2015
Utility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma
Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Annals Of Oncology 2015, 26: 774-779. PMID: 25605745, PMCID: PMC4374388, DOI: 10.1093/annonc/mdv010.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaInternational Workshop CriteriaFDG-PET scansRefractory peripheral T-cell lymphomaBaseline FDG-PET scanCR/CRuT-cell lymphomaPositron emission tomographyConventional radiologyPET criteriaStable diseaseEnd pointFDG-PETConventional stagingPET statusResponse assessmentPivotal phase 2 trialEmission tomographyDeoxyglucose positron emission tomographyExploratory end pointsObjective response ratePET-positive diseasePrimary end pointProgression-free survivalPhase 2 study
2014
Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. Journal Of Hematology & Oncology 2014, 7: 11. PMID: 24456586, PMCID: PMC4016573, DOI: 10.1186/1756-8722-7-11.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticCellulitisDepsipeptidesDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansInfusions, IntravenousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRemission InductionTime FactorsTreatment OutcomeVenous ThrombosisVomitingConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaCR/CRuDuration of responseObjective response rateT-cell lymphomaDurable responsesPrior therapySystemic therapyMedian DORMedian progression-free survivalCutaneous T-cell lymphomaReported safety profileProgression-free survivalUnconfirmed complete responseSubset of patientsLong-term responseIndependent review committeeTreatment of patientsSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsLack of responseHeavy pretreatmentStable diseasePrimary endpoint
2012
Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy. Journal Of Clinical Oncology 2012, 30: 631-636. PMID: 22271479, DOI: 10.1200/jco.2011.37.4223.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDiarrheaDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalPneumoniaTreatment OutcomeVascular DiseasesVomitingYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaPrior systemic therapyCR/CRuSystemic therapyT-cell lymphomaPrior therapyComplete response/unconfirmed complete responseResponse ratePrior stem cell transplantationEfficacy of romidepsinSingle-agent romidepsinObjective response ratePhase II studyPrimary end pointPhase II trialUnconfirmed complete responseStem cell transplantationIndependent review committeeDrug Administration approvalSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsManageable toxicityII trialOpen label