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Real-world effectiveness and safety of ixazomib-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma.
Annals of Hematology ( IF 3.5 ) Pub Date : 2020-04-01 , DOI: 10.1007/s00277-020-03981-z
Evangelos Terpos 1 , Karthik Ramasamy 2, 3 , Nadjoua Maouche 2, 4 , Jiri Minarik 5 , Ioannis Ntanasis-Stathopoulos 1 , Eirini Katodritou 6 , Matthew W Jenner 7 , Hana Plonkova 8 , Maria Gavriatopoulou 1 , Grant D Vallance 2 , Tomas Pika 5 , Maria Kotsopoulou 9 , Jaimal Kothari 2, 3 , Tomas Jelinek 8 , Efstathios Kastritis 1 , Robin Aitchison 10 , Meletios A Dimopoulos 1 , Athanasios Zomas 11 , Roman Hajek 8
Affiliation  

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.

中文翻译:

埃沙佐米-来那度胺-地塞米松在复发/难治性多发性骨髓瘤中的实际疗效和安全性。

复发/难治性多发性骨髓瘤(RRMM)治疗方案的真实数据代表了治疗决策的重要组成部分。由主治医师进行的这项多中心,回顾性观察研究评估了ixazomib-来那度胺-地塞米松(IRd)在155位通过希腊,英国和捷克共和国的早期抢救计划接受ixazomib的患者中的有效性和安全性。中位年龄为68岁。东部合作肿瘤小组的表现状态≥2的占17%;先前治疗的中位数为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。ixazomib的中位暴露时间为9.6个月。总体缓解率为74%,包括35%或更高的部分缓解或更好(16%的完全缓解)。中位无进展生存期(PFS)为27.6个月(先前有1例或> 1例的患者分别为27.6和19.9个月)。IRd治疗≥6个月与更长的PFS相关(危险比0.06)。在没有疾病进展的情况下,由于不良事件/毒性,有14名患者(9%)停用IRd。在35%的患者中报告了周围神经病变(3-4%为3%)。这些发现支持了在更广泛的实际RRMM人群中进行的TOURMALINE-MM1 III期试验的结果。在35%的患者中报告了周围神经病变(3-4%为3%)。这些发现支持了在更广泛的实际RRMM人群中进行的TOURMALINE-MM1 III期试验的结果。在35%的患者中报告了周围神经病变(3-4%为3%)。这些发现支持了在更广泛的实际RRMM人群中进行的TOURMALINE-MM1 III期试验的结果。
更新日期:2020-04-01
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