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- Title
Randomized placebo-controlled trial of granulocyte colony stimulating factor (G-CSF) as supportive care after induction chemotherapy in adult patients with acute myeloid leukaemia: a study of the United Kingdom Medical Research Council Adult Leukaemia Working Party
- Authors
Wheatley, Keith; Goldstone, Anthony H.; Littlewood, Tim; Hunter, Anne; Burnett, Alan K.
- Abstract
The role of granulocyte colony stimulating factor (G-CSF) as supportive therapy following intensive induction chemotherapy for acute myeloid leukaemia (AML) in adults was investigated in a randomized trial. G-CSF (Lenograstim, 263 μg/d) or placebo was administered from day 8 after the end of chemotherapy until neutrophil recovery to 0·5 × 109/l (or for up to 10 d). Eight hundred and three patients were entered. Neutrophil recovery was quicker with G-CSF ( P < 0·0001), but this did not lead to differences in the number, severity or duration of infections. There were no substantial supportive care savings, although G-CSF patients spent 2 d less in hospital ( P = 0·01). Complete remission (CR) rates were similar between arms (73% G-CSF, 75% placebo, P = 0·5), as were reasons for failure (induction death: P = 0·7; resistant disease: P = 0·5) and, for remitters, 5-year disease-free survival (34% vs. 38%, P = 0·3). Overall survival at 5 years was 29% with G-CSF vs. 36% with placebo ( P = 0·10). Both CR rate ( P = 0·006) and overall survival ( P = 0·006) were worse with G-CSF in patients aged <40 years, but this may be a chance effect. There is some evidence from this trial of an adverse effect of G-CSF but these data need to be viewed in the context of the evidence from the other trials.
- Subjects
GRANULOCYTES; DRUG therapy; CLINICAL trials; ACUTE myeloid leukemia; PLACEBOS
- Publication
British Journal of Haematology, 2009, Vol 146, Issue 1, p54
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/j.1365-2141.2009.07710.x