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Title
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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
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Author
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Institution/Organisation
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EORTC GIMENA Leukemia Grps
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Abstract
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| 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-CSIF; (B) G-CSIF during chemotherapy; (C) G-CSIF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes; and (D) G-CSIF 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-CSIF 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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Language
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English
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Source (journal)
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Blood / American Society of Hematology. - New York, N.Y.
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Publication
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New York, N.Y.
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2005
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ISSN
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0006-4971
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DOI
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10.1182/BLOOD-2004-09-3728
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Volume/pages
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106
:1
(2005)
, p. 27-34
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ISI
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000230156500012
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Full text (Publisher's DOI)
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Full text (open access)
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