"Bendamustine in the treatment of patients with indolent non-Hodgkin lymphoma refractory or relapse to rituximab treatment: An open-label, single-agent, multicenter study in China"

作者全名："Gao, Yan; Liu, Yizhen; Wang, Yafei; Zhang, Qingyuan; Wu, Depei; Ye, Xu; Wu, Jianqiu; Xu, Wei; Zhou, Jianfeng; Yang, Yu; Cen, Hong; Zhang, Feng; Xiang, Ying; Tang, Xiaoqiong; Ding, Kaiyang; Lin, JinYing; Ma, Lei; Wang, Shunqing; Yu, Hao; Zhao, Yang; Song, Bin; Lv, Fangfang; Huang, Huiqiang"

作者地址："[Gao, Yan; Huang, Huiqiang] Sun Yat Sen Univ, Collaborat Innovat Ctr Canc Med, State Key Lab Oncol South China, Canc Ctr, Guangzhou, Peoples R China; [Liu, Yizhen; Lv, Fangfang] Fudan Univ, Shanghai Canc Ctr, Shanghai Med Coll, Dept Med Oncol, Shanghai, Peoples R China; [Wang, Yafei] Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Dept Hematol, Key Lab Canc Prevent & Therapy, Tianjin, Peoples R China; [Zhang, Qingyuan] Harbin Med Univ, Dept Med Oncol, Canc Hosp, Harbin, Peoples R China; [Wu, Depei] Soochow Univ, Inst Hematol, Affiliated Hosp 1, Suzhou, Peoples R China; [Ye, Xu] Guangzhou Med Univ, Dept Hematol, Affiliated Hosp 2, Guangzhou, Peoples R China; [Wu, Jianqiu] Nanjing Med Univ, Jiangsu Canc Hosp, Jiangsu Red Cross Canc Ctr, Jiangsu Inst Canc Res,Dept Med Oncol,Affiliated H, Nanjing, Peoples R China; [Xu, Wei] Jiangsu Prov Hosp, Hematol Dept, Nanjing, Peoples R China; [Zhou, Jianfeng] Huazhong Univ Sci & Technol, Hematol Dept, Tongji Med Coll, Wuhan, Peoples R China; [Yang, Yu] Fujian Med Univ, Dept Lymphoma & Head & Neck Canc, Affiliated Tumor Hosp, Fuzhou, Fujian, Peoples R China; [Cen, Hong] Guangxi Med Univ, Dept Hematol Lymphoma & Pediat Oncol, Affiliated Tumor Hosp, Nanning, Peoples R China; [Cen, Hong; Ma, Lei] Oncol Med Coll, Nanning, Peoples R China; [Zhang, Feng] Anhui Oncol Hosp, Bengbu Med Coll, Dept Hematol, Bengbu, Peoples R China; [Xiang, Ying] Chongqing Canc Hosp, Dept Hematol & Oncol, Chongqing, Peoples R China; [Tang, Xiaoqiong] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Ding, Kaiyang] Anhui Med Univ, Dept Hematol, Prov Hosp Affiliated, Hefei, Anhui, Peoples R China; [Lin, JinYing] Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Hematol, Nanning, Peoples R China; [Ma, Lei] Guangzhou Med Univ, Affiliated Tumor Hosp, Nanning, Peoples R China; [Wang, Shunqing] Guangzhou First Peoples Hosp, Dept Hematol, Guangzhou, Peoples R China; [Yu, Hao] Nanjing Med Univ, Dept Biostat, Nanjing, Peoples R China; [Zhao, Yang] Nanjing Baosida Pharmaceut Technol Co Ltd, Nanjing, Peoples R China; [Song, Bin] Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China"

通信作者："Huang, HQ (通讯作者)，Sun Yat Sen Univ, Collaborat Innovat Ctr Canc Med, State Key Lab Oncol South China, Canc Ctr, Guangzhou, Peoples R China.; Lv, FF (通讯作者)，Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, 270 Dongan Rd, Shanghai 200032, Peoples R China."

来源：CANCER

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000900757600001

JCR分区：Q1

影响因子：6.2

年份：2023

卷号：129

期号：4

开始页：551

结束页：559

文献类型：Article

关键词：bendamustine; DOR; indolent B-cell non-Hodgkin lymphoma; ORR; PFS; safety

摘要："BackgroundThe optimal treatment strategy for refractory or relapse (R/R) indolent non-Hodgkin lymphoma (iNHL) has not been fully identified. This study aims to investigate the efficacy and tolerance of bendamustine hydrochloride developed in native Chinese corporation in the treatment of patients with R/R iNHL. MethodsA total of 101 patients from 19 centers were enrolled in this study from July 2016 to February 2019. Bendamustine hydrochloride (120 mg/m(2)) was given on days 1 and 2 of each 21-day treatment cycle for six planned cycles or up to eight cycles if tolerated. Parameters of efficacy and safety were analyzed. ResultsThe median age of the patients was 53.44 (range, 24.4-74.6) years old. A total of 56 (55.44%) patients completed at least six treatment cycles, and the relative dose intensity was 93.78%. The overall response rate was 72.28%, and the median duration of response was 15.84 months (95% confidence interval [CI], 13.77-27.48 months). Median progression-free survival was 16.52 months (95% CI, 14.72-23.41 months), and the median overall survival was not reached. Grade 3 or 4 hematologic toxicities included neutropenia (77.22%), thrombocytopenia (29.70%), and anemia (15.84%). The most frequent nonhematologic adverse events (any grade) included nausea, vomiting, fatigue, fever, decreased appetite, and weight loss. Seven patients died during the trial, and four cases may be related to the investigational drug. ConclusionsThis study reveals that bendamustine hydrochloride is a feasible treatment option for the indolent B-cell non-Hodgkin lymphoma patient who has not remitted or relapsed after treatment with rituximab. All adverse events were predictable and manageable."

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