Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study

Keywords

Medicine, Azacitidine, Internal medicine, Hazard ratio, Clinical endpoint

References

• International scoring system for evaluating prognosis in myelodysplastic syndromes.Peter L. Greenberg, Christopher Cox, Michelle M. LeBeau — 1997
• Results of intensive chemotherapy in 998 patients age 65 years or older with acute myeloid leukemia or high‐risk myelodysplastic syndrome:Hagop M. Kantarjian, Susan O’Brien, Jörge E. Cortes — 2006
• Intensive chemotherapy followed by allogeneic or autologous stem cell transplantation for patients with myelodysplastic syndromes (MDSs) and acute myeloid leukemia following MDS.T. de Witte — 2001
• Low-dose ara-C in acute nonlymphocytic leukemia and myelodysplastic syndromes: a review of 20 years' experience.Bruce D. Cheson, Richard Simon — 1987
• A phase II study of intensive chemotherapy with fludarabine, cytarabine, and mitoxantrone in P glycoprotein-negative high-risk myelodysplastic syndromes.Thomas Prébet, Sophie Ducastelle, Stephan Debotton — 2004
• Proposals for the classification of the myelodysplastic syndromesJohn M. Bennett, Daniel Catovsky, M. T. Daniel — 1982
• Discrete sequential boundaries for clinical trialsK. K. Gordon Lan, David L. DeMets — 1983
• Comparison of idarubicin + ara-C-, fludarabine + ara-C-, and topotecan + ara-C-based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts.Elihu H. Estey, Peter F. Thall, Jörge E. Cortes — 2001
• CDKN2B methylation status and isolated chromosome 7 abnormalities predict responses to treatment with 5-azacytidineKavita Raj, A M John, Aloysius Ho — 2007
• Modes of action of the DNA methyltransferase inhibitors azacytidine and decitabineCarlo Stresemann, Frank Lyko — 2008
• Standard and low-dose chemotherapy for the treatment of myelodysplastic syndromes.Bruce D. Cheson — 1998
• Intensive chemotherapy is not recommended for patients aged >60 years who have myelodysplastic syndromes or acute myeloid leukemia with high‐risk karyotypesSabine Knipp, Barbara Hildebrand, Andrea Kündgen — 2007
• S-HAM induction chemotherapy with or without GM-CSF in patients with high-risk myelodysplastic syndromesWalter Verbeek, Bernhard Wörmann, P. Koch — 1997
• A predictive model for the clinical response to low dose ara‐C: a study of 102 patients with myelodysplastic syndromes or acute leukaemiaEva Hellström‐Lindberg, Karl‐Henrik Robèrt, Gösta Gahrton — 1992
• Intensive chemotherapy with idarubicin, cytarabine, etoposide, and G-CSF priming in patients with advanced myelodysplastic syndrome and high-risk acute myeloid leukemiaW.-K. Hofmann, Gerhard Heil, C. Zander — 2004
• Allogeneic stem cell transplantation for myelodysplastic syndrome.A. John Barrett, Bipin N. Savani — 2008
• Definitions and standards in the diagnosis and treatment of the myelodysplastic syndromes: Consensus statements and report from a working conference.Peter Valent, Hans‐Peter Horny, John M. Bennett — 2007
• Guidelines for the diagnosis and therapy of adult myelodysplastic syndromesDavid Bowen, Dominic Culligan, Simon N. Jowitt — 2003
• A comparison of low‐dose cytarabine and hydroxyurea with or without all‐trans retinoic acid for acute myeloid leukemia and high‐risk myelodysplastic syndrome in patients not considered fit for intensive treatmentAlan K. Burnett, Donald Milligan, Archie Prentice — 2007
• The evaluation of low-dose cytarabine in the treatment of myelodysplastic syndromes: A phase-III intergroup studyK B Miller, K. Kyungmann, Francis S. Morrison — 2005

