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 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.affiliation: Department of Hematology, University Tor Vergata, St Eugenio Hospital, P.le dell'Umanesimo, 10, 00144 Rome, Italy. mc7673@mclink.it
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jehn
authors.forename: Roberto
authors.initials: R
authors.lastname: Stasi
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marie
authors.forename: Petra
authors.initials: P
authors.lastname: Muus
authors.forename: Francois
authors.initials: F
authors.lastname: Lefrère
authors.forename: Zwi
authors.initials: Z
authors.lastname: Berneman
authors.forename: George
authors.initials: G
authors.lastname: Fillet
authors.forename: Claudio
authors.initials: C
authors.lastname: Denzlinger
authors.forename: Roel
authors.initials: R
authors.lastname: Willemze
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Leone
authors.forename: Marco
authors.initials: M
authors.lastname: Casini
authors.forename: Francesco
authors.initials: F
authors.lastname: Ricciuti
authors.forename: Marco
authors.initials: M
authors.lastname: Vignetti
authors.forename: Filip
authors.initials: F
authors.lastname: Beeldens
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
authors.forename: Theo
authors.initials: T
authors.lastname: De Witte
mesh_terms: D000208:Acute Disease; D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000078224:Lenograstim; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis
chemical_list: D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim