RAY研究（MCL 3001）：伊布替尼VS西罗莫司在RR MCL患者中疗效：一项随机对照开放性多中心Ⅲ期研究

2017-10-17 梅斯医学梅斯医学

研究背景•套细胞淋巴瘤（MCL）是一种侵袭性B细胞淋巴瘤，预后极差。虽然治疗不断进步，依然没有国际公认的RRMCL的治疗方案。•西罗莫司在欧洲批准用于RRMCL单药治疗，单药伊布替尼也批准用于治疗复发套细胞淋巴瘤，两者之间疗效是否存在差异目前尚无研究。研究目的•本研究目的是进行一项随机、对照、开放标签、多中心、3期研究，比较伊布替尼和西罗莫司在rr MCL患者（包含≥1种既往含利妥昔单抗化疗方案者

研究背景

•套细胞淋巴瘤（MCL）是一种侵袭性B细胞淋巴瘤，预后极差。虽然治疗不断进步，依然没有国际公认的RRMCL的治疗方案。

•西罗莫司在欧洲批准用于RRMCL单药治疗，单药伊布替尼也批准用于治疗复发套细胞淋巴瘤，两者之间疗效是否存在差异目前尚无研究。

研究目的

•本研究目的是进行一项随机、对照、开放标签、多中心、3期研究，比较伊布替尼和西罗莫司在rr MCL患者（包含≥1种既往含利妥昔单抗化疗方案者）中的疗效和安全性。

研究方法

•研究设计：

•主要终点：独立审查委员会评估的无进展生存期（IRC-PFS）和研究者评估PFS

•次要终点：ORR、 OS、1年存活率、 DoR、到下次需治疗的时间（TTNT）、患者报告的临床结局和安全性

研究结果——PFS、OS

伊布替尼单药治疗PFS达15.6个月，OS达30.3个月

研究结果——ORR

伊布替尼组患者的ORR均显著高于西罗莫司组，且在复发一线及后线治疗中获益明显

研究结果——更早使用，更早获益

越早使用伊布替尼，生存获益越好
首次复发后使用，中位PFS和OS高达25.4和42.1个月

首次复发后使用伊布替尼治疗，

中位PFS高达25.4个月

首次复发后使用伊布替尼治疗，

中位OS高达42.1个月

研究结果——安全性

1.伊布替尼组患者常见不良反应（≥20%）为腹泻、咳嗽和疲乏，多为轻度。

2.西罗莫司组主要是血小板减少、贫血、腹泻、疲乏。

3.≥3级AEs：伊布替尼组vs 西罗莫司组=68%vs 87%。

研究启示

•RAY研究是首个伊布替尼单药与对照药物头对头比较、治疗既往接受过治疗的MCL的3年随访经典研究

•伊布替尼单药治疗RRMCLPFS达15.6个月，OS达30.3个月

•越早使用伊布替尼，生存获益越好，首次复发后使用，中位PFS和OS高达25.4和42.1个月

如需了解更多淋巴瘤的前沿信息请扫描二维码访问“淋巴瘤亿刻”网站。

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2018-04-30 amyloid

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2017-12-04 1771ae4158m

学习一下很不错

76 0
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2017-11-03 哈哈869

学了

80 0
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2017-11-02 哈哈869

已阅

74 0
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2017-11-02 哈哈869

学了

74 0
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2017-11-02 哈哈869

学习

0 0
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04 09:16:38 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258367, encodeId=a78225836ec8, content=学了, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Fri Nov 03 16:41:37 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258098, encodeId=97cb258098b7, content=已阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, 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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:53 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257722, encodeId=da5c25e72255, content=已阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:50 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257721, encodeId=136425e72110, content=学习学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:46 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
2017-11-02 哈哈869

学习学了

40 0
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2017-11-01 哈哈869

学了

48 0
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2017-11-01 哈哈869

已阅

57 0
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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Thu Nov 02 17:56:10 CST 2017, time=2017-11-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258095, encodeId=a20d258095b1, content=学习学了, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Thu Nov 02 17:56:07 CST 2017, time=2017-11-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257723, encodeId=696d25e72332, content=学了, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:53 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257722, encodeId=da5c25e72255, content=已阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:50 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257721, encodeId=136425e72110, content=学习学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKcmgibQ4oCrK7Z6f4CvMcs4k7QUGCkhopcGxvxaBfVciadECSIwaRVttllIOEKumpEaRrq5PoOUxow/0, createdBy=e3bb2081203, createdName=哈哈869, createdTime=Wed Nov 01 07:48:46 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
2017-11-01 哈哈869

学习学习了

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