本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2402614

摘要内容如下：

背景

奥西替尼（Osimertinib）是治疗晚期非小细胞肺癌（NSCLC）表皮生长因子受体（EGFR）突变的推荐药物，也是切除的EGFR突变NSCLC的辅助治疗药物。EGFR-酪氨酸激酶抑制剂已在不可切除的III期EGFR突变NSCLC中显示出初步疗效。

方法

在这项3期、双盲、安慰剂对照试验中，我们将放化疗期间或放化疗后无进展的不可切除的EGFR突变的III期NSCLC患者随机分配接受奥西替尼或安慰剂治疗，直到出现疾病进展（通过盲法独立中心评价评估）或停止治疗方案。主要终点是通过盲法独立中心审查评估的无进展生存期。

结果

共有216名接受放化疗的患者被随机分配接受奥西替尼（143名患者）或安慰剂（73名患者）。与安慰剂组相比，奥西替尼组的无进展生存期获益显著：奥西替尼组的中位无进展生存期为39.1个月，安慰剂组为5.6个月，疾病进展或死亡的风险比为0.16（95%可信区间[CI]，0.10~0.24；P<0.001）。在12个月时，奥西替尼组存活且无进展的患者百分比为74%（95%CI，65至80），安慰剂组为22%（95%CI，13至32）。中期总生存数据（成熟度，20%）显示，84%的奥西替尼患者（95%CI，75-89）和74%的安慰剂患者（95%CI，57-85）的36个月总生存率，死亡风险比为0.81（95%CI，0.42-1.56；P=0.53）。奥西替尼组3级或更高级别不良事件的发生率为35%，安慰剂组为12%；放射性肺炎（多数级别，1至2级）的报告率分别为48%和38%。没有出现新的安全问题。

结论

与安慰剂相比，奥西替尼治疗不可切除的Ⅲ期EGFR突变NSCLC患者的无进展生存期显著延长。（由阿斯利康（AstraZeneca）资助；Laura ClinicalTrials.gov，NCT03521154）。

英文原文如下：

Abstracts

BACKGROUND  Osimertinib is a recommended treatment for advanced non-small-cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation and as adjuvant treatment for resected EGFR-mutated NSCLC. EGFR-tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR-mutated NSCLC.

METHODS  In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR-mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review.

RESULTS  A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75 to 89) and 74% with placebo (95% CI, 57 to 85), with a hazard ratio for death of 0.81 (95% CI, 0.42 to 1.56; P = 0.53). The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1 to 2) was reported in 48% and 38%, respectively. No new safety concerns emerged.

CONCLUSIONS  Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC. (Funded by AstraZeneca; LAURA ClinicalTrials.gov number, NCT03521154.).

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