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Eur Urol Oncol:晚期肾细胞癌患者接受一线Pembrolizumab加Axitinib治疗时出现的肝脏毒性的特征和管理

2021-07-27 AlexYang MedSci原创

在KEYNOTE-426(NCT02853331)研究中,Pembrolizumab加axitinib对从未治疗的晚期肾细胞癌的疗效要比比sunitinib更好。然而,3/4级转氨酶升高的发生率却相对

在KEYNOTE-426(NCT02853331)研究中,Pembrolizumab加axitinib对从未治疗的晚期肾细胞癌的疗效要比比sunitinib更好。然而,3/4级转氨酶升高的发生率却相对较高。

近期,有研究人员进一步阐述了接受pembrolizumab-axitinib治疗患者的转氨酶升高的特点

研究包括了参加KEYNOTE-426的患者。对潜在肝脏疾病的3个标准化MedDRA查询用来鉴定肝脏事件分析亚群(HEAS)的患者。表征了丙氨酸氨基转移酶事件的特点,包括发病时间、恢复时间、皮质类固醇的使用以及对研究治疗的再挑战。

HEAS包括189/429(44%)名Pembrolizumab-axitinib治疗患者和128/425(30%)名Sunitinib治疗患者。3/4级肝脏不良事件在联合治疗组更常见,分别为22%(94/429)与7%(29/425);3%(13/429)的患者因肝脏不良事件而中止联合治疗。在pembrolizumab-axitinib组,125/426名患者(29%)的丙氨酸氨基转移酶(ALT)≥3×正常上限(ULN),发病的中位时间为84天(范围,7-840天)。在ALT≥3×ULN的患者中,120/125(96%)的患者在研究治疗中断/中止后恢复到<3×ULN,恢复的中位时间为15 天(3-176天):68/120(57%)的患者接受了皮质类固醇治疗。100名患者重新接受一种或两种研究治疗,其中45/100(45%)的患者ALT≥3×ULN复发,所有45名患者在研究治疗中断/中止后恢复到ALT<3×ULN。没有发生致命的肝脏事件。

接受pembrolizumab+axitinib治疗患者的首次ALT≥3×ULN事件表征

综上所述,pembrolizumab-axitinib的3/4级转氨酶升高的发生率更高。因此,应仔细评估和处理这些事件,并及时中断或中止研究治疗,并决定是否使用皮质类固醇治疗。另外,重新进行一种或两种药物治疗的决定应基于事件的严重程度和完整的因果关系评估

原始出处:

Brian I Rini , Michael B Atkins , Elizabeth R Plimack et al. Characterization and Management of Treatment-emergent Hepatic Toxicity in Patients with Advanced Renal Cell Carcinoma Receiving First-line Pembrolizumab plus Axitinib. Results from the KEYNOTE-426 Trial. Eur Urol Oncol. Jul 2021

 

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    2022-05-17 feather89
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    2022-03-04 snf701207
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    2021-09-07 chendoc242
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    2021-10-17 minlingfeng
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    2021-07-28 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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发表在Nature Scientific Reports杂志上最新研究显示,Hesperos 公司的"human-on-a-chip"芯片装置通过模拟心脏和肝脏,可以测量两种已知的可可损害心脏的小分子药物浓度和代谢,并能够提供对人体毒性的准确数据。

J Hepatol:土三七的肝脏毒性机制研究

MedSci评:药物的肝毒性引人重视,但是能够对其进行如此透彻研究,而且能够在国际权威杂志上发表高质量的论文,并不容易。这篇文章非常值得国内做中药研究,或药物毒理的会员借鉴。  三七   “三七”是传统的名贵中药材,有活血化瘀、消肿止痛作用,常用于跌打损伤、活血化瘀的治疗。菊科的“土三七”和“三七”仅一字之差,却含有一种叫吡咯烷的毒物,会造成肝内小静脉内皮损伤,继而出现小静脉闭塞

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