2016
Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma
Foss F, Pro B, Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma. Cancer Medicine 2016, 6: 36-44. PMID: 27981793, PMCID: PMC5269566, DOI: 10.1002/cam4.939.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaLines of therapyLong-term outcomesT-cell lymphomaPrior therapyAdverse eventsTreatment of PTCLPivotal phase 2 trialAggressive non-Hodgkin lymphomaLast prior therapyObjective response rateFirst-line treatmentPhase 2 trialUnconfirmed complete responseLine of treatmentNon-Hodgkin lymphomaUse of romidepsinDisease refractorySalvage treatmentDose modificationMedian durationMost patientsPrior linesComplete responseRomidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. Journal Of Hematology & Oncology 2016, 9: 22. PMID: 26965915, PMCID: PMC4785666, DOI: 10.1186/s13045-016-0243-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDisease ProgressionDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedNauseaNeoplasm Recurrence, LocalNeutropeniaRemission InductionTime FactorsTreatment OutcomeYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaStable diseaseT-cell lymphomaClinical benefitPivotal trialsCell lymphomaDay 1Good responseLong stable diseaseObjective response rateProgression-free survivalUnconfirmed complete responseT-cell malignanciesHistone deacetylase inhibitorsProlonged dosingDurable responsesMedian durationObjective responsePartial responseComplete responseCurrent therapiesProtocol amendmentCell malignanciesPatients
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