XELOX(capecitabine plus oxaliplatin)plus bevacizumab(anti-VEGF-A antibody)with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer:a multicenter,open-label,randomized,controlled,phase 3 trial  

作　　者：Qiu-Zhong Pan Jing-Jing Zhao Liang Liu Dong-Sheng Zhang Li-Ping Wang Wen-Wei Hu De-Sheng Weng Xiang Xu Yi-Zhuo Li Yan Tang Wei-Hong Zhang Jie-Yao Li Xiao Zheng Qi-Jing Wang Yong-Qiang Li Tong Xiang Li Zhou Shuang-Ning Yang Chen Wu Rong-Xing Huang Jia He Wei-Jiao Du Lu-Jun Chen Yue-Na Wu Bin Xu Qiong Shen Yi Zhang Jing-Ting Jiang Xiu-Bao Ren Jian-Chuan Xia 

机构地区：[1]State Key Laboratory of Oncology in South China,Guangdong Provincial Clinical Research Center for Cancer,Collaborative Innovation Center for Cancer Medicine,Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong 510060,PR China [2]Department of Biotherapy,Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong 510060,PR China [3]Tianjin Medical University Cancer Institute and Hospital,National Clinical Research Center for Cancer,Tianjin 300060,PR China [4]Key Laboratory of Cancer Immunology and Biotherapy,Tianjin 300060,PR China [5]Department of Biotherapy/Immunology,Tianjin Medical University Cancer Institute and Hospital,Tianjin 300060,PR China [6]Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou 510060,PR China [7]Department of Oncology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,PR China [8]Department of Tumor Biological Treatment,the Third Affiliated Hospital of Soochow University,Changzhou,Jiangsu 213003,PR China [9]Jiangsu Engineering Research Center for Tumor Immunotherapy,Changzhou,Jiangsu 213003,PR China [10]Institute for Cell Therapy of Soochow University,Changzhou,Jiangsu 213003,PR China [11]Department of Stem Cell&Regenerative Medicine,State Key Laboratory of Trauma,Burn and Combined Injury,Daping Hospital,Army Medical University,Chongqing 400042,PR China [12]Imaging Diagnosis and Interventional Center,Sun Yat-sen University Cancer Center,Guangzhou,Guangdong 510060,PR China

出　　处：《Signal Transduction and Targeted Therapy》2024年第5期2104-2113,共10页信号转导与靶向治疗（英文）

基　　金：This study was funded by the National Key R&D Program of China for J‐CX(grant number 2018YFC1313400);the National Natural Science Foundation of China for J.‐C.X.(grant number 81773110).We express our gratitude to all participating patients and their families,as well as to the study groups and investigators from the participating centers.

摘　　要：Fluoropyrimidine-based combination chemotherapy plus targeted therapy is the standard initial treatment for unresectable metastatic colorectal cancer(mCRC),but the prognosis remains poor.This phase 3 trial(ClinicalTrials.gov:NCT03950154)assessed the efficacy and adverse events(AEs)of the combination of PD-1 blockade-activated DC-CIK(PD1-T)cells with XELOX plus bevacizumab as a first-line therapy in patients with mCRC.A total of 202 participants were enrolled and randomly assigned in a 1:1 ratio to receive either first-line XELOX plus bevacizumab(the control group,n=102)or the same regimen plus autologous PD1-T cell immunotherapy(the immunotherapy group,n=100)every 21 days for up to 6 cycles,followed by maintenance treatment with capecitabine and bevacizumab.The main endpoint of the trial was progression-free survival(PFS).The median follow-up was 19.5 months.Median PFS was 14.8 months(95%CI,11.6-18.0)for the immunotherapy group compared with 9.9 months(8.0-11.8)for the control group(hazard ratio[HR],0.60[95%CI,0.40-0.88];p=0.009).Median overall survival(OS)was not reached for the immunotherapy group and 25.6 months(95%CI,18.3-32.8)for the control group(HR,0.57[95%CI,0.33-0.98];p=0.043).Grade 3 or higher AEs occurred in 20.0%of patients in the immunotherapy group and 23.5%in the control groups,with no toxicity-associated deaths reported.The addition of PD1-T cells to first-line XELOX plus bevacizumab demonstrates significant clinical improvement of PFS and OS with well tolerability in patients with previously untreated mCRC.

关 键 词：PD1 immunotherapy BEVACIZUMAB 

分 类 号：R730.51[医药卫生—肿瘤]