Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France.
David Geffen School of Medicine at University of California, Los Angeles, Santa Monica, California.
J Thorac Oncol. 2019 May;14(5):793-801. doi: 10.1016/j.jtho.2019.01.016. Epub 2019 Jan 31.
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.
Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m 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.
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.
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.
在 II/III 期 KEYNOTE-010 研究（ClinicalTrials.gov，NCT01905657）中，与多西他赛相比，先前接受治疗的、程序性死亡配体 1 表达（肿瘤比例评分≥1%）、晚期 NSCLC 患者接受帕博利珠单抗治疗可显著延长总生存期。现将健康相关生活质量（HRQoL）结果报告如下。
患者按 1:1:1 的比例随机分为帕博利珠单抗 2 或 10 mg/kg，每 3 周一次；或多西他赛 75 mg/m，每 3 周一次。使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷（QLC）核心 30（C30）、EORTC 肺癌 13（LC13）和 EuroQoL-5D 评估 HRQoL。主要分析包括基线至第 12 周时全球健康状况（GHS）/生活质量（QoL）评分、功能和症状域的平均变化，以及 EORTC LC13 咳嗽、呼吸困难和胸痛复合终点恶化的时间。
在所有三种仪器中，患者报告的结果都具有很高的依从性。与多西他赛相比，无论帕博利珠单抗剂量或肿瘤比例评分状态如何（无统计学意义），帕博利珠单抗治疗患者从基线到 12 周时 QLQ-C30 GHS/QoL 评分更好。与多西他赛相比，接受帕博利珠单抗治疗的患者中有更多的患者“改善”了 GHS/QoL 的状态，而更多的患者“恶化”了状态。与多西他赛相比，许多 EORTC 症状域的报告有显著改善，而与多西他赛相比，报告有恶化。与多西他赛相比，帕博利珠单抗 10 mg/kg 与 QLQ-LC13 复合终点的真实恶化时间显著延长（双侧名义 p=0.03），而 2 mg/kg 剂量则没有。
这些发现表明，与多西他赛相比，在这一 NSCLC 患者人群中，帕博利珠单抗在维持或改善 HRQoL 和症状方面的程度更大。
