帕博利珠单抗对比化疗作为晚期食管癌二线治疗方案对KEYNOTE-181研究中健康相关生活质量的影响
Impact of Pembrolizumab Versus Chemotherapy as Second-Line Therapy for Advanced Esophageal Cancer on Health-Related Quality of Life in KEYNOTE-181.
作者信息
Adenis Antoine, Kulkarni Amit S, Girotto Gustavo C, de la Fouchardiere Christelle, Senellart Helene, van Laarhoven Hanneke W M, Mansoor Wasat, Al-Rajabi Raed, Norquist Josephine, Amonkar Mayur, Suryawanshi Shailaja, Bhagia Pooja, Metges Jean-Philippe
机构信息
Institut du Cancer de Montpellier and IRCM, Université Montpellier, Montpellier, France.
Merck & Co, Inc, Kenilworth, NJ.
出版信息
J Clin Oncol. 2022 Feb 1;40(4):382-391. doi: 10.1200/JCO.21.00601. Epub 2021 Nov 3.
PURPOSE
In the phase III KEYNOTE-181 study (NCT02564263) 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.
目的
在晚期食管癌（EC）患者的III期KEYNOTE-181研究（NCT02564263）中，帕博利珠单抗单药治疗作为二线治疗，与化疗相比，可延长程序性死亡配体1联合阳性评分（CPS）≥10的患者的总生存期。我们展示了对鳞状细胞癌（SCC）、CPS≥10以及CPS≥10的SCC人群预先设定的健康相关生活质量（HRQoL）分析结果。
患者和方法
使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷核心30（QLQ-C30）、EORTC QLQ EC问卷（OES18）和欧洲五维健康量表（EQ-5D）来测量HRQoL。对接受≥1剂研究治疗并完成≥1次HRQoL评估的患者的数据进行分析。关键分析包括从基线到第9周全球健康状况/生活质量、功能或症状子量表的最小二乘均值变化，以及特定子量表的恶化时间（≥10分恶化）。
结果
HRQoL人群包括387例SCC患者。在基线和第9周时，两个治疗组中所有三份问卷的依从率和完成率相似。从基线到第9周，治疗组之间在全球健康状况/生活质量评分方面未观察到具有临床意义的差异（最小二乘均值差异为2.80；95%置信区间为-1.48至7.08）；两个治疗组的患者从基线到第9周，QLQ-C30和QLQ-OES18的功能和症状评分总体上保持稳定。疼痛（风险比[HR]为1.22；95%置信区间为0.79至1.89）、反流（HR为2.38；95%置信区间为1.33至4.25）和吞咽困难（HR为1.53；95%置信区间为1.02至2.31）子量表的恶化时间在治疗组之间相似。在CPS≥10（n = 218）和CPS≥10的SCC（n = 166）亚组中，这些结果总体相似。
结论
在晚期EC患者中，帕博利珠单抗单药治疗和化疗在SCC、CPS≥10以及CPS≥10的SCC患者中维持了HRQoL。
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