Cited by

• 10th anniversary of the Austrian MDS Platform: aims and ongoing projectsSonja Burgstaller, Peter Bettelheim, Otto Krieger — 2014
• Machine Learning Based Analysis of DNA Methylation Patterns in Pediatric Acute LeukemiaChristofer Bäcklin — 2015
• Efficacy of a 3-day, low-dose treatment with 5-azacytidine followed by donor lymphocyte infusions in older patients with acute myeloid leukemia or chronic myelomonocytic leukemia relapsed after allograftingRoberto González-Quevedo González — 2010
• A phase 2 study of vorinostat in acute myeloid leukemiaViswanath Krishnan — 2009
• Hematopoietic stem cell transplantation for myelodysplastic syndrome.Tobías Schleider — 2010
• Pharmacotherapy of myelodysplastic syndromesB. C. Cheserek, W. K. Ng’etich — 2010
• Epigenetic approaches in the treatment of myelodysplastic syndromes: clinical utility of azacitidineJosé Ramón López de los Mozos Jiménez — 2010
• Gene expression profiling of myelodysplastic CD34+ hematopoietic stem cells treated in vitro with decitabine.Lohania J. Aruca Alonso — 2011
• Evidence of persistent neurologic injury following thrombotic thrombocytopenic purpuraAntonio Millán Puelles — 2011
• Impact of TET2 mutations on response rate to azacitidine in myelodysplastic syndromes and low blast count acute myeloid leukemiasA. Vena — 2011
• Treatment of higher-risk myelodysplastic syndrome.Bonnie Gold, Roger Simons — 2011
• Epigenetic Drug DiscoveryAlfredo Alan, Boris Pritsker — 2012
• Interest of the association azacitidine–lenalidomide as frontline therapy in high-risk myelodysplasia or acute myeloid leukemia with complex karyotypeWinston M. Estes — 2012
• Activity of alemtuzumab in acute myelogenous leukemia and myelodysplastic syndrome with chromosome 7 aberrations.Raoul Tibes, Pierre Noël — 2011
• The pituitary tumour epigenome: aberrations and prospects for targeted therapyО. О. Левицких — 2012
• Acute myeloid leukaemia in adults.V.N. Mordkovich, E.M. Temper — 2013
• Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromesCarrasco Flores, Dean Orestes — 2013
• An evolutionary perspective on chronic myelomonocytic leukemiaKrystal R. Seger — 2013
• A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trialMarshall R Thompson — 2013
• Development of an Epstein–Barr virus‐associated lymphoproliferative disorder in a patient treated with azacitidine for chronic myelomonocytic leukaemiaJuro Horiuti, Hideaki Kita — 2014

Related papers

• Sequential azacitidine and lenalidomide in patients with high-risk myelodysplastic syndromes and acute myeloid leukaemia: a single-arm, phase 1/2 studyCourtney D. DiNardo, Naval Daver, Elias Jabbour — 2014
• Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia.Michael Dickinson, Honar Cherif, Pierre Fenaux — 2018
• A Phase II Study of Selinexor, a First-in-Class XPO1 Inhibitor, in Patients with Myelodysplastic Syndromes and Oligoblastic Acute Myeloid Leukaemia Refractory to Hypomethylating AgentsJustin Taylor, Xiaoli Mi, Alexander Penson — 2020
• 5-azacitidine prolongs overall survival in patients with myelodysplastic syndrome - a systematic review and meta-analysisR. Gurion, Liat Vidal, A. Gafter-Gvili — 2010
• Prospective Comparison of Azacitidine Treatment between 7-Days and 5-Days Schedules for Patients with Higher-Risk Myelodysplastic Syndromes; Results of Japan Adult Leukemia Study Group MDS212 TrialToru Kiguchi, Shinya Sato, Kensuke Usuki — 2019
• Clinical benefit and survival endpoints from a phase III trial comparing decitabine (DAC) vs supportive care (SC) in patients with advanced myelodysplastic syndromes (MDS)H. I. Saba, C. S. Rosenfeld, Jean‐Pierre J. Issa — 2005
• Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion–dependent anemia and thrombocytopeniaGuillermo Garcia‐Manero, António Almeida, Aristoteles Giagounidis — 2016
• Comparison of Two Different Therapeutic Regimens with Azacitidine and Lenalidomide (Combined versus Sequential) in Higher-Risk Myelodysplastic Syndromes. Update of Long-Term Results of a Randomized Phase II Multicenter StudyCarlo Finelli, Cristina Clissa, Matilde Y. Follo — 2018
• Results of a Randomized, Open-Label, Phase IIIb Study of 2 Schedules of Decitabine in Higher-Risk Myelodysplastic Syndrome PatientsDepei Wu, Xin Du, Jie Jin — 2012
• Effect of Romiplostim in Patients (pts) with Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving AzacytidineHagop M. Kantarjian, Frank Giles, Peter L. Greenberg — 2008