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 <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.
Wheatley
Keith
K
Birmingham Clinical Trials Unit, School of Cancer Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, UK. k.wheatley@bham.ac.uk
Goldstone
Anthony H
AH
Littlewood
Tim
T
Hunter
Anne
A
Burnett
Alan K
AK
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay; D000078224:Lenograstim; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim