Introduction: In the phase II/III KEYNOTE‐010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1–expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health‐related quality of life (HRQoL) results are reported here. Methods: Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m2 every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ–Lung Cancer 13 (LC13), and EuroQoL‐5D. Key analyses included mean baseline‐to‐week‐12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ‐LC13 composite endpoint of cough, dyspnea, and chest pain. Results: Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ‐C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab‐treated patients had “deteriorated” status and more had “improved” status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ‐LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two‐sided p = 0.03), but not for the 2‐mg/kg dose. Conclusions: These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population.

中文翻译：

---

KEYNOTE-010 中与健康相关的生活质量：派姆单抗与多西他赛在既往治疗过的晚期、表达 PD-L1 的 NSCLC 患者中的 2/3 期研究

简介：在 II/III 期 KEYNOTE-010 研究（ClinicalTrials.gov，NCT01905657）中，与多西他赛相比，帕博利珠单抗显着延长了先前治疗过的、程序性死亡配体 1 表达（肿瘤比例评分≥1%）晚期 NSCLC 患者的总生存期. 健康相关生活质量 (HRQoL) 结果在此报告。方法：患者以 1:1:1 的比例随机接受派姆单抗 2 或 10 mg/kg 每 3 周一次或多西他赛 75 mg/m2 每 3 周一次。HRQoL 使用欧洲癌症研究和治疗组织 (EORTC) 生活质量问卷 (QLC) 核心 30 (C30)、EORTC QLQ–肺癌 13 (LC13) 和 EuroQoL-5D 进行评估。关键分析包括全球健康状况 (GHS)/生活质量 (QoL) 评分、功能和症状领域的平均基线到第 12 周变化，咳嗽、呼吸困难和胸痛的 QLQ-LC13 复合终点和恶化时间。结果：患者报告的结果依从性在所有三种工具中都很高。从基线到 12 周，与多西他赛相比，派姆单抗与更好的 QLQ-C30 GHS/QoL 评分相关，无论派姆单抗剂量或肿瘤比例评分状态如何（不显着）。与多西他赛相比，帕博利珠单抗治疗的患者“恶化”状态较少，而 GHS/QoL 状态“改善”的患者较多。派姆单抗在许多 EORTC 症状领域报告了名义上的显着改善，而多西他赛报告了名义上的显着恶化。与多西他赛相比，派姆单抗 10 mg/kg 的 QLQ-LC13 复合终点的真实恶化时间显着延长（名义双侧 p = 0.03），但不适用于 2-mg/kg 剂量。结论：这些发现表明，在该 NSCLC 患者群体中，与多西他赛相比，帕博利珠单抗在更大程度上维持或改善了 HRQoL 和症状。