Quality of Life With Pembrolizumab for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040

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.