2025
An evaluation of denileukin diftitox for the treatment of relapsed or refractory cutaneous T-cell lymphoma
Goyal A, Foss F. An evaluation of denileukin diftitox for the treatment of relapsed or refractory cutaneous T-cell lymphoma. Expert Opinion On Biological Therapy 2025, ahead-of-print: 1-8. PMID: 40489974, DOI: 10.1080/14712598.2025.2517853.Peer-Reviewed Original ResearchConceptsDenileukin difitoxResponse rateRefractory cutaneous T-cell lymphomaCutaneous T-cell lymphomaPlaque stage diseaseCells expressing CD25Adverse events gradeCapillary leak syndromeElevated hepatic transaminasesImmunoregulatory T cellsT-cell lymphomaExpressing tumor cellsDiphtheria toxin AMultiple mechanisms of actionHigh response rateSezary syndromeInfusion reactionsCD25 expressionDenileukin diftitoxMycosis fungoidesStage diseaseHepatic transaminasesMechanism of actionT cellsIL-2Imetelstat in myeloid malignancies: current data and future directions
Bidikian A, Bewersdorf J, Kewan T, Podoltsev N, Stahl M, Zeidan A. Imetelstat in myeloid malignancies: current data and future directions. Expert Review Of Anticancer Therapy 2025, 25: 517-528. PMID: 40116730, DOI: 10.1080/14737140.2025.2482721.Peer-Reviewed Original ResearchMyelodysplastic syndromeLR-MDSClinical trialsPotential disease-modifying propertiesLow-risk myelodysplastic syndromesElevated liver enzymesLR-MDS patientsTreat myelodysplastic syndromeSearch of PubMedTransfusion independenceEssential thrombocythemiaInfusion reactionsMyeloid malignanciesDisease-modifying propertiesCombination therapySurvival benefitEffective telomerase inhibitorImetelstatTelomerase reactivationPatient populationLiver enzymesMyelofibrosisCancer cellsMalignancyConference abstractsP-565. A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics
Kumar P, Rolle C, Emu B, Henry Z, Martorell C, McKinnon J, Slim J, Cash R, Anstett K. P-565. A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics. Open Forum Infectious Diseases 2025, 12: ofae631.763. PMCID: PMC11778372, DOI: 10.1093/ofid/ofae631.763.Peer-Reviewed Original ResearchJournal of Antimicrobial ChemotherapyBaseline characteristicsViral loadMultidrug resistanceAntimicrobial chemotherapyCohort 2Maintenance of virologic suppressionHigher HIV viral loadClinical outcomes of patientsExposure to antiretroviralsGenotypic sensitivity scoreCD4 cell countHIV viral loadCD4 T cellsOutcomes of patientsLong-term efficacyRetrospective observational studyHigh viral loadLong-term useVirologic suppressionInfusion reactionsStudy designT cellsSafety profileClinical outcomes
2024
Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Foss F, Kim Y, Prince H, Akilov O, Querfeld C, Seminario-Vidal L, Fisher D, Kuzel T, Yannakou C, Geskin L, Feldman T, Sokol L, Allen P, Dang N, Cabanillas F, Wong H, Ooi C, Xing D, Sauter N, Singh P, Czuczman M, Duvic M. Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2024, 43: 1198-1209. PMID: 39700456, PMCID: PMC11949209, DOI: 10.1200/jco-24-01549.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaTreatment-emergent adverse eventsTime to responseT-cell lymphomaTumor burdenRefractory cutaneous T-cell lymphomaEnd pointsEfficacy end pointCapillary leak syndromePrimary efficacy analysisSecondary end pointsHuman interleukin-2Unmet medical needMedian DORSystemic therapyInfusion reactionsOpen-labelDenileukin diftitoxEfficacy analysisAdverse eventsInterleukin-2Safety resultsQ1-Q3PatientsResponse rateIs there Evidence for a Continued Benefit for Long‐Term Lecanemab Treatment? A Benefit/Risk Update from Long‐Term Efficacy, Safety and Biomarker Data
van Dyck C, Sperling R, Dhadda S, Li D, Hersch S, Irizarry M, Kramer L. Is there Evidence for a Continued Benefit for Long‐Term Lecanemab Treatment? A Benefit/Risk Update from Long‐Term Efficacy, Safety and Biomarker Data. Alzheimer's & Dementia 2024, 20: e092094. PMCID: PMC11713166, DOI: 10.1002/alz.092094.Peer-Reviewed Original ResearchOpen-label extensionAlzheimer's diseaseBrain regions of individualsMultiple measures of cognitionMeasures of cognitionAmyloid-betaTau spreadingMarkers of amyloidAD studiesRegions of individualsBrain regionsHuman IgG1 monoclonal antibodyPhase 2 studyMonths of treatmentLong-term efficacyLecanemabLonger-term dosingIgG1 monoclonal antibodyInfusion reactionsMultiple measuresRandomized studySafety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients
