Efficacy and safety of PD-1 blockade plus long-course chemoradiotherapy in locally advanced rectal cancer(NECTAR):a multi-center phase 2 study

作     者：Zhengyang Yang Jiale Gao Jianyong Zheng Jiagang Han Ang Li Gang Liu Yi Sun Jie Zhang Guangyong Chen Rui Xu Xiao Zhang Yishan Liu Zhigang Bai Wei Deng Wei He Hongwei Yao Zhongtao Zhang Zhengyang Yang;Jiale Gao;Jianyong Zheng;Jiagang Han;Ang Li;Gang Liu;Yi Sun;Jie Zhang;Guangyong Chen;Rui Xu;Xiao Zhang;Yishan Liu;Zhigang Bai;Wei Deng;Wei He;Hongwei Yao;Zhongtao Zhang

作者机构：Department of General SurgeryBeijing Friendship HospitalCapital Medical UniversityState Key Lab of Digestive HealthNational Clinical Research Center for Digestive DiseasesBeijingChina Department of Gastrointestinal SurgeryThe First Affiliated Hospital of Air Force Medical UniversityXi'anChina Department of General SurgeryBeijing Chaoyang HospitalCapital Medical UniversityBeijingChina Department of General SurgeryBeijing Xuanwu HospitalCapital Medical UniversityBeijingChina Department of General SurgeryTianjin Medical University General HospitalTianjinChina Department of AnorectalTianjin People's HospitalTianjinChina Department of Radiology Beijing Friendship HospitalCapital Medical UniversityBeijingChina Department of PathologyBeijing Friendship HospitalCapital Medical UniversityBeijingChina Department of Thoracic Surgery/Institute of Thoracic OncologyWest China HospitalSichuan UniversityChengduChina 

出 版 物：《Signal Transduction and Targeted Therapy》 (信号转导与靶向治疗（英文）)

年 卷 期：2024年第9卷第4期

页      面：1721-1729页

核心收录：

学科分类：0710[理学-生物学] 1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：support in this study.This study was supported by China Association of Gerontology and Geriatrics,the National Natural Science Foundation of China (82202884) Beijing Hospitals Authority Clinical Medicine Development of special funding support (ZLRK202302) National Key Technologies R&D Program (2015BAl13B09) National Key Technologies R&D Program of China (2017YFC0110904) Clinical Center for Colorectal Cancer,Capital Medical University (1192070313) 

主　　题：rectal cancer phase 

摘      要：Adding PD-1 blockade in the neoadjuvant regimens for locally advanced rectal cancer(LARC)patients with microsatellite stable(MsS)/mismatch repair-proficient(pMMR)tumors is an attractive,but debatable *** phase 2,multicenter,prospective,single-arm study enrolled patients from 6 centers from June 2021 to November *** advanced rectal cancer(LARC,cT_(3-4a)N_(0)M_(0) and cT_(1-4a)N_(1-2)M_(0))patients aged≥18 years with the distance from distal border of tumor to anal verge≤10 cm(identified by Magnetic Resonance Imaging)were qualifed for *** patients received long-course radiotherapy(50 Gy/25 fractions,2 Gy/fraction,5 days/week)and three 21-day cycles capecitabine(850-1000 mg/m2,bid,po,day1-14)and three 21-day cycles tislelizumab(200 mg,***,day8)as *** mesorectal excision(TME)was 6-12 weeks after the end of radiotherapy to achieve radical resection.A total of 50 patients were enrolled in this *** pathological complete response rate was 40.0%[20/50,95%confidence interval(CI):27.61-53.82%],while 15(30.0%,95%CI:19.1-43.75%),9(18.0%,95%CI:9.77-30.8%),2(4.0%,95%CI:1.10-13.46%)patients respectively achieved grade 1,2,and 3 tumor ***-related adverse events(TRAEs)occurred in 28(56.0%)LARC patients,including 26(52.0%)with grade I-II and 2(4.0%)with grade II(1 with grade 3 immune-related colitis and 1 with grade 3 rash).PD-1 blockade plus long-course chemoradiotherapy(CRT)showed promising therapeutic effects according to pathological complete response rate and is well-tolerated in LARC patients.A larger randomized controlled study is desired to further validate the above findings.