2019
Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial
Garcia-Manero G, Roboz G, Walsh K, Kantarjian H, Ritchie E, Kropf P, O'Connell C, Tibes R, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Jabbour E, Issa JJ, Hao Y, Keer HN, Azab M, Savona MR. Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial. The Lancet Haematology 2019, 6: e317-e327. PMID: 31060979, PMCID: PMC9012213, DOI: 10.1016/s2352-3026(19)30029-8.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeMyelodysplastic syndromeRefractory cohortAdverse eventsRefractory diseaseHypomethylating agentEastern Cooperative Oncology Group performance statusNorth American medical centersInternational Prognostic Scoring SystemCommon grade 3Phase 2 partWorse adverse eventsOpen-label studyProportion of patientsPrognostic scoring systemOverall responseChronic myelomonocytic leukemiaNew therapeutic optionsAmerican medical centersEligible patientsFebrile neutropaeniaIntravenous decitabinePrimary endpointRefractory patientsStudy drug
2017
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