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 ResearchConceptsPeripheral 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
2020
Cost-effectiveness of polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma
Patel KK, Isufi I, Kothari S, Foss F, Huntington S. Cost-effectiveness of polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. Leukemia & Lymphoma 2020, 61: 3387-3394. PMID: 32835553, DOI: 10.1080/10428194.2020.1808208.Peer-Reviewed Original ResearchConceptsIncremental cost-effectiveness ratioLarge B-cell lymphomaB-cell lymphomaPola-BRR DLBCLRefractory diffuse large B-cell lymphomaLonger progression-free survivalRecent phase II trialDiffuse large B-cell lymphomaProgression-free survivalTransplant-ineligible patientsPhase II trialUS payer perspectiveCost-effectiveness ratioII trialOverall survivalTreatment strategiesPayer perspectiveLifetime horizonIncremental effectivenessIncremental costPolatuzumabRituximabLymphomaDLBCL
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
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
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
2011
Multicenter Phase II Trial of Temozolomide in Mycosis Fungoides/Sézary Syndrome: Correlation with O6-Methylguanine-DNA Methyltransferase and Mismatch Repair Proteins
Querfeld C, Rosen ST, Guitart J, Rademaker A, Pezen DS, Dolan ME, Baron J, Yarosh DB, Foss F, Kuzel TM. Multicenter Phase II Trial of Temozolomide in Mycosis Fungoides/Sézary Syndrome: Correlation with O6-Methylguanine-DNA Methyltransferase and Mismatch Repair Proteins. Clinical Cancer Research 2011, 17: 5748-5754. PMID: 21747120, PMCID: PMC3725971, DOI: 10.1158/1078-0432.ccr-11-0556.Peer-Reviewed Original ResearchMeSH KeywordsAdaptor Proteins, Signal TransducingAdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingDacarbazineDNA DamageDNA Mismatch RepairFemaleHumansMaleMiddle AgedMutL Protein Homolog 1MutS Homolog 2 ProteinMycosis FungoidesNuclear ProteinsO(6)-Methylguanine-DNA MethyltransferaseSezary SyndromeTemozolomideTreatment OutcomeConceptsMycosis fungoides/Sézary syndromeMulticenter phase II trialPhase II trialMF/SSMethylguanine-DNA methyltransferaseMutL homolog 1II trialSézary syndromeMedian disease-free survivalMismatch repair protein expressionGrade 3 thrombocytopeniaMedian overall survivalDisease-free survivalEfficacy of temozolomideRepair protein expressionProtein expression levelsOral derivativeComplete remissionConstitutional symptomsFrequent toxicitiesGastrointestinal symptomsHematologic toxicityPartial remissionClinical responseOverall survivalEvaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma
Foss FM. Evaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma. Expert Opinion On Drug Metabolism & Toxicology 2011, 7: 1141-1152. PMID: 21726160, DOI: 10.1517/17425255.2011.595404.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaT-cell lymphomaRefractory peripheral T-cell lymphomaPhase I/II trialEarly phase I/II trialsCutaneous T-cell lymphomaAggressive T-cell lymphomaT-cell lymphoma subtypesFrequent adverse eventsStem cell transplantationT-cell neoplasmsII trialAdverse eventsMost patientsHodgkin's diseasePreclinical findingsClinical efficacyLymphoma trialsPoor outcomeConventional therapyHodgkin's lymphomaReversible thrombocytopeniaHematologic malignanciesClinical trialsClinical studies
2002
A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96
Bailey HH, Levy D, Harris LS, Schink JC, Foss F, Beatty P, Wadler S. A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96. Gynecologic Oncology 2002, 85: 464-468. PMID: 12051875, DOI: 10.1006/gyno.2002.6647.Peer-Reviewed Original ResearchConceptsProgression-free rateAdvanced ovarian cancerOvarian cancerPerillyl alcoholMedian progression-free survivalPrior platinum-based therapyAdvanced ovarian carcinomaMedian overall survivalObjective response ratePhase II studyPhase II trialProgression-free survivalLDL cholesterol levelsPlatinum-based therapyGastrointestinal toxicityII trialPrimary endpointRecurrent diseaseUnacceptable toxicityII studyOverall survivalPartial responseHistoric controlsCholesterol levelsOvarian carcinoma