Approximately 20% of patients with non–small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients.

大约20%的非小细胞肺癌（NSCLC）患者被诊断为III期疾病。目前对于这些患者的最合适的治疗方法还没有达成共识。

In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Patients in the experimental group who had R0 resections received adjuvant treatment with nivolumab for 6 months. The primary end point was a pathological complete response (0% viable tumor in resected lung and lymph nodes). Secondary end points included progression-free survival and overall survival at 24 months and safety.

在这项开放标签的2期试验中，我们将可切除的IIIA或IIIB期NSCLC患者随机分配到新辅助治疗Nivolumab加铂类化疗（实验组）或单独化疗（对照组），然后进行手术。实验组中R0切除的患者接受nivolumab的辅助治疗6个月。主要终点是病理完全反应（切除的肺部和淋巴结中0%的活体肿瘤）。次要终点包括24个月的无进展生存期和总生存期以及安全性。

A total of 86 patients underwent randomization; 57 were assigned to the experimental group and 29 were assigned to the control group. A pathological complete response occurred in 37% of the patients in the experimental group and in 7% in the control group (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = 0.02). Surgery was performed in 93% of the patients in the experimental group and in 69% in the control group (relative risk, 1.35; 95% CI, 1.05 to 1.74). Kaplan– Meier estimates of progression-free survival at 24 months were 67.2% in the experimental group and 40.9% in the control group (hazard ratio for disease progression, disease recurrence, or death, 0.47; 95% CI, 0.25 to 0.88). Kaplan–Meier estimates of overall survival at 24 months were 85.0% in the experimental group and 63.6% in the control group (hazard ratio for death, 0.43; 95% CI, 0.19 to 0.98). Grade 3 or 4 adverse events occurred in 11 patients in the experimental group (19%; some patients had events of both grades) and 3 patients in the control group (10%).

共有86名患者接受了随机分组；57人被分配到实验组，29人被分配到对照组。实验组有37%的患者出现病理完全反应，对照组有7%（相对风险，5.34；95%置信区间[CI]，1.34至21.23；P = 0.02）。实验组93%的患者进行了手术，对照组69%的患者进行了手术（相对风险，1.35；95%CI，1.05至1.74）。实验组24个月无进展生存期的Kaplan-Meier估计值为67.2%，对照组为40.9%（疾病进展、疾病复发或死亡的危险比为0.47；95%CI，0.25至0.88）。实验组24个月的总生存率Kaplan-Meier估计为85.0%，对照组为63.6%（死亡危险比为0.43；95%CI，0.19至0.98）。实验组有11名患者发生3级或4级不良事件（19%；一些患者同时发生两种级别的事件），对照组有3名患者（10%）。

In patients with resectable stage IIIA or IIIB NSCLC, perioperative treatment with nivolumab plus chemotherapy resulted in a higher percentage of patients with a pathological complete response and longer survival than chemotherapy alone.

在可切除的IIIA或IIIB期NSCLC患者中，围手术期使用nivolumab加化疗治疗，与单独化疗相比，病理完全反应的患者比例更高，生存期更长。

本文章转载于：SCI天天读

原文链接：https://mp.weixin.qq.com/s/PWTY3cPu6cveNEFNDqmBGg