2019
Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
O’Connor O, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d’Amore F, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR, . Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. Journal Of Clinical Oncology 2019, 37: 613-623. PMID: 30707661, PMCID: PMC6494247, DOI: 10.1200/jco.18.00899.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAurora Kinase AAzepinesDisease ProgressionDisease-Free SurvivalDrug Resistance, NeoplasmEarly Termination of Clinical TrialsFemaleHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedProtein Kinase InhibitorsPyrimidinesRecurrenceTime FactorsYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaProgression-free survivalOverall response rateT-cell lymphomaComparator armInvestigational Aurora A kinase inhibitorResponse rateMedian progression-free survivalTwo-year overall survivalRandomized phase III studyRandomized phase III trialIndependent data monitoring committeeEfficacy of alisertibMore prior therapiesSingle-agent comparatorCommon adverse eventsPhase III studyPhase III trialsIndependent central reviewData monitoring committeeDrug discontinuationIntravenous romidepsinOral alisertibPrior therapy
2018
The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project
Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica 2018, 103: 1191-1197. PMID: 29599200, PMCID: PMC6029527, DOI: 10.3324/haematol.2017.186577.Peer-Reviewed Original ResearchConceptsBone marrow transplantationInternational T-cell ProjectPeripheral T-cell lymphoma patientsT-cell lymphoma patientsT-cell ProjectOverall survivalMarrow transplantationLymphoma patientsRelapsed Peripheral T-Cell LymphomaPeripheral T-cell lymphomaUnivariate Cox regression analysisChemotherapy-sensitive diseaseMedian overall survivalFirst-line therapyFirst-line treatmentOverall survival rateSurvival of patientsCox regression analysisEnd of treatmentStandard of careT-cell lymphomaMedian followPrimary refractoryBetter OSRefractory/A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma
Foss FM, Parker T. A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma. The Oncologist 2018, 23: 397-e30. PMID: 29438091, PMCID: PMC5896711, DOI: 10.1634/theoncologist.2017-0658.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaOverall response rateIntermediate-grade B-cellB cellsPartial responseResponse ratePhase I dose-escalation studyRefractory acute lymphoblastic leukemiaI dose-escalation studyT-cell non-Hodgkin lymphomaB-cell non-Hodgkin lymphomaPositron emission tomography scanSecond-generation purine nucleoside analogAggressive B-cell lymphomasPhase IDose of clofarabineGrade 3 leukopeniaLow-dose cohortMinimal hematologic toxicityRefractory acute leukemiaRefractory low gradeRefractory lymphoid malignanciesSingle-agent rituximab
2016
Clinical 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
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 responseUtility 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
2011
Relapsed and refractory PTCL—into the therapeutic abyss
Foss F. Relapsed and refractory PTCL—into the therapeutic abyss. Nature Reviews Clinical Oncology 2011, 8: 321-322. PMID: 21468128, DOI: 10.1038/nrclinonc.2011.51.Peer-Reviewed Original ResearchMeSH KeywordsAminopterinAntineoplastic AgentsDrug Resistance, NeoplasmFolic Acid AntagonistsHematologyHumansLymphoma, T-Cell, PeripheralNeoplasm Recurrence, LocalSalvage Therapy
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
2006
Efficacy of low dose clofarabine in refractory precursor T- acute lymphoblastic leukemia.
Choi J, Foss F. Efficacy of low dose clofarabine in refractory precursor T- acute lymphoblastic leukemia. The Yale Journal Of Biology And Medicine 2006, 79: 169-72. PMID: 17940627, PMCID: PMC1994805.Peer-Reviewed Original ResearchMeSH KeywordsAdenine NucleotidesAdultArabinonucleosidesBone Marrow NeoplasmsClinical Trials as TopicClofarabineDrug Administration ScheduleDrug Resistance, NeoplasmHumansImmunophenotypingLeukemia-Lymphoma, Adult T-CellMaleRecurrenceSkin NeoplasmsStem Cell TransplantationTransplantation, HomologousTreatment OutcomeConceptsLow dose clofarabineLymphoblastic leukemiaAllogeneic stem cell transplantationSignificant clinical activityStem cell transplantationNear complete responseAcute lymphoblastic leukemiaPediatric B-ALLT-cell leukemiaAllogeneic transplantsComplete responsePoor prognosisCell transplantationB-ALLPrecursor TClinical activityNew agentsNovel nucleoside analogueClofarabinePatientsLeukemiaNucleoside analoguesSignificant activityRemissionTransplantation
2002
Diphtheria fusion protein therapy of chemoresistant malignancies.
Frankel AE, Rossi P, Kuzel TM, Foss F. Diphtheria fusion protein therapy of chemoresistant malignancies. Current Cancer Drug Targets 2002, 2: 19-36. PMID: 12188918, DOI: 10.2174/1568009023333944.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsClinical Trials as TopicDiphtheria ToxinDrug Resistance, NeoplasmHumansNeoplasmsRecombinant Fusion ProteinsConceptsTargeted toxinsFusion protein therapyDiphtheria toxinChemotherapy-refractory cancersSelective ligandsTumor-selective ligandsChemoresistant diseaseCombination chemotherapyNeoplastic stem cellsRefractory cancerChemoresistant malignancyGroup IPseudomonas exotoxinWidespread cancerTherapyCell functionCancer therapyAntiviral proteinProtein therapyCancerToxin