接受 PD-L1 表达水平≥50%的一线治疗的晚期非小细胞肺癌患者接受西米普利单抗单药治疗的患者报告结局：EMPOWER-Lung 1 研究。

Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study.

机构信息

Istanbul Medeniyet University, Faculty of Medicine, Istanbul, Turkey.

Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.

出版信息

Cancer. 2023 Jan 1;129(1):118-129. doi: 10.1002/cncr.34477. Epub 2022 Oct 29.

BACKGROUND

In the EMPOWER-Lung 1 trial (ClinicalTrials.gov, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%. Patient-reported outcomes were evaluated among trial participants.

METHODS

Adults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model repeated measures analysis estimated overall change from baseline for PD-L1 ≥50% and intention-to-treat populations. Kaplan-Meier analysis estimated time to definitive deterioration.

RESULTS

In PD-L1 ≥50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ-C30 and QLQ-LC13 scores showed moderate-to-high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32-0.71) to 0.63 (95% CI, 0.41-0.96). Cemiplimab showed lower risk of definitive deterioration for disease-related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment-related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p < .05). Results were similar in the intention-to-treat population.

CONCLUSIONS

Results support cemiplimab for first-line therapy of advanced NSCLC from the patient's perspective. Improved survival is accompanied by improvements versus platinum-doublet chemotherapy in GHS/QOL and functioning and reduction in symptom burden.

背景

在 EMPOWER-Lung 1 试验（ClinicalTrials.gov，NCT03088540）中，与接受含铂双药化疗相比，cemiplimab 为程序性死亡配体 1（PD-L1）≥50%的晚期非小细胞肺癌（NSCLC）患者带来了更长的生存期。本试验对参与者的患者报告结局进行了评估。

方法

ECOG 体能状态为 0-1 的 NSCLC 成年患者被随机分配接受 cemiplimab 350 mg，每 3 周 1 次，或含铂双药化疗。在每个治疗周期的基线和第 1 天，患者接受欧洲癌症研究和治疗组织生活质量核心 30 项问卷（QLQ-C30）和肺癌模块（QLQ-LC13）问卷。混合模型重复测量分析估计 PD-L1≥50%患者和意向治疗人群的总体基线变化。Kaplan-Meier 分析估计明确恶化的时间。

结果

在 PD-L1≥50%患者（cemiplimab，n=283；化疗，n=280）中，基线 QLQ-C30 和 QLQ-LC13 评分显示出中高度的功能和低症状负担。与化疗相比，cemiplimab 改善了全球健康状况/生活质量（GHS/QOL）、功能和大多数症状量表的基线变化。与化疗相比，各功能量表的明确恶化风险降低；风险比为 0.48（95%CI，0.32-0.71）至 0.63（95%CI，0.41-0.96）。cemiplimab 显示出较低的疾病相关（呼吸困难、咳嗽、胸痛、身体其他部位疼痛、疲劳）和治疗相关症状（周围神经病变、脱发、恶心/呕吐、食欲减退、便秘、腹泻）明确恶化风险（名义 p<0.05）。意向治疗人群的结果相似。