Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSPRISCHIN, DannyHARRINGTON, Kevin J.GREIL, RichardSOULIERES, DenisTAHARA, MakotoJR, Gilberto de CastroPSYRRI, AmandaBRANA, IreneNEUPANE, PrakashBRATLAND, AseFUEREDER, ThorstenHUGHES, Brett G. M.MESIA, RicardNGAMPHAIBOON, NuttapongRORDORF, TamaraISHAK, Wan Zamaniah WanHONG, Ruey-LongMENDOZA, Rene GonzalezJIA, LiyiCHIROVSKY, DianaNORQUIST, JosephineJIN, FanBURTNESS, Barbara2022-06-202022-06-202022ORAL ONCOLOGY, v.128, article ID 105815, 12p, 20221368-8375https://observatorio.fm.usp.br/handle/OPI/47088Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumabchemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031).& nbsp;Materials and Methods: HRQoL was measured using the European Organisation for Research and Treatment of Cancer 30-question quality-of-life (EORTC QLQ-C30), the EORTC 35-question quality-of-life head and neck cancer-specific module (EORTC QLQ-H & N35), and the EuroQol 5-dimension 3-level instruments (EQ-5D-3L). Secondary endpoints included mean change from baseline in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) at week 15 and time to deterioration (TTD) in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H & N35 pain and swallowing.& nbsp;Results: Of 882 enrolled participants, 844 received > 1 dose of study treatment and completed > 1 HRQoL assessment; adherence was > 79% at week 15 across treatment groups. At week 15, EORTC QLQ-C30 GHS/QoL scores remained stable; no clinically meaningful between-group differences were observed (least squares mean difference, pembrolizumab vs cetuximab-chemotherapy, 0.24; 95% CI,-3.34 to 3.82; pembrolizumabchemotherapy vs cetuximab-chemotherapy, 0.40; 95% CI,-3.46 to 4.26). Median TTD in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H & N35 pain and swallowing scores was not reached over 51 weeks across groups, showing stable HRQoL. TTD was similar between groups for EORTC QLQ-C30 GHS/QoL (pembrolizumab vs cetuximab-chemotherapy: HR, 1.38; 95% CI, 0.95-2.00; pembrolizumab-chemotherapy vs cetuximabchemotherapy: HR, 1.37; 95% CI, 0.94-2.00), as was TTD in EORTC QLQ-H & N35 pain and swallowing scores.& nbsp;Conclusions: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC.engrestrictedAccessPhase III clinical trialChemotherapy head and neck neoplasmsImmunotherapyPatient reported outcome measuresPembrolizumabeuropean-organizationcancernivolumabcetuximabpembrolizumabarticleCopyright ELSEVIER10.1016/j.oraloncology.2022.105815Oncology1879-0593