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.

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 microg/d) or placebo was administered from day 8 after the end of chemotherapy until neutrophil recovery to 0.5 x 10(9)/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