Jiang Fengjuan, Chen Jin, Liu Hui, Li Lijuan, Lu Wenli, Fu Rong
1Department of Hematology, Tianjin Medical University General Hospital, 154 Anshan Street, Heping District, Tianjin, 300052 People's Republic of China.
3Department of Graduate School, Tianjin Medical University, Tianjin, 300070 People's Republic of China.
Indian J Hematol Blood Transfus. 2018 Apr;34(2):216-226. doi: 10.1007/s12288-018-0937-x. Epub 2018 Mar 7.
Bortezomib began to be used in the treatment of light chain (AL) amyloidosis in recent years. We performed the first meta-analysis of randomized clinical trials and clinical controlled trials to evaluate the effect and safety of bortezomib treatment for AL amyloidosis. We conducted a search (until July 2016) in electronic databases (PubMed databases and the Cochrane Central Register of Controlled Trials bases from the year 2003). There were 205 records we searched and eight studies was included (n = 617 persons). We demonstrated that bortezomib treatment significantly improved overall response rate (ORR), complete response, a cardiac response rate, 2-year overall survival and the risk of neuropathy and reduced overall mortality compared to controls without bortezomib therapy. From the comparison and subgroup analysis of ORR between bortezomib group and no bortezomib group, the patients with bortezomib had a higher ORR, especially patients pretreated with bortezomib before high-dose melphalan followed by autologous stem cell transplant compared to no pretreatment. In addition, patients with bortezomib in standard dosage had significantly higher ORR. According to our results, bortezomib should be used in AL amyloidosis patients to improve response rate and survival rate and future relevant randomized controlled trials require to be performed.
硼替佐米近年来开始用于治疗轻链(AL)淀粉样变性。我们首次对随机临床试验和临床对照试验进行荟萃分析,以评估硼替佐米治疗AL淀粉样变性的效果和安全性。我们在电子数据库(2003年以来的PubMed数据库和Cochrane对照试验中央注册库)中进行检索(截至2016年7月)。共检索到205条记录,纳入8项研究(n = 617人)。我们证明,与未接受硼替佐米治疗的对照组相比,硼替佐米治疗显著提高了总缓解率(ORR)、完全缓解率、心脏缓解率、2年总生存率,降低了神经病变风险和总死亡率。通过硼替佐米组和非硼替佐米组之间ORR的比较和亚组分析,接受硼替佐米治疗的患者ORR更高,尤其是与未进行预处理相比,在大剂量美法仑联合自体干细胞移植前接受硼替佐米预处理的患者。此外,标准剂量硼替佐米治疗的患者ORR显著更高。根据我们的结果,硼替佐米应用于AL淀粉样变性患者以提高缓解率和生存率,未来需要开展相关随机对照试验。