title: Efficacy of granulocyte colony-stimulating factor in the treatment of acute myelogenous leukaemia: a multicentre randomized study.
abstract: To investigate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in patients with acute myelogenous leukaemia, a multicentre randomized study was performed. From October 1993 to September 1996, 270 patients with newly diagnosed acute myelogenous leukaemia were randomized to G-CSF or control groups after remission induction therapy. The G-CSF group received G-CSF (Filgrastim) from 48 h after the completing chemotherapy until the absolute neutrophil count exceeded 1.5 x 10(9)/l. The control group did not receive G-CSF unless severe infection occurred. There were 245 evaluable patients (120 and 125 in the G-CSF and control groups respectively). The complete remission rate was similar in the G-CSF and control groups (80.8% versus 76.8%), as was the 5-year probability of disease-free survival (34.5% versus 33.6%) and overall survival (42.7% versus 35.6%). Neutrophil recovery was significantly faster in the G-CSF group than in the control group (12 d versus 18 d, P = 0.0001). The median duration of febrile neutropenia was significantly shorter in the G-CSF group than in the control group (3 d versus 4 d, P = 0.0001). In conclusion, prophylactic administration of G-CSF after remission induction therapy for acute myelogenous leukaemia is safe and useful even in patients without infection on completing chemotherapy.
authors.affiliation: Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Usuki
authors.forename: Akio
authors.initials: A
authors.lastname: Urabe
authors.forename: Toru
authors.initials: T
authors.lastname: Masaoka
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Ohno
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mizoguchi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hamajima
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Miyazaki
authors.forename: Yousirou
authors.initials: Y
authors.lastname: Niitsu
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yoshida
authors.forename: Akira
authors.initials: A
authors.lastname: Miura
authors.forename: Akira
authors.initials: A
authors.lastname: Shibata
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Abe
authors.forename: Yasusada
authors.initials: Y
authors.lastname: Miura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
authors.forename: Takeo
authors.initials: T
authors.lastname: Nomura
authors.forename: Tadami
authors.initials: T
authors.lastname: Nagao
authors.forename: Hidehiko
authors.initials: H
authors.lastname: Saitou
authors.forename: Shigeru
authors.initials: S
authors.lastname: Shirakawa
authors.forename: Minoru
authors.initials: M
authors.lastname: Ohkuma
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Matsuda
authors.forename: Toru
authors.initials: T
authors.lastname: Nakamura
authors.forename: Atsushi
authors.initials: A
authors.lastname: Horiuchi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kuramoto
authors.forename: Ikurou
authors.initials: I
authors.lastname: Kimura
authors.forename: Syozo
authors.initials: S
authors.lastname: Irino
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Niho
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Takatsuki
authors.forename: Masao
authors.initials: M
authors.lastname: Tomonaga
authors.forename: Haruto
authors.initials: H
authors.lastname: Uchino
authors.forename: Fumimaro
authors.initials: F
authors.lastname: Takaku
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D005260:Female; D005334:Fever / Q000150:complications / Q000188:drug therapy; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009503:Neutropenia; D011994:Recombinant Proteins; D012074:Remission Induction / Q000379:methods
chemical_list: D000900:Anti-Bacterial Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor