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JCO：吉非替尼vs.厄洛替尼的非劣效性研究

2016-03-31 zhaozhou 译 MedSci原创

吉非替尼厄洛替尼非劣效性研究
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 在全球范围，肺癌是一种主要致死的癌症。肺癌中有大约85%是非小细胞肺癌，最常见的非小细胞肺癌的类型是腺癌。随之靶向表皮生长因子受体EGFR酪氨酸激酶的药物的问世，非小细胞肺癌尤其是腺癌的治疗已经取得了巨大的进展。吉非替尼和厄洛替尼作为第一代EGFR酪氨酸激酶抑制剂，二者具有相同的骨架结构，不可逆地结合在EGFR的ATP结合口袋。厄洛替尼推荐的和最大的耐受剂量是相同的，均为150mg/d

在全球范围，肺癌是一种主要致死的癌症。肺癌中有大约85%是非小细胞肺癌，最常见的非小细胞肺癌的类型是腺癌。随着靶向表皮生长因子受体EGFR酪氨酸激酶的药物的问世，非小细胞肺癌尤其是腺癌的治疗已经取得了巨大的进展。吉非替尼和厄洛替尼作为第一代EGFR酪氨酸激酶抑制剂，二者具有相同的骨架结构，不可逆地结合在EGFR的ATP结合口袋。厄洛替尼推荐的和最大的耐受剂量是相同的，均为150mg/d，而吉非替尼的最大耐受剂量是其标准推荐剂量250mg/d的三倍。
 

作为两种大名鼎鼎的受体酪氨酸激酶抑制剂，剂量的选择却有着巨大的差距。因此，研究人员开展了一项三期临床试验来对比二者的用药剂量。受试者均是早前接受过治疗的肺腺癌患者，他们被随机分组，分别接受吉非替尼或者厄洛替尼的治疗，从而研究吉非替尼相较于厄洛替尼的非劣性。主要的终点是无进展生存时间（PFS）。561名患者参与了此项研究。其中401人携带有EGFR突变。两组间所有的基线因素均是平衡的。吉非替尼和厄洛替尼的中位PFS和总生存时间分别为6.5、7.5个月和22.8、24.5个月。二者的反应率分别为45.9%和44.1%。EGFR突变阳性的患者接受吉非替尼和厄洛替尼的中位PFS时间分别为8.3和10.0个月。主要的3或4级毒性为皮疹和ALT/AST上升。
 
这些研究并没有从PFS的角度证明出吉非替尼相对于厄洛替尼的非劣效性。尽管统计学上并没有差异，但是考虑到吉非替尼副作用更小，仍然用于治疗EGFR突变阳性腺瘤。

原始出处：

Yoshiko Urata et al. Randomized Phase III Study Comparing Gefitinib With Erlotinib in Patients With Previously Treated Advanced Lung Adenocarcinoma: WJOG 5108L. JCO. Published Ahead of Print on March 28, 2016 as 10.1200/JCO.2015.63.4154

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    2016-06-26 lidong40

    #JCO#

    0

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    2016-10-28 lixiao3326

    #非劣效性#

    0

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    2016-09-05 tonychen21

    #非劣效#

    0

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    2016-04-11 12498d2fm51(暂无昵称)

    #非劣效性研究#

    0

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    2016-04-02 ms306040998833292

    #厄洛替尼#

    0

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