以达雷妥尤单抗为基础的联合方案治疗复发难治多发性骨髓瘤的效果与安全性

Efficacy and safety of daratumumab-based combined regimens for relapsed/refractory multiple myeloma

目的探讨以达雷妥尤单抗为基础的联合方案治疗复发难治多发性骨髓瘤(RRMM)的效果与安全性。方法回顾性病例系列研究。回顾性分析2020年1月至2022年12月济宁市第一人民医院38例RRMM患者的临床资料,所有患者均采用以达雷妥尤单抗为基础的联合方案治疗。其中12例采用Dd(达雷妥尤单抗联合地塞米松)方案,20例采用DPD(Dd方案基础上联合泊马度胺)方案,6例采用DVD(Dd方案基础上联合硼替佐米)方案。分析患者疗效和不良反应发生情况,采用Kaplan-Meier法进行生存分析。结果中位随访时间9.5个月(1.0个月,32.5个月),治疗时间中位数6.2个月(3.2个月,25.6个月)。38例患者中完全缓解7例(18.7%),非常好的部分缓解9例(23.6%),部分缓解10例(26.3%),微小缓解4例(10.5%),疾病稳定5例(13.1%),疾病进展3例(7.9%),总有效率(ORR)78.9%(30/38)。Dd方案治疗组ORR 66.7%(8/12),DVD方案治疗组ORR 83.3%(5/6),DPD方案治疗组ORR 85.0%(17/20)。DVD方案治疗组和DPD方案治疗组ORR比较差异无统计学意义(χ^(2)=0.01,P>0.05);DVD方案治疗组和Dd方案治疗组ORR比较差异无统计学意义(χ^(2)=0.55,P>0.05);DPD方案治疗组和Dd方案治疗组ORR比较差异无统计学意义(χ^(2)=1.47,P>0.05)。38例患者中位无进展生存(PFS)时间为12.5个月(95%CI:8.5~24.2个月),中位总生存(OS)时间未达到,1年OS率为89.4%。38例患者中,发生输注反应5例,发生3级中性粒细胞减少7例、3级血小板计数减少9例、重度贫血12例,未发生因不耐受不良反应而停药或药物减量情况。结论以达雷妥尤单抗为基础的联合方案治疗RRMM效果和安全性较好。

Objective To explore the clinical efficacy and safety of daratumumab-based combined regimens for relapsed/refractory multiple myeloma(RRMM).Methods A retrospective case series study was conducted.The clinical data of 38 patients with RRMM in Jining NO.1 People's Hospital from Janunary 2020 to December 2022 were retrospectively analyzed.All patients were treated with daratumumab-based combined regimens.The Dd regimen(12 cases)was treated with daratumumab and dexamethasone,the DPD regimen(20 cases)was treated with pomalodomide based on the Dd regimen,the DVD regimen(6 cases)was treated with bortezomib based on the Dd regimen.The therapeutic efficacy and adverse reactions of all groups were analyzed.Kaplan-Meier method was used for survival analysis.Results The median follow-up time was 9.5 months(1.0 months,32.5 months)and the median treatmemt time was 6.2 months(3.2 months,25.6 months).Among 38 patients,7 cases(18.7%)achieved complete remission,9 cases(23.6%)achieved very good partial remission,10 cases(26.3%)achieved partial remission,4 cases(10.5%)achieved minimal remission,5 cases(13.1%)achieved stable disease,3 cases(7.9%)had the progression of the disease.The overall response rate(ORR)was 78.9%(30/38).The ORR was 66.7%(8/12),83.3%(5/6),85.0%(17/20),respectively in the Dd group,DVD group and DPD group.There was no statistically significant difference in the ORR between the DVD group and DPD group(χ^(2)=0.01,P>0.05);there was no statistically significant difference in the ORR between the DVD group and Dd group(χ^(2)=0.55,P>0.05);there was no statistically significant difference in the ORR between the DPD group and Dd group(χ^(2)=1.47,P>0.05).The median progression-free survival(PFS)time was 12.5 months(95%CI:8.5-24.2 months),the median overall survival(OS)time was not reached,and the 1-year OS rate was 89.4%.Among 38 patients,the main adverse reactions during treatment were infusion-related adverse reactions in 5 cases,grade 3 neutropenia in 7 cases,grade 3 thrombocytopenia in 9 cases,severe anemia in 12 cases;no one had drug discontinuation or drug reduction due to the intolerance of adverse reactions.Conclusions Daratumumab-based combined regimens in the treatment of RRMM show a favorable efficacy and safety.