<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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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorRISCHIN, Danny
dc.contributor.authorHARRINGTON, Kevin J.
dc.contributor.authorGREIL, Richard
dc.contributor.authorSOULIERES, Denis
dc.contributor.authorTAHARA, Makoto
dc.contributor.authorJR, Gilberto de Castro
dc.contributor.authorPSYRRI, Amanda
dc.contributor.authorBRANA, Irene
dc.contributor.authorNEUPANE, Prakash
dc.contributor.authorBRATLAND, Ase
dc.contributor.authorFUEREDER, Thorsten
dc.contributor.authorHUGHES, Brett G. M.
dc.contributor.authorMESIA, Ricard
dc.contributor.authorNGAMPHAIBOON, Nuttapong
dc.contributor.authorRORDORF, Tamara
dc.contributor.authorISHAK, Wan Zamaniah Wan
dc.contributor.authorHONG, Ruey-Long
dc.contributor.authorMENDOZA, Rene Gonzalez
dc.contributor.authorJIA, Liyi
dc.contributor.authorCHIROVSKY, Diana
dc.contributor.authorNORQUIST, Josephine
dc.contributor.authorJIN, Fan
dc.contributor.authorBURTNESS, Barbara
dc.date.accessioned2022-06-20T15:26:17Z
dc.date.available2022-06-20T15:26:17Z
dc.date.issued2022
dc.description.abstractObjectives: 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.eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipMerck Sharp Dohme Corp
dc.description.sponsorshipMerck & Co., Inc., Kenilworth, NJ, USA
dc.identifier.citationORAL ONCOLOGY, v.128, article ID 105815, 12p, 2022
dc.identifier.doi10.1016/j.oraloncology.2022.105815
dc.identifier.eissn1879-0593
dc.identifier.issn1368-8375
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/47088
dc.language.isoeng
dc.publisherELSEVIEReng
dc.relation.ispartofOral Oncology
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright ELSEVIEReng
dc.subjectPhase III clinical trialeng
dc.subjectChemotherapy head and neck neoplasmseng
dc.subjectImmunotherapyeng
dc.subjectPatient reported outcome measureseng
dc.subjectPembrolizumabeng
dc.subject.othereuropean-organizationeng
dc.subject.othercancereng
dc.subject.othernivolumabeng
dc.subject.othercetuximabeng
dc.subject.otherpembrolizumabeng
dc.subject.wosOncologyeng
dc.title<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>eng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryMalásia
hcfmusp.affiliation.countrySuíça
hcfmusp.affiliation.countryTailândia
hcfmusp.affiliation.countryNoruega
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryGrécia
hcfmusp.affiliation.countryJapão
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryÁustria
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryAustrália
hcfmusp.affiliation.countryTaiwan
hcfmusp.affiliation.countryMéxico
hcfmusp.affiliation.countryisoau
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hcfmusp.affiliation.countryisoes
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hcfmusp.affiliation.countryisono
hcfmusp.affiliation.countryisoth
hcfmusp.affiliation.countryisoch
hcfmusp.affiliation.countryisomy
hcfmusp.affiliation.countryisotw
hcfmusp.affiliation.countryisomx
hcfmusp.author.externalRISCHIN, Danny:Peter MacCallum Canc Ctr, Med Oncol, 305 Grattan St, Melbourne, Vic 3000, Australia; Univ Melbourne, 305 Grattan St, Melbourne, Vic 3000, Australia
