Takamori Shinkichi, Shimokawa Mototsugu, Komiya Takefumi
Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-machi, Yufu-shi, 879-5593, Japan.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, 812-0054, Japan.
J Cancer Res Clin Oncol. 2023 Nov;149(14):13175-13184. doi: 10.1007/s00432-023-05167-2. Epub 2023 Jul 21.
Because patients younger than 40 years are rarely enrolled in clinical trials in non-small cell lung cancer (NSCLC), their survival benefit of immune checkpoint inhibitors (ICIs) needs to be clarified.
The National Cancer Database was queried for patients who were diagnosed with stage IV NSCLC between 2016 and 2018. ICIs were administered in the first-line setting. The overall survival (OS) of patients with stage IV NSCLC according to the receipt of ICIs was compared in different age groups (< 40, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years). Multivariate analyses identified the clinical characteristics predictive of OS. Propensity score matching (PSM) was conducted to reduce the biases arising from clinical characteristics.
This study included 126,476 patients with stage IV NSCLC. In univariate analysis, ICI treatment was not associated with a survival benefit in patients younger than 40 years with stage IV NSCLC relative to their ICI-naïve counterparts after PSM (median OS: 24.2 months vs. 24.0 months, hazard ratio [HR] = 1.01, 95% confidence interval [CI] = 0.81-1.27, P = 0.9031). Multivariate analysis revealed that ICI use was not an independent predictor of OS in patients with stage IV NSCLC < 40 years old (HR = 0.96, 95% CI = 0.76-1.21, P = 0.7230). Sequential improvement of the HR was observed with increasing age.
Our study suggested a poor survival benefit of ICIs in stage IV NSCLC patients younger than 40 years old, which should be validated in prospective studies.
由于年龄小于40岁的患者很少纳入非小细胞肺癌(NSCLC)的临床试验,因此需要明确免疫检查点抑制剂(ICIs)对他们的生存获益情况。
查询国家癌症数据库中2016年至2018年间被诊断为IV期NSCLC的患者。ICIs用于一线治疗。比较不同年龄组(<40岁、40 - 49岁、50 - 59岁、60 - 69岁、70 - 79岁和≥80岁)接受ICIs的IV期NSCLC患者的总生存期(OS)。多因素分析确定了预测OS的临床特征。进行倾向评分匹配(PSM)以减少临床特征引起的偏差。
本研究纳入了126476例IV期NSCLC患者。在单因素分析中,PSM后,IV期NSCLC年龄小于40岁的患者接受ICI治疗相对于未接受ICI治疗的患者未显示出生存获益(中位OS:24.2个月对24.0个月,风险比[HR]=1.01,95%置信区间[CI]=0.81 - 1.27,P = 0.9031)。多因素分析显示,ICI的使用不是年龄<40岁的IV期NSCLC患者OS的独立预测因素(HR = 0.96,95% CI = 0.76 - 1.21,P = 0.7230)。随着年龄增长,HR呈逐步改善趋势。
我们的研究表明,ICIs对年龄小于40岁的IV期NSCLC患者的生存获益较差,这一点应在前瞻性研究中得到验证。