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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

Wheatley, Keith, Goldstone, Anthony H., Littlewood, Tim, Hunter, Anne and Burnett, Alan Kenneth 2009. 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. British Journal of Haematology 146 (1) , pp. 54-63. 10.1111/j.1365-2141.2009.07710.x

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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 lg/d) or placebo was administered from day 8 after the end of chemotherapy until neutrophil recovery to 0Æ5 · 109/l (or for up to 10 d). Eight hundred and three patients were entered. Neutrophil recovery was quicker with G-CSF (P < 0Æ0001), 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 = 0Æ01). Complete remission (CR) rates were similar between arms (73% G-CSF, 75% placebo, P = 0Æ5), as were reasons for failure (induction death: P = 0Æ7; resistant disease: P = 0Æ5) and, for remitters, 5-year disease-free survival (34% vs. 38%, P = 0Æ3). Overall survival at 5 years was 29% with G-CSF vs. 36% with placebo (P = 0Æ10). Both CR rate (P = 0Æ006) and overall survival (P = 0Æ006) 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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords: AML, growth factor, G-CSF, induction, randomized trial
Publisher: Wiley-Blackwell
ISSN: 0007-1048
Last Modified: 25 Jun 2017 03:18
URI: https://orca.cardiff.ac.uk/id/eprint/26182

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