Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 80 Vasilissis Sophias, 11528, Athens, Greece.
Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Ann Hematol. 2020 May;99(5):1049-1061. doi: 10.1007/s00277-020-03981-z. Epub 2020 Apr 1.
Real-world data on regimens for relapsed/refractory multiple myeloma (RRMM) represent an important component of therapeutic decision-making. This multi-centric, retrospective, observational study conducted by the treating physicians evaluated the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in 155 patients who received ixazomib via early access programs in Greece, the UK, and the Czech Republic. Median age was 68 years; 17% had an Eastern Cooperative Oncology Group performance status ≥ 2; median number of prior therapies was 1 (range 1-7); 91%, 47%, and 17% had received prior bortezomib, thalidomide, and lenalidomide, respectively. Median duration of exposure to ixazomib was 9.6 months. Overall response rate was 74%, including 35% very good partial response or better (16% complete response). Median progression-free survival (PFS) was 27.6 months (27.6 and 19.9 months in patients with 1 or > 1 prior lines, respectively). IRd treatment for ≥ 6 months was associated with longer PFS (hazard ratio 0.06). Fourteen patients (9%) discontinued IRd due to adverse events/toxicity in the absence of disease progression. Peripheral neuropathy was reported in 35% of patients (3% grades 3-4). These findings support the results of the phase III TOURMALINE-MM1 trial in a broader real-world RRMM population.
在复发/难治性多发性骨髓瘤 (RRMM) 患者的治疗决策中,真实世界数据是一个重要组成部分。这项由治疗医生开展的多中心、回顾性、观察性研究评估了伊沙佐米-来那度胺-地塞米松 (IRd) 在希腊、英国和捷克共和国通过早期准入计划接受伊沙佐米治疗的 155 例患者中的有效性和安全性。中位年龄为 68 岁;17%的患者东部肿瘤协作组体能状态 ≥ 2;中位既往治疗数为 1(范围 1-7);91%、47%和 17%的患者分别接受过硼替佐米、沙利度胺和来那度胺治疗。伊沙佐米暴露的中位持续时间为 9.6 个月。总体缓解率为 74%,包括 35%的非常好的部分缓解或更好(16%的完全缓解)。中位无进展生存期 (PFS) 为 27.6 个月(有 1 或 >1 条既往治疗线的患者分别为 27.6 和 19.9 个月)。IRd 治疗≥6 个月与更长的 PFS 相关(风险比 0.06)。由于无疾病进展的不良事件/毒性,有 14 例患者(9%)停止使用 IRd。有 35%的患者报告有周围神经病(3%为 3-4 级)。这些发现支持了 III 期 TOURMALINE-MM1 试验在更广泛的 RRMM 人群中的结果。