J. Clin. Med:依鲁替尼治疗 CLL 患者的长期疗效和安全性:真实生活体验。

2022-01-11 MedSci原创 MedSci原创

依鲁替尼在 CLL 中有效且耐受性良好。在现实生活中获得的反应是持久的,并且药物的安全性是有利的

伊布替尼是一种一流的共价布鲁顿酪氨酸激酶(BTK)抑制剂,可阻断慢性淋巴细胞白血病(CLL)细胞中的b细胞受体(BCR)信号传导,这种机制在启动和维持疾病以及促进其进展中发挥关键作用。依鲁替尼已在新发和复发/难治性慢性淋巴细胞白血病 (CLL) 患者中显示出显着的临床影响,即使在细胞遗传学和分子标志物不利的情况下也是如此。

除了在临床试验中收集的信息外,关于伊布替尼在现实生活中使用的数据也很少,只有少数研究对其长期结果、生存和治疗的依从性有成熟的数据。这次研究的目的是报告在CLL患者中使用伊布替尼的单中心真实经验,根据意大利的处方规则,该药物允许在复发和难治性的情况下使用,无论以前接受过任何治疗,以及在发生不良细胞遗传学特征(del(17p))、TP53mut或65岁以上患者的前线环境中。

所有在研究机构使用依鲁替尼治疗的 CLL 患者的数据都经过回顾性审查。46 名患者接受了 ibrutinib 作为一线 (10名) 或第二或更高级治疗 (36名)。5 名患者出现 TP53 突变;11例染色体17p缺失。

图1:在接受一线治疗的患者((A)组)和接受伊布替尼二线治疗的患者((B)组)中,中期评估和最佳结果之间的反应演变。y轴表示患者的%。

图2:根据治疗线得出的无进展生存期(PFS)和总生存期(OS)曲线。y轴表示患者存活率的%。

在一线治疗的患者中,最佳总体缓解率 (ORR) 为 90.0%。在接受依鲁替尼作为二线或后线治疗的患者中,ORR 为 97.2%。中位无进展生存期为 28.8 和 21。一线和二线/二线治疗的患者分别为 1 个月。一线治疗的患者未达到中位总生存期,二线/晚期治疗的患者为 4.9 年。3-4 级血液学毒性为中性粒细胞减少、血小板减少和贫血。3-4 级血液外毒性包括腹泻、皮疹、子宫膀胱脱垂、血管炎和败血症。

图3:所有治疗患者的下一次治疗时间((A)),根据治疗线((B))。y轴表示患者的%。

总而言之,研究证明依鲁替尼在 CLL 中有效且耐受性良好。在现实生活中获得的反应是持久的,并且药物的安全性是有利的。值得注意的是,意大利第二代BTK抑制剂(如阿卡拉布替尼、扎努布鲁替尼)即将在日常临床实践中出现,已经显示出相当的疗效,但预计比伊布鲁替尼有更少的AEs,可能会再次改变CLL的治疗模式。

 

原始出处:

Broccoli A, Argnani L, Morigi A, Nanni L, Casadei B, Pellegrini C, Stefoni V, Zinzani PL. Long-Term Efficacy and Safety of Ibrutinib in the Treatment of CLL Patients: A Real Life Experience. Journal of Clinical Medicine. 2021; 10(24):5845. https://doi.org/10.3390/jcm10245845

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    2022-01-14 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

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    2022-01-13 148bdd8em77暂无昵称

    nice

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    2022-01-13 ms5000001067645374

    0

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