Impact of Pembrolizumab Versus Chemotherapy as Second-Line Therapy for Advanced Esophageal Cancer on Health-Related Quality of Life in KEYNOTE-181
Impact of Pembrolizumab Versus Chemotherapy as Second-Line Therapy for Advanced Esophageal Cancer on Health-Related Quality of Life in KEYNOTE-181
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DOI：
10.1200/jco.21.00601
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发表时间：
2022-02-01
影响因子：
45.3
通讯作者：
Metges, Jean-Philippe
中科院分区：
文献类型：
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作者：
Adenis, Antoine;Kulkarni, Amit S.;Metges, Jean-Philippe
在晚期食管癌（EC）患者的III期KEYNOTE-181研究（）中，与化疗相比，帕博利珠单抗单药治疗延长了程序性死亡配体1联合阳性评分（CPS）>= 10的患者的总生存期。我们提出了鳞状细胞癌（SCC）、CPS >= 10和CPS >= 10 SCC人群的预先指定的健康相关生活质量（HRQoL）分析的结果。患者和方法HRQoL使用欧洲癌症研究和治疗组织（EORTC）生活质量问卷核心30（QLQ-C30）、EORTC QLQ EC问卷（OES 18）、欧洲五维健康量表（EQ-5D）。在接受>= 1剂研究治疗并完成>= 1次HRQoL评估的患者中分析数据。主要分析包括基线至第9周的最小二乘平均变化的全球健康状况/生活质量，功能或症状的子量表，和时间恶化（>= 10点恶化）为特定subscales.RESULTS的HRQoL人口包括387例SCC患者。在基线和第9周，两个治疗组中所有三份问卷的依从性和完成率相似。从基线至第9周，未观察到治疗组间总体健康状况/生活质量评分存在具有临床意义的差异（最小二乘均值差异，2.80; 95% CI，-1.48至7.08）;从基线至第9周，两个治疗组的患者通常表现出QLQ-C30和QLQ-OES 18的功能和症状评分稳定。治疗组间疼痛（风险比[HR]，1.22; 95% CI，0.79 - 1.89）、反流（HR，2.38; 95% CI，1.33 - 4.25）和吞咽困难（HR，1.53; 95% CI，1.02 - 2.31）子量表的至恶化时间相似。这些结果在CPS >= 10（n = 218）和CPS >= 10 SCC（n = 166）亚组中基本相似。结论在晚期EC患者中，Pembrolizumab单药治疗和化疗维持了SCC、CPS >= 10和CPS >= 10 SCC患者的HRQoL。
PURPOSE In the phase III KEYNOTE-181 study () of patients with advanced esophageal cancer (EC), pembrolizumab monotherapy prolonged overall survival versus chemotherapy as second-line therapy in patients with programmed death ligand 1 combined positive score (CPS) >= 10. We present the results of the prespecified health-related quality-of-life (HRQoL) analyses of the squamous cell carcinoma (SCC), CPS >= 10, and CPS >= 10 SCC populations.PATIENTS AND METHODS HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC QLQ EC questionnaire (OES18), and EuroQol 5-dimension questionnaire (EQ-5D). Data were analyzed in patients who received >= 1 dose of study treatment and completed >= 1 HRQoL assessment. Key analyses included baseline to week 9 least squares mean change in global health status/quality of life, functional or symptom subscales, and time to deterioration (>= 10-point deterioration) for specific subscales.RESULTS The HRQoL population included 387 patients with SCC. Compliance and completion rates for all three questionnaires were similar in both treatment groups at baseline and week 9. No clinically meaningful differences in global health status/quality of life scores were observed between treatment groups from baseline to week 9 (least squares mean difference, 2.80; 95% CI, -1.48 to 7.08); patients in both treatment groups generally exhibited stable functioning and symptom scores of the QLQ-C30 and QLQ-OES18 from baseline to week 9. Time to deterioration for pain (hazard ratio [HR], 1.22; 95% CI, 0.79 to 1.89), reflux (HR, 2.38; 95% CI, 1.33 to 4.25), and dysphagia (HR, 1.53; 95% CI, 1.02 to 2.31) subscales were similar between treatment groups. These findings were generally similar in the CPS >= 10 (n = 218) and CPS >= 10 SCC (n = 166) subgroups.CONCLUSION In patients with advanced EC, pembrolizumab monotherapy and chemotherapy maintained HRQoL in patients with SCC, CPS >= 10, and CPS >= 10 SCC.