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抗 PD-1/PD-L1 单药治疗非小细胞肺癌患者的真实世界经验:一项回顾性奥地利多中心研究。

Real-world experience with anti-PD-1/PD-L1 monotherapy in patients with non-small cell lung cancer : A retrospective Austrian multicenter study.

机构信息

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.

出版信息

Wien Klin Wochenschr. 2021 Nov;133(21-22):1122-1130. doi: 10.1007/s00508-021-01940-w. Epub 2021 Sep 15.

Abstract

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

方法

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。

结果

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)。

结论

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。

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