2019
Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration
Savona M, Kantarjian H, Roboz G, O'Connell C, Walsh K, Tibes R, Yee K, Stock W, Griffiths E, Jabbour E, Lunin S, Rosenblat T, Podoltsev N, Issa J, Su X, Azab M, Garcia-Manero G. Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration. Blood 2019, 134: 2957. DOI: 10.1182/blood-2019-129962.Peer-Reviewed Original ResearchMDS/CMML patientsMDS/CMMLPhase 2 studyObjective responseCMML patientsSurvival benefitClinical trialsMedian OSMyelodysplastic syndromeAstex PharmaceuticalsSurvival analysisTreatment discontinuationHematological improvementPartial responseComplete responseEarly progressionOtsuka PharmaceuticalDaiichi SankyoLandmark analysisHMA treatmentLandmark responsesCycle 4Prospective phase 2 studyBoehringer IngelheimAdvisory Committee
2018
Long Term Results of a Randomized Phase 2 Dose-Response Study of Guadecitabine, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Garcia-Manero G, Ritchie E, Walsh K, Savona M, Kantarjian H, Kropf P, O'Connell C, Tibes R, Daver N, Jabbour E, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Issa J, Naim S, Hao Y, Azab M, Roboz G. Long Term Results of a Randomized Phase 2 Dose-Response Study of Guadecitabine, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). Blood 2018, 132: 231. DOI: 10.1182/blood-2018-99-110465.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalDose groupMyelodysplastic syndromeTreatment-naïveChronic myelomonocytic leukemiaCMML patientsBristol-Myers SquibbHypomethylating agentAdverse eventsAstex PharmaceuticalsM2 groupMDS patientsMD cohortJazz PharmaceuticalsMarrow CRBM blastsHematological improvementMost patientsSpeakers bureauDaiichi SankyoHMA treatmentJanssen PharmaceuticalsTP53 mutationsCelgene Corporation
2017
Hypomethylating agent therapy use and survival in older patients with chronic myelomonocytic leukemia in the United States: A large population‐based study
Zeidan AM, Hu X, Long JB, Wang R, Ma X, Podoltsev NA, Huntington SF, Gore SD, Davidoff AJ. Hypomethylating agent therapy use and survival in older patients with chronic myelomonocytic leukemia in the United States: A large population‐based study. Cancer 2017, 123: 3754-3762. PMID: 28621841, PMCID: PMC6540984, DOI: 10.1002/cncr.30814.Peer-Reviewed Original ResearchConceptsChronic myelomonocytic leukemiaRisk of deathSupportive careEnd Results-Medicare databaseOlder adultsMedian OS timeOverall survival benefitCohort of patientsProportional hazards modelUse of HMAsMedian OSAgent therapySurvival benefitOS timeCMML patientsMyelomonocytic leukemiaHazards modelHMA treatmentPatientsTemporal improvementSecondary analysisPropensity scoreLimited evidenceSurvival changesApproval
2014
First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Garcia-Manero G, Ritchie E, Walsh K, Savona M, Kropf P, O’Connell C, Tibes R, Daver N, Jabbour E, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Issa J, Chung W, Naim S, Taverna P, Hao Y, Azab M, Kantarjian H, Roboz G. First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). Blood 2014, 124: 529. DOI: 10.1182/blood.v124.21.529.529.Peer-Reviewed Original ResearchTreatment-naïve patientsMyelodysplastic syndromeChronic myelomonocytic leukemiaTreatment armsCMML patientsHypomethylating agentClinical responseAdverse eventsAstex PharmaceuticalsSGI-110Marrow CRNaïve patientsTransfusion independenceHematological improvementMDS patientsHigh-risk myelodysplastic syndromePhase 1 clinical trialECOG PS 2Treatment-naïve groupRisk myelodysplastic syndromesBaseline patient characteristicsFirst clinical resultsDose-response studySignificant differencesMedian follow