2024
Real World Data on Efficacy and Safety of EPOCH in T-Cell Lymphoma
Straining R, Foss F, Schiffer M, Amin K, Agarwal S, Isufi I, Huntington S, Kothari S, Seropian S, Girardi M, Sethi T. Real World Data on Efficacy and Safety of EPOCH in T-Cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2024 PMID: 39368885, DOI: 10.1016/j.clml.2024.09.005.Peer-Reviewed Original ResearchT-cell lymphomaHeterogeneous group of lymphoid malignanciesGroup of lymphoid malignanciesPeripheral T-cell lymphomaAggressive T-cell lymphomaCutaneous T-cell lymphomaT cellsResponse rateR/R settingComplete responseLymphoid malignanciesPoor outcomeAnaplastic large cell lymphomaFrontline treatment regimensLarge cell lymphomaCombination of prednisoneHeterogeneous groupCell lymphomaChemotherapy optionsCaucasian patientsFirst-linePositive patientsTreatment regimensGrade 3LymphomaChart review study of real-world clinical outcomes in patients with cutaneous T-cell lymphoma treated with extracorporeal photopheresis in the US in 2017–2019
Girardi M, Carlson K, Huang X, Corman S, Edmundson P, Schmier J, Kale H, Raina R, Foss F. Chart review study of real-world clinical outcomes in patients with cutaneous T-cell lymphoma treated with extracorporeal photopheresis in the US in 2017–2019. Journal Of Dermatological Treatment 2024, 35: 2360568. PMID: 38852942, DOI: 10.1080/09546634.2024.2360568.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaCutaneous T-cell lymphoma patientsExtracorporeal photopheresisResponse rateClinical outcomesMonths of ECP treatmentMedian time to responseReal-world treatment patternsECP initiationLymph node involvementStage IV diseaseAdvanced-stage diseaseT-cell lymphomaTime to responseEffective treatment optionPercentage of patientsChart review studyIV diseaseSezary syndromeNode involvementConcomitant therapySystemic therapyMedian ageMycosis fungoidesChart review
2023
Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial
Jacobsen E, Maruyama D, Porcu P, Tobinai K, Allen P, Ishitsuka K, Tsukasaki K, Kusumoto S, Foss F, Yamauchi N, Morishima S, Imaizumi Y, Izutsu K, Feldman T, Kawamata T, Kakurai Y, Yamauchi H, Biserna N, Inoue A, Tsutsumi S, Horwitz S. Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial. Blood 2023, 142: 303. DOI: 10.1182/blood-2023-172512.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaAdult T-cell leukemia/lymphomaT-cell non-Hodgkin lymphomaObjective response rateDuration of responseProgression-free survivalT-cell lymphomaMedian DORATLL groupPTCL groupData cutoffAdverse eventsClinical activityResponse rateRefractory peripheral T-cell lymphomaMedian progression-free survivalAngioimmunoblastic T-cell lymphomaT-cell leukemia/lymphomaDose-expansion cohortsDose-expansion phaseMedian prior therapiesPreliminary efficacy assessmentComplete response rateDose-escalation phasePhase 2 trial
2021
A Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01
Foss F, Porcu P, Horwitz S, Izutsu K, Ishitsuka K, Kato K, Jin J, Du Y, Inoue A. A Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01. Blood 2021, 138: 2533. DOI: 10.1182/blood-2021-144676.Peer-Reviewed Original ResearchR Peripheral T Cell LymphomaTreatment-emergent adverse eventsPeripheral T-cell lymphomaALK-positive anaplastic large cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaPhase 2 studyOverall response rateKyowa Hakko KirinPersonal feesCohort 1Current equity holderDaiichi SankyoResponse rateSeattle GeneticsOno PharmaceuticalCohort 2Computed tomographyMonomorphic epitheliotropic intestinal T-cell lymphomaActive central nervous system (CNS) involvementADC therapeuticsSerious treatment-emergent adverse eventsRefractory peripheral T-cell lymphomaNodal peripheral T-cell lymphomaAllogeneic hematopoietic cell transplantNovel Single Agents Are Equivalent to Conventional Chemotherapy Inpatients with Relapsed and Refractory Mature T-Cell Lymphomas: A Meta-Analysis
Shafagati N, Stuver R, Boussi L, Koh M, Park A, Bain P, Foss F, Shen C, Jain S. Novel Single Agents Are Equivalent to Conventional Chemotherapy Inpatients with Relapsed and Refractory Mature T-Cell Lymphomas: A Meta-Analysis. Blood 2021, 138: 1431. DOI: 10.1182/blood-2021-150315.Peer-Reviewed Original ResearchOverall response rateT-cell lymphomaHistological subtypesNovel single agentsSingle agentHistone deacetylase inhibitorsConventional chemotherapyResponse rateCentral RegisterPartial responsePTCL-NOSClinical trialsChemotherapy agentsComparable overall response ratesGeneric inverse variance methodCutaneous T-cell lymphomaPhase IParticular histological subtypeSpeakers bureauCochrane Central RegisterProgression-free survivalMature T-cell lymphomasPI3K/Akt/mTORDuration of responseInverse variance methodEPOCH Is a Safe and Effective Treatment Option for Aggressive T-Cell Lymphomas
Sethi T, Gerstein R, Schiffer M, Amin K, Agarwal S, Foss F. EPOCH Is a Safe and Effective Treatment Option for Aggressive T-Cell Lymphomas. Blood 2021, 138: 4547. DOI: 10.1182/blood-2021-151238.Peer-Reviewed Original ResearchAggressive T-cell lymphomaCutaneous T-cell lymphomaT-cell lymphomaAnaplastic large cell lymphomaSubcutaneous panniculitis-like T-cell lymphomaAngioimmunoblastic T-cell lymphomaAdult T-cell leukemia/lymphomaProgression-free survivalOverall response rateNon-Hodgkin lymphomaResponse rateR settingOverall survivalCR rateAdverse effectsPanniculitis-like T-cell lymphomaGrade 3 adverse effectsGrade 4 adverse effectsMedian progression-free survivalAllogeneic stem cell transplantPeripheral T-cell lymphomaT-cell leukemia/lymphomaYale-New Haven HospitalFirst lineEfficacy of etoposideResponse to Extracorporeal Photopheresis in Patients with Cutaneous T-Cell Lymphoma: A Retrospective Medical Chart Review
Girardi M, Johnson A, Carlson K, Huang X, Corman S, Edmundson P, Kale H, Rusibamayila N, Foss F. Response to Extracorporeal Photopheresis in Patients with Cutaneous T-Cell Lymphoma: A Retrospective Medical Chart Review. Blood 2021, 138: 1405. DOI: 10.1182/blood-2021-151116.Peer-Reviewed Original ResearchCutaneous T-cell lymphomaBody surface areaNew skin lesionsHalf of patientsExtracorporeal photopheresisT-cell lymphomaMallinckrodt PharmaceuticalsECP initiationClinical outcomesClinical trialsSkin lesionsInterim analysisRetrospective medical chart review studyResponse rateClinical Global Impressions-Improvement scoreDiagnosis of CTCLTreatment of CTCLClinical sitesStructured case report formRetrospective medical chart reviewMedical chart review studyReal-world clinical practiceSpeakers bureauStage IV diseaseAdvanced stage diseaseEfficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial
Cowan R, Scarisbrick J, Zinzani P, Nicolay J, Sokol L, Pinter‐Brown L, Quaglino P, Iversen L, Dummer R, Musiek A, Foss F, Ito T, Rosen J, Medley M. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: 2225-2238. PMID: 34273208, PMCID: PMC9290719, DOI: 10.1111/jdv.17523.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalBlood tumor burdenSézary syndromeMycosis fungoidesB2 patientsBlood involvementTumor burdenInvestigator-assessed progression-free survivalSuperior objective response rateTreatment-emergent adverse eventsRefractory mycosis fungoidesGreater clinical benefitCD8 ratioAdverse eventsSystemic therapyClinical benefitMogamulizumabPatient responseSustained reductionNext treatmentPatientsResponse rateCell countVorinostat
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 responseA drug safety evaluation of mogamulizumab for the treatment of cutaneous T-Cell lymphoma
Afifi S, Mohamed S, Zhao J, Foss F. A drug safety evaluation of mogamulizumab for the treatment of cutaneous T-Cell lymphoma. Expert Opinion On Drug Safety 2019, 18: 769-776. PMID: 31303060, DOI: 10.1080/14740338.2019.1643837.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaTreatment optionsTreatment of CTCLSkin-homing T cellsRare non-Hodgkin lymphomaSystemic treatment optionsMF/SSNew treatment optionsNon-Hodgkin lymphomaDrug Administration approvalDrug safety evaluationLow response rateAdvanced diseaseAdult patientsPrior linesAdministration approvalT cellsMogamulizumabResponse rateAgent efficacyPatientsRecent FoodLymphomaDisease statesEffect of leucovorin administration on mucositis and skin reactions in patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma treated with pralatrexate*
