OBJECTIVES To describe the treatment patterns and determine the effectiveness and safety of nivolumab treatment for non-small cell lung cancer (NSCLC) in real-world setting in Japan. MATERIALS AND METHODS Japanese patients with NSCLC who received nivolumab were analyzed retrospectively. Patients who had started nivolumab treatment between April 2016 and December 2016 were enrolled. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness and safety of nivolumab treatment and that of treatments just before and after nivolumab treatment, and programmed death-ligand 1 (PD-L1) expression status, if available, were collected. Factors associated with nivolumab effectiveness identified by univariate and multivariate analyses were further investigated for plotting Kaplan-Meier curves of epidermal growth factor receptor (EGFR) gene mutation status, PD-L1 expression status, and Eastern Cooperative Oncology Group performance status (ECOG PS). RESULTS In this study, 901 NSCLC patients were enrolled. Nivolumab was used the most as a second line treatment with a median number of nivolumab doses of five. The median overall survival (OS) was 14.6 months, one-year survival rate was 54.3 %, and median progression-free survival (PFS) was 2.1 months. The objective response rate was 20.5 % and disease control rate was 57.4 %. According to multivariate analyses, better OS and PFS were associated with favorable ECOG PS and absence of liver metastasis. Better PFS was observed in patients without EGFR mutation and patients with smoking history. PFS and best overall response in PD-L1 expression subgroups were expression level-dependent. The overall incidence of irAEs was 45.8 %, and the incidence of adverse events of grade 3 or higher was 14.0 %. CONCLUSION The real-world effectiveness and safety of nivolumab is consistent with that reported by previous clinical trials and other real-world data. Subgroup analysis showed that ECOG PS, EGFR mutation status, smoking status, and PD-L1 were associated with the effectiveness of nivolumab.

中文翻译：

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尼伏鲁单抗在非小细胞肺癌患者中的实际疗效和安全性：日本的一项多中心回顾性观察研究。

目的描述在现实世界中日本对非小细胞肺癌（NSCLC）进行nivolumab治疗的治疗方式并确定其有效性和安全性。材料与方法回顾性分析了接受了nivolumab治疗的日本NSCLC患者。纳入2016年4月至2016年12月开始使用nivolumab治疗的患者。有关患者人口统计学和临床​​背景，从诊断到尼古鲁单抗治疗的治疗模式，尼古鲁单抗治疗的有效性和安全性以及尼古鲁单抗治疗前后的治疗以及程序性死亡配体1（PD-L1）表达状态的信息，如果可用，已收集。通过单因素和多因素分析确定的与纳武单抗有效性相关的因素被进一步调查，以绘制表皮生长因子受体（EGFR）基因突变状态，PD-L1表达状态和东部合作肿瘤小组表现状态（ECOG PS）的Kaplan-Meier曲线。结果本研究共纳入901名NSCLC患者。Nivolumab最多用作二线治疗，nivolumab剂量的中位数为五次。中位总体生存期（OS）为14.6个月，一年生存率为54.3％，中位无进展生存期（PFS）为2.1个月。客观缓解率为20.5％，疾病控制率为57.4％。根据多变量分析，更好的OS和PFS与良好的ECOG PS和无肝转移相关。在没有EGFR突变的患者和有吸烟史的患者中观察到更好的PFS。PD-L1表达亚组中的PFS和最佳总体反应与表达水平有关。irAEs的总发生率为45.8％，3级或更高级别的不良事件发生率为14.0％。结论尼伏鲁单抗在现实世界中的有效性和安全性与先前的临床试验和其他现实世界数据所报告的一致。亚组分析表明，ECOG PS，EGFR突变状态，吸烟状态和PD-L1与nivolumab的有效性相关。结论尼伏鲁单抗在现实世界中的有效性和安全性与先前的临床试验和其他现实世界数据所报告的一致。亚组分析表明，ECOG PS，EGFR突变状态，吸烟状态和PD-L1与nivolumab的有效性相关。结论尼伏鲁单抗在现实世界中的有效性和安全性与先前的临床试验和其他现实世界数据所报告的一致。亚组分析表明，ECOG PS，EGFR突变状态，吸烟状态和PD-L1与nivolumab的有效性相关。