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 resultsEV-201 study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy.
Rosenberg J, Heath E, O'Donnell P, Hahn N, Balar A, Gartner E, Melhem-Bertrandt A, Petrylak D. EV-201 study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy. Journal Of Clinical Oncology 2018, 36: tps542-tps542. DOI: 10.1200/jco.2018.36.6_suppl.tps542.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerCheckpoint inhibitorsUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EMulticenter phase 2 studyOngoing phase 1 studiesImmune checkpoint inhibitor therapyAntitumor activityCheckpoint inhibitor therapyDisease control ratePhase 2 doseSafety/tolerabilityTreatment-related AEsImmune checkpoint inhibitorsPhase 2 studyMajority of patientsPhase 1 studyUrinary tract infectionTreatment of patientsTransitional cell carcinomaAssessment of durationMonomethyl auristatin EWarrants further investigationAntibody-drug conjugates
2017
A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.
Petrylak D, Arkenau H, Perez-Gracia J, Krebs M, Santana-Davila R, Yang J, Rege J, Mi G, Ferry D, Herbst R. A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma. Journal Of Clinical Oncology 2017, 35: 349-349. DOI: 10.1200/jco.2017.35.6_suppl.349.Peer-Reviewed Original ResearchTreatment-related AEsECOG PS 0Median durationPS 0PD-L1Urothelial carcinomaDay 1Phase 1a/b trialPlatinum-based systemic therapyTreatment-related grade 4Advanced urothelial carcinomaElevated alanine aminotransferaseNew safety signalsElevated aspartate aminotransferaseBaseline tumor tissuePreliminary efficacy dataTransitional cell carcinomaEligible ptsMeasurable diseaseMedian PFSStable diseasePartial responseProgressive diseaseSystemic therapyMedian age
2012
Randomized phase II study of docetaxel with or without ramucirumab (IMC-1121B) or icrucumab (IMC-18F1) in patients with urothelial transitional cell carcinoma (TCC) following progression on first-line platinum-based therapy.
Petrylak D, Chi K, Vogelzang N, Sonpavde G, Rutstein M, Schwartz J, Fox F, Wang W, Abad L, Cosaert J, Grebennik D. Randomized phase II study of docetaxel with or without ramucirumab (IMC-1121B) or icrucumab (IMC-18F1) in patients with urothelial transitional cell carcinoma (TCC) following progression on first-line platinum-based therapy. Journal Of Clinical Oncology 2012, 30: tps4675-tps4675. DOI: 10.1200/jco.2012.30.15_suppl.tps4675.Peer-Reviewed Original ResearchProgression-free survivalTransitional cell carcinomaHuman IgG1 monoclonal antibodyVEGF receptor 2Platinum-based therapyDay 1VEGFR-1IgG1 monoclonal antibodyMonoclonal antibodiesFirst-line platinum-based therapyMedian progression-free survivalPrior platinum-based therapyRandomized phase II studyVascular endothelial growth factor (VEGF) pathwayEndothelial growth factor pathwayPrior antiangiogenic therapyUrothelial transitional cell carcinomaOpen-label treatmentPhase II studySecondary outcome measuresDuration of responseLevels of PlGFPlacental growth factorOne-sided alphaSoluble VEGFR-2
2009
A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer
Barlow L, Laudano M, Mann M, Desai M, Petrylak D, Benson M, McKiernan J. A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer. Journal Of Clinical Oncology 2009, 27: e16047-e16047. DOI: 10.1200/jco.2009.27.15_suppl.e16047.Peer-Reviewed Original ResearchPhase I trialPhase I/II trialIntravesical agentsNab-paclitaxelI trialII trialIntravesical therapyBladder cancerSystemic absorptionInvasive transitional cell bladder cancerResponse ratePhase II efficacy studyTis transitional cell carcinomaNanoparticle albumin-bound paclitaxelTransitional cell bladder cancerOngoing phase I trialDose-escalation modelDose-escalation trialEvidence of diseaseGrade 1 toxicityHigh-risk patientsHigh-grade TaInvasive bladder cancerAlbumin-bound paclitaxelTransitional cell carcinoma
2007
