摘要
目的:系统评价Daratumumab治疗新诊断不适合移植及复发难治多发性骨髓瘤(MM)的疗效和安全性,以探索MM新的治疗方案。方法:计算机检索PubMed, Embase, Cochrane Library, OVID,Web of Science, Wanfang, CNKI等电子数据库,检索时限为从建库至2020年11月。收集Daratumumab组对比其他疗法治疗新诊断不适合移植及复发难治MM的随机对照试验。由两位评论员按照Cochrane系统评价的方法,分别进行资料提取、质量评价,并交叉核对,RevMan 5.3软件和Stata 15.1软件进行Meta分析。结果:共纳入5项研究,共2964例MM患者,其中3项研究是关于复发难治MM,纳入1521例患者;2项研究是关于新诊断不适合移植MM,纳入1443例患者。在疗效方面,Daratumumab组较对照组,新诊断不适合移植MM亚组和复发难治MM亚组,严格意义的完全缓解、完全缓解、总反应率、12个月无进展生存时间均明显提高。在安全性方面,Daratumumab组较对照组,新诊断不适合移植MM亚组和复发难治MM亚组,3级及以上的血小板减少发生率、淋巴细胞减少发生率、中性粒细胞减少发生率,上呼吸道感染发生率比较差异均无统计学意义,Daratumumab组输注反应发生率为43%。结论:对于新诊断不适合移植及复发难治MM,Daratumumab组与其他疗法比较,严格意义的完全缓解、完全缓解、总反应率、12个月无进展生存时间均明显提高,3级及以上的血小板减少发生率、淋巴细胞减少发生率、中性粒细胞减少发生率、上呼吸道感染发生率均无明显升高,输注反应发生率较高,但可控。
Objective: To systematically review the efficacy and safety of Daratumumab monoclonal antibody in the treatment of ineligible for stem-cell transplantation and relapsed or refractory multiple myeloma(MM), in order to find effective and safe treatment options for MM patients. Methods: A comprehensive search was conducted until November 2020. Two reviewers collected a randomized controlled trial about Daratumumab in the treatment of patients with ineligible for stem-cell transplantation and relapsed or refractory MM. Revman 5.3 software and Stata 15.1 software were used for statistical analysis. Results: A total of 5 studies were included, with 2964 patients enrolled, 3 studies about relapsed or refractory MM, including 1521 patients, 2 studies about ineligible for stem-cell transplantation MM, including 1443 patients. The results of Meta-analysis showed that the treatment plan with Daratumumab could significantly increase the sCR, CR, ORR, 12 months PFS either relapsed or refractory MM group or ineligible for stem-cell transplantation MM group.There were no significant differences in the degrade ≥3 thrombocytopenia rate, the degrade ≥3 lymphopenia rate, the degrade ≥3 neutropenia rate, and upper respiratory tract infection rate. Conclusion: In ineligible for stem-cell transplantation and relapsed or refractory MM, the treatment plan with Daratumumab is effective and safe.
作者
郭怀鹏
康蕾
刘聪
周柰岑
刘英
崔栋
刘利
GUO Huaipeng;KANG Lei;LIU Cong;ZHOU Naicen;LIU Ying;CUI Dong;LIU Li(The Second Affiliated Hospital of Air Force Medical University,Xi'an,710083,China)
出处
《临床血液学杂志》
CAS
2021年第11期795-801,806,共8页
Journal of Clinical Hematology
