<p>Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048</p>

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art_RISCHIN_pPembrolizumab_alone_or_with_chemotherapy_for_recurrent_or_2022.PDF (2.77 MB)
Citações na Scopus
15
Tipo de produção
article
Data de publicação
2022
DOI
Scopus
Web of Science
PubMed
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ELSEVIER
Autores
RISCHIN, Danny
HARRINGTON, Kevin J.
GREIL, Richard
SOULIERES, Denis
TAHARA, Makoto
PSYRRI, Amanda
BRANA, Irene
NEUPANE, Prakash
BRATLAND, Ase
Citação
ORAL ONCOLOGY, v.128, article ID 105815, 12p, 2022
Projetos de Pesquisa
Unidades Organizacionais
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Resumo
Objectives: 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.
Palavras-chave
Phase III clinical trial, Chemotherapy head and neck neoplasms, Immunotherapy, Patient reported outcome measures, Pembrolizumab
URI
https://observatorio.fm.usp.br/handle/OPI/47088
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MDR
Artigos e Materiais de Revistas Científicas - HC/ICESP
Artigos e Materiais de Revistas Científicas - LIM/24
Artigos e Materiais de Revistas Científicas - ODS/03
Artigos e Materiais de Revistas Científicas - ODS/10