达雷妥尤单抗联合方案治疗初诊多发性骨髓瘤效果观察

Efficacy observation of daratumumab-combination regimens for newly diagnosed multiple myeloma

目的探讨达雷妥尤单抗(Dara)联合方案治疗初诊多发性骨髓瘤(NDMM)的效果及安全性。方法回顾性病例系列研究。回顾性收集山东大学齐鲁医院、烟台市毓璜顶医院、青岛医学院附属医院黄岛院区、泰安市中心医院2020年4月至2022年3月应用含Dara方案治疗的34例NDMM患者临床资料。分析患者疗效、生存及不良反应发生情况。采用Cox比例风险模型分析患者总生存(OS)及微小残留病(MRD)转阴的影响因素。结果34例NDMM患者中,男性19例,女性15例;年龄<65岁21例,≥65岁13例。中位随访时间[M(Q1,Q3)]为22个月(19个月,26个月),应用Dara周期数的中位数为7个(5个,11个),总体反应率(ORR)97.1%(33/34)。是否接受造血干细胞移植、治疗不同周期数分层患者间最佳疗效分布差异均有统计学意义(均P≤0.05),其他临床特征分层患者间差异均无统计学意义(均P>0.05)。1年无进展生存率79.4%,1年OS率94.1%。多因素Cox回归分析结果显示,含Dara方案治疗周期数是MRD转阴的独立影响因素(6个周期比2个周期,HR=0.267,95%CI:0.076~0.935,P=0.039),年龄≥65岁为OS的独立危险因素(HR=35.313,95%CI:1.709~729.669,P=0.021)。3级及以上血液学不良反应发生率为20.6%(7/34),非血液学不良反应主要为感染[44.1%(15/34)]、四肢及躯干水肿[41.2%(14/34)]。结论以Dara为基础的方案治疗NDMM的ORR较高,随着治疗周期数的增加,缓解深度加深,且不良反应较轻。

Objective To investigate the efficacy and safety of daratumumab(Dara)-combination regimens for newly diagnosed multiple myeloma(NDMM).Methods A retrospective case series study was conducted.The clinical data of 34 patients with NDMM receiving treatment regimen including Dara from Qilu Hospital of Shandong University,Yantai Yuhuangding Hospital,Huangdao Branch of Affiliated Hospital of Qingdao University and Taian City Central Hospital between April 2020 and March 2022 were retrospectively collected.The efficacy,survival and adverse reactions of patients were analyzed.Cox proportional risk model was used to analyze the factors affecting overall survival(OS)and minimal residual disease(MRD)turning negative.Results Among 34 patients with NDMM,there were 19 males and 15 females,with 21 cases aged<65 years and 13 cases aged≥65 years.The median follow-up duration[M(Q1,Q3)]was 22 months(19 months,26 months),the median of Dara treatment cycles was 7(5,11),and the overall response rate(ORR)reached 97.1%(33/34).There were statistically significant differences in the optimal efficacy of patients stratified by receiving hematopoietic stem cell transplantation or not and receiving different treatment cycles(all P≤0.05),while there were no statistically significant differences in patients stratified by other clinical features(all P>0.05).The 1-year progression-free survival rate was 79.4%and the 1-year OS rate was 94.1%.Multivariate Cox regression analysis showed that the cycle number of treatment regimens containing Dara was an independent influencing factor of MRD turning negative(6 cycles vs.2 cycles,HR=0.267,95%CI:0.076-0.935,P=0.039);age≥65 years was an independent risk factor for OS(HR=35.313,95%CI:1.709-729.669,P=0.021).The incidence of hematological adverse reactions grade 3 or above was 20.6%(7/34),and the non-hematological adverse reactions primarily included infection[44.1%(15/34)]and edema of extremity and trunk[41.2%(14/34)].Conclusions The Dara-based regimens for NDMM exhibit a high ORR.The remission depth accelerated with the increasing number of treatment cycle,and the adverse reactions are mild.