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Ann Hematol:吉列替尼单药治疗复发/难治性 FLT3 突变急性髓细胞白血病的真实世界研究

2022-06-29 网络 网络

患有 FLT3 突变的复发性或难治性 (R/R) 急性髓性白血病 (AML) 的患者预后不佳。本文旨在描述关于吉列替尼治疗 FLT3 突变的 R/R AML 的真实世界数据

急性髓系白血(AML)是成人中最常见的急性白血病类型,对于患有 FLT3 突变的复发性或难治性 (R/R) 急性髓性白血病 (AML) 的患者预后常常不佳。吉列替尼是一种最近获批用于 R/R AML 患者的 FLT3 酪氨酸激酶抑制剂 (TKI),在真实世界中,根据批准的3期临床试验的结果,大多数FLT3突变的AML患者在诱导期间接受米多司妥林治疗,而在海军上将试验中,只有12%的患者在前期接受FLT3抑制剂治疗。因此,对治疗模式、反应和安全性的“真实世界”分析是有必要的。

此次报道的文献旨在描述关于吉列替尼治疗 FLT3 突变的 R/R AML 的真实世界数据,并将结果与​​匹配的 FLT3 突变的 R/R AML 患者接受基于化疗的补救方案治疗的结果进行比较。

图1:患者采用的吉特替尼治疗情况。每个条形图代表一个病人。CR:完全响应

来自六个学术中心的 25 名患者接受了吉列替尼治疗 FLT3 突变的 R/R AML。80% 接受过强化诱导方案治疗,其中 40% 接受过 TKI 治疗。12 名患者 (48%) 使用吉列替尼获得完全缓解 (CR)。整个队列的估计中位总生存期 (OS) 为 8 (CI 95% 0-16. 2) 个月,达到 CR 的患者明显高于未达到 CR 的患者(16.3 个月,CI 95% 0-36.2 vs. 2.6 个月,CI 95% 1.47-3.7;p 值 = 0.046)。

图2:Kaplan-Meier曲线:接受吉特替尼治疗的患者的总生存期。A:全组;B:吉特替尼治疗后完全缓解患者与未完全缓解患者的比较

图3 :Kaplan-Meier曲线:gilteritinib治疗组与强化挽救性方案治疗组生存率比较。A:总体生存率;B:无事件生存。SOC:护理标准

在多变量 cox 回归分析中,实现 CR 是延长 OS 的唯一预测因子​​(HR 0.33 95% CI 0.11-0.97,p = 0.044)。先前的 TKI 暴露不影响 OS,但与更好的无事件生存期相关(HR 0.15 95% CI 0.03-0.71,p = 0.016)。接受吉列替尼和强化抢救治疗的患者之间的年龄和 ELN 风险匹配比较显示有相似的反应率(两组均为 50%);gilteritinib 和匹配对照组的中位 OS 分别为 9.6 个月 (CI 95% 2.3-16.8) 和 7 个月 (CI 95% 5.1-8.9) (p = 0.869)。

总之,在真实世界中,包括在经过大量预处理、暴露于 TKI 的患者中,吉列替尼是被证实有效且耐受度良好的。在研究团队的分析中,与临床试验相比,患者似乎在治疗过程中更早的时间点接受吉列替尼,在flt3突变的R/R环境中更早地对该药物进行测序可能会优化该药物的结果。吉列替尼与venetoclax和其他靶向治疗方法的联合策略可能是进一步改善反应的另一种方法,应在临床试验中进一步寻求。

 

原始出处:

Shimony S, Canaani J, Kugler E, Nachmias B, Ram R, Frisch A, Ganzel C, Vainstein V, Moshe Y, Aumann S, Yeshurun M, Ofran Y, Raanani P, Wolach O. Gilteritinib monotherapy for relapsed/refractory FLT3 mutated acute myeloid leukemia: a real-world, multi-center, matched analysis. Ann Hematol. 2022 Jun 24. doi: 10.1007/s00277-022-04895-8. Epub ahead of print. PMID: 35739428.

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    2022-06-30 fengyi812
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    2022-06-30 chengjn
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    2022-06-30 freve
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    2022-06-30 fengyi816
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    2022-06-30 ms5000000644045955

    不错,学习了。

    0

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