Brahmer J, Long G, Hamid O, Garon E, Herbst R, Andre T, Armand P, Bajorin D, Bellmunt J, Burtness B, Choueiri T, Cohen E, Diaz L, Shitara K, Kulkarni G, McDermott D, Shah M, Tabernero J, Vogel A, Zinzani P, Jafari N, Bird S, Snyder E, Gause C, Bracco O, Pietanza M, Gruber T, Ribas A. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. European Journal Of Cancer 2024, 199: 113530. PMID: 38295556, PMCID: PMC11227881, DOI: 10.1016/j.ejca.2024.113530.Peer-Reviewed Original ResearchConceptsImmune-mediated adverse eventsAdverse eventsInfusion reactionsSafety profileClinical trialsPembrolizumab discontinuationPembrolizumab monotherapyNon-small cell lung cancerSafety of pembrolizumabDose of pembrolizumabTreated with prednisoneCell lung cancerLow steroid dosesPopulation of patientsSteroid doseMedian durationPembrolizumabAE onsetPooled analysisLung cancerCancer clinical trialsSafety dataPatientsCancer typesInfusion
2023
Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial
Merrill J, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh S, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James J, Zack D. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial. Arthritis & Rheumatology 2023, 75: 2185-2194. PMID: 37459248, DOI: 10.1002/art.42652.Peer-Reviewed Original ResearchConceptsSystemic lupus erythematosusLoss of improvementPrimary endpointLupus erythematosusWeek 32B cellsEfficacy-evaluable populationImproved disease activityPhase 2 trialProportion of patientsTreatment-related toxicityTreatment of patientsPlacebo-ControlledCorticosteroid injectionDisease activityInfusion reactionsTrough concentrationsPatient subsetsPlasma cellsPatientsSecondary analysisMonoclonal antibodiesStatistical significanceEndpointPlacebo
2022
Association of iron infusion reactions with ABO blood type
Butt A, Muradashvili T, Soliman S, Li F, Burns AJ, Brooks A, Browning S, Bar N, Borgman G, Goshua G, Hwa J, Martin K, Rinder H, Tormey C, Pine AB, Bona RD, Lee AI, Neparidze N. Association of iron infusion reactions with ABO blood type. European Journal Of Haematology 2022, 109: 519-525. PMID: 35871468, DOI: 10.1111/ejh.13838.Peer-Reviewed Original ResearchConceptsGreater oddsBlood typeYale Cancer CenterInfusion-related reactionsRetrospective chart reviewLarger patient numbersABO blood typeType AB bloodChart reviewInfusion reactionsMost patientsHematology clinicIron sucroseMultivariable analysisProspective studyCancer CenterPatient numbersIron dextranRisk factorsIron infusionIron repletionPatientsPossible associationAB bloodBloodUpdated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents
Wolf J, Abzug MJ, Anosike BI, Vora SB, Waghmare A, Sue PK, Olivero RM, Oliveira CR, James SH, Morton TH, Maron GM, Young JL, Orscheln RC, Schwenk HT, Bio LL, Willis ZI, Lloyd EC, Hersh AL, Huskins CW, Soma VL, Ratner AJ, Hayes M, Downes K, Chiotos K, Grapentine SP, Wattier RL, Lamb GS, Zachariah P, Nakamura MM. Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents. Journal Of The Pediatric Infectious Diseases Society 2022, 11: 177-185. PMID: 35107571, PMCID: PMC8903349, DOI: 10.1093/jpids/piab124.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMonoclonal antibody therapyPediatric infectious diseasesAntibody therapyEmergency use authorizationSevere diseasePostexposure prophylaxisHigh riskCOVID-19Severe acute respiratory syndrome coronavirus 2Certain high-risk conditionsSpecific monoclonal antibody therapyAcute respiratory syndrome coronavirus 2Infectious diseasesRespiratory syndrome coronavirus 2Moderate COVID-19Pediatric critical care medicineSyndrome coronavirus 2Coronavirus disease 2019Critical care medicineHigh-risk conditionsSeries of teleconferencesHigh-risk exposureBamlanivimab monotherapyInfusion reactionsControlled Trials
2021
First Line Chemo-Free Therapy with the BRAF Inhibitor Vemurafenib Combined with Obinutuzumab Is Effective in Patients with Hcl
Park J, Winer E, Huntington S, von Keudell G, Vemuri S, Shukla M, Kinoshita J, Falco V, Gore S, Stone R, Abdel-Wahab O, Tallman M. First Line Chemo-Free Therapy with the BRAF Inhibitor Vemurafenib Combined with Obinutuzumab Is Effective in Patients with Hcl. Blood 2021, 138: 43. DOI: 10.1182/blood-2021-151074.Peer-Reviewed Original ResearchHairy cell leukemiaAdverse eventsEfficacy of vemurafenibCR rateFebrile neutropeniaInfusion reactionsMonth 4Month 2Dose reductionDay 1Grand roundsResponse rateTreatment of HCLDrug-related adverse eventsMedian absolute CD4 countUntreated hairy cell leukemiaRefractory hairy cell leukemiaAdvisory CommitteeComplete response rateDurability of remissionGrade 1 feverMRD-negativity ratesMulti-center clinical trialSubsequent infusion reactionsAbsolute CD4 countTHE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS
