2021
Phase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Pook D, Appleman L, Waterhouse D, Horvath L, Edenfield W, Matsubara N, Danila D, Aggarwal R, Petrylak D, Sartor A, Sumey C, Adra N, Armstrong A, Cheng F, Stieglmaier J, Kouros-Mehr H, Dorff T. Phase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: tps183-tps183. DOI: 10.1200/jco.2021.39.6_suppl.tps183.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisDose-expansion phasePerformance status 0Phase 2 doseObjective tumor responseT effector cellsASCO Annual MeetingTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
2020
Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Danila D, Edenfield W, Aggarwal R, Petrylak D, Sartor A, Sumey C, Dorff T, Yu E, Adra N, Waterhouse D, Armstrong A, Horvath L, Pook D, Appleman L, Lau A, Salvati M, Kouros-Mehr H. Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2020, 38: tps5589-tps5589. DOI: 10.1200/jco.2020.38.15_suppl.tps5589.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisPhase IDose-expansion phasePerformance status 0Objective tumor responsePhase II doseT effector cellsTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
2018
Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Tangen C, Rosenthal M, Petrylak D, Thompson I, Chi K, De Bono J, Fandi A, Araujo J, Eisenberger M, Logothetis C, Quinn D, Fizazi K, Higano C, George D, Morris M, Small E, Tannock I, Kelly W. Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2018, 36: lba5005-lba5005. DOI: 10.1200/jco.2018.36.18_suppl.lba5005.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerDocetaxel/prednisoneOverall survivalCaucasian manHazard ratioLymph nodesRisk factorsProstate cancerMedian overall survivalPerformance status 0Phase III trialsPooled hazard ratioShorter overall survivalIndividual patient dataProportional hazards modelAfrican American menStatus 0Primary endpointIII trialsMedian hemoglobinMedian ageLiver diseaseMultivariable analysisPrognostic importance
2006
Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report
Smith D, Mackler N, Hussain M, Dunn R, Montie J, Wood D, Lee C, Petrylak D, Quinn D, Vaishampayan U. Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report. Journal Of Clinical Oncology 2006, 24: 4541-4541. DOI: 10.1200/jco.2006.24.18_suppl.4541.Peer-Reviewed Original ResearchTransitional cell carcinomaAdvanced transitional cell carcinomaPT0 rateArm IArm IITreatment of TCCGrade 3/4 hematologic toxicitiesM0 transitional cell carcinomaAdequate organ functionCycles of therapyGrade 3 toxicityPerformance status 0Pathologic complete respondersNational Cancer InstituteBristol-Myers SquibbNeoadjuvant paclitaxelStatus 0Complete respondersEvaluable subjectsHematologic toxicityNeoadjuvant chemotherapyPrimary endpointPositive patientsResection rateClinical T3