JCO:替莫唑胺治疗小细胞肺癌:随机双盲研究

2018-06-16 海北 MedSci原创

已有的研究显示,替莫唑胺(TMZ)和PARP抑制剂都在小细胞肺癌(SCLC)中表现出了活性。最近,研究人员进行了一项II期随机双盲研究,评估了将PARP抑制剂veliparib加入TMZ,是否可改善4个月的无进展生存期(PFS)。

已有的研究显示,替莫唑胺(TMZ)和PARP抑制剂都在小细胞肺癌(SCLC)中表现出了活性。最近,研究人员进行了一项II期随机双盲研究,评估了将PARP抑制剂veliparib加入TMZ,是否可改善4个月的无进展生存期(PFS)。
该研究共招募了104名复发性SCLC患者。在周期28天的试验中,患者以1:1的比例被随机分配到第1-7天口服40 mg veliparib或安慰剂,每天两次。第1-5天患者还会口服TMZ,150-200 mg / m2 /天,直至疾病进展,出现不可接受的毒性或取消同意为止。
研究人员在第4周和第8周对患者进行成像,来确定响应,并且此后每8周进行一次成像。主要终点是4个月时PFS的改善。次要目标包括总体缓解率(ORR),总生存期(OS),以及TMZ与veliparib的安全性和耐受性。探索性目标包括PARP-1和SLFN11免疫组化表达,MGMT启动子甲基化,和循环肿瘤细胞定量。
结果显示,TMZ / veliparib(36%)与TMZ /安慰剂(27%; P = .19)之间的4个月PFS无显着差异。使用TMZ / veliparib后,中位OS也没有显着改善(8.2个月; 95%CI,6.4至12.2个月; v 7.0个月; 95%CI,5.3至9.5个月; P = 0.50)。
然而,接受TMZ / veliparib的患者的ORR显着高于TMZ /安慰剂组(39%vs 14%; P = 0.016)。 TMZ / veliparib更常发生3/4级血小板减少和中性粒细胞减少:分别为50% vs 9%,31% vs 7%。
在用TMZ / veliparib治疗的SLFN11阳性肿瘤患者中观察到显着延长的PFS(5.7 v 3.6个月; P = 0.009)和OS(12.2 v 7.5个月; P = 0.014)。
因此,4个月PFS和中位OS在两组之间无差异,而TMZ / veliparib组可以观察到ORR的显着改善。 SLFN11的表达与接受TMZ / veliparib的患者的PFS和OS的改善相关。

原始出处:

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    2018-07-23 lidong40
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    2018-06-24 jihuaijun1112

    学习学习学习

    0

  4. 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    2018-06-24 jihuaijun1112

    学习学习学习

    0

  5. 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createdName=jihuaijun1112, createdTime=Tue Jun 19 08:04:26 CST 2018, time=2018-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325190, encodeId=188232519053, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Mon Jun 18 21:42:09 CST 2018, time=2018-06-18, status=1, ipAttribution=)]
    2018-06-24 jihuaijun1112

    学习学习学习

    0

  6. 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createdName=jihuaijun1112, createdTime=Tue Jun 19 08:04:26 CST 2018, time=2018-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325190, encodeId=188232519053, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Mon Jun 18 21:42:09 CST 2018, time=2018-06-18, status=1, ipAttribution=)]
    2018-06-21 jihuaijun1112

    学习学习学习

    0

  7. 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    2018-06-20 jihuaijun1112

    学习学习学习

    0

  8. 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    2018-06-20 jihuaijun1112

    学习学习学习

    0

  9. 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createdName=jihuaijun1112, createdTime=Tue Jun 19 08:04:26 CST 2018, time=2018-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325190, encodeId=188232519053, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Mon Jun 18 21:42:09 CST 2018, time=2018-06-18, status=1, ipAttribution=)]
    2018-06-19 jihuaijun1112

    学习学习学习

    0

  10. 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