Lancet Respir Med:Furmonertinib一线治疗EGFR突变阳性NSCLC的效果明显优于吉非替尼!

2022-06-11 MedSci原创 MedSci原创

Furmonertinib一线治疗EGFR突变阳性NSCLC的疗效明显优于吉非替尼,而且安全性可控。

Furmonertinib (AST2818) 是一种不可逆的、选择性的第三代EGFR酪氨酸激酶抑制剂。该研究旨在比较Furmonertinib与一代EGFR酪氨酸激酶抑制剂吉非替尼作为一线方案治疗EGFR突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)的疗效和安全性。

FURLONG研究是一项在我国大陆的55家医院开展的多中心、双盲、随机的3期临床试验,招募了年满18岁、组织学明确诊断的不可切除的局部晚期或转移性IIIB/IIIC/IV期NSCLC患者,且要求患者携带EGFR第19外显子缺失或第21外显子Leu858Arg突变。受试患者(1:1)随机接受Furmonertinib(80mg/天)或吉非替尼(250mg/天)口服治疗直到出现疾病进展、不可耐受的毒性、撤出试验或其他中断原因。主要终点是无进展生存期和安全性。


无进展生存率

2019年5月30日至2019年12月5日,共筛查了750位患者,其中358位被随机分至Furmonertinib组(n=178)或吉非替尼组(n=180)。吉非替尼组有一位患者未接受治疗被排除分析。中位随访了21.0个月,Furmonertinib组和吉非替尼组的无进展生存期分别是20.8个月和11.1个月(风险比[HR] 0.44,p<0.0001)。


不良反应

Furmonertinib组和吉非替尼组分别有20位(11%)和32位(18%)患者发生了3级及以上的治疗相关的不良反应,分别有10位(6%)和11位(6%)患者报告了治疗相关的严重不良反应,分别有10位(6%)和3位(2%)患者死于不良反应,但经判定均与治疗无关。

综上,在EGFR突变阳性的NSCLC患者中,Furmonertinib作为一线疗法展现出了明显优于吉非替尼的疗效,而且安全性可控。Furmonertinib有望成为这类患者的新治疗选择。

原始出处:

Yuankai Shi, et al. Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study. The Lancet Respiratory Medicine. June 02, 2022. https://doi.org/10.1016/S2213-2600(22)00168-0

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    2023-01-16 howi
  4. 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  5. 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    2022-08-28 循证小兵

    #Furmonertinib##吉非替尼#比??实在不灵,至少与#奥希替尼#比吧。这是国产的第三代TKI,这个研究设计实在太拉kua了! 而且Furmonertinib没有二线适应症,直接上一线,也是醉了!!不知道这个药以后在国内如何卖??

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1816366, encodeId=660d1816366c6, content=<a href='/topic/show?id=28dd9e5029b' target=_blank style='color:#2F92EE;'>#阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97502, encryptionId=28dd9e5029b, topicName=阳性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/XhttJCp4Aq9gKA5n4v9elclQlVQTDenMiaEiadlI5D3gtmfSiaicoIY4ZsuibrQKLibDdxBKVY8oS6B2FicqJlT93clow/132, createdBy=03202500144, createdName=ms7258648636991762, createdTime=Tue Oct 25 11:29:46 CST 2022, time=2022-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1803574, encodeId=53ee18035e4aa, content=<a href='/topic/show?id=0b3fe551971' target=_blank style='color:#2F92EE;'>#突变阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75519, encryptionId=0b3fe551971, topicName=突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKjqGDO7icVKUiaT7urgwXvnvzWtp0fMFU46Xfib8oavFKygiaWtibXReS6ZUh3PImsNicGAwTO5HXxoicnA/132, createdBy=ee262500130, createdName=ms7474195563676018, createdTime=Wed Mar 08 00:29:46 CST 2023, time=2023-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831585, encodeId=4f5118315857e, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Jan 16 09:29:46 CST 2023, time=2023-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1785113, encodeId=bc3d1e85113cf, content=<a href='/topic/show?id=0b4f65992c' target=_blank style='color:#2F92EE;'>#EGFR突变阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6599, encryptionId=0b4f65992c, topicName=EGFR突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Sun Feb 05 13:29:46 CST 2023, time=2023-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1241517, encodeId=47f9124151e5a, content=<a href='/topic/show?id=16e510461857' target=_blank style='color:#2F92EE;'>#Furmonertinib#</a>与<a href='/topic/show?id=154f3891074' target=_blank style='color:#2F92EE;'>#吉非替尼#</a>比??实在不灵,至少与<a href='/topic/show?id=b0054454337' target=_blank style='color:#2F92EE;'>#奥希替尼#</a>比吧。这是国产的第三代TKI,这个研究设计实在太拉kua了! 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    2022-06-11 liuyiping
  7. 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  8. 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    2022-06-10 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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