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Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open-label study

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收录情况： ◇ SCIE

作者：
Deng Lijuan[1] * ; Li Zhiming[2] ; Zhang Huilai[3] ; Huang Haiwen[4] ; Hu Jianda[5] ; Liu Lihong[6] ; Liu Ting[7] ; Jin Jie[8] ; Zhu Zunmin[9] ; Li Wenyu[10] ; Huang Zhenqian[11] ; Huang Wenrong[12] ; Zhou Keshu[13] ; Yang Haiyan[14] ; Zhang Mingzhi[15] ; Ding Kaiyang[16] ; Zhou Hui[17] ; Hu Yu[18] ; Shuang Yuerong[19] ; Cao Junning[20] ; Gao Sujun[21] ; Li Dengju[22] ; Sun Zimin[23] ; Zhang Qingyuan[24] ; Yi Shuhua[25] ; Ji Chunyan[26] ; Zhang Liansheng[27] ; Hou Cheng[28] ; Du Yue[28] ; Wang Weige[28] ; Zhao Renbin[28] ; Song Yuqin[1] ; Zhu Jun[1] ;
机构： [1]Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China. [2]Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. [3]Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China. [4]Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China. [5]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China. [6]Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [7]Department of Hematology, West China Hospital, Sichuan University, Chengdu, China. [8]Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. [9]Department of Hematology, Henan Provincial People's Hospital, Zhengzhou, China. [10]Department of Lymphoma, Guangdong Provincial People's Hospital, Guangzhou, China. [11]Department of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [12]Department of Hematology, The Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China. [13]Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. [14]Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [15]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [16]Department of Hematological Oncology, Anhui Province Cancer Hospital, Hefei, China. [17]Department of Lymphoma and Hematology, Hunan Cancer Hospital, Changsha, China. [18]Department of Hematology, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. [19]Department of Hematology and Lymphoma, Jiangxi Cancer Hospital, Nanchang, China. [20]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [21]Department of Hematology, The First Hospital of Jilin University, Changchun, China. [22]Department of Hematology, Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. [23]Department of Hematology, Anhui Provincial Hospital, Hefei, China. [24]Department of Internal Medicine-Oncology, Cancer Hospital of Harbin Medical University, Harbin, China. [25]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [26]Department of Oncology Medicine, Qilu Hospital of Shandong University, Jinan, China. [27]Department of Oncology Medicine, Lanzhou University Second Hospital, Lanzhou, China. [28]Beijing InnoCare Pharma Tech Co., Ltd., Beijing, China.
出处：
DOI： 10.1002/ajh.27064
ISSN：

摘要：
Marginal zone lymphoma (MZL) is an indolent type of non-Hodgkin lymphoma that develops through pathological B cell receptor signaling. Orelabrutinib, a new-generation oral small molecule Bruton's tyrosine kinase inhibitor, was evaluated in relapsed/refractory (r/r) MZL patients. Previously treated r/r MZL patients received orelabrutinib 150 mg once daily in a phase 2, multicenter, single-arm study conducted in China. The primary endpoint was overall response rate (ORR) assessed by an Independent Review Committee (IRC) based on the Lugano 2014 classification. Other efficacy, safety, and pharmacokinetic profiles were evaluated as secondary outcome measures. A total of 111 patients were enrolled, of which 90 patients had MZL confirmed by central pathology review, who were mainly with extra-nodal MZL of mucosa-associated lymphoid tissue (MALT, 46.7%) and nodal MZL (35.6%). The majority had late-stage disease, with stage IV accounting for 75.6%. After a median follow-up duration of 24.3 months, the IRC-assessed ORR was 58.9% (95% confidence interval [CI], 48.0-69.2), with rates of complete response and partial response being 11.1% and 47.8%, respectively. The IRC-assessed median duration of response was 34.3 months, and the IRC-assessed median progression-free survival (PFS) was not reached with a 12-month PFS rate of 82.8% (95% CI, 72.6-89.5). The rate of overall survival at 12 months was 91.0% (95% CI, 82.8-95.4). Common all-grade treatment-related adverse events (TRAEs) included anemia (27.9%), neutrophil count decrease (23.4%), white blood cell count decrease (18.0%), platelet count decrease (17.1%), blood present in urine (16.2%), rash (14.4%), and upper respiratory tract infection (10.8%). Thirty-four patients (30.6%) experienced grade 3 or higher TRAEs. Serious TRAEs occurred in 18 patients (16.2%), of which pneumonia (5.4%) was the most common. Seven patients (6.3%) discontinued orelabrutinib due to TRAEs. Orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in Chinese patients with r/r MZL.© 2023 Wiley Periodicals LLC.

基金：
InnoCare Pharma Tech Co., Ltd
语种：
外文
被引次数：
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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 2 区 血液学
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 血液学
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出版当年[2023]版：
Q1 HEMATOLOGY
最新[2023]版：
Q1 HEMATOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Deng Lijuan,Li Zhiming,Zhang Huilai,et al.Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open-label study[J].AMERICAN JOURNAL OF HEMATOLOGY.2023,98(11):1742-1750.doi:10.1002/ajh.27064.
APA：
Deng Lijuan,Li Zhiming,Zhang Huilai,Huang Haiwen,Hu Jianda...&Zhu Jun.(2023).Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open-label study.AMERICAN JOURNAL OF HEMATOLOGY,98,(11)
MLA：
Deng Lijuan,et al."Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open-label study".AMERICAN JOURNAL OF HEMATOLOGY 98..11(2023):1742-1750

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