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Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial

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作者：
Li Zhiming[1,2] * ; Jiang Wenqi[3] ; Zhou Hui[4] ; Cen Hong[5] ; Zhang Mingzhi[6] ; Lv Fangfang[7] ; Zhang Qingyuan[8] ; Sun Xiuhua[9] ; Liu Lihong[10] ; Huang Yunhong[11] ; Yang Haiyan[12] ; Gao Sujun[13] ; He Chuan[14] ; Yang Wei[15] ; Li Wenyu[16] ; Yu Ding[17] ; Yang Yu[18] ; Cheng Ying[19] ; Qian Zhengzi[20] ; Xiang Ying[21] ; Guo Qunyi[22] ; Xu Bing[23] ; Song Yuqin[24] ; Zhang Liling[25] ; Lin Lie[26] ; Shen Jianzhen[27] ; Yan Feng[28] ; Liu Huilan[29] ; Zhang Donghua[30] ; Wang Jishi[31] ; Zhou Min[32] ; Zhu Xiongpeng[33] ; Zhang Weihua[34] ; Zhao Weili[35] ; Feng Ru[36] ; Zhang Xiaohong[37] ; Jin Jie[38] ; Zhong Meizuo[39] ; Zhang Mei[40] ; Wang Jingbo[41] ; Jing Hongmei[42] ; Wang Zhao[43] ; Zhao Hongguo[44] ; Zhu Jun[24] ;
机构： [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center,Guangzhou, China [2]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer,Guangzhou, China [3]Center of Excellence in Oncology, Guangzhou R&F Hospital, Guangzhou, China [4]Department of Lymphoma & Hematology, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha,China [5]Department of Hematology/Oncology and Pediatric Oncology, Guangxi Medical University Affiliated Cancer Hospital, Nanning, China [6]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [7]Department of Medical Oncology, Fudan University Shanghai Cancer Center,Shanghai, China [8]Deparment of Mammary and Lymphatic Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China [9]Department of Medical Oncology, The Second Hospital of Dalian Medical University,Dalian, China [10]Department of Hematology, The Fourth Hospital of Hebei Medical University,Shijiazhuang, China [11]Department of Lymphoma, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China [12]Department of Lymphoma Medical Oncology, Zhejiang Cancer Hospital, Hangzhou,China [13]Department of Hematology, The First Hospital of Jilin University, Changchun, China [14]Department of Hematology, West China Hospital, Sichuan University, Chengdu,China [15]Department of Hematology, Shengjing Hospital of China Medical University,Shenyang, China [16]Department of Lymphoma, Guangdong Provincial People's Hospital, Guangdong Academy of Sciences, Guangzhou, China [17]Department of Lymphoma, Hubei Cancer Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan, China [18]Department of Lymphoma, Head and Neck Oncology, Fujian Cancer Hospital,Fuzhou, China [19]Department of Hematology, Jilin Cancer Hospital, Changchun, China [20]Department of Lymphoma, Tianjin Medical University Cancer Institute & Hospital,Tianjin, China [21]Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing,China [22]Department of Hematology and Oncology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai, China [23]Department of Hematology, The First Affiliated Hospital of Xiamen University,Xiamen, China [24]Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing,China [25]Department of Lymphoma, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [26]Department of Hematology, Hainan General Hospital, Haikou, China [27]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China [28]Department of Hematology, Third Affiliated Hospital of Suzhou University, First People's Hospital of Changzhou, Changzhou, China [29]Department of Hematology, Anhui Provincial Hospital, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China [30]Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [31]Department of Hematology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China [32]Department of Medical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China [33]Department of Hematology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, China [34]Department of Hematology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China [35]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics,National Research Center for Translational Medicine at Shanghai, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [36]Department of Hematology, Nanfang Hospital, Southern Medical University,Guangzhou, China [37]Department of Hematology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [38]Department of Hematology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [39]Department of Oncology, Xiangya Hospital, Central South University, Changsha,China [40]Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China [41]Department of Hematology, Aerospace Central Hospital, Beijing, China [42]Department of Hematology, Peking University Third Hospital, Beijing, China [43]Department of Hematology, Beijing Friendship Hospital, Capital Medical University,Beijing, China [44]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao,China
出处：
DOI： 10.1136/jitc-2024-008895

