2024
A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2.
Loriot Y, Siefker-Radtke A, Friedlander T, Necchi A, Wei A, Sridhar S, Garmezy B, Arroyo S, Gartside E, Liu J, Campbell C, Bader J, Petrylak D. A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2. Journal Of Clinical Oncology 2024, 42: tps4619-tps4619. DOI: 10.1200/jco.2024.42.16_suppl.tps4619.Peer-Reviewed Original ResearchUrothelial cancerMonomethyl auristatin ECohort 2Cohort 1Nectin-4Optimal doseExposure to normal tissuesInterim analysisBlinded independent central reviewMetastatic urothelial cancerObjective response ratePenetrate solid tumorsAdequate organ functionDisease control rateProgression-free survivalPlatinum-based chemotherapyDuration of responseECOG performance statusPreliminary antitumor activityIndependent central reviewPlasma half-lifeWeeks follow-upMetastatic UCRECIST v1.1Enfortumab vedotin
2023
Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study. Journal Of Clinical Oncology 2023, 41: 19-19. DOI: 10.1200/jco.2023.41.6_suppl.19.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsDual primary endpointsTreatment-related AEsCycles of docetaxelPrimary endpointSecondary endpointsDocetaxel armRadiographic progression-free survivalCastration-resistant prostate cancerBlinded independent central reviewCycles of placeboData cutoff dateSafety of pembrolizumabSubsequent anticancer therapyTreatment-related deathsAndrogen deprivation therapyECOG performance statusKey secondary endpointProgression-free survivalIndependent central reviewEligible ptsDeprivation therapyRECIST 1.1Baseline characteristics
2019
External 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 validation
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
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
2012
Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy.
Pond G, Sonpavde G, Choueiri T, Qu A, Vaughn D, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Beer T, Stadler W, O'Donnell P, Sternberg C, Rosenberg J, Molins J. Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy. Journal Of Clinical Oncology 2012, 30: 4522-4522. DOI: 10.1200/jco.2012.30.15_suppl.4522.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaMedian overall survivalOverall survivalPrior chemotherapyUrothelial carcinomaLiver metastasesPerformance statusPrognostic factorsSecond-line systemic therapyOptimal cutpointSignificant negative prognostic impactECOG performance statusFirst study treatmentSecond-line chemotherapyPhase II trialKaplan-Meier methodNegative prognostic impactProportional hazards regressionLikelihood ratio χBaseline HbII trialMetastatic diseaseOS independentPrognostic impact