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J Clin Oncol:乐伐替尼治疗间变性甲状腺癌的疗效和安全性

2021-05-09 Nebula MedSci原创

乐伐替尼单药治疗可能不能有效治疗间变性甲状腺癌~

间变性甲状腺癌(ATC),一种侵袭性的恶性肿瘤,预后较差,目前尚无有效的治疗方案,特别是对于不携带BRAF突变或NTRK或RET基因融合的患者。

Lenvatinib(乐伐替尼)已获得FDA批准用于治疗放射性碘难治性的分化型甲状腺癌,也已在小规模的ATC患者研究(n=17)中被证实具有治疗活性。

本研究旨在进一步评估乐伐替尼用于ATC患者的疗效

这是一项开放标签、国际性的、多中心的II期研究,招募了至少有一处可检测到的靶向病灶的ATC患者,予以乐伐替尼 24 mg/日

。主要终点是客观缓解率(ORR)和安全性。初次缓解4周后再次确认缓解。其他终点包括无进展生存期和总体生存期(OS)。

由于中期分析未达到15%的最低ORR阈值,该研究被提前中止。中期分析纳入了前20位患者。整体分析纳入了招募和治疗的所有34位患者。

靶病灶的体积变化

在整体分析中,一位患者获得了部分缓解(ORR 2.9%,95%CI 0.1-5.3)。一半以上的可评估患者出现了肿瘤缩小;三位患者的肿瘤缩小超过了30%

无进展生存期和总生存期

中位无进展生存期为2.6个月(95%CI 1.4-2.8);中位总生存期为3.2个月(95%CI 2.8-8.2)

最常见的治疗相关的不良事件(AE)有高血压(56%)、食欲减退(29%)、疲劳(29%)和口腔炎(29%)。无治疗相关出血事件或5级治疗相关不良事件发生。

综上所述,乐伐替尼用于ATC患者的安全性可控,但很多不良事件导致了ATC进展。该研究结果表明,乐伐替尼单药治疗可能不能有效治疗ATC;需要进一步研究验证。

原始出处:

Lori J. Wirth, et al. Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. Journal of Clinical Oncology. May 07, 2021. https://ascopubs.org/doi/full/10.1200/JCO.20.03093

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1721013, encodeId=49ae1e2101358, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Mon Oct 18 14:59:53 CST 2021, time=2021-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866075, encodeId=54f018660e5ed, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Oct 08 01:59:53 CST 2021, time=2021-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463758, encodeId=254c1463e5818, content=<a href='/topic/show?id=7d27381288e' target=_blank style='color:#2F92EE;'>#变性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38128, encryptionId=7d27381288e, topicName=变性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f69f6545041, createdName=huangdf, createdTime=Tue May 11 08:59:53 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032901, encodeId=3569103290120, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038279, encodeId=588910382e9f0, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964054, encodeId=c601964054d2, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=71382214290, createdName=120e0b45m85(暂无昵称), createdTime=Sun May 09 18:51:09 CST 2021, time=2021-05-09, status=1, ipAttribution=)]
    2021-10-08 minlingfeng
  3. [GetPortalCommentsPageByObjectIdResponse(id=1721013, encodeId=49ae1e2101358, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Mon Oct 18 14:59:53 CST 2021, time=2021-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866075, encodeId=54f018660e5ed, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Oct 08 01:59:53 CST 2021, time=2021-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463758, encodeId=254c1463e5818, content=<a href='/topic/show?id=7d27381288e' target=_blank style='color:#2F92EE;'>#变性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38128, encryptionId=7d27381288e, topicName=变性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f69f6545041, createdName=huangdf, createdTime=Tue May 11 08:59:53 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032901, encodeId=3569103290120, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038279, encodeId=588910382e9f0, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964054, encodeId=c601964054d2, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=71382214290, createdName=120e0b45m85(暂无昵称), createdTime=Sun May 09 18:51:09 CST 2021, time=2021-05-09, status=1, ipAttribution=)]
    2021-05-11 huangdf
  4. [GetPortalCommentsPageByObjectIdResponse(id=1721013, encodeId=49ae1e2101358, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Mon Oct 18 14:59:53 CST 2021, time=2021-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866075, encodeId=54f018660e5ed, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Oct 08 01:59:53 CST 2021, time=2021-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463758, encodeId=254c1463e5818, content=<a href='/topic/show?id=7d27381288e' target=_blank style='color:#2F92EE;'>#变性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38128, encryptionId=7d27381288e, topicName=变性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f69f6545041, createdName=huangdf, createdTime=Tue May 11 08:59:53 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032901, encodeId=3569103290120, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038279, encodeId=588910382e9f0, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun May 09 20:59:53 CST 2021, time=2021-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964054, encodeId=c601964054d2, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=71382214290, createdName=120e0b45m85(暂无昵称), createdTime=Sun May 09 18:51:09 CST 2021, time=2021-05-09, status=1, ipAttribution=)]
    2021-05-09 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2021-05-09 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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放射性碘难治性分化型甲状腺癌(RR-DTC)患者发生肺转移可能会恶化总生存(OS)预后。SELECT试验是一项3期研究,Tahara等人在该试验中分析了肺转移对患者存活预后的影响进行了分析。

NEJM :乐伐替尼-派姆单抗治疗晚期肾细胞癌效果优于舒尼替尼

对于晚期肾细胞癌患者,乐伐替尼-派姆单抗治疗较舒尼替尼相比,在提高患者无进展生存期和总生存期方面具有显著优势

2019 专家共识:乐伐替尼治疗甲状腺癌期间不良事件的管理

乐伐替尼是一种口服多激酶抑制剂,经批准用于治疗侵袭性、局部进展或转移、放射碘不敏感的分化型甲状腺癌。本文主要针对乐伐替尼治疗甲状腺癌期间不良事件的管理提供共识指导。

Clin Cancer Res:ST6GAL1,乐伐替尼易感性FGF19驱动的肝癌的新血清生物标志物!

本研究旨在探究可指示对乐伐替尼敏感性的HCC生物标记物。

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