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Lancet Gastroen Heptaol:胃癌二线化疗,白蛋白结合型紫杉醇vs溶剂型紫杉醇

2017-01-20 MedSci MedSci原创

每周使用溶剂型紫杉醇是晚期胃癌的二线化疗方案之一。白蛋白结合型紫杉醇纳米粒(nab-paclitaxel)的开发是为了提高紫杉醇的溶解度且不必术前用药进而避免了与溶剂型紫杉醇相关的输液反应。此外,与溶剂型紫杉醇相比,高剂量的白蛋白结合型紫杉醇可以通过更短的输液时间达到较高的药物浓度。但具体效果如何?最新一期的The Lancet Gastroenterology & Heptaology在

注射用紫杉醇(白蛋白结合型)


每周使用溶剂型紫杉醇是晚期胃癌的二线化疗方案之一。白蛋白结合型紫杉醇纳米粒(nab-paclitaxel)的开发是为了提高紫杉醇的溶解度且不必术前用药进而避免了与溶剂型紫杉醇相关的输液反应。此外,与溶剂型紫杉醇相比,高剂量的白蛋白结合型紫杉醇可以通过更短的输液时间达到较高的药物浓度。但具体效果如何?最新一期的The Lancet Gastroenterology & Heptaology在线发表了一项研究,探究了与溶剂型紫杉醇相比,白蛋白结合型紫杉醇治疗晚期胃癌患者的疗效和安全性。

这是一项在日本的72个机构进行的随机、开放性、非劣效性Ⅲ期试验。患者均为一线化疗方案含氟嘧啶治疗效果不佳的大于20岁的晚期胃癌患者,同时这些患者也存在疾病进展或在最终剂量的辅助化疗后24周内复发。研究人员把这些患者随机(1:1:1)分为3组:每3周(每一周期21天的第一天)接受一次静脉注射白蛋白结合型紫杉醇(260 mg/平方米);每周白蛋白结合型紫杉醇(100mg/平方米,一周期28天的第1、8、15天);或每周溶剂型紫杉醇(80mg/平方米,一周期28天的第1、8、15天)。主要终点是全分析组的总生存期,全分析组包括所有随机分配的患者中的那些接受了至少一种紫杉醇且具有非劣效性(风险比为1.25)者。

在2013年3月13日-2015年5月14日,共招募到了741例患者,随机分为每3周接受一次白蛋白结合型紫杉醇组(n = 247),每周白蛋白结合型紫杉醇组(N = 246),或每周溶剂型紫杉醇组者(N = 248)。三组的总生存期的中位时间分别为:9.99个月(四分位距[IQR],6.05-15.05)、11.1个月(9.9–13.0)、10.9个月(9.4–11.8)。每周白蛋白结合型紫杉醇不劣于每周溶剂型紫杉醇(HR 0.97,97.5% CI 0.76-1.23;单侧非劣效性 P = 0.0085),而每3周白蛋白结合型紫杉醇并不非劣于溶剂型紫杉醇(1.06,95% CI 0.87–1.31;单侧非劣效性 P = 0.062)。主要的3级或更严重的药物不良反应为嗜中性白血球减少症(三组分别为:158例 [65%,共244名患者]、99 例[41%共241名患者]、71例[ 29%,共243名患者])、外周感觉神经病变(49例[20%]、6例[2%]、6例[2%])、发热性中性粒细胞减少(30例[12]、7例[3%]、2例[1%])。过敏反应在每3周白蛋白结合型紫杉醇组(2例[1%])和每周白蛋白结合型紫杉醇组(3例[1%])更不少出现,与每周溶剂型紫杉醇组相比(13例[5%])。总共报告了4例治疗相关的死亡(每3周白蛋白结合型紫杉醇组,1例急性肺炎;每周白蛋白结合型紫杉醇组,1例发热性中性粒细胞减少/肺炎和1例感染性休克;每周溶剂型紫杉醇组,1例呼吸系统疾病/间质性肺病)。

研究结果表明:在总生存期方面,每周接受白蛋白结合型紫杉醇治疗非劣于每周接受溶剂型紫杉醇治疗,白蛋白结合型紫杉醇的有点使得它将是胃癌二线治疗的潜在方案。

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    2017-10-30 howi
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    2017-09-06 许安
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beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Sat Jan 21 23:57:40 CST 2017, time=2017-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171791, encodeId=78d31e179170, content=文章太好了,多读受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Sat Jan 21 11:31:41 CST 2017, time=2017-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171724, encodeId=c5ec1e17245b, content=学习一下,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Sat Jan 21 06:58:56 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-01-22 珙桐
  7. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171724, encodeId=c5ec1e17245b, content=学习一下,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Sat Jan 21 06:58:56 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-01-22 蔬菜

    相关研究多不多

    0

  8. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Sat Jan 21 23:57:40 CST 2017, time=2017-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171791, encodeId=78d31e179170, content=文章太好了,多读受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Sat Jan 21 11:31:41 CST 2017, time=2017-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171724, encodeId=c5ec1e17245b, content=学习一下,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Sat Jan 21 06:58:56 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-01-21 cqykthl

    很好的医学咨询

    0

  9. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=171724, encodeId=c5ec1e17245b, content=学习一下,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Sat Jan 21 06:58:56 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-01-21 1e10c84am36(暂无匿称)

    文章太好了,多读受益

    0

  10. 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    2017-01-21 三生有幸9135

    学习一下,谢谢分享

    0

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