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.

• Authors: 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, EORTC/GIMEMA Leukemia Group
• Journal: Blood (Blood) Vol. 106 Issue 1 Pg. 27-34 (Jul 01 2005) ISSN: 0006-4971 [Print] United States
• PMID: 15761020 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Adjuvants, Immunologic
• Antineoplastic Agents
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Lenograstim

Topics

• Acute Disease
• Adjuvants, Immunologic (administration & dosage, adverse effects)
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage)
• Disease-Free Survival
• Drug Therapy, Combination
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects)
• Humans
• Lenograstim
• Leukemia, Myeloid (drug therapy, mortality)
• Male
• Middle Aged
• Recombinant Proteins (administration & dosage, adverse effects)
• Survival Analysis