Effects of long-term treatment with recombinant human granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndrome.
We examined the effects of long-term treatment with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) in 61 patients with myelodysplastic syndrome (MDS). Patients were randomly assigned to receive daily subcutaneous injection of 60 micrograms/m2, 125 micrograms/m2 or 250 micrograms/m2 for 8 weeks. A significant increase in granulocyte counts including neutrophils and eosinophils was shown from one week after the start of the treatment in all three dose groups. The increase in granulocyte counts reached a plateau at the 4th week and was sustained during the treatment period. However, no consistent change in other cell lineages including monocytes, lymphocytes, reticulocytes and platelets were observed. Nevertheless peak-levels of these cells were significantly higher than the pre-treatment levels. In higher dose groups, the number of patients developing infections was reduced. There was no significant difference in the incidence of adverse events among the 3 dose groups, and the toxicity was generally well-tolerated. These observations indicate that treatment with rhGM-CSF can be of potential therapeutic benefit to patients with MDS.
1st Department of Medicine, Kyoto University School of Medicine, Japan.
Y
Y
Yoshida
T
T
Nakahata
A
A
Shibata
M
M
Takahashi
Y
Y
Moriyama
K
K
Kaku
T
T
Masaoka
T
T
Kaneko
S
S
Miwa
D000293:Adolescent; D000328:Adult; D000368:Aged; D003141:Communicable Diseases / Q000150:complications; D004305:Dose-Response Relationship, Drug; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006410:Hematopoiesis; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor