兰州大学机构库
Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open-label study
2023-11
Online publication date2023-08
Source PublicationAMERICAN JOURNAL OF HEMATOLOGY   Impact Factor & Quartile
ISSN0361-8609 ; 1096-8652
EISSN1096-8652
Volume98Issue:11Pages:1742-1750
page numbers9
AbstractMarginal 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.
PublisherWILEY
DOI10.1002/ajh.27064
Indexed BySCIE
Language英语
WOS Research AreaHematology
WOS SubjectHematology
WOS IDWOS:001066141800001
Original Document TypeArticle
PMID 37647123
Citation statistics
Cited Times:1[WOS]   [WOS Record]     [Related Records in WOS]
Document Type期刊论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/568226
Collection兰州大学
第二临床医学院
Corresponding AuthorZhu, Jun
Affiliation
1.Peking Univ, Dept Lymphoma, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst, Beijing, Peoples R China;
2.Sun Yat Sen Univ, Dept Med Oncol, Ctr Canc, Guangzhou, Peoples R China;
3.Tianjin Med Univ, Dept Lymphoma, Natl Clin Res Ctr Canc,Key Lab Canc Prevent & The, Tianjins Clin Res Ctr Canc,Canc Inst & Hosp, Tianjin, Peoples R China;
4.Soochow Univ, Dept Hematol, Affiliated Hosp 1, Suzhou, Peoples R China;
5.Fujian Med Univ, Dept Hematol, Union Hosp, Fuzhou, Peoples R China;
6.Hebei Med Univ, Dept Hematol, Hosp 4, Shijiazhuang, Peoples R China;
7.Sichuan Univ, West China Hosp, Dept Hematol, Chengdu, Peoples R China;
8.Zhejiang Univ, Affiliated Hosp 1, Dept Hematol, Sch Med, Hangzhou, Peoples R China;
9.Henan Prov Peoples Hosp, Dept Hematol, Zhengzhou, Peoples R China;
10.Guangdong Prov Peoples Hosp, Dept Lymphoma, Guangzhou, Peoples R China;
11.Guangzhou Med Univ, Dept Hematol, Affiliated Hosp 1, Guangzhou, Peoples R China;
12.Chinese Peoples Liberat Army Gen Hosp, Dept Hematol, Med Ctr 5, Beijing, Peoples R China;
13.Zhengzhou Univ, Henan Canc Hosp, Dept Hematol, Affiliated Canc Hosp, Zhengzhou, Peoples R China;
14.Zhejiang Canc Hosp, Dept Oncol, Hangzhou, Peoples R China;
15.Zhengzhou Univ, Dept Oncol, Affiliated Hosp 1, Zhengzhou, Peoples R China;
16.Anhui Prov Canc Hosp, Dept Hematol Oncol, Hefei, Peoples R China;
17.Hunan Canc Hosp, Dept Lymphoma & Hematol, Changsha, Peoples R China;
18.Huazhong Univ Sci & Technol, Dept Hematol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China;
19.Jiangxi Canc Hosp, Dept Hematol & Lymphoma, Nanchang, Peoples R China;
20.Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai, Peoples R China;
21.First Hosp Jilin Univ, Dept Hematol, Changchun, Peoples R China;
22.Huazhong Univ Sci & Technol, Dept Hematol, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China;
23.Anhui Prov Hosp, Dept Hematol, Hefei, Peoples R China;
24.Harbin Med Univ, Dept Internal Med Oncol, Canc Hosp, Harbin, Peoples R China;
25.Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Natl Clin Res Ctr Blood Dis, State Key Lab Expt Hematol,Haihe Lab Cell Ecosyst, Tianjin, Peoples R China;
26.Shandong Univ, Dept Oncol Med, Qilu Hosp, Jinan, Peoples R China;
27.Lanzhou Univ, Dept Oncol Med, Hosp 2, Lanzhou, Peoples R China;
28.Beijing InnoCare Pharma Tech Co Ltd, Beijing, Peoples R China
Recommended Citation
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.
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),1742-1750.
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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