Lancet Respirat Med:三代酪氨酸激酶抑制剂Furmonertinib在EGFR T790M突变的NSCLC患者中的疗效可期!

2021-03-30 MedSci原创 MedSci原创

Furmonertinib有望成为中国患者人群一代或二代EGFR TKI治疗后的新选择

Furmonertinib(呋喃替尼,AST2818)是三代表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI),靶向敏化的EGFR和EGFR Thr790Met(T790M)突变

本研究旨在评估Furmonertinib用于携带EGFR T790M突变的晚期非小细胞肺癌(NSCLC)患者的疗效和安全性。

这是一项在中国大陆的46家医院开展的单臂、开放标签的2b期试验,招募了经一代或二代EGFR TKI治疗后进展的或原发性携带EGFR T790M突变的局部晚期或转移性NSCLC患者,予以Furmonertinib治疗(80 mg,口服,1/日)。主要终点是客观缓解率。

病情改善情况

2018年6月4日-2018年12月8日,共220位患者接受了Furmonertinib治疗,全部纳入了疗效和安全性分析。截止2020年1月29日,71位(32%)患者仍在接受治疗。中位随访持续时间为9.6个月(范围0.7-19.4个月)。客观缓解率为74%

无进展存活期

3级及以上的不良事件发生于58位(26%)患者,治疗相关的3级及以上的不良事件发生于25位(11%)患者。最常见的3级及以上不良事件有γ-谷氨酰转移酶升高(5例;2%)、天冬氨酸转氨酶增加、低钠血症、高血压、肺炎、高镁血症和心包积液(各3例;1%)。

治疗相关不良事件

10位(5%)患者报告了与治疗相关的腹泻,16位(7%)患者报告了与治疗相关的斑疹,全都是1-2级。52位(24%)患者报告了重度不良事件,其中12例(5%)可能与治疗相关。

综上所述,Furmonertinib在携带EGFR T790M突变的NSCLC患者中表现出良好的疗效和可接受的安全性。Furmonertinib有望成为中国患者人群一代或二代EGFR TKI治疗后的新选择。

原始出处:

Yuankai Shi, et al. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. The Lancet Respiratory Medicine. March 26, 2021.

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    2021-12-26 zhlpower
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    2021-10-24 jklm09
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    2021-04-13 howi
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01:35:59 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610977, encodeId=cda516109e77b, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Thu Apr 01 01:35:59 CST 2021, time=2021-04-01, status=1, ipAttribution=)]
    2021-08-31 jklm09
  5. 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  6. 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  7. 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    2021-04-01 redcrab
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ERBB2/HER2(表皮生长因子2)基因在癌症中经常被扩增或出现突变。既往研究已证实了在乳腺癌和其他癌症中HER2的基因扩增以及蛋白质的过表达,并已开发及批准了许多靶向HER2的疗法。