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.

Amadori, S., Suciu, S., Jehn, U., Stasi, R., Thomas, X., Marie, J.p., et al. (2005). 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. BLOOD, 106(1), 27-34 [10.1182/blood-2004-09-3728].

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, SERGIO;
2005-01-01

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.
2005
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/15 - MALATTIE DEL SANGUE
English
antibiotic agent; antifungal agent; antineoplastic agent; cytarabine; etoposide; idarubicin; recombinant granulocyte colony stimulating factor; acute granulocytic leukemia; acute leukemia; adult; aged; article; bacterial infection; bleeding; bone pain; cancer combination chemotherapy; cancer survival; cardiotoxicity; chemotherapy induced emesis; chill; clinical trial; controlled clinical trial; controlled study; diarrhea; female; fever; hematopoiesis; human; hypotension; liver toxicity; major clinical study; male; mycosis; nausea; neutropenia; open study; phase 3 clinical trial; priority journal; pruritus; randomized controlled trial; rash; relapse; rigor; treatment outcome; Acute Disease; Adjuvants, Immunologic; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; Drug Therapy, Combination; Female; Granulocyte Colony-Stimulating Factor; Humans; Leukemia, Myeloid; Male; Middle Aged; Recombinant Proteins; Survival Analysis
Amadori, S., Suciu, S., Jehn, U., Stasi, R., Thomas, X., Marie, J.p., et al. (2005). 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. BLOOD, 106(1), 27-34 [10.1182/blood-2004-09-3728].
Amadori, S; Suciu, S; Jehn, U; Stasi, R; Thomas, X; Marie, Jp; Muus, P; Lefrere, 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
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/41640
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