Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
Gupta S, Loriot Y, Van Der Heijden M, Bedke J, Valderrama B, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky M, Lee J, Swami U, Sridhar S, De Giorgi U, Wright P, Lu Y, Guan X, Dillon R, Homet Moreno B, Powles T. Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2024, 42: 4502-4502. DOI: 10.1200/jco.2024.42.16_suppl.4502.Peer-Reviewed Original ResearchTime to pain progressionPlatinum-based chemotherapyPatient-reported outcomesBPI-SFMedian time to pain progressionPatients treated with platinum-based chemotherapyBrief Pain Inventory Short FormMetastatic urothelial cancerProgression-free survivalKaplan-Meier methodPhase 3 trialSurvival follow-upPatient-reported outcome assessmentsEnfortumab vedotinOverall survivalPain progressionTransient worseningUrothelial cancerQuality of Life QuestionnairePost-progressionSevere painImproved survivalWorst painFollow-upGlobal health status/qualityPatient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab
Milowsky M, O'Donnell P, Hoimes C, Petrylak D, Flaig T, Moon H, Friedlander T, Mar N, McKay R, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret A, Yu Y, Dillon R, Kataria R, Beaumont J, Purnajo I, Rosenberg J. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. Journal Of Clinical Oncology 2024, 42: 1403-1414. PMID: 38215355, PMCID: PMC11095879, DOI: 10.1200/jco.23.01547.Peer-Reviewed Original ResearchBPI-SF worst painPatient-reported outcomesEnfortumab vedotinEORTC QLQ-C30 quality of lifeBPI-SFQuality of lifeCisplatin-ineligibleUrothelial cancerWorst painTreatment armsBrief Pain Inventory Short FormAdvanced urothelial cancerPhase Ib/II trialBaseline to weekPatient-reported outcomes analysisAssociated with preservationTreatment of Cancer Quality of Life Questionnaire-Core QuestionnairePatients' quality of lifeSmall-to-moderate improvementsClinically meaningful improvementsPatient-reported outcome instrumentsEuropean Organization for Research and TreatmentEORTC QLQ-C30First-lineClinical outcomes