达雷妥尤单抗为基础的方案治疗伴肾功能损害的多发性骨髓瘤患者的疗效与安全性

The Efficacy and Safety of Daratumumab-Based Regimen in Treatment of Multiple Myeloma Patients with Renal Impairment

目的:探讨达雷妥尤单抗为基础的方案治疗伴肾功能损害的多发性骨髓瘤(MM)患者的疗效与安全性。方法:回顾性分析2021年1月至2022年3月于3家医院接受以达雷妥尤单抗为基础的方案治疗的15例伴肾功能损害MM患者的临床资料,患者分别接受达雷妥尤单抗单药、达雷妥尤单抗联合地塞米松或达雷妥尤单抗联合硼替佐米、地塞米松方案治疗,分析其疗效和生存情况。结果:15例患者中位年龄64(54-82)岁,其中IgG型6例,IgA型2例,IgD型1例,轻链型6例。中位肾小球滤过率(eGFR)为22.48 ml/(min·1.73 m^(2))。11例可判断疗效的MM患者,总体反应率为91%(10/11例),其中严格意义的完全缓解(sCR)1例,非常好的部分缓解(VGPR)2例,部分缓解(PR)3例,微小缓解(MR)4例。15例患者可评价肾脏反应,总体反应率为60%(9/15例),其中完全缓解(CR)4例,PR 1例,MR 4例。达最佳肾脏反应的中位时间为21(7-56)d。中位随访时间3个月,15例患者的中位无进展生存期和中位总生存期未达到。应用达雷妥尤单抗为基础的方案治疗后,血液学不良反应主要为1-2级中性粒细胞减少,非血液学不良反应主要为输液相关不良反应和感染。结论:以达雷妥尤单抗为基础的方案治疗伴肾功能损害的多发性骨髓瘤患者具有较好的近期疗效及安全性。

Objective: To investigate the efficacy and safety of daratumumab in treatment of multiple myeloma(MM) patients with renal impairment(RI). Methods: The clinical data of 15 MM patients with RI who received daratumumab-based regimen from January 2021 to March 2022 in three centers were retrospectively analyzed. Patients were treated with daratumumab or daratumumab combined with dexamethasone or daratumumab combined with bortezomib and dexamethasone and the curative effect and survival were analyzed. Results: The median age of 15 patients was 64(ranged 54-82) years old. Six patients were IgG-MM, 2 were IgA-MM,1 was IgD-MM and 6 were light chain MM. Median estinated glomerular filtration rate(eGFR) was 22.48 ml/(min·1.73 m^(2)). Overall response rate of 11 patients with MM was 91%(≥MR), including 1 case of stringent complete response(sCR), 2 cases of very good partial response(VGPR), 3 cases of partial response(PR) and 4 cases of minor response(MR). The rate of renal response was 60%(9/15), including 4 cases of complete response(CR), 1 case of PR and 4 cases of MR. A median time of optimal renal response was 21(ranged 7-56) days. With a median follow-up of 3 months, the median progression-free survival and overall survival of all patients were not reached. After treatment with daratumumab-based regimen, grade 1-2 neutropenia was the most common hematological adverse reaction. Non-hematological adverse reactions were mainly infusion-related adverse reactions and infections. Conclusion: Daratumumab-based regimens have good short-term efficacy and safety in the treatment of multiple myeloma patients w ith renal impairment.