JAMA Oncol:卡非佐米+来那度胺+地塞米松继以来那度胺维持可有效预防高危冒烟型骨髓瘤进展成多发性骨髓瘤

2021-09-23 Nebula MedSci原创

高危冒烟型骨髓瘤采用新的三联治疗方案,如 KRd 和来那度胺维持治疗,或可通过显著延迟终末器官疾病的发展而改变冒烟型骨髓瘤的自然史

冒烟型骨髓瘤 (smoldering myeloma) 是指符合多发性骨髓瘤诊断标准,但病情进展缓慢且没有临床症状的多发性骨髓瘤。高危的冒烟型骨髓瘤在5年内发展为症状性多发性骨髓瘤的风险约为75%。来那度胺治疗可降低进展风险;但是,新的三联治疗方案的效果更好,早期冒烟型骨髓瘤可能对治疗更敏感。

本研究旨在评估卡非佐米(carfilzomib)、来那度胺和地塞米松 (KRd) 联合来那度胺维持治疗作为高危的冒烟型骨髓瘤的早期干预的效果,以确定微小残留病灶(MRD)阴性的完全缓解(CR)的发生率。

研究流程

这是一项单臂、单中心的 2 期非随机对照试验,评估了 KRd 治疗后的缓解率。早期冒烟型骨髓瘤患者接受 8 个疗程的KRd 治疗,继以 28 个疗程的来那度胺维持治疗。主要终点是 MRD 阴性的完全缓解率。次要终点包括 MRD 阴性完全缓解的持续时间和进展成多发性骨髓瘤的发生率。

无进展成多发性骨髓瘤的生存率

共招募了 54 位患者(中位年龄 59岁,30 位男性),中位随访了 31.9 个月(范围 6.7-102.9 个月)。MRD 阴性的完全缓解率为 70.4%(95% CI 56.4%-82.0%),缓解中位持续时间为 5.5 年。8 年内无进展为多发性骨髓瘤的概率为 91.2%(95% CI 67.4%-97.9%),无死亡发生。21 位(38.9%)患者发生了 3 级的非血液学不良事件,包括血小板减少症、红疹和肺感染,无 4 级不良事件。

总结,该研究结果提示高危冒烟型骨髓瘤采用新的三联治疗方案,如 KRd 和来那度胺维持治疗,或可通过显著延迟终末器官疾病的发展而改变冒烟型骨髓瘤的自然史

原始出处:

Kazandjian D, Hill E, Dew A, et al. Carfilzomib, Lenalidomide, and Dexamethasone Followed by Lenalidomide Maintenance for Prevention of Symptomatic Multiple Myeloma in Patients With High-risk Smoldering Myeloma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. Published online September 16, 2021. doi:10.1001/jamaoncol.2021.3971

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    2022-08-17 jml2009
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    2022-07-10 屋顶瞄爱赏月

    签到学习

    0

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    2022-05-27 清风徐来2022

    #卡非佐米#+#来那度胺#+地塞米松继以来那度胺维持可有效预防高危#冒烟型骨髓瘤#进展成#多发性骨髓瘤#

    0

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    2022-07-01 minlingfeng

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