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                  <mods:namePart>Rischin, Danny</mods:namePart>
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                  <mods:namePart>Bratland, Åse</mods:namePart>
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                  <mods:namePart>Fuereder, Thorsten</mods:namePart>
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                  <mods:namePart>Hughes, Brett G.M.</mods:namePart>
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                  <mods:namePart>González Mendoza, René</mods:namePart>
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                  <mods:namePart>Jia, Liyi</mods:namePart>
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                  <mods:namePart>Chirovsky, Diana</mods:namePart>
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                  <mods:namePart>Norquist, Josephine</mods:namePart>
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                  <mods:namePart>Jin, Fan</mods:namePart>
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                  <mods:dateIssued encoding="iso8601">2023-03-21T18:11:11Z2023-03-21T18:11:11Z2022-052023-03-21T18:11:11Z</mods:dateIssued>
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               <mods: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&amp;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&amp;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&amp;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&amp;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.</mods:abstract>
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               <mods:accessCondition type="useAndReproduction">cc-by-nc-nd (c) Elsevier Ltd, 2022 https://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess</mods:accessCondition>
               <mods:subject>
                  <mods:topic>Anticossos monoclonals</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Quimioteràpia</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Malalties cròniques</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Càncer de coll</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Càncer de cap</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Monoclonal antibodies</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Chemotherapy</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Chronic diseases</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Neck cancer</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Head cancer</mods:topic>
               </mods:subject>
               <mods:titleInfo>
                  <mods: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</mods:title>
               </mods:titleInfo>
               <mods:genre>info:eu-repo/semantics/article info:eu-repo/semantics/acceptedVersion</mods:genre>
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