2018
EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer.
Hoimes C, Petrylak D, Flaig T, Carret A, Melhem-Bertrandt A, Rosenberg J. EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2018, 36: tps532-tps532. DOI: 10.1200/jco.2018.36.6_suppl.tps532.Peer-Reviewed Original ResearchObjective response rateMicrotubule-disrupting agent monomethyl auristatin ECheckpoint inhibitorsMetastatic urothelial cancerAntibody-drug conjugatesUrothelial cancerFirst-line cisplatin-based chemotherapyResponse rateOngoing phase 1 studiesImmune checkpoint inhibitor therapyCheckpoint inhibitor therapyDisease control rateDose-expansion studyFirst-line cisplatinPhase 1b studyPlatinum-containing regimenImmune checkpoint inhibitorsCisplatin-based chemotherapyPhase 1 studyTumor immune infiltrationDuration of responseMMAE antibody–drug conjugatesTreatment of patientsTransitional cell carcinomaPhase 1 study results
2013
Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy
Galsky M, Moshier E, Krege S, Lin C, Hahn N, Ecke T, Sonpavde G, Pond G, Godbold J, Oh W, Bamias A. Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy. Urologic Oncology Seminars And Original Investigations 2013, 32: 48.e1-48.e8. PMID: 24055428, DOI: 10.1016/j.urolonc.2013.07.001.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellCisplatinClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansMiddle AgedModels, BiologicalNeoplasm MetastasisOutcome Assessment, Health CarePrognosisProportional Hazards ModelsSurvival AnalysisUrologic NeoplasmsConceptsFirst-line cisplatin-based chemotherapyMetastatic urothelial cancerCisplatin-based chemotherapyResponse to treatmentUrothelial cancerMetastatic UCPredicting SurvivalCompletion of first-line chemotherapyConcordance indexBaseline white blood countBootstrap-corrected concordance indexVisceral metastatic sitesFirst-line chemotherapyPhase III trialsBaseline performance statusOutcomes of patientsWhite blood countCox proportional hazards modelsPosttreatment variablesProportional hazards modelMedian survivalMetastatic sitesIII trialsPerformance statusPrognostic nomogramRelationship between 6‐ and 9‐month progression‐free survival and overall survival in patients with metastatic urothelial cancer treated with first‐line cisplatin‐based chemotherapy
Galsky M, Krege S, Lin C, Hahn N, Ecke T, Moshier E, Sonpavde G, Godbold J, Oh W, Bamias A. Relationship between 6‐ and 9‐month progression‐free survival and overall survival in patients with metastatic urothelial cancer treated with first‐line cisplatin‐based chemotherapy. Cancer 2013, 119: 3020-3026. PMID: 23720197, DOI: 10.1002/cncr.28145.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCisplatinClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCohort StudiesDisease ProgressionDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoplasm MetastasisProportional Hazards ModelsRandomized Controlled Trials as TopicTreatment OutcomeUrinary Bladder NeoplasmsConceptsProgression-free survivalCisplatin-based chemotherapyFirst-line cisplatin-based chemotherapyOverall survivalMedian OSUrothelial carcinomaLandmark analysisFirst-line treatment of patientsIndependent cohortMedian progression-free survivalIndependent cohort of patientsMetastatic urothelial carcinomaFirst-line treatmentAnalysis of patientsCohort of patientsPhase 3 trialTreatment of patientsLead-time biasClinical trial endpointsProportional hazards modelMetastatic UCNovel regimensPredicting OSTreatment initiationTrial endpointsPost-treatment prognostic model for patients (pts) with metastatic urothelial cancer (UC) treated with first-line chemotherapy.
Galsky M, Moshier E, Krege S, Lin C, Hahn N, Ecke T, Sonpavde G, Pond G, Godbold J, Oh W, Bamias A. Post-treatment prognostic model for patients (pts) with metastatic urothelial cancer (UC) treated with first-line chemotherapy. Journal Of Clinical Oncology 2013, 31: 256-256. DOI: 10.1200/jco.2013.31.6_suppl.256.Peer-Reviewed Original ResearchFirst-line chemotherapyMetastatic UCCox proportional hazards modelsProportional hazards modelUrothelial cancerPredicting SurvivalConcordance indexTreated with first-line chemotherapyFirst-line cisplatin-based chemotherapyTreatment of metastatic UCBootstrap-corrected concordance indexMetastatic urothelial cancerCisplatin-based chemotherapyHazards modelCycles of chemotherapyFirst-line treatmentOutcomes of PTAssociated with survivalDuration of treatmentResponse to treatmentMedian survivalTreatment discontinuationChemotherapyNomogramPrognostic modelProgression-free survival as an endpoint for clinical trials in first-line metastatic urothelial cancer.
Galsky M, Krege S, Lin C, Hahn N, Ecke T, Moshier E, Sonpavde G, Godbold J, Oh W, Bamias A. Progression-free survival as an endpoint for clinical trials in first-line metastatic urothelial cancer. Journal Of Clinical Oncology 2013, 31: 251-251. DOI: 10.1200/jco.2013.31.6_suppl.251.Peer-Reviewed Original ResearchProgression-free-survivalFirst-line cisplatin-based chemotherapyMetastatic urothelial cancerCisplatin-based chemotherapyFirst-line treatmentOverall survivalUrothelial cancerMetastatic UCLandmark analysisTreatment of metastatic urothelial cancerMedian progression-free-survivalPresence of visceral metastasesProgression-free survivalPhase II trialAnalysis of patientsShorter response durationLead-time biasProportional hazards modelMedian OSVisceral metastasesII trialIII trialsNovel regimensPredicting OSFirst-line
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