■在将治疗持续时间限制为2年的研究中,已经确定了一线pembrolizumab的疗效,但2年后停止pembrolizumab的决定通常由医生决定。ATHENA是一项使用综合管理数据库的回顾性队列研究,首先旨在探索pembrolizumab的最佳持续时间,其次是晚期非小细胞肺癌(NSCLC)患者的现实生活预后因素。
■使用法国国民健康保险数据库(SNDS),我们确定了2015年至2022年在法国发生肺癌的患者.从医院提取或推断治疗和患者特征,门诊护理,药房送货报告。使用Cox模型通过倾向得分倒数加权估计持续时间的风险比(HR),以考虑混杂因素。通过LASSO程序选择的Cox模型确定了一线人群的预后因素。
■391,106名肺癌患者被确定,其中43,359人接受了pembrolizumab治疗晚期疾病.有67%(29,040/43,359)的男性,诊断时的中位年龄为65岁。中位随访时间为25.9个月(min-max,[0-97.6]),一线开始派姆单抗治疗后的中位总生存期(OS)为15.7个月[CI95,15.3~16.0].在多变量分析中,几个协变量与较差的操作系统独立相关,包括男性接受化学免疫疗法,年龄,医院类别,高剥夺指数,首次pembrolizumab住院,和糖尿病史,利尿剂,β受体阻滞剂,止痛药处方.在pembrolizumab开始后29个月的标志性时间,超过2年的延续与比固定的2年治疗更好的OS无关,HR=0.97[0.75-1.26]p=0.95。
这项研究支持以下观点:2年后停用派姆单抗对晚期NSCLC患者可能是安全的。然而,因为观察性研究容易混淆和选择偏差,因果关系不能肯定。
■这项研究没有获得任何具体资助。
UNASSIGNED: The efficacy of front-line pembrolizumab has been established in studies that limit treatment duration to 2 years, but decision to stop pembrolizumab after 2 years is often at physician\'s discretion. ATHENA is a retrospective cohort study using a comprehensive administrative database aimed firstly at exploring the optimal duration of pembrolizumab and secondly real-life prognosis factors in patients with advanced non-small cell lung cancer (NSCLC).
UNASSIGNED: Using the French National Health Insurance database (SNDS), we identified patients with incident lung cancer in France from 2015 to 2022. Treatments and patients\' characteristics were extracted or inferred from hospital, outpatient care, pharmacy delivery reports. The duration\'s hazard ratio (HR) was estimated with Cox model weighted by inverse of propensity score to account for confounding. Prognostics factors in first line population were identified with Cox model selected by a LASSO procedure.
UNASSIGNED: 391,106 patients with lung cancer were identified, of whom 43,359 received up-front pembrolizumab for an advanced disease. There were 67% (29,040/43,359) of male and the median age at diagnosis was 65 years old. After a median follow-up time of 25.9 months (min-max, [0-97.6]), the median overall survival (OS) after pembrolizumab initiation in first line was 15.7 [CI 95, 15.3-16.0] months. In multivariable analysis, several covariables were independently associated with worse OS, including male sex with chemo-immunotherapy, age, hospital category, high deprivation index, inpatient hospitalization for first pembrolizumab, and history of diabetes, diuretic, beta blocker, painkiller prescription. At landmark time of 29 months after pembrolizumab initiation, continuation beyond 2 years was not associated with better OS than a fixed 2-year treatment, HR = 0.97 [0.75-1.26] p = 0.95.
UNASSIGNED: This study supports the notion that stopping pembrolizumab after 2 years could be safe for patients with advanced NSCLC. However, because observational studies are prone to confounding and selection bias, causality cannot be affirmed.
UNASSIGNED: This study did not receive any specific grant.