Li M, Khan S, Proctor D, Gaidos J, Al-Bawardy B. THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS. Inflammatory Bowel Diseases 2021, 27: s45-s46. DOI: 10.1093/ibd/izaa347.110.Peer-Reviewed Original ResearchInflammatory bowel diseaseBiologic agentsAdverse eventsSmall molecule therapiesClinical remissionMucosal healingBowel diseaseConcomitant cirrhosisConcomitant corticosteroid therapyDifferent biologic agentsPrimary sclerosing cholangitisQuarter of patientsCohort of patientsEffectiveness of biologicsSmall molecule agentsConcomitant thiopurinesCorticosteroid therapyIBD patientsIBD therapyCertolizumab pegolSclerosing cholangitisAdult patientsBiologic therapyInfusion reactionsSecondary outcomesInitial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents
Wolf J, Abzug MJ, Wattier RL, Sue PK, Vora SB, Zachariah P, Dulek DE, Waghmare A, Olivero R, Downes KJ, James SH, Pinninti SG, Yarbrough A, Aldrich ML, MacBrayne CE, Soma VL, Grapentine SP, Oliveira CR, Hayes M, Kimberlin DW, Jones SB, Bio LL, Morton TH, Hankins JS, Marόn-Alfaro G, Timberlake K, Young JL, Orscheln RC, Schwenk HT, Goldman DL, Groves HE, Huskins WC, Rajapakse NS, Lamb GS, Tribble AC, Lloyd E, Hersh AL, Thorell EA, Ratner AJ, Chiotos K, Nakamura MM. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents. Journal Of The Pediatric Infectious Diseases Society 2021, 10: 629-634. PMID: 33388760, PMCID: PMC7799019, DOI: 10.1093/jpids/piaa175.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMonoclonal antibody therapyHigh-risk groupAntibody therapyEmergency use authorizationCOVID-19Moderate coronavirus disease 2019Pediatric intensive care medicinePediatric-specific evidenceTreatment of mildPediatric infectious diseasesHigh-quality evidenceCoronavirus disease 2019Intensive care medicineSeries of teleconferencesREGN-COV2Infusion reactionsPediatric HematologyTimely administrationRisk factorsRoutine administrationDisease 2019Severe diseaseCare medicineHigh riskModest benefit
2020
AML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, Van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. AML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s182. DOI: 10.1016/s2152-2650(20)30716-3.Peer-Reviewed Original ResearchCC armOlder patientsTransplant ratesLower transplant-related mortalityIncidence of gradeNon-relapse mortalityTransplant-related mortalityMajority of patientsFavorable safety profileFebrile neutropeniaInduction therapyPrior therapyActive diseaseRefractory AMLSalvage therapyDurable responsesGraft failureInfusion reactionsEngraftment dataMedian ageSafety profilePatient populationAdvanced ageDisease progressionGrade 3Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors
Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsStable diseaseDose escalationCommon treatment-related adverse eventsAnti-c-Met antibodyTreatment-related adverse eventsDose-expansion phaseI Dose-EscalationAcceptable safety profileResponse Evaluation CriteriaDose-limiting toxicitySubset of patientsLinear pharmacokinetic profilePeak plasma concentrationAcute infusion reactionsHuman phase IDose cohortsDose expansionRECIST criteriaAdverse eventsEscalation cohortsInfusion reactionsObjective responsePartial responseTargeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial. Transplantation And Cellular Therapy 2020, 26: s32-s33. DOI: 10.1016/j.bbmt.2019.12.575.Peer-Reviewed Original ResearchHematopoietic cell transplantationSalvage therapyOlder patientsCC armConventional careCC patientsConventional hematopoietic cell transplantationGrade 3 febrile neutropeniaAllogeneic hematopoietic cell transplantationPre-treated patientsPhase 3 trialFailure of chemotherapyYears of ageFebrile neutropeniaInduction therapyActive diseaseMyeloablative conditioningRefractory AMLBackground PatientsBM blastsInfusion reactionsMethods PatientsTransplant candidatesAllogeneic transplantationCurative therapy
2019
Daratumumab in the Clinic, a Real-Word Experience at Yale Cancer Center
Browning S, Parker T, Bar N, Seropian S, Lee A, Anderson T, Neparidze N. Daratumumab in the Clinic, a Real-Word Experience at Yale Cancer Center. Blood 2019, 134: 5569. DOI: 10.1182/blood-2019-130134.Peer-Reviewed Original ResearchSmilow Cancer HospitalMultiple myelomaRefractory MMInfusion reactionsSpeakers bureauCancer HospitalReal-word experienceReal-world practice patternsAnti-plasma cell therapyTransplant-eligible patientsYale Cancer CenterInfusion-related reactionsAdverse event profileLeukotriene receptor antagonistsProgression-free survivalRefractory multiple myelomaPatient-reported qualityManagement of patientsOverall response rateJanssen Scientific AffairsClonal plasma cellsExcellent safety profileMulti-center studyDrug combination regimensInfusion reaction rates
2017
Physician volume and discontinuation of rituximab during lymphoma treatment.
