2023
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefit
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
2012
943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC)
Corman J, Dawson N, Hall S, Nabhan C, Ferrari A, Armstrong A, Murdock M, Stewart F, Sheikh N, Petrylak D. 943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix311. DOI: 10.1016/s0923-7534(20)33504-3.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerTotal nucleated cell countImmune responseHigher baseline prostate-specific antigenPhase 2 open-label studyCell countBaseline prostate-specific antigenAntigen-specific immune responsesCastrate-resistant prostate cancerT cell proliferative responsesAutologous cellular immunotherapyCostimulatory molecules CD54Sipuleucel-T treatmentOpen-label studySpeakers bureauHigher total nucleated cell countSanofi-AventisVirginia Mason Medical CenterRisk of deathCell proliferative responsesProstate-specific antigenNucleated cell countD exposureBristol-Myers SquibbCD54 upregulation