短程放疗序贯化疗联合抗PD-1抗体治疗后腹腔镜手术对局部进展期直肠癌短期疗效的前瞻性研究  

Short-term efficacy of laparoscopic surgery after short-course radiotherapy followed by sequential chemotherapy combined with anti-PD-1 antibody therapy for locally advanced rectal cancer:a prospective study

作　　者：张鹏[1] 刘炜圳 陈鑫 林振宇[2] 杨明 张兰 蔡明 尹玉平 王征[1] 高金波[1] 张涛[2] 陶凯雄[1] Zhang Peng;Liu Weizhen;Chen Xin;Lin Zhenyu;Yang Ming;Zhang Lan;Cai Ming;Yin Yuping;Wang Zheng;Gao Jinbo;Zhang Tao;Tao Kaixiong(Department of Gastrointestinal Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Department of Cancer Center,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Department of Pathology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Department of Radiology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China)

机构地区：[1]华中科技大学同济医学院附属协和医院胃肠外科,武汉430022 [2]华中科技大学同济医学院附属协和医院肿瘤中心,武汉430022 [3]华中科技大学同济医学院附属协和医院病理科,武汉430022 [4]华中科技大学同济医学院附属协和医院放射科,武汉430022

出　　处：《中华消化外科杂志》2022年第6期766-772,共7页Chinese Journal of Digestive Surgery

基　　金：国家自然科学基金(81874061,81874184,82072736)。

摘　　要：目的探讨短程放疗序贯化疗联合抗程序性死亡[蛋白]-1(PD-1)抗体治疗后腹腔镜手术对局部进展期直肠癌的短期疗效。方法采用前瞻性研究方法。选取2019年11月至2020年9月华中科技大学同济医学院附属协和医院收治的30例局部进展期直肠癌患者的临床病理资料。患者经短程放疗序贯化疗联合抗PD-1抗体治疗后,再行腹腔镜手术治疗。观察指标:(1)入组患者情况。(2)短程放疗序贯化疗联合抗PD-1抗体治疗及不良反应情况。(3)术前评估与手术完成情况。(4)术后情况及病理学检查结果。(5)术后辅助化疗及随访情况。采用门诊和电话方式进行随访。短程放疗序贯化疗联合抗PD-1抗体治疗期间每3周随访1次,了解患者不良反应发生情况;手术治疗后2年内每3个月随访1次,此后每6个月随访1次,了解患者肿瘤复发和生存情况。随访时间截至2022年3月。正态分布的计量资料以x±s表示,偏态分布的计量资料以M(范围)表示,计数资料以绝对数或百分比表示。采用Kaplan-Meier法计算生存率并绘制生存曲线。结果(1)入组患者情况。筛选出符合条件的患者30例;男17例,女13例;年龄为(57±16)岁;术前原发肿瘤分期cT3期、cT4期分别为22、8例;术前淋巴结转移分期cN0期、cN1期、cN2期分别为4、16、10例;术前患者临床分期Ⅱ期、Ⅲ期分别为4、26例。30例患者中,术前影像学评估环周切缘阳性21例、直肠壁外血管侵犯12例。30例患者肿瘤下缘距肛缘距离为4.7(1.9~9.0)cm,肿瘤长径为5.4(2.1~10.0)cm。30例患者中,肿瘤组织错配修复完整28例、错配修复缺陷1例,1例因治疗前未成功行活组织病理学检查缺失肿瘤组织错配修复资料。(2)短程放疗序贯化疗联合抗PD-1抗体治疗及不良反应情况。30例患者术前均完成短程放疗,其中3例未行化疗联合抗PD-1抗体治疗,24例完成2个疗程化疗联合抗PD-1抗体治疗,3例完成1个疗程化疗联合�Objective To investigate the short-term efficacy of laparoscopic surgery after short-course radiotherapy followed by sequential chemotherapy combined with anti-programmed death-1(PD-1)antibody therapy for locally advanced rectal cancer.Methods The prospective study was conducted.The clinicopathological data of 30 locally advanced rectal cancer patients who were admitted to the Union Hospital of Tongji Medical College of Huazhong University of Science and Technology from November 2019 to September 2020 were selected.Patients underwent laparos-copic surgery after short-course radiotherapy followed by sequential chemotherapy combined with anti-PD-1 antibody therapy.Observation indicators:(1)situations of the enrolled patients;(2)situations of short-course radiotherapy followed by sequential chemotherapy combined with anti-PD-1 antibody therapy and adverse events;(3)preoperative evaluation and surgical situations;(4)postoperative situations and pathological examinations;(5)postoperative adjuvant chemo-therapy and follow-up.Follow-up was conducted using outpatient examination and telephone interview up to March 2022.Patients were followed up once every 3 weeks during the period of short-course radiotherapy followed by sequential chemotherapy combined with anti-PD-1 antibody therapy to detect the adverse events and patients were followed up once every 3 months during the first postoperative 2 years and once every 6 months thereafter to detect tumor recurrence and survival of patients.Measurement data with normal distribution were represented as Mean±SD,and measurement data with skewed distribution were represented as M(range).Count data were described as absolute numbers or percentages.The Kaplan-Meier method was used to calculate survival rates and draw survival curves.Results(1)Situations of the enrolled patients.A total of 30 patients were selected for eligibility.There were 17 males and 13 females,aged(57±16)years.Cases with preoperative primary tumor in stage cT3 and cT4 were 22 and 8,respectively.Cases with pre

关 键 词：直肠肿瘤 局部进展期 新辅助放化疗 免疫治疗 腹腔镜检查 

分 类 号：R735.37[医药卫生—肿瘤]