2023
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☆
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 ResearchConceptsProgression-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 benefitExternal Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
Halabi S, Yang Q, Roy A, Luo B, Araujo J, Logothetis C, Sternberg C, Armstrong A, Carducci M, N. K, de Bono J, Petrylak D, Fizazi K, Higano C, Morris M, Rathkopf D, Saad F, Ryan C, Small E, Kelly W. External Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer. Journal Of Clinical Oncology 2023, 41: 2736-2746. PMID: 37040594, PMCID: PMC10414709, DOI: 10.1200/jco.22.02661.Peer-Reviewed Original ResearchConceptsOverall survivalPrognostic modelPrognostic groupsRisk groupsProstate cancerChemotherapy-Naïve Metastatic CastrationLow-risk prognostic groupsCastration-resistant prostate cancerPrognostic risk groupingsIntermediate-risk groupMedian overall survivalPhase III trialsGroup of patientsPrognostic risk groupsResistant prostate cancerRandomized clinical trialsTime-dependent areaDifferent treatment classesIII trialsInhibitor trialsRisk groupingClinical trialsTreatment subgroupsSpecific subgroupsTrial status
2021
698P Analysis of hard-to-treat subgroups from EV-301: A phase III trial of enfortumab vedotin (EV) vs chemotherapy for 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, Sridhar S, Pappot H, Gurney H, Bedke J, van der Heijden M, Campbell M, Wu C, Matsangou M, Petrylak D. 698P Analysis of hard-to-treat subgroups from EV-301: A phase III trial of enfortumab vedotin (EV) vs chemotherapy for previously treated advanced urothelial carcinoma. Annals Of Oncology 2021, 32: s710-s711. DOI: 10.1016/j.annonc.2021.08.094.Peer-Reviewed Original ResearchPrimary results of EV-301: A phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma.
Powles T, Rosenberg J, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Wu C, Campbell M, Matsangou M, Petrylak D. Primary results of EV-301: A phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2021, 39: 393-393. DOI: 10.1200/jco.2021.39.6_suppl.393.Peer-Reviewed Original ResearchDisease control rateObjective response rateProgression-free survivalMetastatic urothelial carcinomaPlatinum-containing chemotherapyPhase III studyOverall survivalUrothelial carcinomaChemotherapy groupIII studyInterim analysisInvestigator-assessed progression-free survivalOpen-label phase III studyPD-1/L1 inhibitorsPrior platinum-containing chemotherapyTreatment-related adverse eventsRandomized phase III studyWhite blood cell countMaculo-papular rashPrespecified interim analysisRobust clinical benefitTolerable safety profileMedian overall survivalPhase III trialsRate of grade
2019
223TiP EV-301: A phase III trial in progress evaluating enfortumab vedotin versus chemotherapy in patients with locally advanced or metastatic urothelial carcinoma
Petrylak D, Rosenberg J, Lee J, Yonese J, Duran I, Loriot Y, Sonpavde G, Wu C, Gartner E, Melhem-Bertrandt A, Powles T. 223TiP EV-301: A phase III trial in progress evaluating enfortumab vedotin versus chemotherapy in patients with locally advanced or metastatic urothelial carcinoma. Annals Of Oncology 2019, 30: ix75-ix76. DOI: 10.1093/annonc/mdz425.014.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaSeattle GeneticsUrothelial carcinomaDisease progressionCohort 1Microtubule-disrupting agent monomethyl auristatin EDay 1Prior platinum-containing chemotherapyClinical care optionsRadiological disease progressionSafety/tolerabilityTumour response statusPlatinum-containing chemotherapyPhase 2 studyPhase 3 trialPhase III trialsSanofi-AventisPlatinum-based chemotherapyCurrent treatment optionsIndependent central reviewHumanized monoclonal antibodyMonomethyl auristatin ELower survival rateMedian DoRPrimary endpointLBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD
Fizazi K, Mella P, Castellano D, Minatta J, Kalebasty A, Shaffer D, Limon J, Armstrong A, Lopez H, Sharkey B, Saci A, Li J, Wang X, Ciprotti M, Sathyanarayana P, Saad F, Petrylak D, Retz M, Pachynski R, Drake C. LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD. Annals Of Oncology 2019, 30: v885-v886. DOI: 10.1093/annonc/mdz394.045.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerRadiographic progression-free survivalObjective response rateCastration-resistant prostate cancerBristol-Myers SquibbGenentech/RocheAssociation of biomarkersPersonal feesMeasurable diseaseProstate cancerGrade 3/4 treatment-related adverse eventsMedian radiographic progression-free survivalProstate-specific antigen (PSA) response rateResponse rateOngoing androgen deprivation therapyTreatment-related adverse eventsSafety of nivolumabAndrogen deprivation therapyPhase II studyPhase III trialsProgression-free survivalSanofi-AventisInterim analysis resultsMedical writing assistanceNon-financial supportPSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Chi K, Tangen C, Xuan M, Petrylak D, Araujo J, Fizazi K, Quinn D, Morris M, Higano C, Tannock I, Small E, Kelly W. PSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 5021-5021. DOI: 10.1200/jco.2019.37.15_suppl.5021.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerObjective response rateCastration-resistant prostate cancerPSA declinePercentage of patientsPooled odds ratioMultivariable analysisAsian menAA menOdds ratioProstate cancerResponse ratePhase III clinical trialsPhase III trialsResistant prostate cancerSite of metastasisIndividual patient dataLogistic regression modelsMeasurable diseaseIII trialsPerformance statusTreatment armsPrognostic importanceC menRisk factorsExternal validation of a prognostic model for overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Araujo J, Logothetis C, Sternberg C, Armstrong A, Carducci M, Chi K, De Bono J, Petrylak D, Fizazi K, Higano C, Small E, Kelly W. External validation of a prognostic model for overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 5022-5022. DOI: 10.1200/jco.2019.37.15_suppl.5022.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrognostic risk groupsMedian overall survivalOverall survivalRisk groupsPrognostic modelCastration-resistant prostate cancerECOG performance statusOpioid analgesic usePhase III trialsHigh groupTime-dependent areaAnalgesic useIII trialsPerformance statusProstate cancerRisk scoreTreatment groupsDisease sitesSpecific subgroupsMonthsCharacteristic curveSimilar resultsMenExternal validationRamucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts).
De Wit R, Powles T, Castellano D, Necchi A, Lee J, Van Der Heijden M, Matsubara N, Bamias A, Flechon A, Sternberg C, Drakaki A, Yu E, Hamid O, Zimmermann A, Gao L, Long A, Walgren R, Bell-McGuinn K, Petrylak D. Ramucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts). Journal Of Clinical Oncology 2019, 37: 353-353. DOI: 10.1200/jco.2019.37.7_suppl.353.Peer-Reviewed Original ResearchRandomized phase III trialFavorable prognostic featuresMultivariate Cox regressionPhase III trialsPoor prognostic factorUrothelial carcinoma patientsPopulation pharmacokinetic analysisCase-control analysisExposure-response relationshipHigh exposureWarrants further explorationFirst doseIII trialsPrognostic factorsCarcinoma patientsPrognostic featuresCox regressionDiscontinuation criteriaAcceptable safetyLonger survivalRisk factorsRam exposureORR benefitPharmacokinetic analysisDocetaxelClinical 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 importanceRamucirumab (RAM) exposure-response (ER) relationship in RANGE, a randomized phase III trial of docetaxel (DOC) with or without RAM in advanced urothelial carcinoma (UC) patients (pts) who progressed on or after platinum therapy.
De Wit R, Powles T, Castellano D, Necchi A, Lee J, Van Der Heijden M, Matsubara N, Bamias A, Flechon A, Sternberg C, Drakaki A, Yu E, Hamid O, Zimmermann A, Gao L, Long A, Walgren R, Bell-McGuinn K, Petrylak D. Ramucirumab (RAM) exposure-response (ER) relationship in RANGE, a randomized phase III trial of docetaxel (DOC) with or without RAM in advanced urothelial carcinoma (UC) patients (pts) who progressed on or after platinum therapy. Journal Of Clinical Oncology 2018, 36: 4526-4526. DOI: 10.1200/jco.2018.36.15_suppl.4526.Peer-Reviewed Original Research
2014
The site of visceral metastases (mets) to predict overall survival (OS) in castration-resistant prostate cancer (CRPC) patients (pts): A meta-analysis of five phase III trials.
