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Title: | Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048 |
Author: | Rischin, Danny Harrington, Kevin J. Greil, Richard Soulières, Denis Tahara, Makoto Castro, Gilberto de Psyrri, Amanda Braña, Irene Neupane, Prakash Bratland, Åse Fuereder, Thorsten Hughes, Brett G.M. Mesía Nin, Ricard Ngamphaiboon, Nuttapong Rordorf, Tamara Ishak, Wan Zamaniah Wan Hong, Ruey-Long González Mendoza, René Jia, Liyi Chirovsky, Diana Norquist, Josephine Jin, Fan Burtness, Barbara |
Keywords: | Anticossos monoclonals Quimioteràpia Malalties cròniques Càncer de coll Càncer de cap Monoclonal antibodies Chemotherapy Chronic diseases Neck cancer Head cancer |
Issue Date: | May-2022 |
Publisher: | Elsevier Ltd |
Abstract: | Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031). 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. 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; pembrolizumab-chemotherapy 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 cetuximab-chemotherapy: HR, 1.37; 95% CI, 0.94-2.00), as was TTD in EORTC QLQ-H&N35 pain and swallowing scores. Conclusions: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC. |
Note: | Versió postprint del document publicat a: https://doi.org/10.1016/j.oraloncology.2022.105815 |
It is part of: | Oral Oncology, 2022, vol. 128 |
URI: | http://hdl.handle.net/2445/195747 |
Related resource: | https://doi.org/10.1016/j.oraloncology.2022.105815 |
ISSN: | 1368-8375 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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