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/quality
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
2009
Use of pain at baseline and pain progression to predict overall survival (OS) in patients (pts) with docetaxel pretreated metastatic castration-refractory prostate cancer (CRPC): Results from the SPARC trial
Sartor A, Petrylak D, Sternberg C, Witjes F, Halabi S, Berry W, Petrone M, McKearn T, Noursalehi M, George M. Use of pain at baseline and pain progression to predict overall survival (OS) in patients (pts) with docetaxel pretreated metastatic castration-refractory prostate cancer (CRPC): Results from the SPARC trial. Journal Of Clinical Oncology 2009, 27: 5148-5148. DOI: 10.1200/jco.2009.27.15_suppl.5148.Peer-Reviewed Original ResearchCastration-refractory prostate cancerOverall survivalPain progressionBaseline painSPARC trialChemotherapy trialsPPI scoresMetastatic castration-refractory prostate cancerFirst-line chemotherapy trialsMcGill-Melzack Pain QuestionnaireFirst-line docetaxelMedian overall survivalNarcotic analgesic usePre-treated patientsDaily pain intensityImportant prognostic indicatorEffect of painUse of painShortened overall survivalAnalgesic useCRPC patientsMedian survivalPain intensityPain QuestionnairePrognostic indicator
2008
SATRAPLATIN (S) INCREASES PROGRESSION-FREE SURVIVAL (PFS) AND DELAYS PAIN PROGRESSION IN PATIENTS (PTS) WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) THAT HAVE PROGRESSED AFTER PRIOR DOCETAXEL
Sternberg N, Sartor O, Petrylak D, Witjes F, Bodrogi I, Harper P, James N, Demkov T, Eymard J, Wirth M. SATRAPLATIN (S) INCREASES PROGRESSION-FREE SURVIVAL (PFS) AND DELAYS PAIN PROGRESSION IN PATIENTS (PTS) WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) THAT HAVE PROGRESSED AFTER PRIOR DOCETAXEL. European Urology Open Science 2008, 7: 230. DOI: 10.1016/s1569-9056(08)60635-1.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 response