Surovtsova Irina, Herth Felix J F, Kokh Daria B, Morakis Philipp
Clinical State Registry Baden-Württemberg GmbH, Baden-Württemberg Cancer Registry (BWCR), Stuttgart, Germany.
Department of Pneumology and Critical Care Medicine, Thoraxklinik and Translational Lung Research Center, University of Heidelberg, Heidelberg, Germany.
Pulmonology. 2025 Dec 31;31(1):2457856. doi: 10.1080/25310429.2025.2457856. Epub 2025 Feb 5.
Pembrolizumab with chemotherapy (immunochemotherapy) has shown encouraging overall survival (OS) benefits in non-squamous mNSCLC, as demonstrated by the KEYNOTE-189 trial. However, randomised controlled trials may not fully capture the diversity of real-world patients. This study aims to evaluate immunochemotherapy outcomes in a real-world setting, including subgroups underrepresented in the KEYNOTE-189 trial.
Patients diagnosed with non-squamous mNSCLC 2011-2022 and recorded in Cancer Registry Database of the German Federal State Baden-Württemberg (BWCR), were analysed. OS was assessed using Kaplan-Meier and multivariable Cox models, adjusted for major clinical parameters. Results were compared with KEYNOTE-189.
Among 2630 eligible cases, 1314 patients received chemotherapy alone and 1316 received immunochemotherapy. Median OS (mOS) was 14.1 months (95%CI: 13.1-15.4) for immunochemotherapy and 10.4 months (95%CI: 9.7-11.2) for chemotherapy alone, with an HR of 0.7 (95%CI: 0.64-0.77). A significant benefit was seen in M1c stage (HR 0.7, 95%CI: 0.63-0.79). No significant OS improvement was observed in patients with ECOG 2-3 or bone metastases.
This real-world evidence suggests that immunochemotherapy generally improves OS in mNSCLC. Subgroup analysis showed no survival benefit for patients with ECOG >1 or bone metastasis, but a benefit for patients with M1c stage.
如KEYNOTE-189试验所示，帕博利珠单抗联合化疗（免疫化疗）在非鳞状非小细胞肺癌（mNSCLC）中显示出令人鼓舞的总生存期（OS）获益。然而，随机对照试验可能无法完全反映真实世界患者的多样性。本研究旨在评估真实世界中免疫化疗的疗效，包括KEYNOTE-189试验中代表性不足的亚组。
分析2011年至2022年诊断为非鳞状mNSCLC并记录在德国巴登-符腾堡州癌症登记数据库（BWCR）中的患者。使用Kaplan-Meier法和多变量Cox模型评估OS，并对主要临床参数进行调整。将结果与KEYNOTE-189试验进行比较。
在2630例符合条件的病例中，1314例患者仅接受化疗，1316例接受免疫化疗。免疫化疗的中位OS（mOS）为14.1个月（95%CI：13.1-15.4），单纯化疗为10.4个月（95%CI：9.7-11.2），风险比（HR）为0.7（95%CI：0.64-0.77）。在M1c期观察到显著获益（HR 0.7，95%CI：0.63-0.79）。在ECOG 2-3或有骨转移的患者中未观察到OS有显著改善。
这一真实世界证据表明，免疫化疗总体上可改善mNSCLC的OS。亚组分析显示，ECOG>1或有骨转移的患者无生存获益，但M1c期患者有生存获益。
