2013
A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study
Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leukemia & Lymphoma 2013, 54: 1373-1379. PMID: 23278639, DOI: 10.3109/10428194.2012.742521.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaDenileukin diftitoxT-cell lymphomaAdverse eventsOverall survivalFrequent treatment-related adverse eventsUntreated peripheral T-cell lymphomaMedian progression-free survivalMost frequent adverse eventsMulticenter phase II trialTreatment-related adverse eventsTreatment-related deathsFrequent adverse eventsMedian overall survivalPhase II studyPhase II trialProgression-free survivalOverall survival rateOverall response rateITT populationSafety populationII trialII studyMedian durationLarge trials
2010
Enhancing Existing Approaches to Peripheral T-Cell Lymphoma
Foss FM. Enhancing Existing Approaches to Peripheral T-Cell Lymphoma. Seminars In Hematology 2010, 47: s8-s10. PMID: 20359584, DOI: 10.1053/j.seminhematol.2010.01.012.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaFirst-line therapyT-cell lymphomaNational Comprehensive Cancer Network practice guidelinesEffective first-line therapyStandard treatment optionSame treatment regimenB-cell lymphomaPTCL patientsTreatment regimenDenileukin diftitoxConventional therapyHistopathologic subtypeTreatment optionsNovel agentsPractice guidelinesLymphomaChemotherapy platformTherapyPatientsOutcomesDiftitoxRegimenTransplantSubtypesRole of denileukin diftitox in the treatment of persistent or recurrent cutaneous T-cell lymphoma
Lansigan F, Stearns DM, Foss F. Role of denileukin diftitox in the treatment of persistent or recurrent cutaneous T-cell lymphoma. Cancer Management And Research 2010, Volume 2: 53-59. PMID: 21188096, PMCID: PMC3004568, DOI: 10.2147/cmar.s5009.Peer-Reviewed Original ResearchCutaneous T-cell lymphomaRecurrent cutaneous T-cell lymphomaTreatment of patientsT-cell lymphomaDenileukin diftitoxFusion protein toxinsT cellsCytocidal agentsRare lymphoproliferative disorderPivotal clinical trialsMalignant T cellsBiological response modifiersQuality of lifeMechanism of actionCD25 subunitCommon toxicitiesProgressive lymphomaLymphoproliferative disordersClinical trialsResponse modifiersIL2 receptorTraditional chemotherapyDiftitoxB cellsFDA approval
2007
Efficacy of Denileukin Diftitox in Subcutaneous Panniculitis-Like T-Cell Lymphoma
Hathaway T, Subtil A, Kuo P, Foss F. Efficacy of Denileukin Diftitox in Subcutaneous Panniculitis-Like T-Cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2007, 7: 541-545. PMID: 18021473, DOI: 10.3816/clm.2007.n.040.Peer-Reviewed Original ResearchConceptsT-cell phenotypeDenileukin diftitoxSubcutaneous panniculitis-like T-cell lymphomaPanniculitis-like T-cell lymphomaSubcutaneous panniculitis-like lymphomaSystemic multi-agent chemotherapyAddition of bexaroteneMedian response durationMulti-agent chemotherapyComplete clinical regressionBone marrow transplantationT-cell lymphomaPleomorphic lymphocytesImmunosuppressive therapyRefractory patientsClinical regressionClinical responseMost patientsMarrow transplantationAggressive diseasePrognostic significanceDisease progressionRadiation therapyTraditional therapiesResponse duration
2006
Biologic Correlates of Response and Survival in Patients with Cutaneous T-Cell Lymphoma Treated with Denileukin Diftitox
Chin KM, Foss FM. Biologic Correlates of Response and Survival in Patients with Cutaneous T-Cell Lymphoma Treated with Denileukin Diftitox. Clinical Lymphoma Myeloma & Leukemia 2006, 7: 199-204. PMID: 17229335, DOI: 10.3816/clm.2006.n.059.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsCD4-Positive T-LymphocytesClinical Trials as TopicDiphtheria ToxinFemaleHumansInterleukin-2Interleukin-2 Receptor alpha SubunitLymphoma, T-Cell, CutaneousMaleMiddle AgedMycosis FungoidesReceptors, Interleukin-2Recombinant Fusion ProteinsSkin NeoplasmsTreatment OutcomeConceptsCutaneous T-cell lymphomaAdvanced stage diseaseT-cell lymphomaDenileukin diftitoxMedian survivalBiologic correlatesAdvanced-stage cutaneous T-cell lymphomaResponse ratePhase III registration trialNumber of CD4Single-center seriesAbsolute lymphocyte countOverall response rateT cell populationsCourse of therapyLymphocyte countClinical responseLymphocyte populationsDisease progressionDiftitoxPatientsRegistration trialsHuman interleukinLactate dehydrogenaseSurvivalClinical Experience With Denileukin Diftitox (ONTAK)
