Department of Clinical and Experimental Medicine, Hematology, University of Pisa, Pisa, Italy.
Hematology, Azienda Ospedaliera Universitaria Senese, University of Siena, Siena, Italy.
Eur J Haematol. 2022 Oct;109(4):373-380. doi: 10.1111/ejh.13819. Epub 2022 Jul 13.
We investigate safety and efficacy in common clinical practice of the combination of carfilzomib and dexamethasone (Kd56) approved for the ENDEAVOR trial for the treatment of relapsed or refractory multiple myeloma.
We retro-prospective analyzed 75 patients in three centers in Tuscany, 48 of whom had a clinically relevant comorbidity and 50 of whom were older than 65 years, treated with a median use in the fourth line of therapy. We assessed the efficacy based on the International Myeloma Working Group criteria.
The overall response rate was 60%. Median PFS was 10 months in the general cohort; in patients treated for more than 1 cycle of therapy PFS was 12 months. Quality of response to Kd56 treatment was found to positively impact PFS. Refractory status to previous line of therapy or to lenalidomide or an history of exposure to pomalidomide, seemed to have no impact on survival. We also showed a low adverse events rate, with no neuropathy events, and a relatively small number of cardiovascular events above grade 3 (10%).
Kd56 is an effective and well tolerated regimen in highly pretreated and elderly patients with a good safety profile.
我们研究了卡非佐米和地塞米松（Kd56）联合治疗复发性或难治性多发性骨髓瘤的恩达弗尔试验中批准的在普通临床实践中的安全性和疗效。
我们对托斯卡纳三个中心的 75 名患者进行了回顾性分析，其中 48 名患者有临床相关合并症，50 名患者年龄大于 65 岁，中位治疗线数为四线。我们根据国际骨髓瘤工作组的标准评估了疗效。
总缓解率为 60%。在一般队列中，中位无进展生存期为 10 个月；在接受超过 1 个周期治疗的患者中，无进展生存期为 12 个月。Kd56 治疗反应的质量被发现对无进展生存期有积极影响。对前一线治疗、来那度胺或泊马度胺暴露的耐药状态似乎对生存没有影响。我们还显示了较低的不良事件发生率，没有神经病变事件，且 3 级以上心血管事件相对较少（10%）。
Kd56 是一种在高度预处理和老年患者中有效且耐受性良好的方案，具有良好的安全性。
