Lancet:帕唑帕尼抗软组织肉瘤(PALETTE研究)

2012-05-24 魏冬 医学论坛网

     《柳叶刀》(The Lancet)杂志5月16日在线发表的一项研究表明,帕唑帕尼是既往化疗后转移的非脂肪细胞软组织肉瘤患者的新治疗选择。   该研究是一项在13个国家72个中心开展的随机、双盲、安慰剂对照Ⅲ期临床研究。   受试者为既往接受标准化疗后疾病进展的转移性软组织肉瘤患者。患者既往未接受血管生成抑制剂治疗,研究按2:1的比例随机每日1次给予其帕唑帕尼800mg或安

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  《柳叶刀》(The Lancet)杂志5月16日在线发表的一项研究表明,帕唑帕尼是既往化疗后转移的非脂肪细胞软组织肉瘤患者的新治疗选择。

  该研究是一项在13个国家72个中心开展的随机、双盲、安慰剂对照Ⅲ期临床研究。

  受试者为既往接受标准化疗后疾病进展的转移性软组织肉瘤患者。患者既往未接受血管生成抑制剂治疗,研究按2:1的比例随机每日1次给予其帕唑帕尼800mg或安慰剂,后续无交叉给药。

  研究主要终点是无进展生存,并进行意向治疗分析。

  结果显示,研究共获得了372例患者,其中369例被随机分配到帕唑帕尼(n=246)或安慰剂组(n=123)。

  帕唑帕尼组和安慰剂组中位无进展生存期分别为4.6和1.6个月(P<0.0001),总生存期分别为12.5和10.7个月(P=0.25),最常见不良事件为疲乏(65% 对 49%)、腹泻(58% 对 16%)、恶心(54% 对 28%)、体重减轻(48% 对 20%)和高血压(41% 对 7%)。

  安慰剂和帕唑帕尼的中位相对剂量强度分别为100%和96%。

 
    

评论区 (4)
#插入话题
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    2013-02-17 drj2003
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    2013-02-13 12498e67m28暂无昵称

    #TTE#

    0

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    2012-12-14 howi

    #Lancet#

    0

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    2012-05-26 qilu_qi

    #软组织#

    0