Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927, Grosshansdorf, Germany.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, CRB 440, Baltimore, MD, 21231, USA.
Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.
Nivolumab, a programmed death-1 inhibitor, prolonged overall survival and had a favourable safety profile versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) in the phase III CheckMate 057 trial.
To evaluate health-related quality of life (HRQoL) using patient-reported outcomes.
Disease-related symptoms and general health status were assessed using two validated patient-reported instruments, the Lung Cancer Symptom Scale (LCSS) and the European Quality of Life Five Dimensions (EQ-5D), respectively. The proportion of patients with disease-related symptom improvement at 12 weeks on the LCSS average symptom burden index (ASBI) was a secondary end-point. LCSS 3-item global index (3-IGI), EQ-5D utility index and EQ-5D visual analogue scale (VAS) scores were also determined. Mixed-effects model repeated measures (MMRM) and time to first deterioration analyses assessed longitudinal changes.
Mean baseline LCSS ASBI scores were similar in both arms. By week 12, rates of disease-related improvement (95% confidence interval) were similar between nivolumab (17.8% [13.6-22.7]) and docetaxel (19.7% [15.2-24.7]); however, numerical differences in LCSS ASBI mean change from baseline favoured nivolumab. Subsequently, LCSS ASBI scores improved with nivolumab and worsened with docetaxel, with statistically significant between-arm differences at weeks 12, 24, 30 and 42. HRQoL improvements with nivolumab versus docetaxel were also supported by the LCSS 3-IGI, EQ-5D VAS and MMRM analysis. Time to first HRQoL deterioration was longer with nivolumab than with docetaxel.
Nivolumab improved disease-related symptoms and overall health status versus docetaxel for second-line treatment of advanced non-squamous NSCLC.
NCT01673867.
纳武利尤单抗是一种程序性死亡受体-1 抑制剂，在 III 期 CheckMate 057 试验中，与多西他赛相比，其在先前治疗的晚期非鳞状非小细胞肺癌（NSCLC）患者中延长了总生存期并具有良好的安全性。
使用患者报告的结果评估与健康相关的生活质量（HRQoL）。
使用两种经过验证的患者报告工具，即肺癌症状量表（LCSS）和欧洲五维健康量表（EQ-5D），分别评估疾病相关症状和一般健康状况。LCSS 平均症状负担指数（ASBI）上 12 周时疾病相关症状改善的患者比例为次要终点。还确定了 LCSS 3 项全局指数（3-IGI）、EQ-5D 效用指数和 EQ-5D 视觉模拟量表（VAS）评分。混合效应模型重复测量（MMRM）和首次恶化时间分析评估了纵向变化。
在两个治疗组中，LCSS ASBI 的平均基线评分相似。到第 12 周时，纳武利尤单抗（17.8%[13.6-22.7]）和多西他赛（19.7%[15.2-24.7]）的疾病相关改善率（95%置信区间）相似；然而，从基线到 LCSS ASBI 平均变化的数值差异有利于纳武利尤单抗。随后，LCSS ASBI 评分随着纳武利尤单抗而改善，随着多西他赛而恶化，在第 12、24、30 和 42 周时存在统计学上的组间差异。LCSS 3-IGI、EQ-5D VAS 和 MMRM 分析也支持纳武利尤单抗与多西他赛相比，改善了 HRQoL。与多西他赛相比，纳武利尤单抗的首次 HRQoL 恶化时间更长。
纳武利尤单抗改善了疾病相关症状和整体健康状况，而多西他赛则用于二线治疗晚期非鳞状非小细胞肺癌。
NCT01673867。
