Azacitidine
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Drugs 2012; 72 (8): 1111-1136 0012-6667/12/0008-1111/$55.55/0 Adis ª 2012 Springer International Publishing AG. All rights reserved.
Azacitidine A Review of its Use in the Management of Myelodysplastic Syndromes/Acute Myeloid Leukaemia Gillian M. Keating Adis, Auckland, New Zealand Various sections of the manuscript reviewed by: A.T. Fathi, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; G. Huls, Department of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; L. Maurillo, Chair of Hematology, Tor Vergata Foundation Polyclinic, Rome, Italy; P. Musto, Department of Onco-Hematology, IRCCS, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy; T. Pre´bet, Department of Haematology, Institut Paoli Calmettes, Marseille, France; V. Santini, Haematology SOD, AOU Careggi, University of Florence, Firenze, Italy; T. Uchida, Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan. Data Selection Sources: Medical literature (including published and unpublished data) on ‘azacitidine’ was identified by searching databases (including MEDLINE and EMBASE) for articles published since 1996, bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug. Search strategy: MEDLINE and EMBASE search terms were ‘azacitidine’ and (‘myelodysplastic syndrome’ or ‘myelodysplastic syndromes’). Searches were last updated 16 April 2012. Selection: Studies in patients with myelodysplastic syndromes who received azacitidine. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: Azacitidine, myelodysplastic syndromes, acute myeloid leukaemia, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.
Contents Abstract. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Pharmacodynamic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Pharmacokinetic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Therapeutic Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 The Cancer and Leukemia Group B 9221 Trial. . . . . . . . . . . . . . . . . . . . . . . . . . . .
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