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
2012
Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study
Foss F, Horwitz SM, Coiffier B, Bartlett N, Popplewell L, Pro B, Pinter-Brown LC, Shustov A, Furman RR, Haioun C, Koutsoukos T, O'Connor OA. Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study. Clinical Lymphoma Myeloma & Leukemia 2012, 12: 238-243. PMID: 22542448, DOI: 10.1016/j.clml.2012.01.010.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalToxicity-related discontinuationProgression-free survivalIndependent central reviewMedian survivalInvestigator assessmentMycosis fungoidesCentral reviewMedian durationAggressive diseaseRetrospective analysisGrade 4 adverse eventsPrior systemic therapySubgroup efficacy analysesObjective response rateTransformed Mycosis FungoidesPROPEL StudyAdverse eventsObjective responseSystemic therapyCutaneous lesionsEfficacy analysisPoor prognosisTreatment optionsMedian number