2023
Patient-Reported Outcomes in the Phase 3 CARTITUDE-4 Study of Ciltacabtagene Autoleucel Vs Standard of Care in Patients with Lenalidomide-Refractory Multiple Myeloma after 1-3 Lines of Therapy
Mina R, Mylin A, Yokoyama H, Magen H, Alsdorf W, Minnema M, Shune L, Isufi I, Harrison S, Shah U, Schecter J, Lendvai N, Gries K, Katz E, Slaughter A, Lonardi C, Gilbert J, Li Q, Deraedt W, Filho O, Patel N, Karlin L, Weisel K. Patient-Reported Outcomes in the Phase 3 CARTITUDE-4 Study of Ciltacabtagene Autoleucel Vs Standard of Care in Patients with Lenalidomide-Refractory Multiple Myeloma after 1-3 Lines of Therapy. Blood 2023, 142: 1063. DOI: 10.1182/blood-2023-178798.Peer-Reviewed Original ResearchLenalidomide-refractory multiple myelomaPatient-reported outcomesLines of therapyHealth-related qualityDepth of responseMultiple myelomaSOC armCilta-celMM symptomsPRO compliancePrior linesMonth 12PRO scoresLife Questionnaire Core 30EORTC QLQ-C30 domainsGlobal health statusProgression-free survivalDisease-specific symptomsKaplan-Meier methodBaseline PRO scoresVisual analog scaleStandard of careNumber of patientsTotal symptom scaleQLQ-C30 domainsPatient-Reported Outcomes (PRO) of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naïve, Transfusion-Dependent (TD), Lower-Risk Myelodysplastic Syndromes (LR-MDS): Results from the Phase 3 COMMANDS Study
Oliva E, Platzbecker U, Della Porta M, Garcia-Manero G, Santini V, Fenaux P, Shortt J, Komrokji R, Pelligra C, Guo S, Lord-Bessen J, Xiao H, Yucel A, Miteva D, Rose S, Kreitz S, Sekeres M, Zeidan A. Patient-Reported Outcomes (PRO) of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naïve, Transfusion-Dependent (TD), Lower-Risk Myelodysplastic Syndromes (LR-MDS): Results from the Phase 3 COMMANDS Study. Blood 2023, 142: 4596. DOI: 10.1182/blood-2023-174660.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesEORTC QLQ-C30Patient-reported outcomesErythropoietin-stimulating agentsEpoetin alfaQLQ-C30FACT-AnSustained improvementTreatment armsESA-naïveTransfusion-DependentTreatment tolerabilityStratified Cox proportional hazards regression modelDay 1Cox proportional hazards regression modelCancer Therapy-Anemia (FACT-An) questionnaireLife Questionnaire Core 30Proportional hazards regression modelsMajority of patientsTreatment side effectsPost-baseline visitTransfusion-dependent patientsErythropoiesis stimulating agentsHazards regression modelsPhase 3
2021
Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: A randomized phase 3 trial of enfortumab vedotin versus chemotherapy.
Mamtani R, Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Sridhar S, Pappot H, Valderrama B, Gurney H, Bedke J, Van Der Heijden M, Wu C, Hepp Z, McKay C, Petrylak D. Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: A randomized phase 3 trial of enfortumab vedotin versus chemotherapy. Journal Of Clinical Oncology 2021, 39: 4539-4539. DOI: 10.1200/jco.2021.39.15_suppl.4539.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaOpen-label phase 3 studyCompliance rateGlobal health status scaleRandomized phase 3 trialSymptom scales/itemsLife Questionnaire Core 30Median overall survivalQuestionnaire compliance ratesPhase 3 studyPhase 3 trialCancer Core QualityWeeks of treatmentHealth status scalesRisk of deathQLQ-C30 scoresQLQ-C30 domainsQuality of lifeBenefit/riskScales/itemsPain symptomsAppetite lossLiver metastasesOverall survival
2020
Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC.
de Marinis F, Giaccone G, Herbst R, Oprean C, Szczesna A, Boukovinas I, Bonomi L, Kim Y, Summers Y, Kurata T, Komatsubara K, Chen M, Deng Y, Kuriki H, Mocci S, Phan S, Jassem J, Spigel D. Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC. Journal Of Clinical Oncology 2020, 38: 9594-9594. DOI: 10.1200/jco.2020.38.15_suppl.9594.Peer-Reviewed Original ResearchPatient-reported outcomesGlobal health statusLung cancer-related symptomsLung cancer symptomsCancer-related symptomsChest painWk 48Metastatic NSCLCSymptom burdenPhysical functionCancer symptomsLife Questionnaire Core 30Carboplatin AUC 6Overall clinical benefitStart of treatmentCompletion ratesAUC 5AUC 6Gemcitabine 1250Meaningful worseningNausea/OS benefitQLQ-LC13Primary endpointPD-L1
2019
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
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, de Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. 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. Journal Of Thoracic Oncology 2019, 14: 793-801. PMID: 30711649, DOI: 10.1016/j.jtho.2019.01.016.Peer-Reviewed Original ResearchConceptsGlobal health statusDeath ligand 1Composite endpointPhase II/III studyGHS/QoL scoresLife Questionnaire Core 30Programmed Death Ligand 1Symptom domainsNSCLC patient populationPembrolizumab-treated patientsWeek 12 changesHealth-related qualityLigand 1Quality of lifeGHS/KEYNOTE-010Advanced NSCLCChest painIII studyOverall survivalCancer QualityEuroQol-5D.Life scoresMean baselinePatient population
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