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Quality of Life With Pembrolizumab for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.
Journal of the National Cancer Institute ( IF 9.9 ) Pub Date : 2020-05-14 , DOI: 10.1093/jnci/djaa063
Kevin J Harrington 1 , Denis Soulières 2 , Christophe Le Tourneau 3, 4, 5 , Jose Dinis 6 , Lisa F Licitra 7 , Myung-Ju Ahn 8 , Ainara Soria 9 , Jean-Pascal H Machiels 10 , Nicolas Mach 11 , Ranee Mehra 12 , Barbara Burtness 13 , Misoo C Ellison 14 , Jonathan D Cheng 14 , Diana Romana Chirovsky 14 , Ramona F Swaby 14 , Ezra E W Cohen 15
Affiliation  

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:


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。
更新日期:2020-05-14
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