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帕博利珠单抗治疗非小细胞肺癌的真实世界证据：一项全国性队列研究。

Real-world evidence for pembrolizumab in non-small cell lung cancer: a nationwide cohort study.

作者信息

Hektoen Helga H, Tsuruda Kaitlyn M, Fjellbirkeland Lars, Nilssen Yngvar, Brustugun Odd Terje, Andreassen Bettina K

机构信息

Department of Research, Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.

Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.

出版信息

Br J Cancer. 2025 Jan;132(1):93-102. doi: 10.1038/s41416-024-02895-1. Epub 2024 Nov 3.

DOI:10.1038/s41416-024-02895-1
PMID:39489879
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11724112/
Abstract

BACKGROUND

Based on favourable results from clinical trials, immune checkpoint inhibitors (ICI) have become the standard first line (1 L) systemic anticancer treatment (SACT) for advanced stage non-small cell lung cancer (NSCLC) without targetable mutations. We evaluate whether these results are generalizable to everyday clinical practice and compare overall survival (OS) of patients treated with ICI to a historical cohort of patients treated with chemotherapy and results from clinical trials.

METHODS

Our study comprised all advanced NSCLC patients initiating SACT in 2012-21 in Norway. Clinical characteristics and treatment information was retrieved from Norwegian Health Registries.

RESULTS

Survival for all 8416 advanced NSCLC patients treated with SACT increased concurrently with the gradual implementation of ICIs. Median OS of patients treated with 1 L pembrolizumab after 2017 was better (mono-/combination therapy: 13.8/12.8 months) than for patients treated with chemotherapy before 2017 (8.0 months). Although median OS for patients treated with pembrolizumab was lower in clinical practice than clinical trials (Keynote-024/189: 26.3/22.0 months), the survival benefit relative to chemotherapy was similar.

CONCLUSION

Our nationwide study demonstrated a survival benefit over conventional chemotherapy of a similar magnitude as observed in clinical trials and confirms the effectiveness of pembrolizumab in routine clinical practice.

摘要

背景

基于临床试验的良好结果，免疫检查点抑制剂（ICI）已成为无靶向可及突变的晚期非小细胞肺癌（NSCLC）的标准一线全身抗癌治疗（SACT）。我们评估这些结果是否可推广到日常临床实践，并将接受ICI治疗的患者的总生存期（OS）与接受化疗的历史队列患者以及临床试验结果进行比较。

方法

我们的研究纳入了2012年至2021年在挪威开始接受SACT的所有晚期NSCLC患者。临床特征和治疗信息从挪威健康登记处获取。

结果

随着ICI的逐步应用，所有8416例接受SACT治疗的晚期NSCLC患者的生存率同时提高。2017年后接受一线帕博利珠单抗治疗的患者的中位OS更好（单药/联合治疗：13.8/12.8个月），高于2017年前接受化疗的患者（8.0个月）。尽管在临床实践中接受帕博利珠单抗治疗的患者的中位OS低于临床试验（KEYNOTE-024/189：26.3/22.0个月），但相对于化疗的生存获益相似。

结论

我们的全国性研究表明，与传统化疗相比，生存获益程度与临床试验中观察到的相似，并证实了帕博利珠单抗在常规临床实践中的有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/cb4346ce5cd0/41416_2024_2895_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/9006a750ca6c/41416_2024_2895_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/395268592921/41416_2024_2895_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/2276ebd9f722/41416_2024_2895_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/cb4346ce5cd0/41416_2024_2895_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/9006a750ca6c/41416_2024_2895_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/395268592921/41416_2024_2895_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/2276ebd9f722/41416_2024_2895_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e6/11724112/cb4346ce5cd0/41416_2024_2895_Fig4_HTML.jpg

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