Huntington S, Long J, Hoag J, Wang R, Zeidan A, Giri S, Gore S, Ma X, Gross C, Davidoff A. Physician volume and discontinuation of rituximab during lymphoma treatment. Journal Of Clinical Oncology 2017, 35: 6593-6593. DOI: 10.1200/jco.2017.35.15_suppl.6593.Peer-Reviewed Original ResearchNon-Hodgkin lymphomaEarly discontinuationRituximab discontinuationPhysician volumeProvider volumeEnd Results-Medicare dataB-cell non-Hodgkin lymphomaCell non-Hodgkin lymphomaCox proportional hazards modelDiscontinuation of rituximabSevere infusion reactionsRetrospective cohort studyImpact of discontinuationDays of initiationProportional hazards modelDose-dependent mannerRituximab cyclesRituximab initiationInfusion reactionsOverall survivalCohort studyPrimary outcomeSystemic treatmentLymphoma treatmentRelative riskPhase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.
Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.Peer-Reviewed Original ResearchAdverse eventsTarget engagementPK dataCD4 T effector cellsGrade 3 adverse eventsGrade 1Inducible Co-StimulatorPhase 1 SafetyPrior systemic therapyAdvanced solid tumorsDose limiting toxicitiesT effector cellsPhase 1 studyHours post infusionAgonist monoclonal antibodyNon-tumor tissuesTriple-negative breastQuantitative systems pharmacology modelExposure increasesPreclinical potencyQ21 daysNeck painInfusion reactionsRegulatory cellsSystemic therapy
2014
Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction
Berger M, Vargo C, Vincent M, Shaver K, Phillips G, Layman R, Macrae E, Mrozek E, Ramaswamy B, Wesolowski R, Shapiro C, Lustberg M. Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction. Supportive Care In Cancer 2014, 23: 2019-2024. PMID: 25519756, PMCID: PMC4804339, DOI: 10.1007/s00520-014-2556-x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDexamethasoneDiphenhydramineDrug Administration ScheduleDrug HypersensitivityFamotidineFemaleHumansInfusions, IntravenousMiddle AgedNeoplasm StagingPaclitaxelPremedicationProspective StudiesRetrospective StudiesConceptsInfusion hypersensitivity reactionPaclitaxel-based chemotherapyRescue medication useBreast cancer patientsHypersensitivity reactionsPaclitaxel dosesRescue medicationMedication useSecond doseCancer patientsBreast cancerLife-threatening complicationsMajority of patientsDoses of paclitaxelProspective pilot trialUse of paclitaxelBreast cancer treatmentPrimary endpointInfusion reactionsPremedication regimenSubsequent dosesUnwanted side effectsResultsIn totalPilot trialStudy population
2012
Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Kucuk O, Moran S, Wang J, Bargfrede M, Liu G. Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2012, 30: 4656-4656. DOI: 10.1200/jco.2012.30.15_suppl.4656.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious AEsFebrile neutropeniaCohort 1Phase I/II studyCastration-resistant prostate cancerCommon serious AEsECOG PS 0/1Median age 68Median PSA declinePhase 1/2 studyPhase II portionLyase inhibitorCastrate menPS 0/1Measurable diseaseMedian PSAPrior chemotherapyPSA declineII studyInfusion reactionsNeutrophil countStandard chemotherapyDose escalationWBC count
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