4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
George C, Vaughn D, Petrylak D, Srinivas S, Pili R, Stadler W, De Marco S, Smith D, Nason S, DeWit E. 4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). European Journal Of Cancer Supplements 2007, 5: 309. DOI: 10.1016/s1359-6349(07)71165-5.Peer-Reviewed Original ResearchPhase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
Vaughn D, Srinivas S, Stadler W, Pili R, Petrylak D, De Marco S, Smith D, Nason S, De Wit E, George C. Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). Journal Of Clinical Oncology 2007, 25: 15543-15543. DOI: 10.1200/jco.2007.25.18_suppl.15543.Peer-Reviewed Original ResearchInitial doseResponse rateManageable toxicity profileObjective response ratePlatinum-containing regimenPoor performance statusPrior pelvic irradiationPhase II studySingle-arm studyTransitional cell carcinomaVinca alkaloid classNew microtubule inhibitorMales 78Febrile neutropeniaMeasurable lesionsRenal impairmentCreatinine clearanceEfficacy endpointII studyLast doseMain toxicityPelvic irradiationPerformance statusPeripheral neuropathyCell carcinoma
2006
Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report
Smith D, Mackler N, Hussain M, Dunn R, Montie J, Wood D, Lee C, Petrylak D, Quinn D, Vaishampayan U. Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report. Journal Of Clinical Oncology 2006, 24: 4541-4541. DOI: 10.1200/jco.2006.24.18_suppl.4541.Peer-Reviewed Original ResearchTransitional cell carcinomaAdvanced transitional cell carcinomaPT0 rateArm IArm IITreatment of TCCGrade 3/4 hematologic toxicitiesM0 transitional cell carcinomaAdequate organ functionCycles of therapyGrade 3 toxicityPerformance status 0Pathologic complete respondersNational Cancer InstituteBristol-Myers SquibbNeoadjuvant paclitaxelStatus 0Complete respondersEvaluable subjectsHematologic toxicityNeoadjuvant chemotherapyPrimary endpointPositive patientsResection rateClinical T3
2004
Paclitaxel, carboplatin and gemcitabine (PCG) as neoadjuvant therapy in patients with locally advanced transitional cell carcinoma (TCC) of the bladder
Smith D, Bhandari M, Hussain M, Montie J, Wood D, Lee C, Petrylak D, Vaishampayan U. Paclitaxel, carboplatin and gemcitabine (PCG) as neoadjuvant therapy in patients with locally advanced transitional cell carcinoma (TCC) of the bladder. Journal Of Clinical Oncology 2004, 22: 4541-4541. DOI: 10.1200/jco.2004.22.14_suppl.4541.Peer-Reviewed Original ResearchPaclitaxel, carboplatin and gemcitabine (PCG) as neoadjuvant therapy in patients with locally advanced transitional cell carcinoma (TCC) of the bladder
Smith D, Bhandari M, Hussain M, Montie J, Wood D, Lee C, Petrylak D, Vaishampayan U. Paclitaxel, carboplatin and gemcitabine (PCG) as neoadjuvant therapy in patients with locally advanced transitional cell carcinoma (TCC) of the bladder. Journal Of Clinical Oncology 2004, 22: 4541-4541. DOI: 10.1200/jco.2004.22.90140.4541.Peer-Reviewed Original Research
2000
Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point.
Small E, Lew D, Redman B, Petrylak D, Hammond N, Gross H, Eastham J, Crawford E. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. Journal Of Clinical Oncology 2000, 18: 2537-44. PMID: 10893284, DOI: 10.1200/jco.2000.18.13.2537.Peer-Reviewed Original ResearchConceptsAdvanced transitional cell carcinomaTransitional cell carcinomaCombination of paclitaxelSurvival timeMedian progression-free survival timeNeoadjuvant platinum-based therapySouthwest Oncology Group studyProgression-free survival timeClinical trial end pointsGrade 4 toxicityPoor prognostic featuresTrial end pointsEnrollment of patientsMedian survival timeOverall survival timeCooperative group settingPlatinum-based therapyResponse proportionsAcceptable toxicityExtranodal diseaseNeoadjuvant therapyNeurologic toxicityComplete responsePartial responsePrognostic features
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