2023
A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML
Garcia-Manero G, Podoltsev N, Othus M, Pagel J, Radich J, Fang M, Rizzieri D, Marcucci G, Strickland S, Litzow M, Savoie M, Medeiros B, Sekeres M, Lin T, Uy G, Powell B, Kolitz J, Larson R, Stone R, Claxton D, Essell J, Luger S, Mohan S, Moseley A, Appelbaum F, Erba H. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML. Leukemia 2023, 38: 58-66. PMID: 37935977, DOI: 10.1038/s41375-023-02073-x.Peer-Reviewed Original ResearchConceptsHigh-dose cytarabineAcute myeloid leukemiaDose cytarabineRandomized phase III studyUnfavorable-risk cytogeneticsRandomized multicenter trialOverall remission ratePhase III studyHigh response rateHistone deacetylase inhibitorsInduction therapyFree survivalPrimary endpointRemission rateUntreated patientsIII studyOverall survivalYounger patientsMulticenter trialImproved outcomesMyeloid leukemiaCytogenetic subsetsCytarabineResponse rateHigh doses
2017
Overall survival (OS) and stem cell transplant (SCT) in patients with FLT3 mutations treated with CPX-351 versus 7+3: Subgroup analysis of a phase III study of older adults with newly diagnosed, high-risk acute myeloid leukemia (AML).
Medeiros B, Hogge D, Newell L, Bixby D, Solomon S, Strickland S, Lin T, Erba H, Powell B, Podoltsev N, Ryan R, Chiarella M, Louie A, Lancet J. Overall survival (OS) and stem cell transplant (SCT) in patients with FLT3 mutations treated with CPX-351 versus 7+3: Subgroup analysis of a phase III study of older adults with newly diagnosed, high-risk acute myeloid leukemia (AML). Journal Of Clinical Oncology 2017, 35: e18507-e18507. DOI: 10.1200/jco.2017.35.15_suppl.e18507.Peer-Reviewed Original ResearchHigh-risk acute myeloid leukemiaAcute myeloid leukemiaCPX-351Median overall survivalOverall survivalComplete remissionFLT3 mutationsDe novo acute myeloid leukemiaNovo acute myeloid leukemiaSerious adverse eventsPhase III studyPhase III trialsOverall study populationOlder ptsNeutrophil recoveryIII trialsAdverse eventsIII studyCell transplantAML patientsSafety profileStudy treatmentSubgroup analysisAML subtypesMyeloid leukemia