Ixazomib-lenalidomid-dexamethasone (IRd) in relapsed refractory multiple myeloma (RRMM)-multicenter real-world analysis from Germany and comparative review of the literature.

IF 3 3区 医学 Q2 HEMATOLOGY
Hanna Löffler, Magdalena Braun, Heike Reinhardt, Amelie Rösner, Gabriele Ihorst, Jan Räder, Sina Wenger, Annamaria Brioli, Marie von Lilienfeld-Toal, Maika Klaiber-Hakimi, Eva-Marie Fehr, Markus Munder, Katharina Epp, Karolin Trautmann-Grill, Sarah Decker, Holger Hoff, Ralph Wäsch, Monika Engelhardt
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引用次数: 0

Abstract

With the introduction of novel agents (proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), immuntherapeutics), the outcome of multiple myeloma (MM) patients has improved. The oral PI ixazomib was authorized in the EU in 11/2016 and is indicated in combination with lenalidomide and dexamethasone (IRd) for the treatment of patients with relapsed/refractory MM (RRMM). The study aim was to identify the typical real world (RW) RRMM patient population in Germany treated with IRd and to compare the outcome to prior IRd cohorts. Our retrospective study included consecutive RRMM patients receiving IRd in six large German hospitals between 06/2017 and 12/2021. We identified 24 consecutive RRMM patients within these six institutions. Their median age was 68 years at the start of IRd; 21% carrying high-risk cytogenetics [del17p, t(4;14) and/or t(14;16)]. Patients had a median of 2 prior treatment lines (range, 1-5), prior PI/IMiD exposure was 100%/58%, comparable to previous real world evidence (RWE)-studies. With a median follow-up of 37.7 months, the overall response rate was 70.8%, and median PFS and OS were 22.0 and 62.2 months, respectively. With these German data, our study is closing an important gap of IRd real world data (RWD) reporting across Europe, providing median PFS/OS data and comparison to prior IRd studies. IRd is a well-tolerated and effective triplet regimen, often given as 2nd or 3rd-line therapy in RRMM, with results confirming the registration trial and other international RW-analyses.

伊沙唑米-来那度米-地塞米松(IRd)治疗复发性难治性多发性骨髓瘤(RRMM)——来自德国的多中心真实世界分析和文献比较回顾
随着新型药物(蛋白酶体抑制剂(PIs)、免疫调节药物(IMiDs)、免疫疗法)的引入,多发性骨髓瘤(MM)患者的预后得到了改善。口服PI ixazomib于2016年11月在欧盟获得批准,并与来那度胺和地塞米松(IRd)联合用于治疗复发/难治性MM (RRMM)患者。该研究的目的是确定德国接受IRd治疗的典型现实世界(RW) RRMM患者群体,并将结果与之前的IRd队列进行比较。我们的回顾性研究纳入了2017年6月至2021年12月期间在德国6家大型医院接受IRd治疗的连续RRMM患者。我们在这6个机构中确定了24例连续的RRMM患者。研究开始时,他们的中位年龄为68岁;21%携带高危细胞遗传学[del17p, t(4;14)和/或t(14;16)]。患者既往治疗线中位数为2条(范围1-5),既往PI/IMiD暴露率为100%/58%,与之前的真实世界证据(RWE)研究相当。中位随访37.7个月,总有效率为70.8%,中位PFS和OS分别为22.0和62.2个月。有了这些德国数据,我们的研究缩小了整个欧洲的IRd真实世界数据(RWD)报告的重要差距,提供了中位数PFS/OS数据,并与之前的IRd研究进行了比较。IRd是一种耐受性良好且有效的三联疗法,通常作为RRMM的二线或三线治疗,其结果证实了注册试验和其他国际rw分析。
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来源期刊
Annals of Hematology
Annals of Hematology 医学-血液学
CiteScore
5.60
自引率
2.90%
发文量
304
审稿时长
2 months
期刊介绍: Annals of Hematology covers the whole spectrum of clinical and experimental hematology, hemostaseology, blood transfusion, and related aspects of medical oncology, including diagnosis and treatment of leukemias, lymphatic neoplasias and solid tumors, and transplantation of hematopoietic stem cells. Coverage includes general aspects of oncology, molecular biology and immunology as pertinent to problems of human blood disease. The journal is associated with the German Society for Hematology and Medical Oncology, and the Austrian Society for Hematology and Oncology.
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