JCO：3期TOURMALINE-MM1试验| 复发/难治性MM患者采用伊沙佐米-来那度胺-地塞米松治疗的总生存期终分析

2021-06-11 Nebula MedSci原创

具有不良预后因素的亚组患者可从ixazomib-Rd治疗中获得更大的OS效益

双盲、安慰剂为对照的3期TOURMALINE-MM1研究表明伊沙佐米-来那度胺-地塞米松（ixazomib-Rd）方案相比安慰剂-Rd能显著改善复发/难治性多发性骨髓瘤患者的无进展生存期。本文报告了该研究总生存期（OS）的最终分析结果。

在该试验中，患者被随机分至ixazomib-Rd组（360人）或安慰剂-Rd组（362人），并根据既往治疗次数（1次 vs 2/3次）、蛋白酶体抑制剂（PI）暴露史（有 vs 无）和疾病分期（I-II期 vs III期）分层。总生存期（OS）是关键的次要终点。

意向治疗人群和不同亚组的总生存期

中位随访85个月后，ixazomib-Rd组和安慰剂-Rd组的中位OS分别为53.6 vs 51.6个月（风险比[HR] 0.939，p=0.495）。在预定的亚组中观察到较低的风险比，提示ixazomib-Rd方案与安慰剂-Rd相比具有更大的OS效益：对任何治疗都不敏感（HR 0.794）、对最后一次治疗不敏感（0.742）、65-75岁（0.757）、III期（0.799）、既往治疗过2-3次（0.845）、高风险细胞遗传学（0.870）、高风险细胞遗传学和（或）1q21扩增（0.862）。

各种高风险细胞遗传学特征患者的总生存期

研究治疗后，ixazomib-Rd组 vs 安慰剂-Rd组分别有71.7% vs 69.9%的患者接受了其他抗癌治疗，其中分别有24.7% vs 33.9%的患者接受了达雷木单抗治疗，71.8% vs 76.9%的患者接受了PI治疗。

两组原发恶性肿瘤的新发率相近：ixazomib-Rd组（10.3%）、安慰剂-Rd组（11.9%）。无新发安全性问题。

综上，在本次分析中，ixazomib-Rd与安慰剂-Rd的无进展生存获益并未转化为具有统计学意义的OS获益。具有不良预后因素的亚组患者可从ixazomib-Rd治疗中获得更大的OS效益。

原始出处：

Paul G. Richardson, et al. Final Overall Survival Analysis of the TOURMALINE-MM1 Phase III Trial of Ixazomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. Journal of Clinical Oncology. June 10, 2021

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2021-08-11 涂涂0518

学习中

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2021-11-04 lidong40

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2021-06-13 juliusluan78

#生存期#

24 0
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2021-06-13 12498cb5m16暂无昵称

#总生存期#

34 0
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2021-06-13 vividelife

#伊沙佐米#

33 0
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2021-06-13 freve

#难治性#

23 0
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2021-06-12 1453df99m58暂无昵称

在预定的亚组中观察到较低的风险比，提示ixazomib-Rd方案与安慰剂-Rd相比具有更大的OS效益。

60 0
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2021-06-11 随梦飞扬

在预定的亚组中观察到较低的风险比，提示ixazomib-Rd方案与安慰剂-Rd相比具有更大的OS效益

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