2019
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).
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 analysisDocetaxel
2018
865PD RANGE, a phase III, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): Overall survival results
Petrylak D, Sternberg C, Drakaki A, de Wit R, Nishiyama H, Necchi A, Castellano D, Bamias A, Chi K, van der Heijden M, Matsubara N, Hussain S, Flechon A, Alekseev B, Yu E, Walgren R, Russo F, Zimmermann A, Bell-Mcguinn K, Powles T. 865PD RANGE, a phase III, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): Overall survival results. Annals Of Oncology 2018, 29: viii304-viii305. DOI: 10.1093/annonc/mdy283.074.Peer-Reviewed Original ResearchRamucirumab (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 ResearchAn open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).
Fizazi K, Drake C, Shaffer D, Pachynski R, Saad F, Ciprotti M, Kong G, Ryan C, Petrylak D. An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD). Journal Of Clinical Oncology 2018, 36: tps3126-tps3126. DOI: 10.1200/jco.2018.36.15_suppl.tps3126.Peer-Reviewed Original Research94 Healthcare resource utilization in RANGE: Ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced or metastatic urothelial cancer
Bamias A, Van Der Heijden M, De Wit R, Fléchon A, Nishiyama H, Castellano D, Drakaki A, Matsubara N, Liepa A, Zimmermann A, Bell-Mcguinn K, Hamid O, Petrylak D, Powles T, Necchi A. 94 Healthcare resource utilization in RANGE: Ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced or metastatic urothelial cancer. European Urology Open Science 2018, 17: e140-e141. DOI: 10.1016/s1569-9056(18)30946-1.Peer-Reviewed Original Research
2017
LBA4_PR RANGE: A randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma
Petrylak D, Chi K, Drakaki A, Sternberg C, de Wit R, Nishiyama H, Yu E, Castellano D, Hussain S, Percent I, Fléchon A, Bamias A, van der Heijden M, Matsubara N, Alekseev B, Walgren R, Hamid O, Zimmermann A, Bell-Mcguinn K, Powles T. LBA4_PR RANGE: A randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma. Annals Of Oncology 2017, 28: v621. DOI: 10.1093/annonc/mdx440.028.Peer-Reviewed Original Research
2016
Docetaxel in Advanced and Castration Resistant Prostate Cancer
Petrylak D, Hafez N. Docetaxel in Advanced and Castration Resistant Prostate Cancer. 2016, 77-92. DOI: 10.1007/978-3-319-31341-2_6.Peer-Reviewed Original ResearchResistant prostate cancerProstate cancerMetastatic castrate-resistant prostate cancerCastrate-resistant metastatic diseaseMetastatic castrate-resistant diseaseCastration-resistant prostate cancerCastrate-resistant prostate cancerResistant metastatic diseaseCastrate-resistant diseasePrimary chemotherapeutic agentStandard of careDocetaxel useTaxane cabazitaxelMetastatic diseaseDocetaxel efficacyRandomized trialsResistant diseaseLocal diseaseSuperior survivalDocetaxelChemotherapeutic agentsCancerDiseaseCorticosteroidsCabazitaxel
2014
Phase 1b study of abiraterone acetate (AA) and docetaxel (D) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
Tagawa S, Posadas E, Bruce J, Lim E, Petrylak D, Peng W, Maul R, Smit H, Tran N, Nanus D. Phase 1b study of abiraterone acetate (AA) and docetaxel (D) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 5025-5025. DOI: 10.1200/jco.2014.32.15_suppl.5025.Peer-Reviewed Original ResearchRegional differences observed in the phase 3 trial (ELM-PC 5) with orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel.
Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, De Wit R, De Bono J, Cruz F, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak D, Lee C, Tejura B, Borgstein N, Dreicer R. Regional differences observed in the phase 3 trial (ELM-PC 5) with orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel. Journal Of Clinical Oncology 2014, 32: 5042-5042. DOI: 10.1200/jco.2014.32.15_suppl.5042.Peer-Reviewed Original Research
2012
P114 Safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Phase 2 results from a phase 1/2 study
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Mortimer P, Liu G. P114 Safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Phase 2 results from a phase 1/2 study. European Urology Open Science 2012, 11: 230. DOI: 10.1016/s1569-9056(13)60480-7.Peer-Reviewed Original Research
2009
51 RADIOLOGIC PROGRESSION PREDICTS OVERALL SURVIVAL IN PATIENTS (PTS) WITH ANDROGEN INDEPENDENT PROSTATE CANCER (AIPC) WHO RECEIVED FIRST LINE DOCETAXEL; AN ANALYSIS FROM THE SPARC TRIAL
