2022
Comparative efficacy and tolerability of novel agents vs chemotherapy in relapsed and refractory T-cell lymphomas: a meta-analysis
Shafagati N, Koh M, Boussi L, Park H, Stuver R, Bain P, Foss FM, Shen C, Jain S. Comparative efficacy and tolerability of novel agents vs chemotherapy in relapsed and refractory T-cell lymphomas: a meta-analysis. Blood Advances 2022, 6: 4740-4762. PMID: 35816645, PMCID: PMC9631658, DOI: 10.1182/bloodadvances.2022007425.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsHumansIfosfamideLymphoma, T-Cell, PeripheralNeoplasm Recurrence, LocalConceptsPeripheral T-cell lymphomaOverall response rateR Peripheral T Cell LymphomaCombination chemotherapyT-cell lymphomaSingle agentComparative efficacyRefractory T-cell lymphomaPhase ISingle-agent strategyPhase II trialPlatinum-based regimensPhase III trialsPhase I trialOptimal treatment strategyNovel single agentsRandom-effects modelSignificant subgroup differencesII trialIII trialsI trialHistological subtypesTreatment paradigmClinical trialsDrug classes
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 ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesHumansLymphoma, T-Cell, PeripheralMiddle AgedNeoplasm Recurrence, LocalSurvival AnalysisTreatment OutcomeConceptsPeripheral 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 responseClinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides
Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clinical Lymphoma Myeloma & Leukemia 2016, 16: 637-643. PMID: 27637428, DOI: 10.1016/j.clml.2016.08.009.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaFolliculotropic mycosis fungoidesPrevious systemic therapyMycosis fungoidesDisease involvementCutaneous tumorsTumor stageSystemic therapyRefractory cutaneous T-cell lymphomaSubtypes of CTCLSafety of romidepsinObjective response ratePhase II studyAggressive disease courseReview of diagnosisT-cell lymphomaHistone deacetylase inhibitorsII studyComposite endpointDisease courseHistology reportsClinical efficacyUncommon subtypeFavorable outcomePatientsRomidepsin 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
2015
Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma
Iyer SP, Foss FF. Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma. The Oncologist 2015, 20: 1084-1091. PMID: 26099743, PMCID: PMC4571813, DOI: 10.1634/theoncologist.2015-0043.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsDepsipeptidesHumansLymphoma, T-Cell, PeripheralPrognosisTreatment OutcomeConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaT-cell lymphomaHistone deacetylase inhibitorsPrior therapySpecialty centersTherapeutic approachesExpert hematopathologistsTreatment of PTCLDeacetylase inhibitorsPivotal phase II studiesCutaneous T-cell lymphomaPrior systemic therapyCommon adverse eventsObjective response ratePhase II studyFirst-line treatmentTreatment of patientsNon-Hodgkin lymphomaDifficulty of diagnosisAsthenic conditionsHeavy pretreatmentInduction chemotherapyAdvanced diseaseAdverse eventsUtility 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