Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial
Kantarjian HM, Roboz GJ, Kropf PL, Yee KWL, O'Connell CL, Tibes R, Walsh KJ, Podoltsev NA, Griffiths EA, Jabbour E, Garcia-Manero G, Rizzieri D, Stock W, Savona MR, Rosenblat TL, Berdeja JG, Ravandi F, Rock EP, Hao Y, Azab M, Issa JJ. Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial. The Lancet Oncology 2017, 18: 1317-1326. PMID: 28844816, PMCID: PMC5925750, DOI: 10.1016/s1470-2045(17)30576-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAzacitidineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleHumansInfusions, IntravenousKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaximum Tolerated DoseMiddle AgedNeoplasm InvasivenessNeoplasm StagingPatient SafetyPrognosisProspective StudiesRemission InductionRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsAcute myeloid leukemiaComposite complete responseTreatment-naive patientsTreatment-naive acute myeloid leukaemiaAdverse eventsMyeloid leukemiaComplete responseFebrile neutropeniaIntensive chemotherapyMyelodysplastic syndromeTreatment cyclesCommon serious adverse eventsRefractory acute myeloid leukemiaPhase 2 resultsFrequent grade 3Worse adverse eventsSerious adverse eventsPhase 2 studyPhase 3 studyCohort of patientsPhase 1 studyComplete tumor responseStandard of careNumber of patientsEffective treatment schedule