Efficacy of granulocyte colony-stimulating factor in the treatment of acute myelogenous leukaemia: a multicentre randomized study.
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.
Usuki
Kensuke
K
Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan.
Urabe
Akio
A
Masaoka
Toru
T
Ohno
Ryuzo
R
Mizoguchi
Hideaki
H
Hamajima
Nobuyuki
N
Miyazaki
Tamotsu
T
Niitsu
Yousirou
Y
Yoshida
Yutaka
Y
Miura
Akira
A
Shibata
Akira
A
Abe
Tsukasa
T
Miura
Yasusada
Y
Ikeda
Yasuo
Y
Nomura
Takeo
T
Nagao
Tadami
T
Saitou
Hidehiko
H
Shirakawa
Shigeru
S
Ohkuma
Minoru
M
Matsuda
Tamotsu
T
Nakamura
Toru
T
Horiuchi
Atsushi
A
Kuramoto
Atsushi
A
Kimura
Ikurou
I
Irino
Syozo
S
Niho
Yoshiyuki
Y
Takatsuki
Kiyoshi
K
Tomonaga
Masao
M
Uchino
Haruto
H
Takaku
Fumimaro
F
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
D000900:Anti-Bacterial Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor