First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
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IV期或复发性非小细胞肺癌中的一线Nivolumab。
DOI：
10.1056/nejmoa1613493
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发表时间：
2017-06-22
期刊：
影响因子：
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通讯作者：
CheckMate 026 Investigators
中科院分区：
文献类型：
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作者：
Carbone DP;Reck M;Paz-Ares L;Creelan B;Horn L;Steins M;Felip E;van den Heuvel MM;Ciuleanu TE;Badin F;Ready N;Hiltermann TJN;Nair S;Juergens R;Peters S;Minenza E;Wrangle JM;Rodriguez-Abreu D;Borghaei H;Blumenschein GR Jr;Villaruz LC;Havel L;Krejci J;Corral Jaime J;Chang H;Geese WJ;Bhagavatheeswaran P;Chen AC;Socinski MA;CheckMate 026 Investigators
在既往接受过治疗的非小细胞肺癌（NSCLC）患者中，Nivolumab与多西他赛相比，总生存期更长。在开放标签3期试验中，我们在患有程序性死亡配体1（PD-L1）阳性NSCLC的患者中比较了一线纳武单抗与化疗。我们以1：1的比例将未经治疗的IV期或复发性NSCLC患者和PD-L1肿瘤表达水平为1%或更高的患者随机分配接受nivolumab（以每公斤体重3 mg的剂量静脉注射，每2周一次）或铂类化疗（每3周一次，最多6个周期）。接受化疗的患者可以在疾病进展时交叉接受nivolumab。主要终点是PD-L1表达水平≥ 5%的患者的无进展生存期，通过盲法独立中心审查进行评估。在PD-L1表达水平为5%或更高的423例患者中，纳武利尤单抗组的中位无进展生存期为4.2个月，而化疗组为5.9个月（疾病进展或死亡的风险比，1.15; 95%置信区间[CI]，0.91至1.45; P=0.25），中位总生存期为14.4个月与13.2个月（死亡风险比，1.02; 95% CI，0.80至1.30）。化疗组212例患者中共有128例（60%）接受了nivolumab作为后续治疗。任何级别的治疗相关不良事件发生在71%接受nivolumab的患者和92%接受化疗的患者中。18%接受nivolumab的患者和51%接受化疗的患者发生了3级或4级治疗相关不良事件。在既往未经治疗的IV期或PD-L1表达水平≥ 5%的复发性NSCLC患者中，Nivolumab与化疗相比无进展生存期无显著延长。两组的总生存率相似。与化疗相比，Nivolumab具有良好的安全性特征，没有新的或非预期的安全性信号。（由百时美施贵宝公司和其他公司资助; CheckMate 026 ClinicalTrials.gov编号，）
Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-Ll)-positive NSCLC. We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more. Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemo-therapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy. Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, .)