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ASCO 2014：陆舜谈ALK阳性肺癌的PROFILE 1014研究

2014-05-31 CMT肿瘤 医学论坛网

ASCO肺癌陆舜ALK
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克唑替尼为初治晚期ALK阳性非鳞NSCLC的一线标准治疗 题目：在晚期ALK阳性非鳞NSCLC患者中克唑替尼与培美曲塞+顺铂/卡铂一线治疗的对比：PROFILE 1014 Ⅲ期研究结果（First-line crizotinib versus pemetrexed–cisplatin or pemetrexed–carboplatin in patients with adv

克唑替尼为初治晚期ALK阳性非鳞NSCLC的一线标准治疗

题目：在晚期ALK阳性非鳞NSCLC患者中克唑替尼与培美曲塞+顺铂/卡铂一线治疗的对比：PROFILE 1014 Ⅲ期研究结果（First-line crizotinib versus pemetrexed–cisplatin or pemetrexed–carboplatin in patients with advanced ALK-positive non-squamous non-small cell lung cancer (NSCLC): results of a phase III study (PROFILE 1014).）

摘要号：# 8002

报告时间：2014年6月3日 8:00-11:00 AM CDT(美国中部夏令时间)

报告者：香港中文大学 Tony Mok

Session Title：Lung Cancer - Non-small Cell Metastatic

Session Type：Poster Highlights Session

研究点评

这是在间变性淋巴瘤激酶(ALK)阳性的晚期非小细胞肺癌(NSCLC)患者中进行的一项研究，头对头比较一线给予克唑替尼(Crizotinib)与标准化疗方案培美曲塞+顺铂或培美曲塞+卡铂的疗效。

克唑替尼口服方便，已取得良好疗效，2011年获得美国食品与药物管理局(FDA)的批准，2013年获得我国国家食品药品监督管理总局(CFDA)的批准。

该研究从2011至2013年间纳入343个ALK阳性的非鳞NSCLC初治患者，按照1:1的比例随机接受克唑替尼(250 mg bid，172例)或标准化疗(171例)。主要终点为PFS，次要终点包括客观缓解率(ORR)、总生存(OS)、安全性和患者症状量表的评分。

我所了解到的这是一个阳性结果， 结果不出意料，在ALK阳性的非鳞NSCLC里，克唑替尼显著优于化疗。ORR：74% 对45%;PFS：10.9个月对7.0个月;有68%的患者仍处于随访中，OS结果目前尚未显示出显著的改善(HR=0.821，P=0.1804)，因为化疗的毒性和克唑替尼的口服方便性 此研究可能改变当前临床实践中的标准治疗方案。

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    2014-09-12 quxin068

    #ASC#

    0

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    2014-12-09 xjy02

    #ALK阳性#

    0

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    2014-06-02 sunylz

    #PRO#

    0

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    2014-11-10 hunizi005

    #Profile#

    0

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