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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
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    2014-07-15 quxin068
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摘要号:#8073 第一作者:刘学文,中山大学华南肿瘤学国家重点实验室 背景:肺肉瘤样癌是一种罕见的、高度侵袭性肺部肿瘤,预后差,对传统化疗的抵抗率高。人们对其独特的双向分化模式分子基础了解不多。基于更好地了解肺肉瘤样癌分子发病机制的新治疗策略非常必要。我们使用微阵列单核苷酸多态技术(SNP array)和高通量测序技术来识别新型分子治疗靶点。 方法:从肺肉瘤

ASCO 2014:CTC-HER2或可预测转移性乳腺癌靶向治疗的预后

摘要号:#628 第一作者:江泽飞,军事医学科学院附属医院(北京307医院) 背景:循环肿瘤细胞(CTC)计数的价值已经被广泛认可,但在接受靶向治疗的HER2阳性(荧光原位杂交法1个+或免疫组化法3个+)乳腺癌患者中,循环肿瘤细胞计数以及循环肿瘤细胞中HER2的表达(CTCs-HER2)意义还不明确。 方法:在2010年10月到2013年12月期间共纳入101

ASCO 2014:CSWOG鼻型结外NK/T细胞淋巴瘤的新分期系统

摘要号:8552 第一作者:林桐榆,中山大学肿瘤医院 标题:中国西南临床肿瘤协作组(CSWOG)的新鼻型结外NK/T细胞淋巴瘤分期系统——1项多中心研究 背景:鼻型结外NK/T细胞淋巴瘤(ENKTL)是一种罕见的具有不良预后的高侵袭性疾病。 Ann Arbor分期一直无法确定ENKTL的具体分期方式。本研究将对ENKTL指定一个新的分期系统,以便于识别具有不良

ASCO 2014:化疗+恩度可显著提高骨肉瘤患者生存期

摘要号:# 10538 第一作者:徐海荣,北京积水潭医院骨肿瘤外科 标题:一项受控的,非随机的IIB期骨肉瘤化疗联合再结合内皮抑素的临床研究 背景:本研究目的在于探讨化疗联合再结合内皮抑素(恩度)对于IIB期骨肉瘤的疗效及安全性。 方法:来自北京积水潭医院2008年1月至2012年4月诊断为IIB期骨肉瘤的患者分为联合治疗组和对照组。其化疗方

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