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ARCH PATHOL LAB MED：免疫组化程序性死亡配体-1诊断试验的分析验证和临床应用

2019-06-02 不详 网络

分析验证
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研究表明，与几种肿瘤类型(包括尿路上皮癌)中PD-L1低表达或阴性的患者相比，PD-L1表达高的患者对抗程序性死亡受体-1和抗程序性死亡配体-1 (PD-L1)药物的临床反应普遍得到改善。因此，本研究的目标是验证抗PD-L1单克隆抗体durvalumab治疗尿路上皮癌患者的PD-L1免疫组化诊断试验。 PD-L1 (SP263)检测方法在敏感性、特异性、鲁棒性和准确性方面的研究中已经得到验证，并

研究表明，与几种肿瘤类型(包括尿路上皮癌)中PD-L1低表达或阴性的患者相比，PD-L1表达高的患者对抗程序性死亡受体-1和抗程序性死亡配体-1 (PD-L1)药物的临床反应普遍得到改善。因此，本研究的目标是验证抗PD-L1单克隆抗体durvalumab治疗尿路上皮癌患者的PD-L1免疫组化诊断试验。

PD-L1 (SP263)检测方法在敏感性、特异性、鲁棒性和准确性方面的研究中已经得到验证，并在CD-ON-MEDI4736-1108 (NCT01693562)研究中得到了应用。根据PD-L1表达预先设定的截断点对患者进行疗效分析:PD-L1高(如果>1%的肿瘤区域含有肿瘤相关免疫细胞，则≥25%的肿瘤细胞或≥25%的免疫细胞染色为PD-L1;若≤1%的肿瘤区域含有免疫细胞，≥25%的肿瘤细胞或100%的免疫细胞染色为PD-L1，且PD-L1低/阴性(不符合PD-L1高的标准)。

检测符合所有预先确定的敏感性、特异性和准确性的接受标准。Interreader和intrareader的总体准确率分别为93.0%和92.4%。在日内重现性和日内精度方面，总体一致性分别为99.2%和100%。实验室间总体一致性为92.6%。在CD-ON-MEDI4736-1108研究中，durvalumab在pd - l1高亚组和pd - l1低/阴性亚组均表现出临床活性和持久反应，尽管pd - l1高亚组的客观反应率往往高于pd - l1低/阴性亚组。

PD-L1 (SP263)法测定尿路上皮癌患者的PD-L1中表达准确、重现性高，且具有临床相关性。

原始出处：

Magdalena Zajac, PhD; Anne-Marie Boothman, PhD;Analytical Validation and Clinical Utility of an Immunohistochemical Programmed Death Ligand-1 Diagnostic Assay and Combined Tumor and Immune Cell Scoring Algorithm for Durvalumab in Urothelial Carcinoma

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    2019-11-10 clmlylxy

    #临床应用#

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    2019-12-06 yb6560

    #Pathol#

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    2020-04-14 Eleven11

    #诊断试验#

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    2019-10-07 12498761m56暂无昵称

    #程序性死亡#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1835816, encodeId=a8d6183581695, content=<a href='/topic/show?id=cfdc22e893f' target=_blank style='color:#2F92EE;'>#临床应用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22789, encryptionId=cfdc22e893f, topicName=临床应用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fc8528, createdName=clmlylxy, createdTime=Sun Nov 10 08:27:00 CST 2019, time=2019-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786283, encodeId=001e1e8628394, content=<a href='/topic/show?id=569f13e9045' target=_blank style='color:#2F92EE;'>#Pathol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13790, encryptionId=569f13e9045, topicName=Pathol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Fri Dec 06 16:27:00 CST 2019, time=2019-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026319, encodeId=177220263192e, content=<a href='/topic/show?id=fa9a9165287' target=_blank style='color:#2F92EE;'>#诊断试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91652, encryptionId=fa9a9165287, topicName=诊断试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e183245, createdName=Eleven11, createdTime=Tue Apr 14 03:27:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1803324, encodeId=fce618033242d, content=<a href='/topic/show?id=9a70e52596e' target=_blank style='color:#2F92EE;'>#程序性死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75259, encryptionId=9a70e52596e, topicName=程序性死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b78f2500065, createdName=12498761m56暂无昵称, createdTime=Mon Oct 07 02:27:00 CST 2019, time=2019-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1438912, encodeId=89a1143891279, content=<a href='/topic/show?id=eb522911994' target=_blank style='color:#2F92EE;'>#免疫组化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29119, encryptionId=eb522911994, topicName=免疫组化)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Mon Jun 03 23:27:00 CST 2019, time=2019-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1609804, encodeId=f1811609804f5, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, 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=Mon Jun 03 23:27:00 CST 2019, time=2019-06-03, status=1, ipAttribution=)]
    2019-06-03 zhouqu_8

    #免疫组化#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1835816, encodeId=a8d6183581695, content=<a href='/topic/show?id=cfdc22e893f' target=_blank style='color:#2F92EE;'>#临床应用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22789, encryptionId=cfdc22e893f, topicName=临床应用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fc8528, createdName=clmlylxy, createdTime=Sun Nov 10 08:27:00 CST 2019, time=2019-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786283, encodeId=001e1e8628394, content=<a href='/topic/show?id=569f13e9045' target=_blank style='color:#2F92EE;'>#Pathol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13790, encryptionId=569f13e9045, topicName=Pathol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4b65161, createdName=yb6560, createdTime=Fri Dec 06 16:27:00 CST 2019, time=2019-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026319, encodeId=177220263192e, content=<a href='/topic/show?id=fa9a9165287' target=_blank style='color:#2F92EE;'>#诊断试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91652, encryptionId=fa9a9165287, topicName=诊断试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e183245, createdName=Eleven11, createdTime=Tue Apr 14 03:27:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1803324, encodeId=fce618033242d, content=<a href='/topic/show?id=9a70e52596e' target=_blank style='color:#2F92EE;'>#程序性死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75259, encryptionId=9a70e52596e, topicName=程序性死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b78f2500065, createdName=12498761m56暂无昵称, createdTime=Mon Oct 07 02:27:00 CST 2019, time=2019-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1438912, encodeId=89a1143891279, content=<a href='/topic/show?id=eb522911994' target=_blank style='color:#2F92EE;'>#免疫组化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29119, encryptionId=eb522911994, topicName=免疫组化)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Mon Jun 03 23:27:00 CST 2019, time=2019-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1609804, encodeId=f1811609804f5, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, 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=Mon Jun 03 23:27:00 CST 2019, time=2019-06-03, status=1, ipAttribution=)]
    2019-06-03 ms3994565386320060

    #Med#

    0