2023
Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance
Sridhar S, Powles T, Climent Durán M, Park S, Massari F, Thiery-Vuillemin A, Valderrama B, Ullén A, Tsuchiya N, Aragon-Ching J, Gupta S, Petrylak D, Bellmunt J, Wang J, Laliberte R, di Pietro A, Costa N, Grivas P, Sternberg C, Loriot Y. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance. European Urology 2023, 85: 154-163. PMID: 37714742, DOI: 10.1016/j.eururo.2023.08.001.Peer-Reviewed Original ResearchBest supportive careProgression-free survivalAdvanced urothelial carcinomaFirst-line chemotherapyPlatinum-based chemotherapyOverall survivalFirst-line maintenanceChemotherapy durationMaintenance treatmentUrothelial carcinomaFirst-line platinum-based chemotherapyAnalysis of OSAdvanced urothelial cancerPhase 3 trialAnalysis of subgroupsAdvanced UCPrior chemotherapyProspective trialSafety findingsSupportive careHazard ratioUrothelial cancerDisease progressionChemotherapyOverall populationThe 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
2019
929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study
van der Heijden M, Powles T, Petrylak D, de Wit R, Chi K, Necchi A, Sternberg C, Matsubara N, Nishiyama H, Castellano D, Hussain S, Bamias A, Hozak R, Rhodes R, Xia M, Rasmussen E, Aggarwal A, Wijayawardana S, Bell-McGuinn K, Drakaki A. 929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study. Annals Of Oncology 2019, 30: v373-v374. DOI: 10.1093/annonc/mdz249.028.Peer-Reviewed Original ResearchCombined positive scorePD-L1 statusPersonal feesHazard ratioBasal subtypeMolecular subtypesEli LillyPD-L1 combined positive scorePlatinum-refractory urothelial carcinomaPositive PD-L1 statusTumor cellsSeattle GeneticsExploratory biomarker analysisImmune cell stainingPD-L1 groupRefractory urothelial cancerImproved overall survivalPD-L1 antibodiesPD-L1 immunohistochemistryClaudin-low subtypeRefractory urothelial carcinomaUrothelial carcinoma molecular subtypesArchival tumor tissueBiomarker analysisMedian OSClinical 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
2015
Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC).
Sonpavde G, Pond G, Templeton A, Petrylak D, Tombal B, Rosenthal M, Tannock I. Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2015, 33: 186-186. DOI: 10.1200/jco.2015.33.7_suppl.186.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProgressive diseaseOverall survivalPartial responseAssociation of changesMeasurable diseaseStable diseaseHazard ratioLandmark analysisDay 90Castration-resistant prostate cancerWorld Health Organization criteriaMeasurable disease responseUnconfirmed partial responseECOG performance statusMedian overall survivalNeutrophil-lymphocyte ratioPhase II trialResponse Evaluation CriteriaProportional hazards regressionAccrual of patientsType of progressionMeasurable lesionsRECIST 1.0VENICE trial
2013
Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC).
Tannock I, Fizazi K, Ivanov S, Thellenberg-Karlsson C, Flechon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Aren O, Karyakin O, Elliott T, Birtle A, Magherini E, Petrylak D, Tombal B, Rosenthal M. Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2013, 31: 5002-5002. DOI: 10.1200/jco.2013.31.15_suppl.5002.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDocetaxel/prednisoneFirst-line chemotherapyAflibercept armPlacebo armHazard ratioMedian relative dose intensityRecombinant human fusion proteinStandard first-line chemotherapyCastration-resistant prostate cancerGrowth factorAdequate organ functionCycles of therapyPSA response rateRelative dose intensityFatal adverse eventsProgression-free survivalVascular endothelial growth factorClinical trial informationEndothelial growth factorHuman fusion proteinTrial-specific modulesOral prednisonePrimary endpointPrior chemotherapyA model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed. Journal Of Clinical Oncology 2013, 31: 24-24. DOI: 10.1200/jco.2013.31.6_suppl.24.Peer-Reviewed Original ResearchFirst-line chemotherapyCastrate-resistant prostate cancerMedian overall survivalOverall survivalLow-risk groupRisk groupsPrognostic modelHazard ratioMetastatic castrate-resistant prostate cancerECOG performance statusPhase III trialsImportant prognostic factorProstate-specific antigenTime-dependent areaTime-dependent AUCDocetaxel useMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trials