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Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC

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dc.contributor.authorBarlesi, Fabrice-
dc.contributor.authorGaron, Edward B.-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorFelip, Enriqueta-
dc.contributor.authorHan, Ji-Youn-
dc.contributor.authorKim, Joo-Hang-
dc.contributor.authorAhn, Myung-Ju-
dc.contributor.authorFidler, Mary Jo-
dc.contributor.authorGubens, Matthew A.-
dc.contributor.authorde Castro, Gilberto, Jr.-
dc.contributor.authorSurmont, Veerle-
dc.contributor.authorLi, Qiao-
dc.contributor.authorDeitz, Anne C.-
dc.contributor.authorLubiniecki, Gregory M.-
dc.contributor.authorHerbst, Roy S.-
dc.date.accessioned2020-04-27T10:56:40Z-
dc.date.available2020-04-27T10:56:40Z-
dc.date.issued2019-05-
dc.identifier.citationJournal of Thoracic Oncology, Vol.14 No.5, pp.793-801-
dc.identifier.issn1556-0864-
dc.identifier.other94742-
dc.identifier.urihttps://hdl.handle.net/10371/165203-
dc.description.abstractIntroduction: In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1-expressing (tumor proportion score >= 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here. Methods: Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m(2) every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ-Lung Cancer 13 (LC13), and EuroQoL-5D. Key analyses included mean baseline-to-week-12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain. Results: Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ-C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab-treated patients had "deteriorated" status and more had "improved" status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose. Conclusions: These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.-
dc.subjectPembrolizumab-
dc.subjectPD-L1-
dc.subjectNSCLC-
dc.subjectEORTC QLQ-C30-
dc.subjectEORTC QLQ-LC13-
dc.titleHealth-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1016/j.jtho.2019.01.016-
dc.citation.journaltitleJournal of Thoracic Oncology-
dc.identifier.scopusid2-s2.0-85063347718-
dc.citation.endpage801-
dc.citation.number5-
dc.citation.startpage793-
dc.citation.volume14-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S1556086419300917?via%3Dihub-
dc.identifier.rimsid94742-
dc.identifier.sci000465298700019-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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