Foss FM, Parker TL, Girardi M, Li A. Effect of leucovorin administration on mucositis and skin reactions in patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma treated with pralatrexate*. Leukemia & Lymphoma 2019, 60: 2927-2930. PMID: 31119966, DOI: 10.1080/10428194.2019.1612061.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaCutaneous T-cell lymphomaT-cell lymphomaIncidence of mucositisAddition of leucovorinSkin reactionsLeucovorin administrationMucositis incidenceMucositis occurrenceDisease stabilizationAdverse eventsClinical responseCTCL patientsPoor prognosisLeucovorinMucositisPatientsResponse rateLymphomaPralatrexateIncidenceEfficacyPrognosisDosingAdministrationRandomized 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
Cutaneous T-Cell Lymphoma: Trends in Radiation Doses and Patterns of Care 2004-2015
Miccio JA, Wilson LD, Kann BH, Jairam V, Beckta J, Foss FM, Yeboa DN. Cutaneous T-Cell Lymphoma: Trends in Radiation Doses and Patterns of Care 2004-2015. Anticancer Research 2018, 39: 253-259. PMID: 30591466, DOI: 10.21873/anticanres.13105.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaLow-dose radiotherapyNational Cancer DatabaseMinority of patientsT-cell lymphomaSimilar response ratesHigh-volume facilitiesLogistic regression modelsAdult patientsMost patientsDose administeredCancer DatabaseEffective treatmentResponse rateRadiotherapyHigh dosesPatientsDosesLess toxicityAnnual percentageRadiation dosesRegression modelsAdministeredLymphomaDiseaseDuvelisib, an oral dual PI3K‐δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study
O'Brien S, Patel M, Kahl BS, Horwitz SM, Foss FM, Porcu P, Jones J, Burger J, Jain N, Allen K, Faia K, Douglas M, Stern HM, Sweeney J, Kelly P, Kelly V, Flinn I. Duvelisib, an oral dual PI3K‐δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1318-1326. PMID: 30094870, PMCID: PMC8260004, DOI: 10.1002/ajh.25243.Peer-Reviewed Original ResearchConceptsChronic lymphocytic leukemiaPhase 1 studyTN patientsRR patientsLymphocytic lymphomaLymphocytic leukemiaRefractory chronic lymphocytic leukemiaMedian response durationAdvanced hematologic malignanciesPhase 3 studyOverall response rateCLL/SLLSmall lymphocytic lymphomaPatient's diarrheaExpansion cohortTransaminase elevationHematologic malignanciesPharmacodynamic activityResponse durationPatientsResponse rateΓ inhibitorDuvelisibDual inhibitorLymphomaA 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
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 responseResimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma
Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica 2015, 100: 794-800. PMID: 25795722, PMCID: PMC4450625, DOI: 10.3324/haematol.2015.123711.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaComplete remissionRecombinant immunotoxinCommon adverse eventsDose-escalation trialLow tumor burdenAssessment Tool scoreDurable remissionsEscalation trialPartial remissionAdverse eventsTumor burdenIntravenous infusionPatientsRemissionTool scoreResponse rateSingle-chain antibody fragmentChain antibody fragmentsLymphomaDiphtheria toxinFurther studiesImmunotoxinTrials
2012
Pralatrexate: treatment of T-cell non-Hodgkins lymphoma
Parker T, Barbarotta L, Foss F. Pralatrexate: treatment of T-cell non-Hodgkins lymphoma. Future Oncology 2012, 9: 21-29. PMID: 23252560, DOI: 10.2217/fon.12.168.Peer-Reviewed Original ResearchConceptsRefractory peripheral T-cell lymphomaPeripheral T-cell lymphomaT-cell non-Hodgkin lymphomaVitamin B12 supplementationOverall response rateNon-Hodgkin lymphomaT-cell lymphomaPROPEL trialCommon toxicitiesB12 supplementationPatient populationClinical studiesResponse ratePralatrexateUS FDALymphomaMetabolic inhibitorsTreatmentToxicityNauseaThrombocytopeniaDoseTrialsSupplementationWeeksLong‐term follow‐up and survival of cutaneous T‐cell lymphoma patients treated with extracorporeal photopheresis
Knobler R, Duvic M, Querfeld C, Straus D, Horwitz S, Zain J, Foss F, Kuzel T, Campbell K, Geskin L. Long‐term follow‐up and survival of cutaneous T‐cell lymphoma patients treated with extracorporeal photopheresis. Photodermatology Photoimmunology & Photomedicine 2012, 28: 250-257. PMID: 22971190, DOI: 10.1111/j.1600-0781.2012.00689.x.Peer-Reviewed Original ResearchConceptsDuration of responseOverall response rateExtracorporeal photopheresisOverall survivalSkin responseResponse rateImpact of ECPCutaneous T-cell lymphomaMedian overall survivalSurvival of patientsT-cell lymphomaLong-term treatmentECP initiationDurable responsesPivotal trialsPatientsCohortECP treatmentModern criteriaSurvivalTreatmentDiagnosisTrialsMonthsResponseResults 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