中低位直肠癌新辅助治疗后临床完全缓解或近临床完全缓解的长期预后分析  

Long-term prognostic analysis on complete /near-complete clinical remission for mid-low rectal cancer after neoadjuvant chemoradiotherapy

作　　者：王林[1] 李士杰[2] 张晓燕[3] 孙婷婷[1] 杜长征[1] 陈楠[1] 彭亦凡[1] 姚云峰[1] 詹天成[1] 赵军[1] 蔡勇[4] 李永恒[4] 王维虎 李忠武[5] 孙应实[2] 季加孚[6] 武爱文[1] Wang Lin;Li Shijie;Zhang Xiaoyan;Sun Tingting;Du Changzheng;Chen Nan;Peng Yifan;Yao Yunfeng;Zhan Tiancheng;Zhao Jun;Cai Yong;Li Yongheng;Wang Weihu;Li Zhongwu;Sun Yingshi;Ji Jiafu;Wu Aiwen(Department 3of Gastrointestinal Surgery,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,China;Endoscopy Center,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,China;Department of Radiology,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,China;Department of Radiation Oncology,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,China;Department of Pathology,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,China;Department of Gastrointestinal Surgery,Key Laboratory of Carcinogenesis and Translational Research,Peking University Cancer Hospital &Institute,Beijing100142,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,恶性肿瘤发病机制及转化研究教育部重点实验室,胃肠肿瘤中心三病区,100142 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,内镜中心,100142 [3]北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,影像科,100142 [4]北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,放射治疗科,100142 [5]北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,病理科,100142 [6]北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,胃肠肿瘤中心,100142

出　　处：《中华胃肠外科杂志》2018年第11期1240-1248,共9页Chinese Journal of Gastrointestinal Surgery

基　　金：国家自然科学基金(81773214);首都特色临床研究(Z15110004015105);北京市卫生系统215高层次人才项目(2016).

摘　　要：目的探讨中低位直肠癌新辅助治疗后,评效为临床完全缓解(cCR)或近临床完全缓解(near—cCR)患者实施等待观察疗法或实施器官保留手术的预后。方法收集自2011年3月至2017年8月期间,在北京大学肿瘤医院胃肠中心接受新辅助治疗后疗效评价为cCR或near—cCR、并实施等待观察疗法或器官保留手术(局部切除)的62例中低位直肠癌患者(cCR/near—cCR组)的临床资料进行回顾性病例分析。按照近似1:2配对,选取同时间段在本中心进行新辅助治疗后,接受根治切除并获得病理完全缓解(ypCR)的123例患者(ypCR组)进行预后对比。研究主要终点为:3年非肿瘤再生无病生存率(NR—DFS)和肿瘤特异性生存率(CSS);使用Kaplan—Meier曲线和Log-rank检验进行生存分析。研究次要终点为:3年器官保留率及括约肌保留率。结果cCR/near-cCR组患者男性38例(61.3%)、女性24例(38.7%),中位年龄60(31~79)岁,基线状态肿瘤距肛缘中位距离4(1-8)cm。符合cCR和near—cCR诊断的比例分别为79.0%(49/62)和21.0%(13/62)。全组患者的局部肿瘤再生率为24.2%(15/62)。在15例肿瘤再生患者中,9例接受了补救性根治手术,术后无局部复发事件;4例接受了补救性局部切除,术后局部复发1例;另2例患者拒绝手术。总体转移率为8.1%(5/62),可根治性转移和不可根治性转移率分别为4.8%(3/62)和3.2%(2/62)。3年有效的器官和括约肌保留率分别为85.5%(53/62)和95.2%(59/62)。中位随访36.2(8.6~89.0)月,cCR组和near—cCR组的3年NR—DFS分别为88.6%和83.1%,与ypCR组的3年NR。DFS(94.7%)差异无统计学意义(P=0.217);cCR组和near—cCR组的3年CSS均为100%,与同期ypCR组的3年CSS(93.4%)差异也无统计学意义(P=0.186)。结论新辅助治疗后评效为cCR或near—cCR的直肠癌患者,接受等待观察疗法或器官保留(局部切除)手术,远期预后良好,肿瘤局部再生和远隔转移率低,肿瘤学生存率与根治性手术后获得ypCR的患者相�Objective To investigate the long-term outcome of organ preservation with local excision or "watch and wait"strategy for mid-low rectal cancer patients evaluated as clinical complete remission (cCR)or near-cCR following neoadjuvant chemoradiotherapy (NCRT).Methods Clinical data of 62mid-low rectal cancer patients evaluated as cCR/near-cCR after NCRT undergoing organ preservation surgery with local excision or receiving "watch and wait"strategy at Department of Gastrointestinal Surgery,Peking University Cancer Hospital &Institute from March 2011to August 2017were retrospectively analyzed.According to the approximate 1:2pairing,123patients who underwent radical resection with complete pathological remission(ypCR)after neoadjuvant chemotherapy during the same period were selected for prognosis comparison.The primary endpoint of the study was 3-year non-regrowth disease-free survival (NR-DFS)and tumor specific survival (CSS).Survival analysis was performed using the Kaplan-Meier curve (Log-rank method).The secondary endpoint of the study was 3-year organ preservation and sphincter preservation.Results The retrospective study included 38male and 24female patients.The median age was 60(31-79)years and the median distance from tumor to anal verge was 4(1-8)cm.The ratio of cCR and near-cCR was 79.0%(49/62) and 21.0%(13/62)respectively.Local regrowth rate was 24.2%(15/62).Of 15with tumor regrowth, 9patients received salvage radical rectal resection and no local recurrence was found during follow-up;4patients received salvage local excision among whom one patient had a local recurrence occurred patient;2patients refused further surgery.The overall metastasis rate was 8.1%(5/62), including resectable metastasis (4.8%,3/62)and unresectable metastasis (3.2%,2/62).The valid 3-year organ preservation rate and sphincter preservation rate were 85.5%(53/62)and 95.2%(59/62) respectively.The median follow-up was 36.2(8.6-89.0)months.The 3-year NR-DFS of patients with cCR and near-cCR was 88.6%and 83.1%respectively,which was not sign

关 键 词：盲肠肿瘤 新辅助治疗 临床完全缓解 "等待观察"疗法 器官保留 

分 类 号：R735.37[医药卫生—肿瘤]