Ye Ziqi, Chen Jie, Xuan Zixue, Yang Wenchao, Chen Jing
Department of Pharmacy, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
Department of Pharmacy, the Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
Drug Des Devel Ther. 2019 May 16;13:1707-1716. doi: 10.2147/DDDT.S198117. eCollection 2019.
Administration of subcutaneous (SC) bortezomib in patients with multiple myeloma (MM) has increased in recent years. Yet, it is unclear whether there is sufficient evidence to support the use of SC bortezomib as a standard of care. A systematic review of 4 randomized controlled trials and 8 retrospective trials comparing SC to intravenous (IV) bortezomib among 1,857 MM patients was performed. Embase, PubMed, Clinical Trials.gov, Cochrane Library and reference lists were searched for relevant studies from inception until August 2018. Outcomes of interest included 1-year overall survival (OS), 1-year progression-free survival (PFS), objective response rate (ORR) and adverse events (AEs). Random events meta-analyses were performed. We also performed sensitivity analysis to examine whether the results of the meta-analysis were robust. Compared to IV administration, SC bortezomib had a significantly lower incidence of some all-grade or grade 3-4 AE, such as peripheral sensory neuropathy, leukopenia and thrombocytopenia (<0.05). There was no statistical difference in 1-year OS, 1-year PFS, ORR between SC and IV bortezomib (>0.05). The data presented so far consistently show that SC bortezomib has become a standard of care for patients with MM.
近年来,皮下注射(SC)硼替佐米用于多发性骨髓瘤(MM)患者的情况有所增加。然而,目前尚不清楚是否有足够的证据支持将皮下注射硼替佐米作为一种标准治疗方法。我们对4项随机对照试验和8项回顾性试验进行了系统评价,这些试验比较了1857例MM患者皮下注射与静脉注射(IV)硼替佐米的效果。检索了Embase、PubMed、ClinicalTrials.gov、Cochrane图书馆以及参考文献列表,以查找从开始到2018年8月的相关研究。感兴趣的结果包括1年总生存期(OS)、1年无进展生存期(PFS)、客观缓解率(ORR)和不良事件(AE)。进行了随机事件荟萃分析。我们还进行了敏感性分析,以检验荟萃分析的结果是否可靠。与静脉注射相比,皮下注射硼替佐米的一些全级或3-4级AE(如周围感觉神经病变、白细胞减少和血小板减少)的发生率显著较低(<0.05)。皮下注射与静脉注射硼替佐米在1年OS、1年PFS、ORR方面无统计学差异(>0.05)。目前提供的数据一致表明,皮下注射硼替佐米已成为MM患者的一种标准治疗方法。