2023
Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsCarcinoma, Transitional CellHumansImmunoconjugatesUrinary Bladder NeoplasmsConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trialEV-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 ResearchMeSH KeywordsAntibodies, MonoclonalCarcinoma, Transitional CellDocetaxelHumansUrinary Bladder NeoplasmsConceptsProgression-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 benefitAvelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Transitional CellCisplatinDeoxycytidineHumansUrinary BladderUrinary Bladder NeoplasmsConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatmentCell-free DNA Methylation as a Predictive Biomarker of Response to Neoadjuvant Chemotherapy for Patients with Muscle-invasive Bladder Cancer in SWOG S1314
Lu Y, Plets M, Morrison G, Cunha A, Cen S, Rhie S, Siegmund K, Daneshmand S, Quinn D, Meeks J, Lerner S, Petrylak D, McConkey D, Flaig T, Thompson I, Goldkorn A. Cell-free DNA Methylation as a Predictive Biomarker of Response to Neoadjuvant Chemotherapy for Patients with Muscle-invasive Bladder Cancer in SWOG S1314. European Urology Oncology 2023, 6: 516-524. PMID: 37087309, PMCID: PMC10587361, DOI: 10.1016/j.euo.2023.03.008.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersCell-Free Nucleic AcidsChemotherapy, AdjuvantDNADNA MethylationHumansMusclesNeoadjuvant TherapyProspective StudiesUrinary Bladder NeoplasmsConceptsMuscle-invasive bladder cancerNeoadjuvant chemotherapyCooperative group trialsCell-free DNA methylationProspective cooperative group trialsPathologic responseBladder cancerRadical cystectomyNAC responseChemotherapy responseTreatment responseGroup trialsCycles of chemotherapyNeoadjuvant chemotherapy responseAdvanced bladder cancerStandard of careBladder cancer patientsIndependent predictive abilityGene expression signaturesMetastatic diseaseCancer patientsPredictive biomarkersPathologic respondersCurrent exploratory analysisInvasive approach
2022
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellCisplatinFollow-Up StudiesHumansUrinary Bladder NeoplasmsConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rateFORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysis
2001
Transitional cell carcinoma of the bladder: New approaches to the treatment of advanced disease
Petrylak D. Transitional cell carcinoma of the bladder: New approaches to the treatment of advanced disease. Current Oncology Reports 2001, 3: 285-286. PMID: 11389810, DOI: 10.1007/s11912-001-0076-6.Peer-Reviewed Original Research
2000
THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER
ENNIS R, PETRYLAK D, SINGH P, BAGIELLA E, O’TOOLE K, BENSON M, OLSSON C. THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER. Journal Of Urology 2000, 163: 1413-1418. PMID: 10751847, DOI: 10.1016/s0022-5347(05)67632-x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinCombined Modality TherapyCystectomyDisease-Free SurvivalDoxorubicinFemaleHumansMaleMethotrexateMiddle AgedMuscle NeoplasmsMuscle, SmoothNeoplasm InvasivenessNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingRetrospective StudiesRisk FactorsTreatment FailureUrinary Bladder NeoplasmsVinblastineConceptsRelapse-free survivalMuscle-invasive bladder cancerM-VAC chemotherapyLow-risk patientsInvasive bladder cancerRisk patientsPelvic failurePelvic relapseCisplatin chemotherapyBladder cancerMultivariate analysisIndependent poor prognostic factorCox proportional hazards modelMUSCLE INVASIVE BLADDERBenefit of chemotherapyHigh-risk featuresHigh-risk patientsPatterns of relapsePelvic lymph nodesKaplan-Meier methodPoor prognostic factorAmerican Joint CommitteePathological stage T3Proportional hazards modelExcellent disease control
1992
Altered Expression of the Retinoblastoma Gene Product: Prognostic Indicator in Bladder Cancer
Cordon-Cardo C, Wartinger D, Petrylak D, Dalbagni G, Fair W, Fuks Z, Reuter V. Altered Expression of the Retinoblastoma Gene Product: Prognostic Indicator in Bladder Cancer. Journal Of The National Cancer Institute 1992, 84: 1251-1256. PMID: 1640484, DOI: 10.1093/jnci/84.16.1251.Peer-Reviewed Original ResearchConceptsBladder cancerRb protein expressionProtein expressionSmall cell lung cancerTumor cellsDisease-free survivalImportant prognostic variablesInitial successful treatmentInvasive bladder cancerMuscle-invasive tumorsTransitional cell carcinomaAggressive biological behaviorPrimary bladder tumorsIndividual tumor cellsRb proteinFrozen tissue sectionsClinical outcomesTransurethral resectionBladder tumorsCell carcinomaPrognostic indicatorLung cancerExperience recurrenceSuperficial carcinomaSuccessful treatment