摘要
目的 比较硼替佐米联合环磷酰胺、地塞米松(VCD)方案与硼替佐米联合来那度胺、地塞米松(VRD)方案在不适合移植的新诊断多发性骨髓瘤(NDMM)患者中的疗效,为临床治疗方案选择提供依据。方法 选取2019年12月至2024年11月的NDMM患者,分为VCD组和VRD组。疗效的评价标准包括完全缓解(CR)、非常好的部分缓解(VGPR)、总缓解率(ORR)及不良反应发生率,logistic回归评估达到VGPR的影响因素。同时比较两组患者无进展生存期(PFS)和总生存期(OS)。结果 共纳入患者60例,每组各30例。治疗4个周期后,达到(VGPR+CR)率VCD组和VRD组分别为40.00%(16.7%+23.3%)和46.67%(26.7%+20.0%);ORR率VCD组和VRD组分别为73.33%和76.67%,差异均无统计学意义(P>0.05)。两组患者治疗期间3级及以上不良反应发生率差异亦无统计学意义(P>0.05)。ISSⅢ期(OR=2.059,95%CI:1.129~3.768,P=0.020)和高危细胞遗传学风险(OR=2.312,95%CI:1.247~4.305,P=0.008)是影响VGPR的独立危险因素。随访截至2025年3月25日,中位PFS VCD组为52.20个月,VRD组为50.00个月,两组患者中位OS均未达到,两组患者累计PFS(χ^(2)=2.163,P=0.141)和OS(χ^(2)=0.823,P=0.367)差异均无统计学意义(P>0.05)。结论 VCD与VRD方案治疗不适合移植的NDMM患者中短期疗效与安全性相当,ISSⅢ期和高危细胞遗传学显著影响疗效,临床需结合患者个体风险特征优化治疗方案选择。
Objective To compare the early efficacy of bortezomib combined with cyclophosphamide or dexamethasone(VCD)and bortezomib combined with lenalidomide or dexamethasone(VRD)for patients with newly diagnosed multiple myeloma(NDMM)who are not suitable for transplantation,and to provide basis for the selection of clinical treatment.Methods A total of 60 NDMM patients from December 2019 to November 2024 were selected,divided into the VCD group and the VRD group.The early efficacy included complete response(CR),better partial response(VGPR),overall response rate(ORR)and adverse events rate.Logistic regression was used to evaluate the influencing factors of VGPR achievement.The progression free survival(PFs)and overall survival(Os)were compared between the two groups.Results After 4 cycles of treatment,achieve(VGPR+CR)rate of VCD group and VRD group were 40.00%(16.7%+23.3%)and 46.67%(26.7%+20.0%),respectively,and the ORR rate of VCD group and VRD group were 73.33%and 76.67%,and with no significant difference between the two groups.There was no significant difference in grade 3 and above adverse events between the two groups during treatment.ISS II(OR:2.059,95%CI:1.129-3.768,P=0.020)and high-risk cytogenetic risk(OR:2.312,95%CI:1.247-4.305,P=0.008)were independent risk factors for VGPR.Up to March 25,2025,the median PFS of VCD group was 52.20 months and that of VRD group was 50.00 months.The median OS of the two groups had not yet reached.There was no significant difference in cumulative PFS(χ^(2)=2.163,P=0.141)and OS(χ^(2)=0.823,P=0.367)between the two groups.Conclusion The short-term efficacy and safety of VCD and VRD regimens in NDMM patients who are not suitable for transplantation are equivalent.isS stage II and high-risk cytogenetics significantly affect the early efficacy.Clinical treatment options should be optimized according to the individual risk characteristics of patients.
作者
许凌云
李晨
XU Lingyun;LI Chen(Department of Hematology,Fuyang People's Hospital,Anhui Fuyang,236000,China)
出处
《临床药物治疗杂志》
2025年第7期51-56,共6页
Clinical Medication Journal
基金
2020年度安徽省自然科学基金(2008085MH249)
2024年度安徽省卫生健康科研项目(AHWJ2024Ab0095)。
