Low-dose non-glycosylated rhGM-CSF is effective for the treatment of delayed hematopoietic recovery after autologous marrow or peripheral blood stem cell transplantation.
Twenty-six patients with hematologic malignancies (20) or solid tumors (six) were treated with non-glycosylated rhGM-CSF (E. coli) for delayed hematopoietic recovery (granulocytes < 0.1 x 10(9)/l on day 21 or < 0.5 x 10(9)/l on day 28) after autologous marrow or peripheral blood stem cell transplantation. Median pretreatment granulocytes were 0.1 x 10(9)/l (range 0-0.4 x 10(9)/l). Treatment with rhGM-CSF was initiated at 60-250 micrograms/m2 subcutaneously daily with dose escalation every 7 days if there was no response. Within 14 days, 21 (84%) of the 25 evaluable patients achieved granulocytes > 0.5 x 10(9)/l and 17 (68%) had granulocytes > 1.0 x 10(9)/l. For those who responded within 14 days, granulocytes were > 0.5 x 10(9)/l at a median of 3 days (range 1-13) and > 1.0 x 10(9)/l at 6 days (range 2-12). Sixteen of the 23 patients receiving an initial rhGM-CSF dose of 60-125 micrograms/m2 achieved granulocytes > 1.0 x 10(9)/l. Three patients discontinued use of rhGM-CSF because of toxicity, and four patients never recovered despite use of rhGM-CSF doses as high as 1000 micrograms/m2. Graft failure-related mortality was 16% at 4 months after transplantation. These results demonstrate that relatively low doses of non-glycosylated rhGM-CSF administered subcutaneously daily can be used to promote granulocyte recovery in patients with delayed engraftment after autologous transplantation. No beneficial effects were seen on red cell or platelet recovery.
Ippoliti
C
C
Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston.
Przepiorka
D
D
Giralt
S
S
Andersson
B S
BS
Wallerstein
R O
RO
Gutterman
J
J
Deisseroth
A B
AB
Champlin
R E
RE
D000293:Adolescent; D000328:Adult; D001804:Blood Transfusion, Autologous; D016026:Bone Marrow Transplantation; D005260:Female; D006031:Glycosylation; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D006098:Granulocytes; D006410:Hematopoiesis / Q000187:drug effects*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use; D013997:Time Factors
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor