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
2015
Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma
Iyer SP, Foss FF. Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma. The Oncologist 2015, 20: 1084-1091. PMID: 26099743, PMCID: PMC4571813, DOI: 10.1634/theoncologist.2015-0043.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaT-cell lymphomaHistone deacetylase inhibitorsPrior therapySpecialty centersTherapeutic approachesExpert hematopathologistsTreatment of PTCLDeacetylase inhibitorsPivotal phase II studiesCutaneous T-cell lymphomaPrior systemic therapyCommon adverse eventsObjective response ratePhase II studyFirst-line treatmentTreatment of patientsNon-Hodgkin lymphomaDifficulty of diagnosisAsthenic conditionsHeavy pretreatmentInduction chemotherapyAdvanced diseaseAdverse eventsResimmune, 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
2014
Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma
Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomarker Research 2014, 2: 16. PMID: 25279222, PMCID: PMC4181623, DOI: 10.1186/2050-7771-2-16.Peer-Reviewed Original ResearchMajority of discontinuationsCommon adverse eventsRefractory PTCLAdverse eventsT-cell lymphomaHematologic toxicityAE profileRomidepsin treatmentGreater incidencePoor bone marrow reserveCutaneous T-cell lymphomaRefractory T-cell lymphomaBone marrow reserveDose of romidepsinFrequent hematologic toxicityLeast stable diseaseSimilar AE profilesTreatment cycles 1Severe hematologic toxicityDurable clinical responsesRefractory aggressive lymphomaOverall clinical benefitCycle 1Overall AE profileNovel drug therapies