2023
2365MO Study EV-103 cohort L: Perioperative treatment w/ enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) w/ muscle invasive bladder cancer (MIBC)
Sridhar S, O'Donnell P, Flaig T, Rosenberg J, Hoimes C, Milowsky M, Srinivas S, George S, McKay R, Petrylak D, Barata P, Hwang C, Cruz-Correa M, Iafolla M, Mckean M, Dreicer R, Brancato S, Lukas J, Yu Y, Moon H. 2365MO Study EV-103 cohort L: Perioperative treatment w/ enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) w/ muscle invasive bladder cancer (MIBC). Annals Of Oncology 2023, 34: s1203. DOI: 10.1016/j.annonc.2023.09.1014.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerInvasive bladder cancerBladder cancerEnfortumabMonotherapyCancerCisplatinStudy EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H.
Flaig T, Rosenberg J, Hoimes C, O'Donnell P, Mar N, Gourdin T, Henry S, Bilen M, George S, Barata P, Srinivas S, Rao S, Assikis V, Burgess E, Ramamurthy C, Haas G, Lukas J, Mildiner-Earley S, Yu Y, Petrylak D. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H. Journal Of Clinical Oncology 2023, 41: 4595-4595. DOI: 10.1200/jco.2023.41.16_suppl.4595.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerEvent-free survivalPhase 1b/2 studyPathological complete responseCancer-related therapyEV treatmentUrothelial cancerSafety profilePD-1/L1 inhibitorsMedian event-free survivalPelvic lymph node dissectionAdvanced urothelial cancerAntitumor activityCisplatin-ineligible patientsManageable safety profileNeoadjuvant treatment optionsOngoing phase 2Pathological downstaging ratePts underwent surgeryTolerable safety profileCentral pathology reviewKey secondary endpointLymph node dissectionPhase 3 studyInvasive bladder cancerCell-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 ResearchConceptsMuscle-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
Cell-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. Journal Of Clinical Oncology 2022, 40: 4506-4506. DOI: 10.1200/jco.2022.40.16_suppl.4506.Peer-Reviewed Original ResearchNeoadjuvant chemotherapyBladder cancer patientsPathologic responseTreatment responseCell-free DNA methylationCancer patientsMuscle-invasive bladder cancer patientsMuscle-invasive bladder cancerCycles of chemotherapyStandard neoadjuvant chemotherapyCooperative group trialsStandard of careProspective cooperative group trialsIndependent predictive abilityRadical cystectomyPredictive biomarkersPathologic respondersBladder cancerGroup trialsMR scoreBlood samplesChemotherapyPatientsPlasma samplesResponse scoresStudy EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible.
Petrylak D, Flaig T, Mar N, Gourdin T, Srinivas S, Rosenberg J, Guseva M, Yu Y, Narayanan S, Hoimes C. Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible. Journal Of Clinical Oncology 2022, 40: 4582-4582. DOI: 10.1200/jco.2022.40.16_suppl.4582.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerTreatment-related adverse eventsUrothelial cancerNeoadjuvant therapyAdverse eventsBladder cancerUnmet needPathological complete response ratePelvic lymph node dissectionEffective neoadjuvant therapyOngoing phase 2Pathological downstaging ratePhase 1b/2 trialComplete response rateKey secondary endpointLymph node dissectionMuscle-invasive diseaseRisk of progressionInvasive bladder cancerStandard of careHigh unmet needPhase 2Antibody-drug conjugatesCancer ptsCT4 tumorsStudy EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible.
Petrylak D, Flaig T, Mar N, Gourdin T, Srinivas S, Rosenberg J, Guseva M, Yu Y, Narayanan S, Hoimes C. Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible. Journal Of Clinical Oncology 2022, 40: 435-435. DOI: 10.1200/jco.2022.40.6_suppl.435.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerTreatment-related adverse eventsUrothelial cancerNeoadjuvant therapyAdverse eventsUnmet needPathological complete response ratePelvic lymph node dissectionEffective neoadjuvant therapyPathological downstaging ratePhase 1b/2 trialComplete response rateKey secondary endpointLymph node dissectionCentral pathology reviewMuscle-invasive diseaseOngoing phase IIRisk of progressionInvasive bladder cancerStandard of careHigh unmet needPhase IIAntibody-drug conjugatesCancer ptsCT4 tumorsStudy EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress).
Hoimes C, Flaig T, Srinivas S, Mar N, Petrylak D, O'Donnell P, Bilen M, Sasse C, Yu Y, Birrenkott M, Rosenberg J. Study EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress). Journal Of Clinical Oncology 2022, 40: tps587-tps587. DOI: 10.1200/jco.2022.40.6_suppl.tps587.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerMetastatic urothelial carcinomaCentral pathology reviewPerioperative therapyPathology reviewMicrotubule-disrupting agent monomethyl auristatin EPathological complete response ratePelvic lymph node dissectionBlinded independent central reviewPathological downstaging rateTolerable safety profileComplete response rateOverall survival benefitDisease-free survivalEvent-free survivalHigh-risk featuresLymph node dissectionPhase 3 studyPD-L1 inhibitorsInvasive bladder cancerIndependent central reviewPlatinum-based therapyMonomethyl auristatin ECurrent standardAntibody-drug conjugatesRandomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011).
Sonpavde G, Plets M, Liss M, Meeks J, Petrylak D, Cole S, McKay R, Gupta S, Hita S, Pereira T, Bangs R, Tangen C, Thompson I, Lerner S. Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011). Journal Of Clinical Oncology 2022, 40: tps591-tps591. DOI: 10.1200/jco.2022.40.6_suppl.tps591.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaMuscle-invasive bladder cancerUpper tract urothelial carcinomaImmune checkpoint inhibitorsWeeks x 4 cyclesPathologic complete remissionEvent-free survivalPhase II trialUpfront surgeryUrothelial carcinomaDay 1II trialNeoadjuvant therapyOverall survivalHigh-risk upper tract urothelial carcinomaCisplatin-ineligible metastatic urothelial carcinomaNeoadjuvant cisplatin-based combination chemotherapyOpen-label phase II trialHigh grade upper tract urothelial carcinomaNeoadjuvant immune checkpoint inhibitorsRandomized phase II trialCisplatin-based combination chemotherapyCisplatin-eligible patientsMetastatic urothelial carcinomaPD-L1 inhibitors
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. DOI: 10.1097/00005392-200005000-00004.Peer-Reviewed Original ResearchRelapse-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 controlTHE 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