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 versus standard of care (SOC) in patients with recurrent/metastatic (R/M) HNSCC whose disease recurred/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 HRQoL population comprised 469 patients (pembrolizumab=241, SOC=228). HRQoL compliance for patients on study at week 15 was 75.3% (116/154) for pembrolizumab and 74.6% (85/114) for SOC. Median time to deterioration in global health status (GHS)/QoL score was 4.8 months and 2.8 months, respectively (HR, 0.79; 95% CI: 0.59, 1.05). At week 15, GHS/QoL scores were stable for pembrolizumab (least squares mean [LSM], 0.39; 95% CI: -3.00, 3.78) but worsened for SOC (LSM, -5.86; 95% CI: -9.68, -2.04); LSM between-group difference was 6.25 points (95% CI: 1.32, 11.18; nominal 2-sided P=.01). Greater difference in LSM score for GHS/QoL occurred with pembrolizumab versus docetaxel (10.23; 95% CI: 3.15, 17.30) compared with pembrolizumab versus methotrexate (6.21; 95% CI: -4.57, 16.99) or pembrolizumab versus cetuximab (-1.44; 95% CI: -11.43, 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC. CONCLUSIONS GHS/QoL was stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in R/M HNSCC.

中文翻译：

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使用 Pembrolizumab 治疗复发性/转移性头颈鳞状细胞癌的生活质量：KEYNOTE-040。


背景头颈鳞状细胞癌（HNSCC）影响健康相关的生活质量（HRQoL）；很少有治疗能够证明具有临床意义的 HRQoL 益处。 KEYNOTE-040 评估了派姆单抗与标准护理 (SOC) 治疗复发/转移性 (R/M) HNSCC 患者的疗效，这些患者在含铂方案后疾病复发/进展。方法 患者接受 200 mg 派姆单抗或 SOC（甲氨蝶呤、多西他赛或西妥昔单抗）。探索性 HRQoL 分析使用欧洲癌症研究与治疗组织 (EORTC) 30 生活质量、EORTC 35 个问题生活质量头颈癌特定模块以及 EuroQoL 5 维度问卷。结果 HRQoL 人群包括 469 名患者（pembrolizumab=241，SOC=228）。第 15 周时研究患者的 HRQoL 依从性，派姆单抗为 75.3% (116/154)，SOC 为 74.6% (85/114)。全球健康状况 (GHS)/QoL 评分恶化的中位时间分别为 4.8 个月和 2.8 个月（HR，0.79；95% CI：0.59，1.05）。第 15 周时，派姆单抗的 GHS/QoL 评分稳定（最小二乘平均值 [LSM]，0.39；95% CI：-3.00，3.78），但 SOC 的 GHS/QoL 评分恶化（LSM，-5.86；95% CI：-9.68，-2.04） ）； LSM 组间差异为 6.25 分（95% CI：1.32，11.18；名义两侧 P=.01）。与派姆单抗与甲氨蝶呤（6.21；95% CI：-4.57，16.99）或派姆单抗与西妥昔单抗（-1.44；16.99）相比，派姆单抗与多西他赛（10.23；95% CI：3.15，17.30）的 GHS/QoL LSM 评分差异更大。 95% CI：-11.43，8.56）。 Pembrolizumab 治疗的患者在第 15 周时功能和症状稳定，与 SOC 没有显着差异。 结论 在第 15 周时，帕博利珠单抗的 GHS/QoL 稳定，但随着 SOC 的增加而下降，支持帕博利珠单抗在 R/M HNSCC 中具有临床意义的益处。