HTA Austria-Austrian Institute for Health Technology Assessment GmbH, Garnisongasse 7/20, 1090, Vienna, Austria.
Department of Internal Medicine, Division of Pulmonology, Medical University Graz, Auenbruggerplatz 15, 8036, Graz, Austria.
Wien Klin Wochenschr. 2021 Nov;133(21-22):1122-1130. doi: 10.1007/s00508-021-01940-w. Epub 2021 Sep 15.
As real-world data regarding immunotherapy for non-small cell lung cancer are lacking for Austria, we conducted a retrospective study in six hospitals to present data from real-world practice.
Patients with metastatic non-small cell lung cancer were stratified into two groups, either patients with first-line pembrolizumab monotherapy (cohort 1) or patients with second-line nivolumab, pembrolizumab or atezolizumab monotherapy (cohort 2). Primary outcome measures were objective response rate and overall survival. A matched-pair analysis was performed to compare overall survival to patients from the Tyrolean Lung Cancer Project as a historical control group.
In total, 89 patients were identified, 42 patients in cohort 1 and 47 patients in cohort 2. The objective response rates were 43.3% and 31.4%, respectively. The median overall survival was 17.0 months (95% CI 11.7-21.5 months) in cohort 1 and 18.7 months (95% CI 9.5-23.4 months) in cohort 2. Treatment-related adverse events grades 3 and 4 were reported in 11.2% of patients. The matched-pair analysis showed a median overall survival of 15.2 months (95% CI 7.6-20.4 months) for first-line pembrolizumab monotherapy compared to 9.8 months (95% CI 7.8-11.6 months) for the historical control (p = 0.43). In cohort 2, a median overall survival of 20.3 months (95% CI 6.9-26.2 months) for second-line immunotherapy compared to 5.4 months (95% CI 3.2-11.7 months) for the historical control (p = 0.18) was shown.
The results are comparable with other real-world studies and, when matched to historical controls, support the improvement in outcomes made possible by these agents.
由于奥地利缺乏关于非小细胞肺癌免疫治疗的真实数据，我们在六家医院进行了一项回顾性研究，以展示真实实践中的数据。
将转移性非小细胞肺癌患者分为两组，一组为一线派姆单抗单药治疗患者（队列 1），另一组为二线纳武利尤单抗、派姆单抗或阿特珠单抗单药治疗患者（队列 2）。主要观察指标为客观缓解率和总生存期。进行了配对分析，将总生存期与作为历史对照的蒂罗尔肺癌项目中的患者进行比较。
共确定了 89 例患者，队列 1 42 例，队列 2 47 例。客观缓解率分别为 43.3%和 31.4%。队列 1 的中位总生存期为 17.0 个月（95%CI 11.7-21.5 个月），队列 2 为 18.7 个月（95%CI 9.5-23.4 个月）。报告有 11.2%的患者出现 3 级和 4 级与治疗相关的不良事件。配对分析显示，一线派姆单抗单药治疗的中位总生存期为 15.2 个月（95%CI 7.6-20.4 个月），而历史对照为 9.8 个月（95%CI 7.8-11.6 个月）（p=0.43）。在队列 2 中，二线免疫治疗的中位总生存期为 20.3 个月（95%CI 6.9-26.2 个月），而历史对照为 5.4 个月（95%CI 3.2-11.7 个月）（p=0.18）。
结果与其他真实世界研究相当，与历史对照匹配时，支持这些药物带来的结局改善。