hcfmusp.author.externalHARRINGTON, Kevin J.:Royal Marsden NHS Fdn Trust, Natl Inst Hlth Res, Radiotherapy & Imaging, Inst Canc Res,Biomed Res Ctr, 15 Cotswold Rd, London SM2 5NG, England
hcfmusp.author.externalGREIL, Richard:Paracelsus Med Univ, Salzburg Canc Res Inst, Hematol & Med Oncol, Hellbrunner Str 34, A-5020 Salzburg, Austria; Canc Cluster Salzburg, Hellbrunner Str 34, A-5020 Salzburg, Austria
hcfmusp.author.externalSOULIERES, Denis:Ctr Hosp Univ Montreal, Haematol Oncol, 1000 St Denis St, Montreal, PQ H2X 0C1, Canada
hcfmusp.author.externalTAHARA, Makoto:Natl Canc Ctr Hosp East, Head & Neck Med Oncol, 6-5-1 Kashiwanoba, Kashiwa, Chiba 2778577, Japan
hcfmusp.author.externalPSYRRI, Amanda:Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Med Oncol, Athens 15772, Greece
hcfmusp.author.externalBRANA, Irene:Vall dHebron Univ Hosp, Vall dHebron Inst Oncol, Med Oncol Dept, Passeig Vall dHebron 119-129, Barcelona 08035, Spain
hcfmusp.author.externalNEUPANE, Prakash:Univ Kansas, Med Ctr, Hematol Oncol, 3901 Rainbow Blvd, Kansas City, MO 66160 USA
hcfmusp.author.externalBRATLAND, Ase:Oslo Univ Hosp, Head & Neck Oncol, Bygg 19, Oslo, Norway
hcfmusp.author.externalFUEREDER, Thorsten:Med Univ Vienna, Med 1, Spitalgasse 23, A-1090 Vienna, Austria
hcfmusp.author.externalHUGHES, Brett G. M.:Royal Brisbane & Womens Hosp, Clin Res Unit, Med Oncol, Butterfield St,Ground Floor,Bldg 34, Herston, Qld 4029, Australia; Univ Queensland, Butterfield St,Ground Floor,Bldg 34, Herston, Qld 4029, Australia
hcfmusp.author.externalMESIA, Ricard:Hosp Duran & Reynals, Catalan Inst Oncol, Head & Neck, Avinguda Gran Via Hosp 199-203, Barcelona 8908, Spain
hcfmusp.author.externalNGAMPHAIBOON, Nuttapong:Mahidol Univ, Ramathibodi Hosp, Med, 270 Rama 6 Rd, Bangkok 10400, Thailand
hcfmusp.author.externalRORDORF, Tamara:Univ Hosp, Oncol, Raemistr 100, Zurich, Switzerland
hcfmusp.author.externalISHAK, Wan Zamaniah Wan:Univ Malaya, Fac Med, Clin Oncol Unit, Jalan Univ, Kuala Lumpur 50603, Wilayah Perseku, Malaysia
hcfmusp.author.externalHONG, Ruey-Long:Natl Taiwan Univ Hosp, Oncol, 1 Changde St Zhongzheng Dist, Taipei 10048, Taiwan
hcfmusp.author.externalMENDOZA, Rene Gonzalez:Ctr Estatal Cancerol Chihuahua, Surg Oncol, C Ejercito Mexicano 3700, El Bajo 31000, Chihuahua, Mexico
hcfmusp.author.externalJIA, Liyi:Merck & Co Inc, Merck Res Labs, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA
hcfmusp.author.externalCHIROVSKY, Diana:Merck & Co Inc, Merck Res Labs, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA
hcfmusp.author.externalNORQUIST, Josephine:Merck & Co Inc, Merck Res Labs, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA
hcfmusp.author.externalJIN, Fan:Merck & Co Inc, Merck Res Labs, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA
hcfmusp.author.externalBURTNESS, Barbara:Yale Univ, Sch Med, Med Oncol, 35 York St,POB 208028, New Haven, CT 06510 USA; Yale Canc Ctr, 35 York St,POB 208028, New Haven, CT 06510 USA
hcfmusp.citation.scopus16
hcfmusp.contributor.author-fmusphcGILBERTO DE CASTRO JUNIOR
hcfmusp.description.articlenumber105815
hcfmusp.description.volume128
hcfmusp.origemWOS
hcfmusp.origem.pubmed35381576
hcfmusp.origem.scopus2-s2.0-85127463915
hcfmusp.origem.wosWOS:000792907400009
hcfmusp.publisher.cityAMSTERDAMeng
hcfmusp.publisher.countryNETHERLANDSeng
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