Neoadjuvant camrelizumab(an anti-PD-1 antibody)plus chemotherapy or apatinib(a VEGFR-2 inhibitor)for initially unresectable stage II–III non-small-cell lung cancer:a multicentre,two-arm,phase 2 exploratory study  

作　　者：Haoran Xia Han Zhang Zheng Ruan Huibiao Zhang Liangdong Sun Hezhong Chen Yongxin Zhou Lele Zhang Dongliang Bian Xinsheng Zhu Jing Zhang Fenghuan Sun Huansha Yu Nan Song Xiaogang Liu Yuming Zhu Haiping Zhang Wenxin He Jian Chen Jie Yang Guohan Chen Shiliang Xie Dongfang Tang Xiaomiao Zhang Liang Duan Deping Zhao Qinchuan Li Peng Zhang Gening Jiang 

机构地区：[1]Department of Thoracic Surgery,Shanghai Pulmonary Hospital,Tongji University School of Medicine,Shanghai,China [2]Department of Thoracic Surgery,Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China [3]Department of Thoracic Surgery,Huadong Hospital Affiliated to Fudan University,Shanghai,China [4]Department of Thoracic Surgery,Changhai Hospital,Naval Medical University,Shanghai,China [5]Department of Thoracic-Cardiovascular Surgery,Tongji Hospital,Tongji University School of Medicine,Shanghai,China [6]Central Laboratory,Shanghai Pulmonary Hospital,Tongji University School of Medicine,Shanghai,China [7]Experimental Animal Center,Shanghai Pulmonary Hospital,Tongji University School of Medicine,Shanghai,China [8]Department of Oncology,Shanghai Pulmonary Hospital,Tongji University School of Medicine,Shanghai,China [9]Department of Thoracic Surgery,Shanghai East Hospital,Tongji University School of Medicine,Shanghai,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第7期3015-3023,共9页信号转导与靶向治疗（英文）

基　　金：supported by the National Natural Science Foundation of China(No.82125001);the Innovation Program of Shanghai Municipal Education Commission(No.2023ZKZD33);the Foundation of Shanghai Pulmonary Hospital(No.FKLY20004 and FKCX2304);the Beijing XiSiKe Clinical Oncology Research Foundation(No.YHR2019-0451);Jiangsu Hengrui Pharmaceuticals Co.,Ltd.We thank all the participants who made the study possible.

摘　　要：This multicentre,two-arm,phase 2 study aimed to explore the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy or apatinib in patients with initially unresectable stage II–III non-small-cell lung cancer(NSCLC).Eligible patients regardless of PD-L1 expression received neoadjuvant camrelizumab 200 mg and platinum-doublet chemotherapy every 3 weeks(arm A)or those with PD-L1-positive tumors received neoadjuvant camrelizumab and apatinib 250 mg once daily(arm B),for 2–4 cycles,followed by surgery.The primary endpoint was major pathological response(MPR)rate.Thirty patients in arm A and 21 in arm B were enrolled.Surgery rates were 50.0%(15/30)in arm A and 42.9%(9/21)in arm B,with all patients achieving R0 resections.Of these patients,the MPR and pathological complete response rates were both 20.0%(95%CI 4.3–48.1)in arm A and were 55.6%(95%CI 21.2–86.3)and 11.1%(95%CI 0.3–48.2)in arm B,respectively.The corresponding objective response rates were 33.3%(95%CI 11.8–61.6)and 55.6%(95%CI 21.2–86.3).With a median follow-up of 22.4 months(95%CI 19.0–26.0),the median event-free survival was not reached(NR;95%CI 13.6-NR)in arm A and 16.8 months(95%CI 8.6-NR)in arm B.Grade 3 or above treatment-related adverse events occurred in eight(26.7%)patients in arm A and three(14.3%)in arm B.Biomarker analysis showed baseline TYROBP expression was predictive of treatment response in arm B.Neoadjuvant camrelizumab plus chemotherapy or apatinib exhibits preliminary efficacy and manageable toxicity in patients with initially unresectable stage II–III NSCLC.

关 键 词：Surgery CHEMOTHERAPY treatment 

分 类 号：R734.2[医药卫生—肿瘤]