摘要
目的系统评价维布妥昔单抗联合苯达莫司汀治疗复发难治性霍奇金淋巴瘤疗效及安全性。方法在中国知网、维普网、万方数据知识服务平台、The Cochrane Library、Wed of Science、PubMed、EMBase等各大数据库中进行文献检索和筛选,对符合纳排标准的文献进行质量评估分析,进一步提取相关研究数据。应用Stata15.0软件进行统计学分析系统评价,观察指标包括总反应率(ORR)、完全缓解率(CR)、2年总生存期(OS)、2年无进展生存期(PFS)、≥3级不良事件(AE)发生率以及停药率。结果纳入14个研究进行系统评价,共548例患者。Meta分析结果显示,维布妥昔单抗联合苯达莫司汀治疗R/R HL具有显著疗效,ORR为82%[95%CI(76%,88%)],CR为62%[95%CI(52%,73%)];2年PFS率为72%[95%CI(61%,84%)],2年OS率为92%[95%CI(87%,96%)]。将文献进行分组分析结果示:临床研究和真实世界研究的ORR分别为81%[95%CI(72%,89%)]、84%[95%CI(75%,93%)],CR率均为62%[95%CI(52%,73%)],两者结果显示疗效并无明显差异。安全性结果分析,≥3级的血液学AE最常见的是中性粒细胞减少为22%、贫血10%;≥3级的非血液学AE最多见的是感染13%、周围感觉神经病变12%;因AE所致停药率17%。亚组分析不良事件结果显示:临床研究和真实世界研究≥3级的血液学AE最常见为中性粒细胞减少分别为26%和17%、贫血分别为16%和4%;临床试验和真实世界研究≥3级的非血液学AE最多见的为感染分别为21%和5%、周围感觉神经病变分别为20%和6%;临床研究和真实世界回顾性研究中因AE出现的停药率分别为21%和9%。结论维布妥昔单抗联合苯达莫司汀治疗R/R HL有着较好的疗效,严重不良事件发生率较低,整体耐受性尚可;相比于维布妥昔单抗单药治疗R/R HL患者疗效更显著。对于治疗R/R HL患者的临床研究和真实世界回顾性研究的疗效评估结果显示并无明显差异,但真实世界研究治疗R/R HL患者严重不良反应发生率较低于临床研究。
Objective To evaluationeffectiveness ofbrentuximab vedotin and bendamustine in the treatment of relapsed and refractory Hodgkin's lymphoma.Methods A literature retrieval was conducted in CNKI,Weipu database,Wanfang Data,the Cochrane Library,Wed of Science,PubMed,EMBase,and other databases and evaluated the quality of the literature and extracted the data.Finally,Stata15.0 was used for statistical analysis to calculate the effective rate,incidence of adverse reactions and drug withdrawal.Results A total of 14 English literature were included for systematic review.Meta-analysis results show that brentuximab vedotin combined with bendamustine has a significant effect in the treatment of relapsed and refractory Hodgkin lymphoma,with the overall response rate was 82%〔95%CI(76%,88%)〕,and complete response rate of 62%〔95%CI(52%,73%)〕;the 2-year OS was 92%〔95%CI(87%,96%)〕,and the 2year PFS was 72%〔95%CI(61%,84%)〕.A subgroup analysis of literature showed that with the overall response rate of the clinical trial and the real world were 81%〔95%CI(72%,89%)〕and 84%〔95%CI(75%,93%)〕,and complete response rate were both 62%〔95%CI(52%,73%)〕.In terms of safety,the incidences of neutropenia and anemia in hematological adverse events≥grade 3 were 22%and 10%;the incidence of infection and peripheral sensory neuropathy in non-hematological adverse events≥grade 3 were 13%and 12%;The rate of drug withdrawal due to adverse events was 17%.Subgroup analysis of adverse events showed that the most common hematological AE of grade≥3 in clinical trials and real-world studies were neutropenia 26%and 17%,the incidence of anemia was 16%and 4%;The most common non-hematologic AE≥3 in clinical trials and realworld studies were infection rates of 21%and 5%,peripheral sensory neuropathy ratewas20%and 6%.The rate of drug withdrawal due to adverse events in clinical trials and real world was 21%and 9%.Conclusion Brentuximab vedotin combined with bendamustine in the treatment of relapsed and refractory Hodgkin lymphoma has a significant effect,it has low incidence of serious adverse events,and the overall adverse events can be tolerabled;compared with brentuximab vedotin monotherapy for relapsed and refractory Hodgkin lymphoma Patients have more effctive.There is no significant difference between the results of clinical and real-world retrospective studies for the treatment of R/R HL patients,but the incidence of severe adverse events was lower in real-world studies than that in clinical studies.
作者
刘珍珍
陶洁
LIU Zhenzhen;TAO Jie(First Hospital of Shanxi Medical University,Taiyuan 030000,China)
出处
《中国全科医学》
北大核心
2023年第S01期92-98,共7页
Chinese General Practice
