Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
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奥希替尼用于未经治疗的表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌
DOI：
10.1056/nejmoa1713137
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发表时间：
2018-01-11
影响因子：
158.5
通讯作者：
Nguyen, Nhung
中科院分区：
文献类型：
--
作者：
Soria, J. -C.;Ohe, Y.;Nguyen, Nhung
希美替尼是一种口服、第三代、不可逆的表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），可选择性抑制EGFR-TKI致敏突变和EGFR T790 M耐药突变。我们在既往未经治疗的EGFR突变阳性晚期非小细胞肺癌（NSCLC）患者中比较了奥希替尼与标准EGFR-TKI。（19号外显子缺失或L 858 R）晚期NSCLC的1：接受奥希替尼的比率为1（以80 mg每日一次的剂量）或标准EGFR-TKI（以250 mg每日一次的剂量的吉非替尼或以150 mg每日一次的剂量的厄洛替尼）。主要终点是评估者评估的无进展生存期。Osimertinib组的中位无进展生存期显著长于标准EGFR-TKI组（18.9个月对10.2个月;疾病进展或死亡的风险比为0.46; 95%可信区间[CI]为0.37至0.57; P
BACKGROUNDOsimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC).METHODSIn this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1: 1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival.RESULTSThe median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P