摘要：
In patients with untreated CD20-positive diffuse large B-cell lymphoma (DLBCL), a phase 3 trial was carried out to evaluate the efficacy and safety of zuberitamab plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab plus CHOP (R-CHOP) treatment regimens.In a 2:1 ratio, eligible patients were assigned randomly to receive treatment of six cycles of either 375 mg/m2 zuberitamab or rituximab together with conventional CHOP chemotherapy. The objective response rate (ORR) at C6D50 served as the primary endpoint, and a non-inferiority margin of 10% was established. The secondary endpoints included the complete response (CR) rate at C6D50, duration of response (DOR), progression-free survival (PFS) and event-free survival (EFS) judged by blinded-independent review committee (BIRC), overall survival (OS) and safety outcomes.Of the 487 randomized patients, 423 patients including 287 in the Hi-CHOP and 136 in the R-CHOP groups completed the C6D50 assessment. For the full analysis set (FAS) and per-protocol set (PPS), BIRC-assessed ORR at C6D50 for the Hi-CHOP and R-CHOP groups were 83.5% versus 81.4% and 95.3% versus 93.7%, respectively. The non-inferiority was confirmed as the lower limit of the two-sided 95% CI for the intergroup differences of -5.2% and -3.3%; both were >-10% in the FAS and PPS. The BIRC-assessed CR rate of Hi-CHOP was significantly higher in PPS (85.7% vs 77.3%, p=0.038), but comparable in FAS (75.2% vs 67.9%, p=0.092). After a median follow-up of 29.6 months, patients in the Hi-CHOP group had a slight advantage with regard to the DOR (HR 0.74, p=0.173), PFS (HR 0.67, p=0.057), EFS (HR 0.90, p=0.517) and OS (HR 0.60, p=0.059). Patients with the germinal-center B cell-like subtype who received Hi-CHOP exhibited statistically significant improvements in ORR (p=0.034) and CR rate (p=0.038) at C6D50, EFS (p=0.046) and OS (p=0.014). Treatment-emergent adverse event occurrence rates were comparable across groups (all p>0.05). Infusion-related responses occurred more often in the Hi-CHOP group (32.1% vs 19.9%, p=0.006), all of grade 1-3 severity.Zuberitamab (375 mg/m2) plus CHOP was non-inferior to R-CHOP regarding ORR but exhibited a higher CR rate and was well tolerated in CD20-positive, previously untreated Chinese patients with DLBCL.Chinese Clinical Trial Registry, ChiCTR2000040602, retrospectively registered.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

基金：
National Natural Science Foundation of China (grant numbers 81872902 and 82073917), National Natural Science Foundation of Guangdong Province (grant number 2023A1515011525), The Lymphoma Research Fund of China Anti-Cancer Association, and the Sun Yat-sen University Cancer Center Clinical Research 308 Program (grant numbers 2014-fxy106 and 2016-fxy-079).
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出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 免疫学 2 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 免疫学 2 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 IMMUNOLOGY Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center,Guangzhou, China [2]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer,Guangzhou, China
通讯作者：
推荐引用方式(GB/T 7714)：
Li Zhiming,Jiang Wenqi,Zhou Hui,et al.Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial[J].Journal For Immunotherapy Of Cancer.2024,12(10):doi:10.1136/jitc-2024-008895.
APA：
Li Zhiming,Jiang Wenqi,Zhou Hui,Cen Hong,Zhang Mingzhi...&Zhu Jun.(2024).Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial.Journal For Immunotherapy Of Cancer,12,(10)
MLA：
Li Zhiming,et al."Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial".Journal For Immunotherapy Of Cancer 12..10(2024)

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