含达雷妥尤单抗方案在复发难治多发性骨髓瘤患者中的疗效与安全性分析  

Analysis of efficacy and safety of daratumumab-containing regimen in relapsed and refractory multiple myeloma patients

作　　者：于倩茹 周霞[2] 吴弘英[2] 郝鲁梅[2] 李雪梅[2] 钟玉萍[2] Yu Qianru;Zhou Xia;Wu Hongying;Hao Lumei;Li Xuemei;Zhong Yuping(School of Clinical Medicine,Weifang Medical University,Weifang 261000,China;Department of Hematology,Qingdao Municipal Hospital(Group),Qingdao 266071,China)

机构地区：[1]潍坊医学院临床医学院,潍坊261000 [2]青岛市市立医院(集团)血液内科,青岛266071

出　　处：《中华医学杂志》2024年第7期521-525,共5页National Medical Journal of China

摘　　要：目的探讨含达雷妥尤单抗的方案在复发难治多发性骨髓瘤(RRMM)患者中的疗效与安全性。方法回顾性分析2020年12月至2023年11月青岛市市立医院收治的42例RRMM患者的临床资料,其中男26例,女16例,年龄为59(47,82)岁。根据患者使用达雷妥尤单抗疗程数不同分为3组:长疗程组(≥9个疗程,n=21)、中疗程组(7~8个疗程,n=12)、短疗程组(≤6个疗程,n=9)。随访截至2023年11月10日,随访时间为15.6(6.0,34.0)个月。患者完成至少2个疗程的治疗后进行疗效评估,包括严格意义上的完全缓解(sCR)、完全缓解(CR)、非常好的部分缓解(VGPR)、部分缓解(PR)、微小缓解(MR)、疾病稳定(SD)和疾病进展(PD)。统计分析患者基本临床特征、治疗的总有效率以及不良反应。采用Kaplan-Meier法绘制生存曲线,比较不同疗程数组间无进展生存时间(PFS)的差异。结果42例患者中,15例(35.7%)合并髓外病变或浆细胞白血病,7例(16.6%)合并淀粉样变性,18例(42.9%)合并肾功能不全。Mayo分期中,骨髓瘤细胞遗传学分层高危25例(59.5%)、标危8例(19%)、因各种原因未获得细胞遗传学数据9例(21.4%)。接受2线治疗的患者16例(38.0%),3线治疗的患者13例(31.0%),4线以上治疗的患者13例(31.0%)。所有患者均接受至少2个疗程的治疗,达到的最佳疾病缓解程度为sCR 4例(9.5%)、CR 3例(7.1%)、VGPR 10例(23.8%)、PR 11例(26.2%)、MR 6例(14.2%),总有效率为80.9%(34/42)。其中长疗程组总有效率为100%(21/21),中疗程组总有效率为91.6%(11/12),短疗程组总有效率为22.2%(2/9)。Kaplan-Meier生存分析显示,短疗程组PFS为5.0(95%CI:3.1~6.9)个月,中疗程组PFS>8.0个月,长疗程组PFS>38.0个月,差异有统计学意义(P<0.05)。≥3级不良反应主要为中性粒细胞减少(3例)、血小板减少(1例)。没有患者因为不良反应终止治疗。结论含达雷妥尤单抗方案治疗RRMM需要更长的疗程数才能达到最大疗效,不良反应可控。Objective To investigate the efficacy and safety in relapsed and refractory multiple myeloma(RRMM)patients with combination regimen of daratumumab.Methods The clinical data of 42 RRMM patients admitted to Qingdao Municipal Hospital from December 2020 to November 2023 were retrospectively analyzed,which included 26 males and 16 females,with a median age of 59(47,82)years old.According to the number of courses of treatment with Daratumumab,patients were divided into three groups:long course group(≥9 courses,n=21),medium course group(7-8 courses,n=12),and short course group(≤6 courses,n=9).The deadline for follow-up was November 10,2023,and the follow-up period was 15.6(6.0,34.0)months.After completing at least 2 courses of treatment,patients were evaluated for efficacy,including stringent complete response(sCR),complete response(CR),very good partial response(VGPR),partial response(PR),minimal response(MR),stable disease(SD),and progressive disease(PD).Basic clinical characteristics of patients,overall response rate of treatment,and adverse reactions were statistically analyzed.Kaplan-Meier method was used to compare the differences of progression-free survival(PFS)in patients with different courses of treatment.Results Among the 42 patients,15(35.7%)had extramedullary disease or plasmacytic leukemia,7(16.6%)had amyloidosis,and 18(42.9%)had renal insufficiency.In Mayo stage,25 patients(59.5%)were at high risk of myeloma cytogenetic stratification,8 patients(19%)were standard risk,9 patients(21.4%)had no cytogenetic data.There were 16 patients with second-line treatment(38.0%),13 patients with third-line treatment(31%),and 13 patients with more than fourth-line treatment(31%).All patients received at least 2 courses of treatment,achieving the best degree of disease response in 4 cases of sCR(9.5%),3 cases of CR(7.1%),10 cases of VGPR(23.8%),11 cases of PR(26.2%),and 6 cases of MR(14.2%).The overall response rate(ORR)was 80.9%(34/42).The overall response rate was 100%(21/21)in the long course group,91.6%(11/12)in

关 键 词：多发性骨髓瘤 达雷妥尤单抗 疗效 安全性 

分 类 号：R733.3[医药卫生—肿瘤]