泽布替尼治疗B细胞淋巴瘤的快速卫生技术评估

Rapid health technology assessment of zanubrutinib in the treatment of B cell lymphomas

目的快速评估新型高选择性布鲁顿酪氨酸激酶(BTK)抑制剂泽布替尼在慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)和套细胞淋巴瘤(MCL)治疗中的有效性、安全性和经济性。方法通过检索PubMed、Cochrane Library、中国知网、万方数据库、维普及卫生技术评估(HTA)网站,收集与泽布替尼相关的系统评价/Meta分析、随机对照试验、药物经济学研究和HTA报告,检索时限为建库/网站起至2023年7月。按照纳入与排除标准筛选文献,分别用相应的评估工具对文献质量进行评价。提取文献数据,对数据进行定性描述。结果共纳入5篇文献,其中3篇为随机对照试验,2篇为经济学研究。在有效性方面,与对照组比较,接受泽布替尼治疗的患者无进展生存期显著延长(P<0.05),总缓解率更高(P<0.05),但两组总生存时间的差异无统计学意义(P>0.05)。在安全性方面,泽布替尼相对于第一代BTK抑制剂伊布替尼的心脏不良事件、主要出血事件发生率和因药物不良事件导致的停药率较低,但相对于传统的化学免疫疗法(苯达莫司汀+利妥昔单抗),泽布替尼的出血事件发生风险仍较高。在经济性方面,泽布替尼相较于伊布替尼在复发或难治MCL患者的治疗中更具有经济性。结论泽布替尼在CLL/SLL和MCL患者中展现出良好的有效性和安全性,同时对于复发或难治的MCL患者具备有一定的经济性优势。

OBJECTIVE To rapidly assess the efficacy,safety and cost-effectiveness of novel highly selective Bruton’s tyrosine kinase(BTK)inhibitor zanubrutinib in the treatment of chronic lymphocytic leukemia(CLL),small lymphocytic lymphoma(SLL)and mantle cell lymphoma(MCL).METHODS Retrieved from PubMed,Cochrane Library,CNKI,Wanfang database,VIP,and health technology assessment(HTA)websites,systematic reviews/meta-analyses,randomized controlled trials(RCTs),pharmacoeconomic studies and HTA reports related to zanubrutinib were collected from the database/website establishment to July 2023.The literature was screened according to inclusion and exclusion criteria,and its quality was assessed by using relevant evaluation tools.Data extraction was presented by qualitative description.RESULTS A total of 5 literature were included,comprising of 3 RCTs and 2 cost-effectiveness analyses.In terms of efficacy,compared with the control group,zanubrutinib treatment resulted in significantly longer progression-free survival(P<0.05)and a higher overall response rate(P<0.05).However,there was no statistical significance in overall survival between 2 groups(P>0.05).In terms of safety,zanubrutinib had lower incidence of cardiac adverse events,incidence of major bleeding events,and drug discontinuation rate due to adverse drug events,compared to first-generation BTK inhibitors ibrutinib;but the risk of bleeding events caused by zanubrutinib was still higher,compared to traditional chemoimmunotherapy(bendamotine+rituximab).In terms of cost-effectiveness,zanubrutinib was found to be cost-effective in the treatment of recurrent or refractory MCL,compared to ibrutinib.CONCLUSIONS Zanubrutinib demonstrates sound efficacy and safety in patients with CLL/SLL and MCL patients.Furthermore,it exhibits economic advantages for patients with relapsed or refractory MCL.