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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.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
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
Sergio Amadori,
Stefan Suciu,
Ulrich Jehn,
Roberto Stasi,
Xavier Thomas,
Jean-Pierre Marie,
Petra Muus,
Francois Lefrère,
Zwi Berneman,
George Fillet,
Claudio Denzlinger,
Roel Willemze,
Pietro Leoni,
Giuseppe Leone,
Marco Casini,
Francesco Ricciuti,
Marco Vignetti,
Filip Beeldens,
Franco Mandelli,
Theo De Witte, for the EORTC/GIMEMA Leukemia Groups
From the Department of Hematology, University Tor Vergata, Rome, Italy; European Organisation for Research and Treatment of Cancer (EORTC) Data Center, Brussels, Belgium; the Department of Hematology, Klinikum Grosshadern Ludwig-Maximilians, Munich, Germany; the Hematology Unit, Regina Apostolorum Hospital, Albano Laziale, Italy; the Department of Hematology, Edouard Herriot Hospital, Lyon, France; the Department of Hematology, Hotel-Dieu Hospital, Paris, France; the Department of Hematology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; the Department of Hematology, Necker Hospital, Paris, France; the Department of Hematology, University Hospital, Edegem, Belgium; the Department of Hematology, Sart-Tilman Hospital, Liege, Belgium; the Department of Hematology, University Hospital, Tubingen, Germany; the Department of Hematology, University Hospital, Leiden, the Netherlands; the Department of Hematology, University Hospital, Ancona, Italy; the Department of Hematology, Catholic University, Rome, Italy; the Department of Hematology, General Hospital, Bolzano, Italy; the Department of Hematology, S. Carlo Hospital, Potenza, Italy; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Data Center, Rome, Italy; and the Department of Hematology, University La Sapienza, Rome, Italy.
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 4 treatment arms: (A) no G-CSF; (B) G-CSF during chemotherapy; (C) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes; and (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 2 x 2 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 = .009), whereas no significant difference was observed between groups A + B and C + D (50.6% vs 56.4%, P = .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 < .001) and a shorter hospitalization (mean, 27.2 vs 29.7 days; P < .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.
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