2023
First-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial.
Aggarwal R, Zhang J, Monk P, Zhu X, Costin D, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial. Journal Of Clinical Oncology 2023, 41: tps5109-tps5109. DOI: 10.1200/jco.2023.41.16_suppl.tps5109.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious adverse eventsPartial responsePrimary endpointPhase 2aRandomized Phase 2b TrialCastration-resistant prostate cancerOral small-molecule inhibitorPhase 2b trialPrime immune cellsRECIST 1.1 criteriaDisease control rateImmune checkpoint inhibitorsPhase 2 studyPlatinum-based chemotherapyDuration of responsePotential predictive biomarkersImmune effector cellsMeasurable diseaseNeuroendocrine variantPSA-PFSRECIST 1.1Safety populationCheckpoint inhibitorsData cutoffAvelumab 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
2020
First-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI).
Petrylak D, Gao X, Vogelzang N, Garfield M, Taylor I, Dougan Moore M, Peck R, Burris H. First-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI). Journal Of Clinical Oncology 2020, 38: 3500-3500. DOI: 10.1200/jco.2020.38.15_suppl.3500.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerAST/ALTAdverse eventsPSA responseAnti-tumor activityPrior therapyAST/ALT elevationElevated AST/ALTCastrate-resistant prostate cancerProstate cancer xenograft modelPreclinical anti-tumor activityPhase 2 doseRECIST partial responseAcceptable safety profileAcute renal failureHuman phase ICancer xenograft modelPrior chemotherapyALT elevationData cutoffRenal failurePartial responseDose escalationRadium-223Enz resistanceAnalysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC).
Bedke J, Merseburger A, Loriot Y, Castellano D, Choy E, Duran I, Rosenberg J, Petrylak D, Dreicer R, Perez-Gracia J, Hoffman-Censits J, Van Der Heijden M, Degaonkar V, Thiebach L, de Ducla S, Fear S, Powles T, Sternberg C. Analysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2020, 38: 492-492. DOI: 10.1200/jco.2020.38.6_suppl.492.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseasePartial responseDisease controlBaseline characteristicsRisk factorsPR/stable diseaseOverall survival durationProspective clinical trialsBroader patient populationAnalysis of outcomesData cutoffUnacceptable toxicityWorse OSComplete responseClinical outcomesMedian timeAnalysis populationPatient populationUrothelial carcinomaSurvival durationClinical trialsCohort 2Disease progressionResponse status
2017
A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.
Petrylak D, Arkenau H, Perez-Gracia J, Krebs M, Santana-Davila R, Yang J, Rege J, Mi G, Ferry D, Herbst R. A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma. Journal Of Clinical Oncology 2017, 35: 349-349. DOI: 10.1200/jco.2017.35.6_suppl.349.Peer-Reviewed Original ResearchTreatment-related AEsECOG PS 0Median durationPS 0PD-L1Urothelial carcinomaDay 1Phase 1a/b trialPlatinum-based systemic therapyTreatment-related grade 4Advanced urothelial carcinomaElevated alanine aminotransferaseNew safety signalsElevated aspartate aminotransferaseBaseline tumor tissuePreliminary efficacy dataTransitional cell carcinomaEligible ptsMeasurable diseaseMedian PFSStable diseasePartial responseProgressive diseaseSystemic therapyMedian age
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 trialPhase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results.
Mateo J, Fizazi K, Pezaro C, Loriot Y, Mehra N, Albiges L, Bianchini D, Varga A, Ryan C, Petrylak D, Shen L, Zhang J, Attard G, De Bono J, Massard C. Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results. Journal Of Clinical Oncology 2015, 33: 268-268. DOI: 10.1200/jco.2015.33.7_suppl.268.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 2 partProgression-free survivalAbiraterone acetateAdverse eventsPrimary endpointTreatment-emergent adverse eventsCastration-resistant prostate cancerECOG PS 0Median PSA-PFSPSA response rateAntitumor activityOpen-label trialDuration of responseCombination of abirateroneMeasurable diseasePSA-PFSRECIST 1.1Secondary endpointsDose intensityOverall survivalPartial responsePS 0PSA responseMedian time
2000
Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point.
