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Blood, 1 July 2005, Vol. 106, No. 1, pp. 27-34. Prepublished online as a Blood First Edition Paper on March 10, 2005; DOI 10.1182/blood-2004-09-3728. This Article Full Text (PDF) All Versions of this Article: 2004-09-3728v1 106/1/27    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Amadori, S. Articles by De Witte, T. Search for Related Content PubMed PubMed Citation Articles by Amadori, S. Articles by De Witte, T. Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted September 27, 2004 Accepted February 25, 2005 Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia: final results of AML-13, a randomized phase 3 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto (EORTC/GIMEMA) Leukemia Groups Sergio Amadori*, Stefan Suciu, Ulrich Jehn, Roberto Stasi, Xavier Thomas, Jean-Pierre Marie, Petra Muus, Francois Lefrere, Zwi Berneman, George Fillet, Claudio Denzlinger, Roel Willemze, Pietro Leoni, Giuseppe Leone, Marco Casini, Francesco Ricciuti, Marco Vignetti, Filip Beeldens, Franco Mandelli, and Theo De Witte Department of Hematology, University Tor Vergata, Rome, Italy EORTC Data Center, Brussels, Belgium Department of Hematology, Klinikum Grosshadern Ludwig-Maximilians, Munich, Germany Hematology Unit, Regina Apostolorum Hospital, Albano Laziale, Italy Department of Hematology, Edouard Herriot Hospital, Lyon, France Department of Hematology, Hotel-Dieu Hospital, Paris, France Department of Hematology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands Department of Hematology, Necker Hospital, Paris, France Department of Hematology, University Hospital, Edegem, Belgium Department of Hematology, Sart-Tilman Hospital, Liege, Belgium Department of Hematology, University Hospital, Tubingen, Germany Department of Hematology, University Hospital, Leiden, The Netherlands Department of Hematology, University Hospital, Ancona, Italy Department of Hematology, Catholic University, Rome, Italy Department of Hematology, General Hospital, Bolzano, Italy Department of Hematology, S. Carlo Hospital, Potenza, Italy GIMEMA Data Center, Rome, Italy Department of Hematology, University La Sapienza, Rome, Italy * Corresponding author; email: mc7673{at}mclink.it. The role of glycosylated recombinant human granulocyte colony-stimulating factor (G-CSF) in the induction treatment of older adults with acute myeloid leukemia (AML) is still uncertain. In this trial, a total of 722 patients with newly diagnosed AML, median age 68 years, were randomized into four treatment arms: (A) no G-CSF; (B) G-CSF during chemotherapy; (C) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes; (D) G-CSF during, and after chemotherapy. The complete remission (CR) rate was 48.9% in group A, 52.2% in group B, 48.3% in group C, and 64.4% in group D. Analysis according to the 2x2 factorial design indicated that the CR rate was significantly higher in patients who received G-CSF during chemotherapy (58.3% for groups B+D vs. 48.6% for groups A+C; P=0.009), whereas no significant difference was observed between groups A+B and C+D (50.6% vs. 56.4%, P=0.12). In terms of overall survival, no significant differences were observed between the various groups. Patients who received G-CSF after chemotherapy had a shorter time to neutrophil recovery (median 20 vs. 25 days; P<0.001) and a shorter hospitalization (mean 27.2 vs. 29.7 days, P<0.001). We conclude that although priming with G-CSF can improve the CR rate, the use of G-CSF during and/or after chemotherapy has no effect on the long-term outcome of AML in older patients. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Divide and conquer: stomping leukemia cells by stimulating them to grow Charles A. 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