IHBN - CHU de Caen, Caen, France.
CHU Bordeaux - Hôpital Haut Leveque, Pessac, France.
Ann Hematol. 2023 Aug;102(8):2137-2151. doi: 10.1007/s00277-023-05278-3. Epub 2023 Jun 10.
Ixazomib (IXA) is an oral proteasome inhibitor (PI) used in combination with lenalidomide and dexamethasone (IXA-Rd) for patients with relapsed and/or refractory multiple myeloma (RRMM). The REMIX study is one of the largest prospective, real-world analysis of the effectiveness of IXA-Rd in the setting of RRMM. Conducted in France between August 2017 and October 2019, the REMIX study, a non-interventional prospective study, included 376 patients receiving IXA-Rd in second line or later and followed for at least 24 months. Primary endpoint was the median progression-free survival (mPFS). Median age was 71 years (Q1-Q3 65.0 - 77.5) with 18.4% of participants older than 80 years. IXA-Rd was initiated in L2, L3 and L4 + for 60.4%, 18.1% and 21.5%, respectively. mPFS was 19.1 months (95% CI [15.9, 21.5]) and overall response rate (ORR) was 73.1%. mPFS was 21.5, 21.9 and 5.8 months in patients receiving IXA-Rd as L2, L3, L4 + respectively. Among patients receiving IXA-Rd in L2 and L3, mPFS was similar for patients previously exposed to lenalidomide (19.5 months) than for those lenalidomide naive (not exposed, 22.6 months, p = 0.29). mPFS was 19.1 months in patients younger than 80 years and 17.4 months in those 80 years or older (p = 0.06) with similar ORR (72.4% and 76.8%) in both subgroups. Adverse events (AEs) were reported in 78.2% of patients including 40.7% of treatment-related AE. IXA discontinuation was due to toxicity in 21% of patients. To conclude, the results of the REMIX study are consistent with the results of Tourmaline-MM1 and confirm the benefit of IXA-Rd combination in real life. It shows the interest of IXA-Rd in an older and frailer population, with an acceptable effectiveness and tolerance.
依沙佐米（IXA）是一种口服蛋白酶体抑制剂（PI），与来那度胺和地塞米松联合用于治疗复发和/或难治性多发性骨髓瘤（RRMM）患者。REMIX 研究是最大的前瞻性、真实世界分析依沙佐米在 RRMM 背景下有效性的研究之一。该研究于 2017 年 8 月至 2019 年 10 月在法国进行，是一项非干预性前瞻性研究，共纳入 376 例接受二线或以上依沙佐米-来那度胺-地塞米松（IXA-Rd）治疗且随访至少 24 个月的患者。主要终点为无进展生存期（mPFS）的中位数。中位年龄为 71 岁（Q1-Q3：65.0-77.5），18.4%的患者年龄大于 80 岁。IXA-Rd 起始用于二线、三线和四线+的比例分别为 60.4%、18.1%和 21.5%。mPFS 为 19.1 个月（95%CI [15.9, 21.5]），总缓解率（ORR）为 73.1%。接受 IXA-Rd 二线、三线和四线+治疗的患者的 mPFS 分别为 21.5、21.9 和 5.8 个月。在接受 IXA-Rd 二线和三线治疗的患者中，先前接受来那度胺治疗的患者（19.5 个月）与未曾接受来那度胺治疗的患者（无暴露，22.6 个月）的 mPFS 相似（p=0.29）。mPFS 在 80 岁以下的患者中为 19.1 个月，在 80 岁或以上的患者中为 17.4 个月（p=0.06），两个亚组的 ORR 相似（72.4%和 76.8%）。78.2%的患者报告了不良事件（AE），包括 40.7%的治疗相关 AE。因毒性而停用 IXA 的患者占 21%。总之，REMIX 研究的结果与 Tourmaline-MM1 研究的结果一致，证实了 IXA-Rd 联合治疗在真实世界中的获益。该研究表明，IXA-Rd 对年龄较大和身体更虚弱的人群具有一定的作用，且有效性和耐受性可接受。
