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      Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial.

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          Abstract

          Hypomethylating drugs are the standard treatment for patients with high-risk myelodysplastic syndromes. Survival is poor after failure of these drugs; there is no approved second-line therapy. We compared the overall survival of patients receiving rigosertib and best supportive care with that of patients receiving best supportive care only in patients with myelodysplastic syndromes with excess blasts after failure of azacitidine or decitabine treatment.

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          Author and article information

          Journal
          Lancet Oncol.
          The Lancet. Oncology
          Elsevier BV
          1474-5488
          1470-2045
          Apr 2016
          : 17
          : 4
          Affiliations
          [1 ] University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX, USA. Electronic address: ggarciam@mdanderson.org.
          [2 ] Hôpital St Louis/Université Paris 7, Paris, France.
          [3 ] Mayo Clinic, Rochester, MN, USA.
          [4 ] University of Maryland, Greenebaum Cancer Center, Baltimore, MD, USA.
          [5 ] Leukemia Program, Cleveland Clinic, Cleveland, OH, USA.
          [6 ] Weill Cornell Medical College, New York, NY, USA.
          [7 ] Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.
          [8 ] Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
          [9 ] Stanford Cancer Center, Stanford, CA, USA.
          [10 ] Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany.
          [11 ] Dana Farber Cancer Institute, Boston, MA, USA.
          [12 ] University of Kansas Medical Center, Westwood, KS, USA.
          [13 ] Universitätsklinikum zu Köln, Klinik I für Innere Medizin, Köln, Nordhein-Westfalen, Germany.
          [14 ] University of Chicago Medical Center, Chicago, IL, USA.
          [15 ] Froedtert Hospital and the Medical College of Wisconsin Division of Hematology and Oncology, Milwaukee, WI, USA.
          [16 ] University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
          [17 ] University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX, USA.
          [18 ] Onconova Therapeutics, Newtown, PA, USA.
          [19 ] Icahn School of Medicine at Mount Sinai, New York, NY, USA.
          Article
          S1470-2045(16)00009-7
          10.1016/S1470-2045(16)00009-7
          26968357
          4a4d3f2e-f31d-4de5-b85a-66c0871eabe4
          Copyright © 2016 Elsevier Ltd. All rights reserved.
          History

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