国产苯达莫司汀联合利妥昔单抗一线治疗惰性B细胞淋巴瘤及老年套细胞淋巴瘤的疗效及安全性——多中心、前瞻性、Ⅱ期临床研究  

Efficacy and safety of bendamustine-rituximab combination therapy for newly diagnosed indolent B-cell non-Hodgkin's lymphoma and elderly mantle cell lymphoma:a multi-center prospective phase II clinical trial in China

作　　者：王慧 贺强 刘丹 邓秀芝[2] 马骥 解琳娜 孙忠亮[3] 刘聪[1] 赵荣荣[1] 卢可 初晓霞[4] 高娜 魏海臣 孙艳花[6] 钟玉萍[7] 邢立杰 张海燕[8] 张颢[9] 徐文伟[10] 李增军[1] Wang Hui;He Qiang;Liu Dan;Deng Xiuzhi;Ma Ji;Xie Linna;Sun Zhongliang;Liu Cong;Zhao Rongrong;Lu Ke;Chu Xiaoxia;Gao Na;Wei Haichen;Sun Yanhua;Zhong Yuping;Xing Lijie;Zhang Haiyan;Zhang Hao;Xu Wenwei;Li Zengjun(Department of Hematology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan 250000,China;Department of Hematology,Weihai Municipal Hospital,Weihai 264200,China;Department of Hematology,Jining First People’s Hospital,Jining 272000,China;Department of Hematology,The Affiliated Yantai Yuhuangding Hospital of Qingdao University,Yantai 264000,China;Department of Hematology,Binzhou Medical University Hospital,Binzhou 256600,China;Department of Hematology,Weifang People’s Hospital,Weifang 261000,China;Department of Hematology,Qingdao Municipal Hospital,Qingdao 266000,China;Department of Hematology,Linyi People’s Hospital,Linyi 276000,China;Department of Hematology,Affiliated Hospital of Jining Medical University,Jining 272000,China;Department of Hematology,The First Affiliated Hospital of Shandong First Medical University,Jinan 250000,China)

机构地区：[1]山东省肿瘤医院,山东第一医科大学附属肿瘤医院淋巴血液科,济南250000 [2]威海市立医院血液科,威海264200 [3]济宁市第一人民医院血液科,济宁272000 [4]烟台毓璜顶医院血液科,烟台264000 [5]滨州医学院附属医院血液科,滨州256600 [6]潍坊市人民医院血液科,潍坊261000 [7]青岛市市立医院血液科,青岛266000 [8]临沂市人民医院血液科,临沂276000 [9]济宁医学院附属医院血液科,济宁272000 [10]山东第一医科大学第一附属医院(山东省千佛山医院)血液科,济南250000

出　　处：《中华血液学杂志》2023年第7期550-554,共5页Chinese Journal of Hematology

摘　　要：目的评价国产苯达莫司汀联合利妥昔单抗一线治疗惰性B细胞淋巴瘤(B-iNHL)和老年套细胞淋巴瘤(MCL)的有效性和安全性。方法于2020年12月1日至2022年9月10日在山东省内10家三甲医院多中心前瞻性研究国产苯达莫司汀联合利妥昔单抗治疗初诊B-iNHL和老年MCL患者的疗效和安全性,所有患者均已完成至少4个周期诱导治疗。结果共入组B-iNHL与年MCL患者72例,中位年龄为55(24~74)岁,美国东部肿瘤协作组体能状态评分(ECOG评分)0~1分者占76.4%,ECOG 2分者占23.6%。滤泡淋巴瘤(FL)占51.4%,边缘区淋巴瘤(MZL)占33.3%,老年MCL占11.1%,不能分类占4.2%。Ann Arbor分期:Ⅲ期占16.7%、Ⅳ期占65.3%。4个周期诱导治疗后,总有效率为98.6%,其中完全缓解(CR)率为83.3%,部分缓解(PR)率为15.3%。仅1例MCL患者治疗中进展,1例FL患者复发。考虑到PET/CT评估与CT评估的差异,即使按照CT评估,其CR率为63.9%。中位随访11(4~22)个月,无进展生存(PFS)率为96.8%,总生存(OS)率为100.0%。主要血液学不良反应包括:3~4级白细胞减少(27.8%,其中8.3%的患者出现粒细胞缺乏伴发热),3~4级淋巴细胞减少(23.6%),3~4级贫血(5.6%)及3~4级血小板减少(4.2%)。非血液学不良反应主要为乏力、恶心/呕吐、皮疹、感染,发生率均低于20.0%。结论国产苯达莫司汀联合利妥昔单抗一线治疗B-iNHL和老年MCL患者安全有效。Objectives This study aimed to assess the efficacy and safety of bendamustine in combination with rituximab(BR regimen)for the treatment of newly diagnosed indolent B-cell non-Hodgkin's lymphoma(B-iNHL)and elderly mantle cell lymphoma(eMCL).Methods From December 1,2020 to September 10,2022,a multi-center prospective study was conducted across ten Grade A tertiary hospitals in Shandong Province,China.The BR regimen was administered to evaluate its efficacy and safety in newly diagnosed B-iNHL and eMCL patients,and all completed at least four cycles of induction therapy.Results The 72 enrolled patients with B-iNHL or MCL were aged 24-74 years,with a median age of 55 years.Eastern Cooperative Oncology Group(ECOG)performance status scores of 0-1 were observed in 76.4%of patients,while 23.6%had scores of 2.Disease distribution included follicular lymphoma(FL)(51.4%),marginal zone lymphoma(MZL)(33.3%),eMCL(11.1%),and the unknown subtype(4.2%).According to the Ann Arbor staging system,16.7%and 65.3%of patients were diagnosed with stageⅢand stageⅣlymphomas,respectively.Following four cycles of BR induction therapy,the overall response rate was 98.6%,with a complete response(CR)rate of 83.3%and a partial response(PR)rate of 15.3%.Only one eMCL patient experienced disease progression during treatment,and only one FL patient experienced a relapse.Even when evaluated using CT alone,the CR rate was 63.9%,considering the differences between PET/CT and CT assessments.The median follow-up duration was 11 months(range:4-22),with a PFS rate of 96.8%and an OS rate of 100.0%.The main hematologic adverse reactions included grade 3-4 leukopenia(27.8%,with febrile neutropenia observed in 8.3%of patients),grade 3-4 lymphopenia(23.6%),grade 3-4 anemia(5.6%),and grade 3-4 thrombocytopenia(4.2%).The main non-hematologic adverse reactions such as fatigue,nausea/vomiting,rash,and infections occurred in less than 20.0%of patients.Conclusion Within the scope of this clinical trial conducted in China,the BR regimen demonstrated efficacy and

关 键 词：苯达莫司汀 利妥昔单抗 惰性B细胞淋巴瘤 套细胞淋巴瘤 治疗 

分 类 号：R733.1[医药卫生—肿瘤]