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.

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-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.

journal_name

Blood

journal_title

Blood

authors

Amadori S,Suciu S,Jehn U,Stasi R,Thomas X,Marie JP,Muus P,Lefrère F,Berneman Z,Fillet G,Denzlinger C,Willemze R,Leoni P,Leone G,Casini M,Ricciuti F,Vignetti M,Beeldens F,Mandelli F,De Witte T,EORTC\/GIMEMA Leukemi

doi

10.1182/blood-2004-09-3728

subject

Has Abstract

pub_date

2005-07-01 00:00:00

pages

27-34

issue

1

eissn

0006-4971

issn

1528-0020

pii

2004-09-3728

journal_volume

106

pub_type

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