Eur Urol:Lenvatinib+Everolimus治疗晚期非透明细胞肾细胞癌患者的单臂、多中心和2期研究

2021-05-18 AlexYang MedSci原创

肾细胞癌(RCC)通常分为两个主要亚型:透明细胞RCC(ccRCC),占RCC病例的80%以上;以及非透明细胞RCC(ncCRCC)(一个总称,包括其余的组织学亚型)。nccRCC的组织学亚型包括乳头

肾细胞癌(RCC)通常分为两个主要亚型:透明细胞RCC(ccRCC),占RCC病例的80%以上;以及非透明细胞RCC(ncCRCC)(一个总称,包括其余的组织学亚型)。nccRCC的组织学亚型包括乳头状RCC、嫌色细胞RCC、未分类的RCC、集合管癌和肾髓质癌等等。

之前,大多数RCC临床试验都集中在ccRCC或混合RCC人群中。然而,在过去的五年中,一些研究已经开始专门招募nccRCC患者,并在该类患者群体中评估了单药VEGF和mTOR抑制剂的治疗效果。令人失望的是,与ccRCC患者观察到的响应率相比,这些研究报告的响应率很低,总的客观反应率(ORRs)从3%到18%不等。

非透明细胞肾细胞癌(nccRCC)占RCC病例≤20%。Lenvatinib(一种多靶的酪氨酸激酶抑制剂)联合everolimus(一种mTOR抑制剂)批准用于治疗之前接受过一次抗血管生成治疗的晚期RCC。

近期,有研究人员确定了Lenvatinib+Everolimus作为晚期nccRCC患者的一线治疗的安全性和有效性

研究是一项开放标签、单臂、多中心的2期研究,招募了不可切除的晚期或转移性nccRCC患者,并且之前没有对晚期疾病进行抗癌治疗。研究的干预措施是Lenvatinib(18毫克)+everolimus(5毫克),每天口服一次。主要终点是调查人员根据实体瘤反应评价标准1.1版本评估的客观反应率(ORR)。次要终点包括无进展生存(PFS)、总生存期(OS)和安全性评估。

研究(开始日期:2017年2月20日)招募了31名nccRCC患者(乳头状,n=20;嫌色细胞,n=9;未分类,n=2)。在数据截止日(2019年7月17日),部分患者具有最好的总体反应(8名患者:乳头状,n=3;嗜铬细胞,n=4;未分类,n=1),总体ORR为26%(95% CI 12-45)。中位PFS为9.2个月(95%CI为5.5-无法估计),中位OS为15.6个月(95%CI为9.2-无法估计)。最常见的治疗性不良事件是疲劳(71%)、腹泻(58%)、食欲下降(55%)、恶心(55%)和呕吐(52%)。研究的限制因素包括样本量小和单臂设计。

不同组织学亚型的疗效结果

Lenvatinib+Everolimus在晚期nccRCC患者中具有良好的抗癌活性,ORR为26%,因此值得进一步的研究

原始出处:

Thomas E Hutson, M Dror Michaelson, Timothy M Kuzel et al. A Single-arm, Multicenter, Phase 2 Study of Lenvatinib Plus Everolimus in Patients with Advanced Non-Clear Cell Renal Cell Carcinoma. Eur Urol. Apr 2021

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1979124, encodeId=059a19e912435, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Oct 13 09:41:20 CST 2021, time=2021-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904066, encodeId=73401904066a5, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 16 08:41:20 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464248, encodeId=edc414642482e, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 20 12:41:20 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966986, encodeId=98dc96698607, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0acb2570971, createdName=12582d2fm84暂无昵称, createdTime=Wed May 19 18:51:12 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966673, encodeId=a3349666e3cf, content=非常帮, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3cc35503886, createdName=ms8000000197177051, createdTime=Tue May 18 22:13:04 CST 2021, time=2021-05-18, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1979124, encodeId=059a19e912435, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Oct 13 09:41:20 CST 2021, time=2021-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904066, encodeId=73401904066a5, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 16 08:41:20 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464248, encodeId=edc414642482e, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 20 12:41:20 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966986, encodeId=98dc96698607, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0acb2570971, createdName=12582d2fm84暂无昵称, createdTime=Wed May 19 18:51:12 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966673, encodeId=a3349666e3cf, content=非常帮, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3cc35503886, createdName=ms8000000197177051, createdTime=Tue May 18 22:13:04 CST 2021, time=2021-05-18, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1979124, encodeId=059a19e912435, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Oct 13 09:41:20 CST 2021, time=2021-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904066, encodeId=73401904066a5, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 16 08:41:20 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464248, encodeId=edc414642482e, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 20 12:41:20 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966986, encodeId=98dc96698607, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0acb2570971, createdName=12582d2fm84暂无昵称, createdTime=Wed May 19 18:51:12 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966673, encodeId=a3349666e3cf, content=非常帮, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3cc35503886, createdName=ms8000000197177051, createdTime=Tue May 18 22:13:04 CST 2021, time=2021-05-18, status=1, ipAttribution=)]
    2021-05-20 tastas
  4. [GetPortalCommentsPageByObjectIdResponse(id=1979124, encodeId=059a19e912435, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Oct 13 09:41:20 CST 2021, time=2021-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904066, encodeId=73401904066a5, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 16 08:41:20 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464248, encodeId=edc414642482e, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 20 12:41:20 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966986, encodeId=98dc96698607, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0acb2570971, createdName=12582d2fm84暂无昵称, createdTime=Wed May 19 18:51:12 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966673, encodeId=a3349666e3cf, content=非常帮, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3cc35503886, createdName=ms8000000197177051, createdTime=Tue May 18 22:13:04 CST 2021, time=2021-05-18, status=1, ipAttribution=)]
    2021-05-19 12582d2fm84暂无昵称

    很好

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1979124, encodeId=059a19e912435, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Oct 13 09:41:20 CST 2021, time=2021-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904066, encodeId=73401904066a5, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 16 08:41:20 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464248, encodeId=edc414642482e, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 20 12:41:20 CST 2021, time=2021-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966986, encodeId=98dc96698607, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0acb2570971, createdName=12582d2fm84暂无昵称, createdTime=Wed May 19 18:51:12 CST 2021, time=2021-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=966673, encodeId=a3349666e3cf, content=非常帮, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3cc35503886, createdName=ms8000000197177051, createdTime=Tue May 18 22:13:04 CST 2021, time=2021-05-18, status=1, ipAttribution=)]
    2021-05-18 ms8000000197177051

    非常帮

    0

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