Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ?50%: The EMPOWER-Lung 1 study

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dc.authoridTÜRK, Haci Mehmet/0000-0003-2206-8148
dc.authoridBrady, Keri J. S./0000-0001-6417-0840
dc.authoridBondarenko, Igor/0000-0002-7071-2471
dc.authoridGumus, Mahmut/0000-0003-3550-9993
dc.authorwosidGumus, Mahmut/HTO-4176-2023
dc.authorwosidTÜRK, Haci Mehmet/B-5013-2015
dc.authorwosidBrady, Keri J. S./K-4463-2017
dc.authorwosidBondarenko, Igor/U-5156-2017
dc.contributor.authorGumus, Mahmut
dc.contributor.authorChen, Chieh-, I
dc.contributor.authorIvanescu, Cristina
dc.contributor.authorKilickap, Saadettin
dc.contributor.authorBondarenko, Igor
dc.contributor.authorOzguroglu, Mustafa
dc.contributor.authorGogishvili, Miranda
dc.date.accessioned2024-06-12T10:56:00Z
dc.date.available2024-06-12T10:56:00Z
dc.date.issued2023
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground In the EMPOWER-Lung 1 trial (, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) >= 50%. Patient-reported outcomes were evaluated among trial participants. Methods Adults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model repeated measures analysis estimated overall change from baseline for PD-L1 >= 50% and intention-to-treat populations. Kaplan-Meier analysis estimated time to definitive deterioration. Results In PD-L1 >= 50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ-C30 and QLQ-LC13 scores showed moderate-to-high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32-0.71) to 0.63 (95% CI, 0.41-0.96). Cemiplimab showed lower risk of definitive deterioration for disease-related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment-related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p < .05). Results were similar in the intention-to-treat population. Conclusions Results support cemiplimab for first-line therapy of advanced NSCLC from the patient's perspective. Improved survival is accompanied by improvements versus platinum-doublet chemotherapy in GHS/QOL and functioning and reduction in symptom burden.en_US
dc.description.sponsorshipSanofi; Regeneron Pharmaceuticalsen_US
dc.description.sponsorshipSanofi; Regeneron Pharmaceuticalsen_US
dc.identifier.doi10.1002/cncr.34477
dc.identifier.endpage129en_US
dc.identifier.issn0008-543X
dc.identifier.issn1097-0142
dc.identifier.issue1en_US
dc.identifier.pmid36308296en_US
dc.identifier.scopus2-s2.0-85141409577en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage118en_US
dc.identifier.urihttps://doi.org/10.1002/cncr.34477
dc.identifier.urihttps://hdl.handle.net/20.500.14551/19638
dc.identifier.volume129en_US
dc.identifier.wosWOS:000875663600001en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofCanceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectCemiplimaben_US
dc.subjectNon-Small Cell Lung Canceren_US
dc.subjectPatient-Reported Outcomesen_US
dc.subjectQuality Of Lifeen_US
dc.subjectSymptom Burdenen_US
dc.subjectQuality-Of-Lifeen_US
dc.subjectOpen-Labelen_US
dc.subjectSymptom Prevalenceen_US
dc.subjectClinical-Trialsen_US
dc.subjectChemotherapyen_US
dc.subjectQlq-C30en_US
dc.subjectPembrolizumaben_US
dc.subjectMulticenteren_US
dc.subjectSurvivalen_US
dc.subjectPhase-3en_US
dc.titlePatient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ?50%: The EMPOWER-Lung 1 studyen_US
dc.typeArticleen_US

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