Lancet oncol:派姆单抗用于治疗晚期胸腺癌的效果和安全性

2018-01-27 MedSci MedSci原创

目前,供胸腺癌患者可选择的治疗方式有限。侵袭性肿瘤常与副肿瘤自身免疫性疾病无典型关联,而胸腺上皮肿瘤细胞也明显表达PD-L1。现有研究人员对pembrolizumab(派姆单抗),一种靶向PD-1的单克隆抗体,用于治疗晚期胸腺癌患者的效果和安全性进行评估。研究人员进行一单臂的II期研究,在多个国家招募在1个或多个一线化疗后出现进展的复发性胸腺癌患者。此外,要求受试者ECOG状态评分0-2分,无自身

目前,供胸腺癌患者可选择的治疗方式有限。侵袭性肿瘤常与副肿瘤自身免疫性疾病无典型关联,而胸腺上皮肿瘤细胞也明显表达PD-L1。现有研究人员对pembrolizumab(派姆单抗),一种靶向PD-1的单克隆抗体,用于治疗晚期胸腺癌患者的效果和安全性进行评估。

研究人员进行一单臂的II期研究,在多个国家招募在1个或多个一线化疗后出现进展的复发性胸腺癌患者。此外,要求受试者ECOG状态评分0-2分,无自身免疫性疾病史或其他要求治疗或影响实验数据的其他恶性肿瘤,以及合适 的器官功能。患者每3周接受200mg 派姆单抗,持续2年。主要评估指标:获得缓解的患者比例。

2015年3月12日=2016年12月16日,共招募41位患者,其中40位符合要求。中位随访时间20个月(IQR 14-26)。获得反应的患者比例是22.5%(95% CI 10.8-38.5);1位(3%获得完全反应,8位(20%)患者获得部分反应,11位(53%)病情稳定。最常见的3级及以上副反应事件是天冬氨酸转移酶和丙氨酸氨基转移酶升高(各5例[13%])。6位(15%)患者出现严重的自身免疫病,包括2例(5%)心肌炎。分析过程中出现17例死亡,但死亡与毒性无关。

对于胸腺癌患者来说,派姆单抗是所有甲状腺癌的有希望的治疗选择。因为胸腺癌中出现严重的自身免疫性疾病的概率要明显超过其他种类类型。因此,紧密监测是很必要的。

原始出处:

Giuseppe Giaccone,et al.Pembrolizumab in patients with thymic carcinoma: a single-arm, single-centre, phase 2 study.TheLancet Oncology, Januaray 25, 2018.
http://dx.doi.org/10.1016/S1470-2045(18)30062-7

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    2018-11-08 minlingfeng
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    2018-03-18 howi
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channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jan 27 22:44:23 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282639, encodeId=00c72826394f, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/14/98b313dfe26b90ecf72d9fa320a8b56b.jpg, createdBy=ca4a2247226, createdName=红木中餐, createdTime=Sat Jan 27 20:50:02 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282630, encodeId=df8c2826302d, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jan 27 20:24:23 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-02-27 天涯183

    非常好的文章.学习了

    0

  6. 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channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jan 27 22:44:23 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282639, encodeId=00c72826394f, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/14/98b313dfe26b90ecf72d9fa320a8b56b.jpg, createdBy=ca4a2247226, createdName=红木中餐, createdTime=Sat Jan 27 20:50:02 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282630, encodeId=df8c2826302d, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jan 27 20:24:23 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-28 1e0e5697m83(暂无匿称)

    henhao

    0

  8. 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channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jan 27 22:44:23 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282639, encodeId=00c72826394f, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/14/98b313dfe26b90ecf72d9fa320a8b56b.jpg, createdBy=ca4a2247226, createdName=红木中餐, createdTime=Sat Jan 27 20:50:02 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282630, encodeId=df8c2826302d, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jan 27 20:24:23 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-27 天涯183

    非常好的文章.学习了

    0

  9. 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channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jan 27 22:44:23 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282639, encodeId=00c72826394f, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/14/98b313dfe26b90ecf72d9fa320a8b56b.jpg, createdBy=ca4a2247226, createdName=红木中餐, createdTime=Sat Jan 27 20:50:02 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282630, encodeId=df8c2826302d, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jan 27 20:24:23 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-27 红木中餐

    henhao

    0

  10. 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channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jan 27 22:44:23 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282639, encodeId=00c72826394f, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/14/98b313dfe26b90ecf72d9fa320a8b56b.jpg, createdBy=ca4a2247226, createdName=红木中餐, createdTime=Sat Jan 27 20:50:02 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282630, encodeId=df8c2826302d, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jan 27 20:24:23 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-27 131****1460

    学习了受益匪浅

    0

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近日,在医学权威杂志JCO上面发表了一篇研究文章,该文章旨在探讨派姆单抗治疗PD-L1阳性复发或转移性鼻咽癌(RM-NPC)患者的安全性及抗肿瘤活性。

lancet oncol:派姆单抗(pembrolizumab)在局部晚期或转移性尿路上皮癌患者中安全性和活性的1期临床研究(KEYNOTE-012)

PD-1及其配体在尿路上皮癌中表达,研究已经发现抑制PD-1途径具有临床益处。近期一项发表在LANCET ONCOL杂志上的文章研究评估了抗PD-1抗体派姆单抗(pembrolizumab)在局部晚期或转移性尿路上皮癌患者中的安全性和活性。这项研究是非随机,多组群,开放标签,1b期试验研究。研究者们从美国和以色列的8家医院招募了18岁及以上的患者,进行组织学或细胞学证实的局部晚期或转移性尿路上皮癌

JNCI:转移性NSCLC:派姆单抗个体化剂量还是固定剂量性价比更高?

药物经济学研究是对提供的药品或服务的治疗成本和收益进行综合评价及比较,以了解其经济性,即性价比。2017年11月,发表在《Journal of the National Cancer Institute》的一项研究调查了派姆单抗个体化剂量(2?mg/kg)与固定剂量(200?mg)相比在转移性非小细胞肺癌(mNSCLC)患者中的药物经济学。

JCO:派姆单抗治疗晚期PD-L1阳性宫颈癌患者效果佳

2017年11月,发表在《J Clin Oncol》的Ib期KEYNOTE-028试验,考察了派姆单抗在晚期、程序性死亡配体1(PD-L1)阳性宫颈癌患者中的安全性和有效性。

ESMO 2016:卡铂+培美曲塞+派姆单抗,可改善NSCLC患者的PFS

欧洲临床肿瘤学会年会上呈现的KEYNOTE-021研究数据显示:对于晚期非鳞状非小细胞肺癌患者,在标准一线化疗基础上(卡铂+培美曲塞)添加派姆单抗,可显著改善患者的总体缓解率、延长PFS。 来自宾夕法尼亚大学的Corey J. Langer博士和同事们对123例IIIB/IV期、未进行化疗的非鳞状非小细胞肺癌患者进行了研究,这些患者的ECOG性能状态评分为0分或1分,并且没有EGFR突变或A