帕博利珠单抗治疗复发性和/或转移性头颈部鳞状细胞癌的生活质量：KEYNOTE-040。
Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.
机构信息
The Institute of Cancer Research/The Royal Marsden National Institute for Health Research Biomedical Research Centre, London, UK.
Hôpital Notre-Dame, Montreal, QC, Canada.
出版信息
J Natl Cancer Inst. 2021 Feb 1;113(2):171-181. doi: 10.1093/jnci/djaa063.
BACKGROUND
Head and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen.
METHODS
Patients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires.
RESULTS
The HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = -3.00 to 3.78) but worsened for SOC (LSM = -5.86, 95% CI = -9.68 to -2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = -4.57 to 16.99) or pembrolizumab vs cetuximab (-1.44, 95% CI = -11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC.
CONCLUSIONS
GHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.
背景
头颈部鳞状细胞癌（HNSCC）影响健康相关生活质量（HRQoL）；很少有治疗方法显示出具有临床意义的 HRQoL 获益。KEYNOTE-040 评估了帕博利珠单抗与复发和/或转移性 HNSCC 患者的标准治疗（SOC）相比，这些患者在含铂方案后疾病复发或进展。
方法
患者接受帕博利珠单抗 200mg 或 SOC（甲氨蝶呤、多西他赛或西妥昔单抗）。使用欧洲癌症研究与治疗组织（EORTC）30 项生活质量问卷、EORTC 35 项头颈部癌症特定模块生活质量问卷和欧洲五维健康量表（EuroQoL）问卷进行探索性 HRQoL 分析。
结果
HRQoL 人群包括 469 名患者（帕博利珠单抗组=241 例，SOC 组=228 例）。在第 15 周时，帕博利珠单抗组患者的 HRQoL 依从率为 75.3%（154 例中有 116 例），SOC 组为 74.6%（114 例中有 85 例）。帕博利珠单抗组和 SOC 组全球健康状况（GHS）和生活质量评分恶化的中位时间分别为 4.8 个月和 2.8 个月（风险比=0.79，95%置信区间[CI]为 0.59 至 1.05）。在第 15 周时，帕博利珠单抗组的 GHS / QoL 评分稳定（最小二乘均值[LSM]=0.39，95%CI=-3.00 至 3.78），而 SOC 组的 GHS / QoL 评分恶化（LSM=-5.86，95%CI=-9.68 至-2.04）；组间 LSM 差异为 6.25 分（95%CI=1.32 至 11.18；双侧名义 P=0.01）。与帕博利珠单抗联合多西他赛（10.23，95%CI=3.15 至 17.30）相比，与帕博利珠单抗联合甲氨蝶呤（6.21，95%CI=-4.57 至 16.99）或帕博利珠单抗联合西妥昔单抗（-1.44，95%CI=-11.43 至 8.56）相比，帕博利珠单抗治疗组患者的 GHS / QoL 评分差异更大。在第 15 周时，接受帕博利珠单抗治疗的患者具有稳定的功能和症状，与 SOC 无显著差异。
结论
在第 15 周时，帕博利珠单抗组患者的 GHS / QoL 评分稳定，但 SOC 组患者的评分下降，支持帕博利珠单抗在复发性和/或转移性 HNSCC 中的具有临床意义的获益。
Zotero 插件