In vitro and in vivo action of recombinant human GM-CSF (rhGM-CSF) in patients with myelodysplastic syndromes.
The availability of rhGM-CSF has allowed the in vivo treatment of patients with cytopenia. Therefore, a phase I-II trial was initiated to study the effect of rhGM-CSF in patients with myelodysplastic syndromes who were not eligible for other kinds of therapy. rhGM-CSF has been tested in 10 patients in doses from 15 micrograms/m2 to 150 micrograms/m2 given intravenously over 8 hours for a cycle of 7 days followed by an interval of 14 days and a second 7-day treatment course. A dose-dependent increase in leukocyte count was observed in 9 of 10 patients. No change in reticulocyte numbers was seen and only one patient experienced an increase in platelet count. Toxicity mainly consisted of mild phlebitis at the site of infusion and sternal pain after bolus injection. An increase in blast cell counts in some patients necessitated the start of low-dose Ara-C therapy.
Hoelzer
D
D
Abteilung Hämatologie, Zentrum der Inneren Medizin, Universität Frankfurt, Federal Republic of Germany.
Ganser
A
A
Völkers
B
B
Greher
J
J
Walther
F
F
D003115:Colony-Stimulating Factors / Q000502:physiology / Q000627:therapeutic use* / Q000633:toxicity; D004341:Drug Evaluation; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D006133:Growth Substances / Q000502:physiology / Q000627:therapeutic use* / Q000633:toxicity; D006801:Humans; D007958:Leukocyte Count; D007970:Leukopenia / Q000188:drug therapy; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use / Q000633:toxicity
D003115:Colony-Stimulating Factors; D006133:Growth Substances; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor