Title
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 studyUse 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
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Research group
Vaccine & Infectious Disease Institute (VAXINFECTIO)
Publication type
article
Publication
New York, N.Y.,
Subject
Human medicine
Source (journal)
Blood / American Society of Hematology. - New York, N.Y.
Volume/pages
106(2005):1, p. 27-34
ISSN
0006-4971
ISI
000230156500012
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
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.
Full text (open access)
https://repository.uantwerpen.be/docman/irua/da0638/5795.pdf
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