2019
Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study.
Khodadoust MS, Rook AH, Porcu P, Foss F, Moskowitz AJ, Shustov A, Shanbhag S, Sokol L, Fling SP, Ramchurren N, Pierce R, Davis A, Shine R, Li S, Fong S, Kim J, Yang Y, Blumenschein WM, Yearley JH, Das B, Patidar R, Datta V, Cantu E, McCutcheon JN, Karlovich C, Williams PM, Subrahmanyam PB, Maecker HT, Horwitz SM, Sharon E, Kohrt HE, Cheever MA, Kim YH. Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study. Journal Of Clinical Oncology 2019, 38: 20-28. PMID: 31532724, PMCID: PMC6943974, DOI: 10.1200/jco.19.01056.Peer-Reviewed Original ResearchConceptsRefractory mycosis fungoidesSézary syndromeOverall response rateMycosis fungoidesTreatment discontinuationFlare reactionAdvanced MF/SSResponse rateMF/Sézary syndromeMulticenter phase II studyMulticenter phase II trialSeverity-Weighted Assessment ToolHigh PD-1 expressionAdvanced mycosis fungoidesEfficacy of pembrolizumabPrior systemic therapySubsequent clinical responseAdvanced-stage diseasePhase II studyPrimary end pointPD-1 expressionPhase II trialFavorable safety profileTotal mutation burdenLack of responseSingle agents vs combination chemotherapy in relapsed and refractory peripheral T‐cell lymphoma: Results from the comprehensive oncology measures for peripheral T‐cell lymphoma treatment (COMPLETE) registry
Stuver RN, Khan N, Schwartz M, Acosta M, Federico M, Gisselbrecht C, Horwitz SM, Lansigan F, Pinter‐Brown L, Pro B, Shustov AR, Foss FM, Jain S. Single agents vs combination chemotherapy in relapsed and refractory peripheral T‐cell lymphoma: Results from the comprehensive oncology measures for peripheral T‐cell lymphoma treatment (COMPLETE) registry. American Journal Of Hematology 2019, 94: 641-649. PMID: 30896890, PMCID: PMC7928240, DOI: 10.1002/ajh.25463.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaComprehensive Oncology MeasuresT-cell lymphomaCombination chemotherapyFirst retreatmentSingle agentCombination therapyR diseaseTreatment RegistryEligibility criteriaR Peripheral T Cell LymphomaHematopoietic stem cell transplantationPrior systemic therapyComplete response rateMedian overall survivalProgression-free survivalStem cell transplantationPrimary endpointAdverse eventsOverall survivalSystemic therapyMore patientsRandomized trialsGrade 3
2015
Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study
O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. Journal Of Clinical Oncology 2015, 33: 2492-2499. PMID: 26101246, PMCID: PMC5087312, DOI: 10.1200/jco.2014.59.2782.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalSulfonamidesTreatment OutcomeConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaInternational Working Group criteriaOverall response rateT-cell lymphomaPrior therapyOverall survivalGroup criteriaResponse rateEnd pointCommon grade 3Prior systemic therapyPrimary end pointSecondary end pointsNovel histone deacetylase inhibitorStem cell transplantationDuration of responseStandard of careDrug Administration approvalHistone deacetylase inhibitorsEvaluable patientsManageable toxicityAdverse eventsDurable responsesPartial responseRomidepsin 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 ResearchConceptsPeripheral 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 events
2014
A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma
Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben‐Yehuda D, Beylot‐Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma. British Journal Of Haematology 2014, 168: 811-819. PMID: 25404094, DOI: 10.1111/bjh.13222.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm StagingRecurrenceSulfonamidesTreatment OutcomeYoung AdultConceptsCutaneous T-cell lymphomaPeripheral T-cell lymphomaObjective response rateT-cell lymphomaPrior systemic therapyStage IV diseaseSystemic therapyAdverse eventsTreatment-related serious adverse eventsRefractory peripheral T-cell lymphomaTreatment-related adverse eventsPan-histone deacetylase inhibitorInfusion site painSkin-directed therapiesGrade 4 thrombocytopeniaSerious adverse eventsPhase II trialJugular vein thrombosisAnti-angiogenic propertiesOpen labelII trialParalytic ileusPeripheral edemaPrimary endpointSite pain
2012
Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study
Foss F, Horwitz SM, Coiffier B, Bartlett N, Popplewell L, Pro B, Pinter-Brown LC, Shustov A, Furman RR, Haioun C, Koutsoukos T, O'Connor OA. Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study. Clinical Lymphoma Myeloma & Leukemia 2012, 12: 238-243. PMID: 22542448, DOI: 10.1016/j.clml.2012.01.010.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalToxicity-related discontinuationProgression-free survivalIndependent central reviewMedian survivalInvestigator assessmentMycosis fungoidesCentral reviewMedian durationAggressive diseaseRetrospective analysisGrade 4 adverse eventsPrior systemic therapySubgroup efficacy analysesObjective response rateTransformed Mycosis FungoidesPROPEL StudyAdverse eventsObjective responseSystemic therapyCutaneous lesionsEfficacy analysisPoor prognosisTreatment optionsMedian numberIdentification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma
Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2012, 119: 4115-4122. PMID: 22394596, DOI: 10.1182/blood-2011-11-390211.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopterinAntimetabolites, AntineoplasticDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleDrug EruptionsFatigueFemaleGastrointestinal DiseasesHumansLymphoma, T-Cell, CutaneousMaleMiddle AgedMucositisNeutropeniaSalvage TherapySkin NeoplasmsThrombocytopeniaConceptsCutaneous T-cell lymphomaRefractory cutaneous T-cell lymphomaT-cell lymphomaAdverse eventsSystemic therapyPrimary cutaneous anaplastic large cell lymphomaCommon grade 3 adverse eventsOnly grade 4 adverse eventCutaneous anaplastic large cell lymphomaGrade 3 adverse eventsGrade 4 adverse eventsAnaplastic large cell lymphomaPrior systemic therapyAcceptable toxicity profileLong-term dosingLarge cell lymphomaFolate carrier 1De-escalation strategiesAcceptable toxicityExpansion cohortStarting doseSézary syndromeSystemic treatmentDosing regimenMycosis fungoidesResults 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
2007
Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma
Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2007, 25: 3109-3115. PMID: 17577020, DOI: 10.1200/jco.2006.10.2434.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansHydroxamic AcidsLymphoma, T-Cell, CutaneousMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingProbabilitySalvage TherapySkin NeoplasmsSurvival AnalysisTreatment OutcomeVorinostatConceptsObjective response rateDuration of responseMF/SSStage IIBAdverse experiencesOral vorinostatPruritus reliefHigh patientCommon drug-related adverse experiencesRefractory cutaneous T-cell lymphomaMedian DORDrug-related adverse experiencesCutaneous T-cell lymphomaEnd pointT-cell lymphoma subtypesPrior systemic therapyStage IIB diseasePrimary end pointSecondary end pointsAcceptable safety profileHistone deacetylase inhibitor vorinostatPhase IIb trialT-cell lymphomaRecurrent mycosis fungoidesIIB disease