Nat Med:Avapritinib在晚期系统性肥大细胞增多症治疗中的安全性和疗效

2021-12-07 MedSci原创 MedSci原创

Avapritinib治疗可使晚期系统性肥大细胞增多症患者产生深度和持久的反应,包括晚期系统性肥大细胞增多症患者KITD816V的分子缓解,并且在推荐的每天200mg的2期剂量下患者耐受性良好。

系统性肥大细胞增多症(SM)是一种罕见的血液系统肿瘤,其特征是肿瘤性肥大细胞在骨髓(BM)、皮肤和其他器官中积聚。肥大细胞介质释放和SM相关器官损伤(称为C发现)导致严重的、虚弱的症状。晚期系统性肥大细胞增多症是一种罕见的血液肿瘤,由KITD816V突变所致,并且其与较差的存活率相关。

近日,顶级医学期刊Nature Medicine上发表了一篇研究文章,这项在晚期系统性肥大细胞增多症患者中进行的1期研究(NCT02561988)旨在评估Avapritinib(BLU-285),一种选择性KITD816V抑制剂的疗效。该研究的主要终点是最大耐受剂量、推荐的2期剂量和Avapritinib治疗的安全性。该研究次要终点包括总体反应率和肥大细胞负荷指标的变化水平。

研究人员对86名患者以每天一次30-400mg Avapritinib的治疗剂量进行了评估,其中69名患者被集中确诊患有晚期系统性肥大细胞增多症。本研究目前尚未达到最大耐受剂量,在剂量扩展队列中探究了每天200mg和300mg的治疗剂量的效果。观察到的最常见的不良事件为眶周水肿(69%)、贫血(55%)、腹泻(45%)、血小板减少(44%)和恶心(44%)。

颅内出血的发生率为13%,但只有1%的患者没有严重的血小板减少症(血小板<50×109/L)。在53名可评估反应的患者中,总体反应率为75%,完全缓解率为36%。Avapritinib分别使92%和99%的患者骨髓肥大细胞和血清类胰蛋白酶减少50%以上。

由此可见,Avapritinib治疗可使晚期系统性肥大细胞增多症患者产生深度和持久的反应,包括晚期系统性肥大细胞增多症患者KITD816V的分子缓解,并且在推荐的每天200mg的2期剂量下患者耐受性良好。

原始出处:

Daniel J. DeAngelo,et al.Safety and efficacy of avapritinib in advanced systemic mastocytosis: the phase 1 EXPLORER trial.Nature Medicine.2021.https://www.nature.com/articles/s41591-021-01538-9

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    2022-05-04 hxzhang
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    2022-10-06 hbwxf
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    2022-07-13 liye789132251
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    2021-12-09 zhaojie88
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    2021-12-08 查查佳佳

    在门诊接受治疗,但仍有部分患者重

    0

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报告巴瑞替尼(一种口服可逆的选择性Janus激酶JAK1/JAK2抑制剂)在活动性类风湿性关节炎 (RA) 患者中已完成的扩展试验的长期安全性。