直肠癌患者新辅助治疗后临床完全缓解或近临床完全缓解行等待观察策略的远期预后:一项来自中国等待观察数据协作组的多中心登记研究  

Long-term outcome of patients with rectal cancer who achieve complete or near complete clinical responses after neoadjuvant therapy:a multicenter registry study of data from the ChineseWatchand Wait Database

作　　者：赵一鸣 王维虎 张卫 王林[1] 李帅 王靖雯 廖乐恩 于冠宇 孙振 屈艳丽[7] 巩阳 卢云[9] 武涛 李云峰[10] 王权[8] 赵国华[7] 肖毅[6] 丁培荣[5] 章真[4] 武爱文[1,11] Zhao Yiming;Wang Weihu;Zhang Wei;Wang Lin;Li Shuai;Wang Jingwen;Liao Leen;Yu Guanyu;Sun Zhen;Qu Yanli;Gong Yang;Lu Yun;Wu Tao;Li Yunfeng;Wang Quan;Zhao Guohua;Xiao Yi;Ding Peirong;Zhang Zhen;Wu Aiwen(Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Gastrointestinal Cancer Center,Unit Il,Peking University Cancer Hospital&Institute,Beijing 100142,China;Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Department of Radiation Oncology,Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Colorectal Surgery,Changhai Hospital,Navy Medical University,Shanghai 200433,China;Department of Radiation Oncology,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai Key Laboratory of Radiation Oncology,Shanghai 200032,China;Department of Colorectal Surgery,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;Department of General Surgery,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Department of General Surgery,Liaoning Cancer Hospital,Shenyang 110042,China;Department of Gastrocolorectal Surgery,the First Hospital of Jilin University,Changchun 130021,China;Department of General Surgery,the Affiliated Hospital of Qingdao University,Qingdao 266555,China;Department of Colorectal Surgery,Yunnan Cancer Hospital,Kunming 650118,China;State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing Key Laboratory of Carcinogenesis and Translational Research,Gastrointestinal Cancer Center,Unit Ill,Peking University Cancer Hospital&Institute,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所胃肠肿瘤中心三病区,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所放射治疗科,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [3]海军军医大学附属长海医院肛肠外科,上海200433 [4]复旦大学上海医学院附属肿瘤医院放射肿瘤科,复旦大学上海医学院肿瘤学系,上海市放射肿瘤学重点实验室,上海200032 [5]中山大学肿瘤防治中心结直肠外科,广州510060 [6]中国医学科学院北京协和医学院,北京协和医院基本外科,北京100730 [7]辽宁省肿瘤医院普通外科,沈阳110042 [8]吉林大学第一医院胃结直肠外科,长春130021 [9]青岛大学附属医院普外科,青岛266555 [10]云南省肿瘤医院结直肠外科,昆明650118 [11]消化系肿瘤整合防治全国重点实验室,恶性肿瘤转化研究北京市重点实验室,北京100142

出　　处：《中华胃肠外科杂志》2024年第4期372-382,共11页Chinese Journal of Gastrointestinal Surgery

基　　金：国家重点研发计划(2021YFF1201104);国家自然科学基金(82173156);扬帆计划-重点医学专业(ZYLX202116)。

摘　　要：目的报告中国直肠癌患者新辅助治疗后等待观察后的远期结局。方法基于真实世界的多中心横断面研究。纳入新辅助治疗后评价为临床完全缓解(cCR)或近cCR(near-cCR)进行等待观察的直肠癌患者以及少数新辅助治疗后疗效较好、以活检为目的行局部切除确认ypCR的患者,随访时间需≥2年;剔除基线时伴有远处转移或带瘤生存自行等待观察的患者。根据以上标准,回顾性收集中国等待观察数据协作组(CWWD)中的数据信息,包括基本信息、新辅助治疗类型、治疗前影像学检查结果、新辅助治疗后疗效评价、补救措施及治疗结局等,分析本组患者新辅助治疗后等待观察后的远期结局,并比较cCR及near-cCR两组间的差异。结果来自8家医疗中心(北京大学肿瘤医院、复旦大学附属肿瘤医院、中山大学附属肿瘤医院、上海长海医院、北京协和医院、辽宁省肿瘤医院、吉林大学附属第一医院以及云南省肿瘤医院)共计318例接受等待观察且随访超过两年的直肠癌患者的临床资料。全组患者中男性221例(69.4%),女性107例(30.6%);中位年龄60(26~86)岁。肿瘤距离肛缘中位距离为3.4(0~10.4)cm。291例接受新辅助治疗后评效为cCR,27例评效为near-cCR。中位随访48.4(10.2~110.3)个月,5年累计总体生存率(OS)为92.4%(95%CI:86.8%~95.7%),5年累计疾病特异生存率(CSS)为96.6%(95%CI:92.2%~98.5%),5年累计器官保留研究校正无病生存率(OP-DFS)为86.6%(95%CI:81.0%~90.7%),5年累计器官保留率(OPR)为85.3%(95%CI:80.3%~89.1%),5年局部再生率为18.5%(95%CI:14.9%~20.8%),5年远处转移率为8.2%(95%CI:5.4%~12.5%)。全组共56例发生局部再生,82.1%(46/56)的局部再生发生于2年内,91.1%(51/56)的局部再生发生于3年内,中位再生时间为11.7(2.5~66.6)个月。91.1%(51/56)的局部再生发生于肠腔内。共23例患者发生远处转移,60.9%(14/23)远处转移发生于2年内,73.9%(17/23)发生于3年内,中位远处�Objective To report the long-term outcomes of Chinese rectal cancer patients after adopting a Watch and Wait(W&W)strategy following neoadjuvant therapy(NAT).Methods This multicenter,cross-sectional study was based on real-world data.The study cohort comprised rectal cancer patients who had achieved complete or near complete clinical responses(cCRs,near-cCRs)after NAT and were thereafter managed by a W&W approach,as well as a few patients who had achieved good responses after NAT and had then undergone local excision for confirmation of pathological complete response.All participants had been followed up for≥2 years.Patients with distant metastases at baseline or who opted for observation while living with the tumor were excluded.Data of eligible patients were retrospectively collected from the Chinese Wait-and-Watch Data Collaboration Group database.These included baseline characteristics,type of NAT,pre-treatment imaging results,evaluation of post-NAT efficacy,salvage measures,and treatment outcomes.We herein report the long-term outcomes of Chinese rectal cancer patients after NAT and W&W and the differences between the cCR and near-cCR groups.Results Clinical data of 318 rectal cancer patients who had undergone W&w for over 2 years and been followed up were collected from eight medical centers(Peking University Cancer Hospital,Fudan University Shanghai Cancer Center,Sun Yat-sen University Cancer Center,Shanghai Changhai Hospital,Peking Union Medical College Hospital,Liaoning Cancer Hospital,the First Hospital of jilin University,and Yunnan Cancer Hospital.)The participants comprised 221 men(69.4%)and 107 women(30.6%)of median age 60(26-86)years.The median distance between tumor and anal verge was 3.4(0-10.4)cm.Of these patients,291 and 27 had achieved cCR or near-cCR,respectively,after NAT.The median duration of follow-up was 48.4(10.2-110.3)months.The 5-year cumulative overall survival rate was 92.4%(95%CI:86.8%-95.7%),5-year cumulative disease-specific survival(CsS)rate 96.6%(95%CI:92.2%-98.5%),5-year cumu

关 键 词：直肠肿瘤 新辅助治疗 等待观察 器官保留 

分 类 号：R735.37[医药卫生—肿瘤]