Assié Jean-Baptiste, Corre Romain, Levra Matteo Giaj, Calvet Christophe Yannick, Gaudin Anne-Françoise, Grumberg Valentine, Jouaneton Baptiste, Cotté François-Emery, Chouaïd Christos
Service de Pneumologie, CHI Créteil, UPEC, Créteil, France.
Service de Pneumologie, Centre Hospitalier Intercommunal de Quimper, Quimper, France.
Ther Adv Med Oncol. 2020 Oct 26;12:1758835920967237. doi: 10.1177/1758835920967237. eCollection 2020.
To describe long-term outcomes of patients treated with nivolumab for advanced non-small cell lung cancer (aNSCLC) in everyday clinical practice in France, with a focus on patients aged ⩾80 years, patients with renal impairment and patients with brain metastases.
The study included all patients with aNSCLC recorded in the French national hospital database, starting nivolumab in 2015-2016 and followed until December 2018. Patients were stratified by age, the presence of renal impairment and brain metastasis, as documented in the hospital discharge summaries. Information was retrieved on demographics, comorbidities and treatment history at baseline. Time to discontinuation of nivolumab treatment and overall survival were estimated using Kaplan-Meier survival analysis.
Overall, 10,452 patients were included, of whom 514 were octogenarians, 479 had renal impairment and 1800 had brain metastases at baseline. Median duration of nivolumab treatment was 2.8 months in the overall population and in both the octogenarian and renally impaired subgroups, and 2.3 months in patients with brain metastases. Median overall survival in these patient groups was 11.7 months (95% confidence interval: 11.3-12.2), 11.7 months (11.3-12.1), 11.7 months (11.3-12.2) and 9.9 months (9.0-10.9) respectively. Three-year overall survival rates were 19.1% (18.1-20.2) in the overall population, 16.5% (11.6-23.4) in octogenarians, 15.9% (11.8-21.4) in patients with renal impairment and 21.7% (19.4-24.2) in those with brain metastases.
This large nationwide retrospective real-life cohort provided narrow estimates of long-term overall survival, which reached 19% at 3 years, consistent with data from phase III trials of nivolumab. Survival rates were comparable in the three special populations of interest and the overall population.
描述在法国日常临床实践中接受纳武利尤单抗治疗的晚期非小细胞肺癌（aNSCLC）患者的长期结局，重点关注年龄≥80岁的患者、肾功能不全患者和脑转移患者。
该研究纳入了法国国家医院数据库中记录的所有aNSCLC患者，这些患者于2015年至2016年开始使用纳武利尤单抗治疗，并随访至2018年12月。根据医院出院小结中记录的年龄、肾功能不全和脑转移情况对患者进行分层。收集了基线时的人口统计学、合并症和治疗史信息。使用Kaplan-Meier生存分析估计纳武利尤单抗治疗停药时间和总生存期。
总体上，共纳入10452例患者，其中514例为八旬老人，479例有肾功能不全，1800例基线时有脑转移。在总体人群以及八旬老人和肾功能不全亚组中，纳武利尤单抗治疗的中位持续时间为2.8个月，脑转移患者为2.3个月。这些患者组的中位总生存期分别为11.7个月（95%置信区间：11.3 - 12.2）、11.7个月（11.3 - 12.1）、11.7个月（11.3 - 12.2）和9.9个月（9.0 - 10.9）。总体人群的三年总生存率为19.1%（18.1 - 20.2），八旬老人为16.5%（11.6 - 23.4），肾功能不全患者为15.9%（11.8 - 21.4），脑转移患者为21.7%（19.4 - 24.2）。
这个大型的全国性回顾性真实世界队列对长期总生存期的估计范围较窄，三年时达到19%，与纳武利尤单抗的III期试验数据一致。在三个感兴趣的特殊人群和总体人群中，生存率相当。
