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Efficacy of granulocyte colony‐stimulating factor in the treatment of acute myelogenous leukaemia: a multicentre randomized study
Author(s) -
Usuki Kensuke,
Urabe Akio,
Masaoka Toru,
Ohno Ryuzo,
Mizoguchi Hideaki,
Hamajima Nobuyuki,
Miyazaki Tamotsu,
Niitsu Yousirou,
Yoshida Yutaka,
Miura Akira,
Shibata Akira,
Abe Tsukasa,
Miura Yasusada,
Ikeda Yasuo,
Nomura Takeo,
Nagao Tadami,
Saitou Hidehiko,
Shirakawa Shigeru,
Ohkuma Minoru,
Matsuda Tamotsu,
Nakamura Toru,
Horiuchi Atsushi,
Kuramoto Atsushi,
Kimura Ikurou,
Irino Syozo,
Niho Yoshiyuki,
Takatsuki Kiyoshi,
Tomonaga Masao,
Uchino Haruto,
Takaku Fumimaro
Publication year - 2002
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1046/j.1365-2141.2002.03251.x
Subject(s) - medicine , filgrastim , granulocyte colony stimulating factor , neutropenia , chemotherapy , randomized controlled trial , gastroenterology , absolute neutrophil count , febrile neutropenia , granulocyte , surgery
Summary. 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 × 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.