《新英格兰医学杂志》2017年6月22日376:2415-2426
http://www.nejm.org/doi/full/10.1056/NEJMoa1613493?query=featured_home
纳武单抗一线治疗IV期或复发性非小细胞肺癌
背景
在既往治疗过的非小细胞肺癌患者中，纳武单抗治疗比多西他赛进一步延长总生存期。在一项开放标签3期临床试验中，我们在程序性死亡配体1（PD-L1）阳性的非小细胞肺癌患者中对纳武单抗一线治疗与化疗进行了比较。
方法
按照1：1的比例，我们随机将PD-L1肿瘤表达水平≥1%、未治疗过的IV期或复发性非小细胞肺癌患者分组，一组接受纳武单抗（3mg/kg体重的剂量静脉输注，每2周一次），一组接受铂类为基础的化疗（每3周一次，至6个周期）。出现肿瘤进展时，接受化疗的患者可以交叉到接受纳武单抗治疗。主要终点为无进展生存期，通过不知情的独立审查中心在PD-L1表达水平≥5%的患者中评价无进展生存期。
结果
在423名PD-L1表达水平≥5%的患者中，纳武单抗组中位无进展生存期为4.2个月，化疗组5.9个月（肿瘤进展或死亡的风险比，1.15；95%置信区间[CI]，0.91-1.45；P=0.25）；中位总生存期14.4个月对比13.2个月（死亡风险比，1.02；95%CI，0.80-1.30）。212名化疗组患者*共中**有128名在随后的治疗中接受了纳武单抗。接受纳武单抗的患者有71%出现了任何级别的治疗相关性不良反应，接受化疗者有92%；接受纳武单抗的患者有18%出现了3、4级治疗相关性不良反应，接受化疗者有51%。
结论
在PD-L1表达水平≥5%、且既往未治疗过的IV期或复发性非小细胞肺癌患者中，与化疗相比，纳武单抗没有明显延长无进展生存期，两组总生存期相近。与化疗相比，纳武单抗有良好的安全性，没有新发或意料外的安全性事件。（由百时美施贵宝和其它单位资助，CheckMate026试验在ClinicalTrials.gov网站注册号NCT02041533）
《壹篇》南南和北北
Original Article
First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer
David P. Carbone, M.D., Ph.D., Martin Reck, M.D., Ph.D., Luis Paz-Ares, M.D., Benjamin Creelan, M.D., Leora Horn, M.D., Martin Steins, M.D., Ph.D., Enriqueta Felip, M.D., Michel M. van den Heuvel, M.D., Tudor-Eliade Ciuleanu, M.D., Firas Badin, M.D., Neal Ready, M.D., T. Jeroen N. Hiltermann, M.D., Suresh Nair, M.D., Rosalyn Juergens, M.D., Ph.D., Solange Peters, M.D., Ph.D., Elisa Minenza, M.D., John M. Wrangle, M.D., Delvys Rodriguez-Abreu, M.D., Hossein Borghaei, D.O., George R. Blumenschein, Jr., M.D., Liza C. Villaruz, M.D., Libor Havel, M.D., Jana Krejci, M.D., Jesus Corral Jaime, M.D., Han Chang, Ph.D., William J. Geese, Ph.D., Prabhu Bhagavatheeswaran, Ph.D., Allen C. Chen, M.D., and Mark A. Socinski, M.D., for the CheckMate 026 Investigators*
N Engl J Med 2017; 376:2415-2426June 22, 2017DOI: 10.1056/NEJMoa1613493
Background
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-L1)–positive NSCLC.
Methods
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.
Results
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 chemotherapy (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.
Conclusions
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, NCT02041533.)
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