2024
Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
Kikuchi E, Gupta S, Loriot Y, Van Der Heijden M, Bedke J, Valderrama B, Flechon A, Petrylak D, De Santis M, Galsky M, Lee J, Swami U, Sridhar S, De Giorgi U, Wright P, Lu Y, Guan X, Dillon R, Homet Moreno B, Powles T. Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2024, 42: 108-108. DOI: 10.1200/jco.2024.42.23_suppl.108.Peer-Reviewed Original ResearchTime to pain progressionPlatinum-based chemotherapyPatient-reported outcomesBPI-SFPatients treated with platinum-based chemotherapyMedian time to pain progressionBrief Pain Inventory Short FormMetastatic urothelial cancerProgression-free survivalKaplan-Meier methodPhase 3 trialSurvival follow-upPatient-reported outcome assessmentsEnfortumab vedotinOverall survivalPain progressionTransient worseningUrothelial cancerPost-progressionQuality of Life QuestionnaireSevere painImproved survivalWorst painFollow-upWeek 4Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
Gupta S, Loriot Y, Van Der Heijden M, Bedke J, Valderrama B, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky M, Lee J, Swami U, Sridhar S, De Giorgi U, Wright P, Lu Y, Guan X, Dillon R, Homet Moreno B, Powles T. Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2024, 42: 4502-4502. DOI: 10.1200/jco.2024.42.16_suppl.4502.Peer-Reviewed Original ResearchTime to pain progressionPlatinum-based chemotherapyPatient-reported outcomesBPI-SFMedian time to pain progressionPatients treated with platinum-based chemotherapyBrief Pain Inventory Short FormMetastatic urothelial cancerProgression-free survivalKaplan-Meier methodPhase 3 trialSurvival follow-upPatient-reported outcome assessmentsEnfortumab vedotinOverall survivalPain progressionTransient worseningUrothelial cancerQuality of Life QuestionnairePost-progressionSevere painImproved survivalWorst painFollow-upGlobal health status/qualityPatient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab
Milowsky M, O'Donnell P, Hoimes C, Petrylak D, Flaig T, Moon H, Friedlander T, Mar N, McKay R, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret A, Yu Y, Dillon R, Kataria R, Beaumont J, Purnajo I, Rosenberg J. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. Journal Of Clinical Oncology 2024, 42: 1403-1414. PMID: 38215355, PMCID: PMC11095879, DOI: 10.1200/jco.23.01547.Peer-Reviewed Original ResearchBPI-SF worst painPatient-reported outcomesEnfortumab vedotinEORTC QLQ-C30 quality of lifeBPI-SFQuality of lifeCisplatin-ineligibleUrothelial cancerWorst painTreatment armsBrief Pain Inventory Short FormAdvanced urothelial cancerPhase Ib/II trialBaseline to weekPatient-reported outcomes analysisAssociated with preservationTreatment of Cancer Quality of Life Questionnaire-Core QuestionnairePatients' quality of lifeSmall-to-moderate improvementsClinically meaningful improvementsPatient-reported outcome instrumentsEuropean Organization for Research and TreatmentEORTC QLQ-C30First-lineClinical outcomes
2023
Patient-reported outcomes (PROs) in KEYNOTE-921: Pembrolizumab (pembro) plus docetaxel for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
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, Saretsky T, Ghate S, Li X, Schloss C, Fizazi K. Patient-reported outcomes (PROs) in KEYNOTE-921: Pembrolizumab (pembro) plus docetaxel for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2023, 41: 129-129. DOI: 10.1200/jco.2023.41.6_suppl.129.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPatient-reported outcomesBPI-SF scoresBPI-SFTotal scoreWk 24Wk 27Castration-resistant prostate cancerPrespecified secondary end pointsEnd pointExploratory end pointsFACT-G totalPrespecified final analysisSecondary end pointsOverall improvement rateSubscale scoresMedian TTPPPain progressionData cutoffAgent therapyMedian timeAnalysis populationStudy treatmentSymptom scoresTrial arms
2018
TRITON3: An international, randomized, open-label, phase III study of the PARP inhibitor rucaparib vs. physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD).
Ryan C, Abida W, Bryce A, Balar A, Dumbadze I, Given R, Morris D, Petrylak D, Redfern C, Scher H, Watkins S, Simmons A, Passler L, Golsorkhi T, Chowdhury S. TRITON3: An international, randomized, open-label, phase III study of the PARP inhibitor rucaparib vs. physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD). Journal Of Clinical Oncology 2018, 36: tps389-tps389. DOI: 10.1200/jco.2018.36.6_suppl.tps389.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerHomologous recombination deficiencyIndependent radiology reviewHomologous recombination (HR) DNA repair genesPhysician's choiceRadiology reviewDeleterious germlineProstate cancerRadiographic progression-free survivalCastration-resistant prostate cancerDNA repair genesObjective response rateProgression-free survivalPretreatment blood samplesAdvanced prostate cancerDuration of responsePatient-reported outcomesRepair genesMCRPC settingSecondary endpointsPrimary endpointRadiographic progressionOverall survivalComparator treatmentSomatic BRCA1
2012
A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy.
Dreicer R, Agus D, Bellmunt J, De Bono J, Petrylak D, Tejura B, Shi Y, Fizazi K. A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy. Journal Of Clinical Oncology 2012, 30: tps4693-tps4693. DOI: 10.1200/jco.2012.30.15_suppl.tps4693.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDisease progressionRadiographic progression-free survivalProstate-specific antigen levelCastration-resistant prostate cancerChemotherapy-naïve menDocetaxel-based therapyPhase 1/2 studyPhase 3 studyProgression-free survivalPatient-reported outcomesNew therapeutic optionsTestosterone synthesis pathwayERG fusion geneBone painMedical castrationNoncurative therapyHormonal therapyPrimary endpointPSA decreasePSA progressionStudy drugMetastatic diseaseObjective responseOverall survival
2006
Quality of Life and Pain in Advanced Stage Prostate Cancer: Results of a Southwest Oncology Group Randomized Trial Comparing Docetaxel and Estramustine to Mitoxantrone and Prednisone
Berry D, Moinpour C, Jiang C, Ankerst D, Petrylak D, Vinson L, Lara P, Jones S, Taplin M, Burch P, Hussain M, Crawford E. Quality of Life and Pain in Advanced Stage Prostate Cancer: Results of a Southwest Oncology Group Randomized Trial Comparing Docetaxel and Estramustine to Mitoxantrone and Prednisone. Journal Of Clinical Oncology 2006, 24: 2828-2835. PMID: 16782921, DOI: 10.1200/jco.2005.04.8207.Peer-Reviewed Original ResearchConceptsPain palliationMP armProstate cancerMcGill Pain Questionnaire-Short FormPrimary patient-reported outcomesPain Questionnaire-Short FormPresent Pain Intensity scaleAndrogen-independent prostate cancerAdvanced stage prostate cancerProstate cancer moduleMedian overall survivalLife Questionnaire C30Cancer Core QualityPatient-reported outcomesSuperior clinical efficacyDisease-related symptomsStage prostate cancerPain intensity scaleQuality of lifeRandom assignmentQuestionnaire-Short FormBone painDE armAnalgesic useEligible patients