ASCO 2014：hhpg-19K可预防晚期NSCLC患者化疗的骨髓抑制

2014-05-31 悄悄译医学论坛网

摘要号：#9614 第一作者：周彩存，上海同济大学附属肺科医院标题：聚乙二醇重组人粒细胞刺激因子(hhpg-19K)预防晚期非小细胞肺癌患者化疗骨髓抑制的Ⅲ期研究——一项多中心随机双盲对照Ⅲ期研究背景：HHPG-19K（19K）是一种长效的聚乙二醇化重组粒细胞集落刺激因子，在每个化疗周期给药一次。该III期研究的目的是调查HHPG-19K作为预防性治疗接受

摘要号：#9614

第一作者：周彩存，上海同济大学附属肺科医院

标题：聚乙二醇重组人粒细胞刺激因子(hhpg-19K)预防晚期非小细胞肺癌患者化疗骨髓抑制的Ⅲ期研究——一项多中心随机双盲对照Ⅲ期研究

背景：HHPG-19K（19K）是一种长效的聚乙二醇化重组粒细胞集落刺激因子，在每个化疗周期给药一次。该III期研究的目的是调查HHPG-19K作为预防性治疗接受骨髓抑制性化疗的晚期非小细胞肺癌患者的疗效/安全性。

方法：患者（1：1：1）随机盲分配到三个治疗组，分别在第一个周期接受19K100mg/kg，6mg/kg固定剂量以及CONTROL (盐水)的治疗。在第一周期结束时揭盲，进行第2-4周期，CONTROL组的患者按照5mg/kg的剂量在化疗后接受每日一次注射48小时剂量的粒细胞集落刺激因子，而随机分配到19k治疗的两组仍按照第一周期的剂量接受治疗。所有患者均接受4个周期的21天多西他赛（75mg/m2）联合顺铂（75mg/m2）或卡铂（曲线下面积5）的治疗。其治疗的主要终点是在第一周期发生3/4级中性粒细胞减少。

结果：本研究共入组151位临床分期为Ⅲ/Ⅳ期非小细胞肺癌化疗患者。3组患者的基本特征被平均分布。结果显示，在第一周期中，与CONTROL 组相比，3/4级中性粒细胞减少的发生率在使用19k 100mg/kg及6mg/kg固定剂量的组别中明显降低。而在第2-4周期中并没有发现统计学差异。在第一周期中，使用19k的两组的3/4级中性粒细胞减少的持续时间以及平均恢复时间均比CONTROL 组减短。在第2-4周期中，这3组的时间相似。发热性中性粒细胞减少只在第一周期中的CONTROL 组被观察到。恶心，疲劳和厌食是观察到的最常见不良反应但在三个组别的所有周期中均显示无统计学意义差异。

结论：这项研究表明，HHPG-19K（无论是使用100mg/kg或6mg固定剂量）的疗效均优于安慰剂治疗，并可以媲美短效粒细胞集落刺激因子的预防疗效。患者对HHPG-19K的耐受性良好，没有观察到意外的不良反应。6毫克固定剂量的给药方式更为方便，可建议应用于日后的临床实践中。临床试验信息：NCT01560195

研究链接：Multicenter randomized double-blind controlled phase III study of hhpg-19K as prophylactic therapy in patients with advanced non-small cell lung cancer (NSCLC) receiving myelosuppressive chemotherapy.

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2014-09-15 jklm09

#SCLC患者#

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2014-07-15 quxin068

#ASC#

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2014-06-02 维他命

#骨髓抑制#

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2014-06-02 xiongliangxl

#NSCLC患者#

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2014-06-02 经常头晕

#晚期NSCLC#

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