Halabi S, Kelly W, Zhou H, Armstrong A, Quinn D, Fizazi K, Solomon N, Tannock I, Petrylak D, Morris M, Small E. The site of visceral metastases (mets) to predict overall survival (OS) in castration-resistant prostate cancer (CRPC) patients (pts): A meta-analysis of five phase III trials. Journal Of Clinical Oncology 2014, 32: 5002-5002. DOI: 10.1200/jco.2014.32.15_suppl.5002.Peer-Reviewed Original Research
2013
A prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy. Journal Of Clinical Oncology 2013, 31: 5011-5011. DOI: 10.1200/jco.2013.31.15_suppl.5011.Peer-Reviewed Original ResearchMedian overall survivalSecond-line chemotherapyFirst-line chemotherapyOverall survivalPrognostic modelRisk groupsECOG performance statusPhase III trialsBaseline prognostic factorsLow-risk groupProstate cancer menProstate-specific antigenDocetaxel useLine chemotherapyMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trialsProspective validationPrognostic variablesA 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
2008
Randomized phase III trial of thalidomide (Th) or placebo (P) for non-metastatic PSA recurrent prostate cancer (PCa) treated with intermittent therapy
Figg W, Aragon-Ching J, Steinberg S, Gulley J, Arlen P, Sartor O, Petrylak D, Higano C, Hussain M, Dahut W. Randomized phase III trial of thalidomide (Th) or placebo (P) for non-metastatic PSA recurrent prostate cancer (PCa) treated with intermittent therapy. Journal Of Clinical Oncology 2008, 26: 5016-5016. DOI: 10.1200/jco.2008.26.15_suppl.5016.Peer-Reviewed Original Research
2007
4010 POSTER Satraplatin increases progression-free survival (PFS) and delays pain progression in hormone refractory prostate cancer (HRPC): Results of SPARC, an international phase III trial with 950 patients
Sternberg C, Sartor O, Petrylak D, Witjes J, Bodrogi I, Harper P, Droz J, James N. 4010 POSTER Satraplatin increases progression-free survival (PFS) and delays pain progression in hormone refractory prostate cancer (HRPC): Results of SPARC, an international phase III trial with 950 patients. European Journal Of Cancer Supplements 2007, 5: 282. DOI: 10.1016/s1359-6349(07)71078-9.Peer-Reviewed Original ResearchSatraplatin (S) demonstrates significant clinical benefits for the treatment of patients with HRPC: Results of a randomized phase III trial
Sternberg C, Petrylak D, Witjes F, Ferrero J, Eymard J, Falcon S, Chatta K, Vaughn D, Berry W, Sartor O. Satraplatin (S) demonstrates significant clinical benefits for the treatment of patients with HRPC: Results of a randomized phase III trial. Journal Of Clinical Oncology 2007, 25: 5019-5019. DOI: 10.1200/jco.2007.25.18_suppl.5019.Peer-Reviewed Original ResearchProgression-free survivalIndependent review committeePain progressionPrior docetaxelPrior chemotherapyRadiologic progressionPain responseSide effectsNon-hematologic side effectsRandomized phase III trialGrade 4 neutropeniaGrade 4 thrombocytopeniaObjective tumor responseDouble-blind studyFrequent side effectsPhase III trialsTreatment of patientsSignificant clinical benefitHRPC patientsSPARC trialTreat basisIII trialsPlacebo armPrimary endpointPSA response311 PAIN AND PSA RESPONSES IN METASTATIC HORMONE REFRACTORY PROSTATE CANCER TREATED WITH SATRAPLATIN: RESULTS OF THE SPARC PHASE III TRIAL
Witjes J, Petrylak D, Sartor O, Demkow T, Ferrero J, Eymard J, Falcon S, Karyakine O, Krieter O, Sternberg C. 311 PAIN AND PSA RESPONSES IN METASTATIC HORMONE REFRACTORY PROSTATE CANCER TREATED WITH SATRAPLATIN: RESULTS OF THE SPARC PHASE III TRIAL. European Urology Open Science 2007, 6: 100. DOI: 10.1016/s1569-9056(07)60310-8.Peer-Reviewed Original Research
2004
SWOG 99–16: Randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA)
Petrylak D, Tangen C, Hussain M, Lara P, Jones J, Talpin M, Burch P, Greene G, Small E, Crawford E. SWOG 99–16: Randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA). Journal Of Clinical Oncology 2004, 22: 3-3. DOI: 10.1200/jco.2004.22.14_suppl.3.Peer-Reviewed Original Research