Small E, Lew D, Redman B, Petrylak D, Hammond N, Gross H, Eastham J, Crawford E. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. Journal Of Clinical Oncology 2000, 18: 2537-44. PMID: 10893284, DOI: 10.1200/jco.2000.18.13.2537.Peer-Reviewed Original ResearchConceptsAdvanced transitional cell carcinomaTransitional cell carcinomaCombination of paclitaxelSurvival timeMedian progression-free survival timeNeoadjuvant platinum-based therapySouthwest Oncology Group studyProgression-free survival timeClinical trial end pointsGrade 4 toxicityPoor prognostic featuresTrial end pointsEnrollment of patientsMedian survival timeOverall survival timeCooperative group settingPlatinum-based therapyResponse proportionsAcceptable toxicityExtranodal diseaseNeoadjuvant therapyNeurologic toxicityComplete responsePartial responsePrognostic featuresDEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER
WEITZMAN A, SHELTON G, ZUECH N, OWEN C, JUDGE T, BENSON M, SAWCZUK I, KATZ A, OLSSON C, BAGIELLA E, PFAFF C, NEWHOUSE J, PETRYLAK D. DEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER. Journal Of Urology 2000, 163: 834-837. PMID: 10687988, DOI: 10.1016/s0022-5347(05)67815-9.Peer-Reviewed Original ResearchConceptsProstate-specific antigenAndrogen-independent prostate cancerIndependent prostate cancerResponse rateMedian timeProstate cancerBaseline prostate-specific antigenSerum prostate-specific antigenMedian PSA increasePSA response rateDexamethasone monotherapyEstramustine administrationPSA declineMedian durationPartial responsePSA increaseDisease 3Day 1Specific antigenWeek 9Day 2EstramustinePatientsDocetaxelDexamethasone
1999
Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer.
Petrylak D, Macarthur R, O'Connor J, Shelton G, Judge T, Balog J, Pfaff C, Bagiella E, Heitjan D, Fine R, Zuech N, Sawczuk I, Benson M, Olsson C. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. Journal Of Clinical Oncology 1999, 17: 958-67. PMID: 10071290, DOI: 10.1200/jco.1999.17.3.958.Peer-Reviewed Original ResearchConceptsAndrogen-independent prostate cancerEPT patientsProstate cancerMPT patientsProgressive metastatic androgen-independent prostate cancerMetastatic androgen-independent prostate cancerDose-limiting myelosuppressionGrade 3/4 granulocytopeniaPSA response ratePhase II doseDoses of docetaxelPhase I trialPharmacokinetics of docetaxelBone painMeasurable diseaseOral estramustinePo tidPain medicationPartial responseSerum PSAI trialNarcotic analgesicsTime of entryPatientsDay 1
1992
Estramustine and Vinblastine: Use of Prostate Specific Antigen as a Clinical Trial End Point for Hormone Refractory Prostatic Cancer
Seidman A, Scher H, Petrylak D, Dershaw D, Curley T. Estramustine and Vinblastine: Use of Prostate Specific Antigen as a Clinical Trial End Point for Hormone Refractory Prostatic Cancer. Journal Of Urology 1992, 147: 931-934. PMID: 1371564, DOI: 10.1016/s0022-5347(17)37426-8.Peer-Reviewed Original ResearchConceptsHormone-refractory prostatic cancerProstatic cancerProgressive hormone-refractory prostate cancerElevated prostate-specific antigen levelsProstate-specific antigen levelHormone-refractory prostate cancerClinical trial end pointsOutpatient treatment regimenRefractory prostate cancerSpecific antigen levelsTrial end pointsProstate-specific antigenManageable toxicityMedian durationPartial responsePSA levelsTreatment regimenEstramustine phosphateAntigen levelsProstate cancerAdditive cytotoxicityMedian decreasePatientsSpecific antigenHuman prostate