以奥妥珠单抗和以利妥昔单抗为基础的方案治疗B细胞非霍奇金淋巴瘤效果及安全性比较的Meta分析  

Comparison of efficacy and safety of obinutuzumab-based regimen versus rituximab-based regimen in treatment of B-cell non-Hodgkin lymphoma: a Meta-analysis

作　　者：陈馨蕊 赵轩竹 梅汉玮 何国平 邱鸣寒 王华庆[1] Chen Xinrui;Zhao Xuanzhu;Mei Hanwei;He Guoping;Qiu Minghan;Wang Huaqing(Department of Oncology,Tianjin People's Hospital,Institute of Translational Medicine of Nankai University People's Hospital,Tianjin 300121,China;School of Integrative Medicine,Tianjin University of Traditional Cinese Medicine,Tianjin 301617,China)

机构地区：[1]天津市人民医院肿瘤科,南开大学人民医院转化医学研究院,天津300121 [2]天津中医药大学中西医结合学院,天津301617

出　　处：《白血病．淋巴瘤》2022年第10期610-617,共8页Journal of Leukemia & Lymphoma

基　　金：国家自然科学基金(82070206);天津市医学重点学科(专科)项目。

摘　　要：目的:系统评价基于奥妥珠单抗和基于利妥昔单抗的方案治疗B细胞非霍奇金淋巴瘤(B-NHL)的有效性和安全性。方法:检索Cochrane临床对照试验资料库、PubMed、Embase、美国血液学会年会会议录、美国临床肿瘤学会年会会议录以及ClinicalTrials数据库中应用含奥妥珠单抗或利妥昔单抗方案治疗B-NHL的相关研究,依据用药情况将患者分为奥妥珠单抗组和利妥昔单抗组。应用Review Manager 5.3软件比较两组的疗效和安全性。结果:共纳入7项随机对照试验,包括4235例患者(滤泡淋巴瘤1430例,弥漫大B细胞淋巴瘤2102例,其他B-NHL患者703例),奥妥珠单抗组和利妥昔单抗组分别有2121例和2114例。在可评价的4162例患者中,奥妥珠单抗组患者客观缓解率(ORR)高于利妥昔单抗组[75.1%(1565/2083)比72.7%(1512/2079);OR=1.19,95%CI 1.01~1.41,P=0.03]。奥妥珠单抗组患者无进展生存(PFS)优于利妥昔单抗组(HR=0.86,95%CI 0.75~0.99,P=0.03)。在可评估不良反应的3542例患者中,奥妥珠单抗组3~4级不良反应发生率高于利妥昔单抗组[61.8%(1098/1776)比54.2%(958/1766);OR=1.50,95%CI 1.29~1.74,P<0.001],其中奥妥珠单抗组3~4级输液相关不良反应发生率[7.5%(158/1776)比3.1%(65/1766);OR=2.56,95%CI 1.91~3.45,P<0.001]和中性粒细胞减少发生率[34.1%(597/1749)比29.4%(511/1738);OR=1.27,95%CI 1.09~1.47,P=0.002]均高于利妥昔单抗组。结论:应用基于奥妥珠单抗方案治疗的B-NHL患者ORR和PFS均优于基于利妥昔单抗方案治疗的患者,但在选择方案时应考虑不良反应的影响。Objective:To systematically evaluate the efficacy and safety of obinutuzumab-based regimen versus rituximab-based regimen in treatment of B-cell non-Hodgkin lymphoma (B-NHL).Methods:The Cochrane clinical controlled trials database, PubMed, Embase, American Society of Hematology meeting proceedings, American Society of Clinical Oncology annual meeting proceedings and ClinicalTrails database were searched for studies on the use of regimens containing obinutuzumab or rituximab for the treatment of B-NHL. Patients were divided into obinutuzumab group and rituximab group according to their medication status. Review Manager 5.3 software was used to compare the efficacy and safety of the two groups.Results:A total of 7 randomized controlled trials were selected, including 4 235 patients (1 430 cases of follicular lymphoma, 2 102 cases of diffuse large B-cell lymphoma, and 703 cases of other B-NHL);2 121 cases were in the obinutuzumab group and 2 114 cases were in the rituximab group. Among 4 162 patients who could be evaluated, the objective response rate (ORR) in the obinutuzumab group was higher than that in the rituximab group [75.1% (1 565/2 083) vs. 72.7% (1 512/2 079);OR = 1.19, 95% CI 1.01-1.41, P = 0.03]. Progression-free survival (PFS) in the obinutuzumab group was better than that in the rituximab group ( HR = 0.86, 95% CI 0.75-0.99, P = 0.03). Among 3 542 patients who could be evaluated for adverse reactions, the incidence of grade 3-4 adverse reactions in the otuzumab group was higher than that in the rituximab group [61.8% (1 098/ 1 776) vs. 54.2% (958/1 766);OR = 1.50, 95% CI 1.29-1.74, P < 0.001], the incidence of grade 3-4 infusive-related adverse reactions [7.5% (158/1 776) vs. 3.1% (65/1 766);OR = 2.56, 95% CI 1.91-3.45, P < 0.001] and neutropenia [34.1% (597/1 749) vs. 29.4% (511/1 738);OR = 1.27, 95% CI 1.09-1.47, P = 0.002] in the obinutuzumab group were higher than those in the rituximab group. Conclusions:The ORR and PFS of B-NHL patients treated with obinutuzumab-based regimen are better than tho

关 键 词：淋巴瘤 非霍奇金 奥妥珠单抗 利妥昔单抗 治疗结果 不良反应 

分 类 号：R733.1[医药卫生—肿瘤]