Witjes J, Petrylak D, Sartor O, Noursalehi M, Sternberg N, Wirth M, Billiet I, Petrone M, McKeam T, George M. 51 RADIOLOGIC PROGRESSION PREDICTS OVERALL SURVIVAL IN PATIENTS (PTS) WITH ANDROGEN INDEPENDENT PROSTATE CANCER (AIPC) WHO RECEIVED FIRST LINE DOCETAXEL; AN ANALYSIS FROM THE SPARC TRIAL. European Urology Open Science 2009, 8: 133. DOI: 10.1016/s1569-9056(09)60059-2.Peer-Reviewed Original Research
2008
565 POSTER Activity of the anti-IGF-IR antibody CP-751,871 in combination with docetaxel as first-line treatment for castration resistant prostate cancer in a randomized Phase II trial
De Bono J, Petrylak D, Calvo E, Saad F, Hudes G, Cooney M, Pollak M, Agus D, Gillessen S, Scranton J. 565 POSTER Activity of the anti-IGF-IR antibody CP-751,871 in combination with docetaxel as first-line treatment for castration resistant prostate cancer in a randomized Phase II trial. European Journal Of Cancer Supplements 2008, 6: 178. DOI: 10.1016/s1359-6349(08)72499-6.Peer-Reviewed Original ResearchLONG TERM CLINICAL OUTCOME OF A PHASE I TRIAL OF INTRAVESICAL DOCETAXEL IN THE MANAGEMENT OF SUPERFICIAL BLADDER CANCER REFRACTORY TO STANDARD INTRAVESICAL THERAPY
Laudano M, Murphy A, Petrylak D, Desai M, Benson M, McKiernan J. LONG TERM CLINICAL OUTCOME OF A PHASE I TRIAL OF INTRAVESICAL DOCETAXEL IN THE MANAGEMENT OF SUPERFICIAL BLADDER CANCER REFRACTORY TO STANDARD INTRAVESICAL THERAPY. Journal Of Urology 2008, 179: 121. DOI: 10.1016/s0022-5347(08)60345-6.Peer-Reviewed Original ResearchSATRAPLATIN (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
605: Androgen Independent Prostate Cancer (AIPC) Patients who Receive Sipuleucel-T Followed by Docetaxel Have Prolonged Survival
Petrylak D, Schellhammer P, Small E, Frohlich M. 605: Androgen Independent Prostate Cancer (AIPC) Patients who Receive Sipuleucel-T Followed by Docetaxel Have Prolonged Survival. Journal Of Urology 2007, 177: 202. DOI: 10.1016/s0022-5347(18)30845-0.Peer-Reviewed Original Research
2006
Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC)
Petrylak D, Mohile S, Shelton G, Carr R, Steinberg J, Sleep D, Melia J, Rieser M, Nanus D, Milowsky M. Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2006, 24: 14512-14512. DOI: 10.1200/jco.2006.24.18_suppl.14512.Peer-Reviewed Original ResearchHormone-refractory prostate cancerPSA declineAdverse eventsTreatment of HRPCPhase III clinical developmentPhase III studyRefractory prostate cancerUnexpected adverse eventsDOC infusionNeutropenic feverIII studyLiver metastasesOral dosesPO QDSelective endothelinPK interactionsReceptor antagonistPlasma concentrationsProstate cancerCYP3A4 activityClinical developmentDay 1DocetaxelPK resultsPharmacokinetics846: Long-Term Follow Up of Intravesical Docetaxel for the Treatment of Superficial Bladder Cancer Resistant to Standard Intravesical Therapy
Masson P, Murphy A, Goetzl M, Desai M, Olsson C, Petrylak D, Benson M, McKiernan J. 846: Long-Term Follow Up of Intravesical Docetaxel for the Treatment of Superficial Bladder Cancer Resistant to Standard Intravesical Therapy. Journal Of Urology 2006, 175: 273. DOI: 10.1016/s0022-5347(18)33082-9.Peer-Reviewed Original Research
2005
Chemotherapy agents and timing of chemotherapy in prostate cancer management
Donohue K, Petrylak D. Chemotherapy agents and timing of chemotherapy in prostate cancer management. Current Prostate Reports 2005, 3: 58-61. DOI: 10.1007/s11918-005-0017-1.Peer-Reviewed Original ResearchHormone-refractory prostate cancerSurvival benefitProstate cancerMetastatic hormone-refractory prostate cancerProstate-specific antigen levelTiming of chemotherapyPhase 2 trialProstate cancer managementMedian survivalPalliative benefitSurvival improvementAntigen levelsClinical trialsChemotherapy agentsCancer managementSingle agentChemotherapeutic agentsDocetaxelTrialsPhase 3Preliminary dataChemotherapyEstramustinePatientsCancerA pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data
Rosenbaum E, Kibel A, Roth B, Wilding G, Dreicer R, Chatta G, Petrylak D, Dipaula R, Beer T, Eisenberger M. A pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data. Journal Of Clinical Oncology 2005, 23: 4565-4565. DOI: 10.1200/jco.2005.23.16_suppl.4565.Peer-Reviewed Original ResearchInterim results from ASCENT: A double-blinded randomized study of DN-101 (high-dose calcitriol) plus docetaxel vs. placebo plus docetaxel in androgen-independent prostate cancer (AIPC)
Beer T, Ryan C, Venner P, Petrylak D, Chatta G, Ruether J, Henner W, Chi K, Cruickshank S. Interim results from ASCENT: A double-blinded randomized study of DN-101 (high-dose calcitriol) plus docetaxel vs. placebo plus docetaxel in androgen-independent prostate cancer (AIPC). Journal Of Clinical Oncology 2005, 23: 4516-4516. DOI: 10.1200/jco.2005.23.16_suppl.4516.Peer-Reviewed Original Research