Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan
Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan
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DOI：
10.1016/j.lungcan.2019.11.014
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发表时间：
2020-02-01
期刊：
影响因子：
5.3
通讯作者：
Ohe, Yuichiro
中科院分区：
文献类型：
--
作者：
Morita, Ryo;Okishio, Kyoichi;Ohe, Yuichiro
目的：描述治疗模式，并确定nivolumab治疗非小细胞肺癌（NSCLC）在现实世界settinginJapan.Materials和方法的有效性和安全性：日本NSCLC患者接受nivolumab进行了回顾性分析。入组了在2016年4月至2016年12月期间开始nivolumab治疗的患者。收集了关于患者人口统计学和临床背景、从诊断到纳武利尤单抗治疗后的治疗模式、纳武利尤单抗治疗的有效性和安全性以及纳武利尤单抗治疗前后的治疗的有效性和安全性以及程序性死亡配体1（PD-L1）表达状态（如果可用）的信息。通过单变量和多变量分析确定的与纳武利尤单抗有效性相关的因素进行了进一步研究，以绘制表皮生长因子受体（EGFR）基因突变状态、PD-L1表达状态和东部肿瘤协作组体力状态（ECOG PS）的Kaplan-Meier曲线。纳武单抗最常用作二线治疗，纳武单抗剂量的中位数为5。中位总生存期（OS）为14.6个月，1年生存率为54.3%，中位无进展生存期（PFS）为2.1个月。客观有效率为20.5%，疾病控制率为57.4%.根据多变量分析，较好的OS和PFS与良好的ECOG PS和无肝转移相关。在无EGFR突变和有吸烟史的患者中观察到更好的PFS。PD-L1表达亚组的PFS和最佳总体缓解具有表达水平依赖性。irAE的总体发生率为45.8%，3级及以上不良事件的发生率为14.0%.Conclusion：纳武利尤单抗的真实世界有效性和安全性与既往临床试验和其他真实世界数据报告的结果一致。亚组分析显示，ECOG PS、EGFR突变状态、吸烟状态和PD-L1与nivolumab的有效性相关。
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.