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.
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 Leukemia Group.
Department of Hematology, University Tor Vergata, St Eugenio Hospital, P.le dell'Umanesimo, 10, 00144 Rome, Italy. mc7673@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 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.
PMID: 15761020 [PubMed - indexed for MEDLINE]
PMCID: PMC1895135