2023
Efficacy of sacituzumab govitecan (SG) in locally advanced (LA) or metastatic urothelial cancer (mUC) by trophoblast cell surface antigen 2 (Trop-2) expression.
Loriot Y, Balar A, Petrylak D, Rezazadeh A, Grivas P, Flechon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Efficacy of sacituzumab govitecan (SG) in locally advanced (LA) or metastatic urothelial cancer (mUC) by trophoblast cell surface antigen 2 (Trop-2) expression. Journal Of Clinical Oncology 2023, 41: 4579-4579. DOI: 10.1200/jco.2023.41.16_suppl.4579.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerProgression-free survivalTrop-2 expressionMedian progression-free survivalSacituzumab govitecanArchival tumor samplesH-scoreCheckpoint inhibitorsUnstratified Cox proportional hazards modelAnti-Trop-2 antibodyTrop-2 protein expressionTumor samplesCox proportional hazards modelTumor cellsAccelerated FDA approvalOverall survival rateC1-3Proportional hazards modelMedian OSBaseline characteristicsData cutoffEfficacy endpointEfficacy outcomesPrimary endpointThe Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. European Urology 2023, 84: 229-241. PMID: 37179240, DOI: 10.1016/j.eururo.2023.04.002.Peer-Reviewed Original ResearchConceptsHormone-sensitive prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalMetastatic hormone-sensitive prostate cancerOligometastatic hormone-sensitive prostate cancerOverall survivalProstate cancerDeprivation therapyHazard ratioAndrogen receptor inhibitionEarly treatment intensificationEfficacy of enzalutamideRisk of undertreatmentSystemic treatment strategiesSecondary efficacy endpointsPhase 3 studyProgression-free survivalNumber of metastasesConfidence intervalsProportional hazards modelPost Hoc AnalysisEfficacy endpointOligometastatic diseaseSecondary endpointsTreatment intensificationAvelumab 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 ResearchConceptsBest 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 treatment
2021
Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy.
Loriot Y, Powles T, Climent Durán M, Sridhar S, Bellmunt J, Petrylak D, Wang J, Costa N, Laliberte R, Di Pietro A, Grivas P, Sternberg C. Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy. Journal Of Clinical Oncology 2021, 39: 438-438. DOI: 10.1200/jco.2021.39.6_suppl.438.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaOverall survivalUrothelial carcinomaOS benefitUnstratified Cox proportional hazards modelProgression-free survival benefitCox proportional hazards modelMetastatic urothelial carcinomaPlatinum-containing chemotherapyDuration of chemotherapyNumber of patientsAnalysis of efficacyProportional hazards modelFirst-line maintenanceDelay/interruptionChemotherapy subgroupEligible patientsBaseline characteristicsDose intensityInvestigator's discretionSupportive careSurvival benefitTreatment armsTreatment patterns
2020
Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial
Drakaki A, Kirby C, van der Heijden M, Petrylak D, Powles T, N. K, Fléchon A, Necchi A, Géczi L, Lee J, Gakis G, Bracarda S, Chowdhury S, Lin C, Keizman D, Vaishampayan U, Zimmermann A, Bell-McGuinn K, Castellano D. Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial. Bladder Cancer 2020, 6: 43-52. DOI: 10.3233/blc-190252.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsProgression-free survivalOverall response ratePrior immune checkpoint inhibitorsUrothelial carcinomaCheckpoint inhibitorsPlatinum-refractory metastatic urothelial carcinomaUnstratified Cox proportional hazards modelMedian progression-free survivalPlatinum-refractory urothelial carcinomaImproved progression-free survivalPre-specified subgroup analysisCox proportional hazards modelMetastatic UC patientsMetastatic urothelial carcinomaAdvanced urothelial carcinomaKaplan-Meier methodSubgroup of patientsProportional hazards modelICI therapyUC patientsDocetaxel armMost patientsAdverse eventsARM patients
2019
Clinical outcomes in Caucasian (C), African American (AA) and Asian men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, N. K, Tangen C, Petrylak D, Araujo J, Fizazi K, Quinn D, Higano C, Tannock I, Small E, Kelly W. Clinical outcomes in Caucasian (C), African American (AA) and Asian men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 186-186. DOI: 10.1200/jco.2019.37.7_suppl.186.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA progression-free survivalProgression-free survivalCastration-resistant prostate cancerPooled hazard ratioMultivariable analysisAsian menHazard ratioProstate cancerMedian PSA progression-free survivalAfrican AmericansMedian progression-free survivalPhase III clinical trialsPhase III trialsResistant prostate cancerIndividual patient dataProportional hazards modelAfrican American menIII trialsPFS outcomesPrognostic factorsClinical outcomesPrognostic importanceTreatment armsCaucasian man
2018
Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Tangen C, Rosenthal M, Petrylak D, Thompson I, Chi K, De Bono J, Fandi A, Araujo J, Eisenberger M, Logothetis C, Quinn D, Fizazi K, Higano C, George D, Morris M, Small E, Tannock I, Kelly W. Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2018, 36: lba5005-lba5005. DOI: 10.1200/jco.2018.36.18_suppl.lba5005.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerDocetaxel/prednisoneOverall survivalCaucasian manHazard ratioLymph nodesRisk factorsProstate cancerMedian overall survivalPerformance status 0Phase III trialsPooled hazard ratioShorter overall survivalIndividual patient dataProportional hazards modelAfrican American menStatus 0Primary endpointIII trialsMedian hemoglobinMedian ageLiver diseaseMultivariable analysisPrognostic importance
2017
Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045.
De Wit R, Bajorin D, Bellmunt J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Vaughn D. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045. Journal Of Clinical Oncology 2017, 35: 4530-4530. DOI: 10.1200/jco.2017.35.15_suppl.4530.Peer-Reviewed Original ResearchAdvanced urothelial cancerGlobal health status/QoL scoreUrothelial cancerKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testHRQOL end pointsSecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisStudy treatmentPembroHazards modelInvestigator's choiceRate of improvementLongitudinal data analysis modelEnd pointHealth-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer.
Vaughn D, Bellmunt J, De Wit R, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Bajorin D. Health-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer. Journal Of Clinical Oncology 2017, 35: 282-282. DOI: 10.1200/jco.2017.35.6_suppl.282.Peer-Reviewed Original ResearchGlobal health status/QoL scoreAdvanced UCKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testAdvanced urothelial cancerHRQOL end pointsInvestigator-choice chemotherapySecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisUrothelial cancerStudy treatmentPembroHazards modelInvestigator's choiceRate of improvement
2009
Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial
Halabi S, Sartor O, Petrylak D, Sternberg C, Witjes J, Noursalehi M, McKearn T, George M. Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial. Journal Of Clinical Oncology 2009, 27: 5150-5150. DOI: 10.1200/jco.2009.27.15_suppl.5150.Peer-Reviewed Original ResearchProgression-free survivalCastration-resistant prostate cancerFirst-line chemotherapyOverall survivalMetastatic castration-resistant prostate cancerChemotherapy-naïve patientsDouble-blind trialDate of randomizationMedian survival timePredictors of OSProportional hazards modelType of progressionSPARC trialLine chemotherapyCRPC patientsNaïve patientsFirst progressionTau measuresProstate cancerLandmark analysisSurvival timeTreatment groupsHazards modelStratification factorsClinical relevance
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 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. 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 control