RVD方案对新诊断多发性骨髓瘤患者缓解深度的研究

A combination of lenalidomide, bortezomib, and dexamethasone(RVD) provides deeper responses in patients with newly diagnosed multiple myeloma

目的:分析来那度胺、硼替佐米及地塞米松(lenalidomide,bortezomib and dexamethasone,RVD)方案治疗新诊断多发性骨髓瘤(newly diagnosed multiple myeloma,NDMM)患者的疗效和安全性.方法:回顾性分析2015年1月至2019年5月首都医科大学附属北京朝阳医院收治的48例NDMM患者,统计其临床特征及治疗疗效.结果:48例患者的中位年龄为59(34~79)岁,Durie-Salmon分期Ⅲ期患者44例;ISS分期Ⅱ期患者15例,Ⅲ期患者19例,12例伴浆细胞瘤,细胞遗传学高危患者占32.5%.全部患者接受RVD方案化疗,中位4(1~9)个周期,总有效率97.9%,完全缓解(complete response,CR)率为35.4%,4个周期较2个周期化疗后非常好的部分缓解(very good partial response,VGPR)以上疗效提高为(84.6% vs. 64.1%);平均采集CD34+细胞数4.2(±2.6)×106/kg;诱导治疗后下一代流式微小残留病变(minimal residual disease,MRD)阴性率为20.6%,其中2例移植前MRD阳性者在移植后MRD转阴.治疗过程中2例发生3~4级血液学毒性,未发生3级以上非血液学不良事件.结论:采用RVD方案治疗NDMM患者4个疗程,缓解率高,不良反应可耐受,且不影响干细胞采集.RVD诱导联合自体造血干细胞移植可进一步提高MRD阴性率.

Objective:This study investigated the efficacy and safety of a combination of lenalidomide,bortezomib,and dexametha-sone(RVD)in patients with newly diagnosed multiple myeloma(NDMM).Methods:The clinical features and responses of 48 patients with NDMM who were treated with RVD from January 2015 to May 2019 in Beijing Chaoyang Hospital were retrospectively analyzed.Results:The median age of the 48 patients was 59 years(range:34-79).Among these,44 patients were Durie-Salmon stageⅢ,15 were ISS stageⅡ,19 were ISS stageⅢ,and 12 had plasmacytoma;32.5%of all patients were cytogenetic high-risk.All patients re-ceived a median of four cycles(range:1-9)of the RVD regimen as induction treatment.The overall response rate was 97.9%,with 35.4%of patients achieving complete response(CR)or better.The rate of very good partial remission(VGPR)or better was increased from 64.1%(after two cycles)to 84.6%(after four cycles).The mean collection of CD34+cells was 4.2(±2.6)×106/kg.Negative minimal residual disease(MRD),as indicated by next-generation flow(NGF),was achieved in 20.6%of patients after induction.Two patients with positive MRD after induction became MRD negative after transplantation.Two patients developed grade 3 or 4 hematologic toxic-ity.No nonhematologic toxicity of grade 3 or 4 was observed.Conclusions:In patients with NDMM,RVD treatment resulted in signifi-cantly improved response rates and exhibited an acceptable risk-benefit profile,with no adverse impact on stem cell collection.RVD combined with transplantation significantly improved the negative rate of MRD,as indicated by NGF.