采用倾向性评分匹配法控制和减小选择性偏倚。结局指标为两组患者倾向评分匹配后的总生存时间(OS)和肿瘤无进展生存时间(PFS),OS定义为第1次新辅助化疗时间(手术+辅助化疗组自手术时间)至末次有效随访时间或患者死亡时间;PFS定义为第1次新辅助化疗时间(手术+辅助化疗组自手术时间)至患者首次影像学诊断进展时间或死亡时间。采用Kaplan-Meier法估计生存率,使用Cox比例风险回归模型比较两组患者的OS和PFS。结果纳入病例2045例,其中手术+辅助化疗组1293例,围手术期化疗组752例。倾向评分匹配后,围手术期化疗组和手术+辅助化疗组各492例患者资料纳入研究,两组患者性别、年龄、体质指数、治疗前肿瘤分期、肿瘤部位的差异均无统计学意义(均P>0.05)。与手术+辅助化疗组相比,围手术期化疗组患者的全胃切除术比例更高(χ^(2)=40.526,P<0.001),切除肿瘤最大直径更小(t=3.969,P<0.001),转移淋巴结数目少(t=1.343,P<0.001),侵犯脉管(χ^(2)=11.897,P=0.001)和神经(χ^(2)=12.338,P<0.001)的比例更低。围手术期化疗组和手术+辅助化疗组胃癌D2根治术�Objective:To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition.Methods:A retrospective cohort study was carried out.Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery+adjuvant chemotherapy in 33 domestic hospitals from January 1,2014 to January 31,2016 were collected.Inclusion criteria:(1)gastric adenocarcinoma was confirmed by histopathology,and clinical stage was cT_(2~4)aN_(0-3)M_(0)(AJCC 8th edition);(2)D2 radical gastric cancer surgery was performed;(3)at least one cycle of neoadjuvant chemotherapy(NAC)was completed;(4)at least 4 cycles of adjuvant chemotherapy(AC)[SOX(S-1+oxaliplatin)or CapeOX(capecitabine+oxaliplatin)]were completed.Exclusion criteria:(1)complicated with other malignant tumors;(2)radiotherapy received;(3)patients with incomplete data.The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group,and those who received only postoperative adjuvant chemotherapy were included in the surgery+adjuvant chemotherapy group.Propensity score matching(PSM)method was used to control selection bias.The primary outcome were overall survival(OS)and progression-free survival(PFS)after PSM.OS was defined as the time from the first neoadjuvant chemotherapy(operation+adjuvant chemotherapy group:from the date of operation)to the last effective follow-up or death.PFS was defined as the time from the first neoadjuvant chemotherapy(operation+adjuvant chemotherapy group:from the date of operation)to the first imaging diagnosis of tumor progression or death.The Kaplan-Meier method was used to estimate the survival rate,and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS.Results:2045 cases were included,including 1293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group.After PSM,492 pairs were included in t

关 键 词：胃肿瘤 真实世界研究 倾向性得分匹配 新辅助治疗 

分 类 号：R735.2[医药卫生—肿瘤]