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

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

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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 strategy.This phase 2,multicenter,prospective,single-arm study enrolled patients from 6 centers from June 2021 to November 2022.Locally advanced rectal cancer(LARC,cT3-4aN0M0 and cT1-4aN1-2M0)patients aged ≥18 years with the distance from distal border of tumor to anal verge ≤10 cm(identified by Magnetic Resonance Imaging)were qualified for inclusion.The 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,iv.gtt,day8)as neoadjuvant.Total 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 study.The 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 regression.Treatment-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 Ⅲ(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.

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

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Department of General Surgery,Beijing Friendship Hospital,Capital Medical University,State Key Lab of Digestive Health,National Clinical Research Center for Digestive Diseases,Beijing,China

Department of Gastrointestinal Surgery,The First Affiliated Hospital of Air Force Medical University,Xi'an,China

Department of General Surgery,Beijing Chaoyang Hospital,Capital Medical University,Beijing,China

Department of General Surgery,Beijing Xuanwu Hospital,Capital Medical University,Beijing,China

Department of General Surgery,Tianjin Medical University General Hospital,Tianjin,China

Department of Anorectal,Tianjin People's Hospital,Tianjin,China

Department of Radiology,Beijing Friendship Hospital,Capital Medical University,Beijing,China

Department of Pathology,Beijing Friendship Hospital,Capital Medical University,Beijing,China

Department of Thoracic Surgery/Institute of Thoracic Oncology,West China Hospital,Sichuan University,Chengdu,China

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China Association of Gerontology and Geriatrics国家自然科学基金Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support国家高技术研究发展计划(863计划)国家高技术研究发展计划(863计划)Clinical Center for Colorectal Cancer,Capital Medical University

82202884ZLRK2023022015BAI13B092017YFC01109041192070313

2024

10.1038/s41392-024-01762-y

信号转导与靶向治疗(英文)

信号转导与靶向治疗(英文)

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ISSN：
年,卷(期)：2024.9(4)
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