Lancet oncol:PD-L1抑制剂Durvalumab±曲美单抗治疗转移性尿路上皮癌

2020-09-23 MedSci原创 MedSci原创

采用基于铂类的标准一线化疗的转移性尿路上皮癌患者的存活预后较差。本研究旨在评估接受PD-L1抑制剂Durvalumab联合或不联合曲美单抗(CTLA-A抑制剂)作为一线疗法的转移性尿路上皮癌患者的总体

采用基于铂类的标准一线化疗的转移性尿路上皮癌患者的存活预后较差。本研究旨在评估接受PD-L1抑制剂Durvalumab联合或不联合曲美单抗(CTLA-A抑制剂)作为一线疗法的转移性尿路上皮癌患者的总体预后。

DANUBE研究是一项在23个国家224个学术/医院中心开展的开放标签、随机化、对照三期试验,招募年满18岁的未治疗过的、不能手术切除的、局部晚期或转移性尿路上皮癌患者,1:1:1随机分至三组:Durvalumab单药组,1500 mg,静滴,1/4周;Durvalumab联合曲美单抗组,1500 mg+75 mg,连用4个疗程,后改为Durvalumab维持(1500 mg/4周);标准化疗组,吉西他滨+卡铂或吉西他滨+顺铂。联合主要终点是总体存活期。

2015年11月24日-2017年3月21日,共1032位患者被随机分至三组,Durvalumab单药组 346位、联合组 342位、化疗组 344位。截止2020年1月27日,中位随访了41.2个月。

在高PD-L1表达人群中,Durvalumab单药组和化疗组的中位总体存活期分别是14.4个月 vs 12.1个月(HR 0.89,95% CI 0.71)。在意向治疗人群中,联合组和化疗组的中位总体存活期分别是15.1个月 vs 12.1个月(0.85,0.72-1.02,p=0.075)。

在安全性人群中,Durvalumab单药组345位患者中共发生了47例(14%)3/4级治疗相关不良反应,而联合组和化疗组分别发生了93例(27%)和188例(60%)。Durvalumab单药组和联合组最常见的3/4级治疗相关不良反应是脂肪酶升高(分别发生了7例[2%]和16例[5%]),化疗组最常见的是中性粒细胞减少(66例[21%])。Durvalumab单药组、联合组和化疗组分别发生了30例(9%)、78例(23%)和50例(16%)重度治疗相关不良反应,分别报道了2例、2例和1例研究药物毒性导致的死亡。

本研究未达到联合主要终点的任一项。有必要进行进一步的研究来鉴定既往未接受过治疗的转移性尿路上皮癌患者采用免疫检查点抑制剂单独或联合方案治疗的疗效。

原始出处:

Thomas Powles, et al. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. The Lancet Oncology. September 21, 2020.

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[GetPortalCommentsPageByObjectIdResponse(id=1865915, encodeId=f39c1865915d3, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon Mar 08 11:06:03 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912442, encodeId=97a9191244248, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, 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createdBy=866a13134648, createdName=mashirong, createdTime=Fri Sep 25 09:06:03 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=887804, encodeId=f4fa88e804ca, content=路漫漫其修远兮, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210725/69b5882b3c3845c19efa131b4ff8b1f7/06ccd8f1857e4e14862049ab235618eb.jpg, createdBy=74c72110107, createdName=Nebula-Qin, createdTime=Wed Sep 23 23:51:16 CST 2020, time=2020-09-23, status=1, ipAttribution=)]
    2020-11-17 jklm09
  5. [GetPortalCommentsPageByObjectIdResponse(id=1865915, encodeId=f39c1865915d3, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon Mar 08 11:06:03 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912442, encodeId=97a9191244248, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, 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createdBy=866a13134648, createdName=mashirong, createdTime=Fri Sep 25 09:06:03 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=887804, encodeId=f4fa88e804ca, content=路漫漫其修远兮, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210725/69b5882b3c3845c19efa131b4ff8b1f7/06ccd8f1857e4e14862049ab235618eb.jpg, createdBy=74c72110107, createdName=Nebula-Qin, createdTime=Wed Sep 23 23:51:16 CST 2020, time=2020-09-23, status=1, ipAttribution=)]
    2021-05-15 howi
  6. 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createdBy=866a13134648, createdName=mashirong, createdTime=Fri Sep 25 09:06:03 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=887804, encodeId=f4fa88e804ca, content=路漫漫其修远兮, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210725/69b5882b3c3845c19efa131b4ff8b1f7/06ccd8f1857e4e14862049ab235618eb.jpg, createdBy=74c72110107, createdName=Nebula-Qin, createdTime=Wed Sep 23 23:51:16 CST 2020, time=2020-09-23, status=1, ipAttribution=)]
    2020-09-25 smartjoy
  7. 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    2020-09-23 Nebula-Qin

    路漫漫其修远兮

    0

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在铂类化疗基础上添加Atezolizumab可延长转移性尿路上皮癌患者的无进展生存期

Eur Urol:转移性尿路上皮癌,先免疫治疗 or 先化疗?

免疫检查点抑制剂(ICIs)对治疗转移性尿路上皮癌(MUC)是具有活性的,并且已经作为一种标准护理加入了化疗(CT)。在此项研究中,研究者探索了ICIs治疗进展后CT的治疗活性。研究包含两组连续的转移性尿路上皮癌(MUC)患者组成的队列(n=28)。

瑞普利单抗用于转移性尿路上皮癌,前景值得期待

世界上规模最大,学术水平最高,最具权威的2019年美国临床肿瘤学会(ASCO)年会于5月31日—6月4日在芝加哥举办。今年的主题为“Caring for Every Patient, Learning from Every Patient”。在本次ASCO年会上,中国研究者再现风采,多项研究结果在大会展示,为全球抗肿瘤研究贡献中国力量。其中,由北京大学肿瘤医院郭军教授与上海交通大学医学院仁济医院黄

PD-L1单抗Bavencio,获得FDA批准用于晚期或转移性尿路上皮癌患者的维持治疗

Bavencio作为一线维持治疗将患者的中位总体生存期(OS)提高了7.1个月。

Lancet oncol:卡博替尼治疗铂耐药的转移性尿路上皮癌

卡博替尼是MET、VEGFR、AXL和RET的多激酶抑制剂,对由调节T细胞和髓系来源抑制细胞减少引起的肿瘤免疫微环境同样有效。在本研究中,研究人员评估了卡博替尼用于转移性铂-复发的移行上皮细胞癌的活性