Foss F. Clinical Experience With Denileukin Diftitox (ONTAK). Seminars In Oncology 2006, 33: 11-16. PMID: 16516670, DOI: 10.1053/j.seminoncol.2005.12.017.Peer-Reviewed Original ResearchConceptsIL-2 receptorCutaneous T-cell lymphomaT-cell lymphomaDenileukin diftitoxIntermediate affinity IL-2 receptorsHuman IL-2 receptorChronic lymphocytic leukemiaActivated T lymphocytesDiphtheria toxinClinical profileHodgkin's lymphomaHematologic disordersT lymphocytesLymphocytic leukemiaB cellsClinical experienceB lymphocytesLymphomaCytocidal actionNumber of leukemiasDiftitoxHigh affinity formCellular protein synthesisReceptorsLymphocytesImmunomodulatory Effects of Rexinoids
Foss F. Immunomodulatory Effects of Rexinoids. Seminars In Oncology 2006, 33: 21-25. PMID: 16516672, DOI: 10.1053/j.seminoncol.2005.12.019.Peer-Reviewed Original ResearchConceptsImmunomodulatory effectsCutaneous T-cell lymphomaReceptor-targeted therapyImproved clinical outcomesT-cell lymphomaPractical clinical approachExtracorporeal photophoresisClinical outcomesDenileukin diftitoxTherapy optionsHematologic malignanciesClinical activityPharmacotherapeutic agentsLymphoid malignanciesClinical approachTumor cellsRexinoidsMalignancyTreatmentDiftitoxLymphomaTherapy
2005
A phase-1 trial of bexarotene and denileukin diftitox in patients with relapsed or refractory cutaneous T-cell lymphoma
Foss F, Demierre MF, DiVenuti G. A phase-1 trial of bexarotene and denileukin diftitox in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2005, 106: 454-457. PMID: 15811959, DOI: 10.1182/blood-2004-11-4570.Peer-Reviewed Original ResearchConceptsRefractory cutaneous T-cell lymphomaCutaneous T-cell lymphomaPhase 1 trialT-cell lymphomaDenileukin diftitoxInterleukin-2High-affinity IL-2 receptorGrade 4 lymphopeniaLeukemia cellsIL-2R expressionIL-2 receptorT-cell leukemia cellsCD25 expressionIL-2RVivo upregulationP75 subunitDiftitoxGrade 2BexaroteneLow dosesPatientsLymphoma cellsBiomodulatory effectDiphtheria toxinLymphoma
2003
Denileukin Diftitox and Hyper-CVAD in the Treatment Human T-Cell Lymphotropic Virus 1–Associated Adult T-Cell Leukemia/Lymphoma
DiVenuti G, Nawgiri R, Foss F. Denileukin Diftitox and Hyper-CVAD in the Treatment Human T-Cell Lymphotropic Virus 1–Associated Adult T-Cell Leukemia/Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2003, 4: 176-178. PMID: 14715100, DOI: 10.3816/clm.2003.n.027.Peer-Reviewed Original ResearchConceptsAdult T-cell leukemia/lymphomaT-cell leukemia/lymphomaDenileukin diftitoxLeukemia/lymphomaClinical remissionHuman T-cell lymphotropic virus-1Human T-cell lymphotropic virusCell leukemia/lymphomaBone marrow myelofibrosisComplete clinical remissionBone marrow biopsyLymphotropic virus-1Acute T-cell leukemiaNormal hematopoiesisT-cell leukemiaLeukemic T cellsExtensive myelofibrosisHyper-CVADInitial therapyMaintenance therapyClinical improvementClinical manifestationsMarrow biopsyDisease progressionT cells
2002
Quality-of-Life Improvements in Cutaneous T-Cell Lymphoma Patients Treated with Denileukin Diftitox (ONTAK®)
Duvic M, Kuzel TM, Olsen EA, Martin AG, Foss FM, Kim YH, Heald PW, Bacha P, Nichols J, Liepa A. Quality-of-Life Improvements in Cutaneous T-Cell Lymphoma Patients Treated with Denileukin Diftitox (ONTAK®). Clinical Lymphoma Myeloma & Leukemia 2002, 2: 222-228. PMID: 11970761, DOI: 10.3816/clm.2002.n.003.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsDiphtheria ToxinDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfusions, IntravenousInterleukin-2Lymphoma, T-Cell, CutaneousMaleMiddle AgedNeoplasm StagingPatient SatisfactionProbabilityPrognosisProspective StudiesQuality of LifeRecombinant Fusion ProteinsReference ValuesRisk AssessmentSkin NeoplasmsStatistics, NonparametricTreatment OutcomeConceptsCutaneous T-cell lymphomaRecurrent cutaneous T-cell lymphomaDenileukin diftitoxPruritus severityOverall QoLSkin appearanceCutaneous T-cell lymphoma patientsAdverse transfusion-related eventsCancer Therapy-General (FACT-G) questionnaireT-cell lymphoma patientsPhase III trialsVascular leak syndromeT-cell lymphomaTransfusion-related eventsSignificant myelosuppressionIII trialsSkin severityStudy endpointLymphoma patientsOutpatient basisIndividual subscale scoresFunctional assessmentPatientsDiftitoxTreatment cycles