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Impact of Nivolumab Versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients With Advanced Squamous Non-Small Cell Lung Cancer: Results From the CheckMate 017 Study
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2018-02-01 , DOI: 10.1016/j.jtho.2017.10.029
Martin Reck , Fiona Taylor , John R. Penrod , Michael DeRosa , Laura Morrissey , Homa Dastani , Lucinda Orsini , Richard J. Gralla

Introduction: In the phase III CheckMate 017 study, nivolumab prolonged overall survival versus docetaxel in previously treated patients with advanced squamous NSCLC. Study objectives included health‐related quality of life (HRQoL) and symptom assessments. Methods: Patients serially completed the Lung Cancer Symptom Scale (LCSS) and European Quality of Life Five Dimensions (EQ‐5D) questionnaires. The LCSS average symptom burden index (ASBI) (mean score for six lung cancer–specific symptoms; range 0–100), LCSS three‐item global index, EQ‐5D utility index, and EQ‐5D visual analog scale scores were analyzed. The proportion of patients exhibiting clinically meaningful improvement (a ≥10‐point decrease) in ASBI scores by week 12 was a secondary end point. Mixed‐effect model repeated measures analysis of HRQoL changes from baseline and analyses of time to HRQoL deterioration were conducted. Results: Baseline mean plus or minus SD LCSS ASBI scores were similar in the nivolumab (29.6 ± 16.4) and docetaxel (29.6 ± 14.7) groups. By week 12, the proportions of patients (95% confidence interval) with clinically meaningful improvement in ASBI scores were 20.0% (13.6–27.7) with nivolumab and 21.9% (15.3–29.8) with docetaxel. At weeks 16 to 54, significant improvements in ASBI scores from baseline were seen with nivolumab; clinically meaningful improvements were observed at weeks 42 to 84. No significant changes in ASBI scores from baseline were observed with docetaxel; at week 36, a clinically meaningful deterioration was seen. Improvements in HRQoL with nivolumab versus with docetaxel were supported by other measures, and time to first HRQoL deterioration was longer. Conclusion: Nivolumab alleviates symptom burden and improves health status versus docetaxel as second‐line squamous NSCLC treatment.

中文翻译:

纳武单抗与多西他赛对晚期鳞状非小细胞肺癌患者健康相关生活质量和症状的影响:CheckMate 017 研究结果

简介:在 III 期 CheckMate 017 研究中,在既往接受过治疗的晚期鳞状 NSCLC 患者中,nivolumab 与多西他赛相比延长了总生存期。研究目标包括健康相关生活质量 (HRQoL) 和症状评估。方法:患者连续完成肺癌症状量表(LCSS)和欧洲生活质量五维(EQ-5D)问卷。分析了 LCSS 平均症状负担指数 (ASBI)(六种肺癌特异性症状的平均评分;范围 0-100)、LCSS 三项总体指数、EQ-5D 效用指数和 EQ-5D 视觉模拟量表评分。到第 12 周,ASBI 评分表现出有临床意义的改善(降低≥10 分)的患者比例是次要终点。对 HRQoL 从基线变化的重复测量分析和 HRQoL 恶化的时间分析进行了混合效应模型。结果:纳武单抗 (29.6 ± 16.4) 和多西他赛 (29.6 ± 14.7) 组的基线平均加减 SD LCSS ASBI 评分相似。到第 12 周,ASBI 评分有临床意义改善的患者比例(95% 置信区间)为 20.0% (13.6-27.7) 纳武单抗和 21.9% (15.3-29.8) 多西他赛。在第 16 周至第 54 周,使用纳武单抗观察到 ASBI 评分较基线显着改善;在第 42 至 84 周观察到有临床意义的改善。多西紫杉醇与基线相比没有观察到 ASBI 评分的显着变化;在第 36 周,观察到有临床意义的恶化。纳武单抗与多西他赛相比 HRQoL 的改善得到了其他措施的支持,并且 HRQoL 首次恶化的时间更长。结论:与多西紫杉醇作为二线鳞状 NSCLC 治疗相比,纳武单抗减轻了症状负担并改善了健康状况。
更新日期:2018-02-01
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