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 response
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
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 survival