接受一线头孢利单抗治疗的晚期非小细胞肺癌患者报告的预后与总体生存率之间的关联
Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy.
摘要(中文译文)
背景：关于晚期非小细胞肺癌（NSCLC）患者患者报告结局（PROs）较基线的变化与总生存期（OS）之间关联的研究已存在。本研究评估了接受一线西米普利单抗（cemiplimab）为基础治疗的晚期NSCLC患者中，基线后PROs与OS之间的关联。方法：我们使用Cox比例风险模型评估了两项III期研究（EMPOWER-Lung 1 [NCT03088540]和EMPOWER-Lung 3 [NCT03409614]）的PRO数据。评估了来自欧洲癌症研究与治疗组织生活质量问卷核心30及生活质量问卷肺癌13模块的12个预设PRO量表。在3、6、9和12个月时进行了界标分析。使用以基线PROs变化作为时间依赖性协变量的时间依赖性分析，以评估基线后PRO改善与OS的关联。结果：在3个月界标时，我们观察到总体健康状况（GHS）/生活质量（QoL）稳定/改善组与恶化/未观察组相比，死亡风险降低56%（HR = 0.44；95% CI：0.32-0.62；名义P < 0.0001）。GHS/QoL在6、9和12个月界标时的结果与3个月界标时的结果一致。时间依赖性分析显示，GHS/QoL每改善10分，死亡风险降低31%（HR = 0.69；95% CI：0.64-0.75；名义P < 0.0001）。结论：在接受一线西米普利单抗为基础治疗的晚期NSCLC患者中，基线后PROs的改善与OS改善相关。这些结果可能为未来临床试验的终点选择和数据解读提供参考。
Abstract
: Research on the association between change from baseline in patient-reported outcomes (PROs) and overall survival (OS) in patients with advanced non-small-cell lung cancer (NSCLC) exists. This study evaluated the association between post-baseline PROs and OS in patients with advanced NSCLC who received first-line cemiplimab-based therapy. : We evaluated PRO data from two phase III studies (EMPOWER-Lung 1 [NCT03088540] and EMPOWER-Lung 3 [NCT03409614]) using a Cox proportional hazards model. Twelve pre-specified PRO scales from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Quality of Life Questionnaire Lung Cancer 13 module were evaluated. Landmark analyses were conducted at 3, 6, 9, and 12 months. Time-dependent analyses using change from baseline PROs as a time-dependent covariate were conducted to evaluate the association of post-baseline PRO improvement with OS. : At the 3-month landmark, we observed a 56% reduction in the risk of death (HR = 0.44; 95% CI: 0.32-0.62; nominal < 0.0001) among stable/improved vs. worsened/unobserved PROs for global health status (GHS)/quality of life (QoL). Results at the 6-, 9-, and 12-month landmarks of GHS/QoL were consistent with those at the 3-month landmark. Time-dependent analyses showed that every 10-point improvement in GHS/QoL was associated with a 31% reduction in the risk of death (HR = 0.69; 95% CI: 0.64-0.75; nominal < 0.0001). : In patients with advanced NSCLC who received first-line cemiplimab-based therapy, improvements in post-baseline PROs are associated with improved OS. These results may inform endpoint selection and interpretation of future clinical trials.
如何引用
AMA
David R Gandara, Tamta Makharadze, Mahmut Gümüş, Miranda Gogishvili, Ahmet Sezer, Eric Kim, et al. Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy.. Cancers. 2026; doi:10.3390/cancers18060916.
APA
David R Gandara, Tamta Makharadze, Mahmut Gümüş, Miranda Gogishvili, Ahmet Sezer, Eric Kim, et al (2026). Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy.. Cancers. https://doi.org/10.3390/cancers18060916
GB/T 7714
David R Gandara, Tamta Makharadze, Mahmut Gümüş, Miranda Gogishvili, Ahmet Sezer, Eric Kim, et al. Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy.[J]. Cancers, 2026 doi:10.3390/cancers18060916.
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