IPAM e.V, Alter Holzhafen 19, 23966, Wismar, Germany.
The Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen-Cilag AB, Stockholm, Sweden.
BMC Cancer. 2020 Mar 30;20(1):260. doi: 10.1186/s12885-020-06738-z.
The objective of this study was to describe the real-world treatment and overall survival (OS) of German patients with a diagnosis of advanced non-small cell lung cancer (aNSCLC), and to explore factors associated with the real-world mortality risk.
This was a retrospective German claims data analysis of incident aNSCLC patients. Data were available from 01/01/2011 until 31/12/2016. Identification of eligible patients took place between 01/01/2012-31/12/2015, to allow for at least 1-year pre-index and follow-up periods. Inpatient and outpatient mutation test procedures after aNSCLC diagnosis were observed. Further, prescribed treatments and OS since first (incident) aNSCLC diagnosis and start of respective treatment lines were described both for all patients and presumed EGFR/ALK/ROS-1-positive patients. Factors associated with OS were analyzed in multivariable Cox regression analysis.
Overall, 1741 aNSCLC patients were observed (mean age: 66·97 years, female: 29·87%). The mutation test rate within this population was 26·31% (n = 458), 26·6% of these patients (n = 122) received a targeted treatment and were assumed to have a positive EGFR/ALK/ROS-1 test result. Most often prescribed treatments were pemetrexed monotherapy as 1 L (21·23% for all and 11·11% for mutation-positive patients) and erlotinib monotherapy as 2 L (25·83%/38·54%). Median OS since incident diagnosis was 351 days in all and 571 days in mutation-positive patients. In a multivariable Cox regression analysis, higher age, a stage IV disease, a higher number of chronic drugs in the pre-index period and no systemic therapy increased the risk of early death since first aNSCLC diagnosis. On the other hand, female gender and treatment with therapies other than chemotherapy were associated with a lower risk of early death.
Despite the introduction of new treatments, the real-world survival prognosis for aNSCLC patients remains poor if measured based on an unselected real-world population of patients. Still, the majority of German aNSCLC patients do not receive a mutation test.
本研究旨在描述德国晚期非小细胞肺癌（aNSCLC）患者的真实世界治疗情况和总生存期（OS），并探讨与真实世界死亡率相关的因素。
这是一项回顾性的德国理赔数据分析，纳入了确诊为 aNSCLC 的患者。数据可追溯至 2011 年 1 月 1 日至 2016 年 12 月 31 日。符合条件的患者于 2012 年 1 月 1 日至 2015 年 12 月 31 日确诊，以确保有至少 1 年的指数前和随访期。观察了 aNSCLC 诊断后的住院和门诊基因突变检测情况。此外，描述了所有患者和假定 EGFR/ALK/ROS-1 阳性患者自首次（确诊）aNSCLC 诊断开始的治疗方法和 OS。采用多变量 Cox 回归分析来评估与 OS 相关的因素。
总体而言，共观察到 1741 例 aNSCLC 患者（平均年龄：66.97 岁，女性：29.87%）。该人群的基因突变检测率为 26.31%（n=458），其中 26.6%（n=122）的患者接受了靶向治疗，假定 EGFR/ALK/ROS-1 检测结果呈阳性。最常开的处方治疗是培美曲塞单药治疗 1 个疗程（所有患者为 21.23%，突变阳性患者为 11.11%）和厄洛替尼单药治疗 2 个疗程（所有患者为 25.83%/38.54%）。所有患者的中位 OS 自确诊以来为 351 天，突变阳性患者为 571 天。在多变量 Cox 回归分析中，年龄较大、IV 期疾病、指数前时期慢性药物数量较高和未进行全身治疗均增加了首次确诊 aNSCLC 后早期死亡的风险。另一方面，女性性别和接受化疗以外的治疗与早期死亡风险降低相关。
尽管新疗法的问世，但如果基于未经选择的真实世界患者人群来衡量，晚期非小细胞肺癌患者的真实世界生存预后仍然较差。尽管如此，大多数德国晚期非小细胞肺癌患者并未接受基因突变检测。
