Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer.
BACKGROUND
The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo.


RESULTS
No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500 x 10(6) per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P less than 0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100.


CONCLUSIONS
In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration.
Nemunaitis
J
J
Fred Hutchinson Cancer Research Center, Seattle, WA.
Rabinowe
S N
SN
Singer
J W
JW
Bierman
P J
PJ
Vose
J M
JM
Freedman
A S
AS
Onetto
N
N
Gillis
S
S
Oette
D
D
Gold
M
M
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002648:Child; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D017053:Infection Control; D007938:Leukemia / Q000601:surgery* / Q000628:therapy; D015470:Leukemia, Myeloid, Acute / Q000601:surgery; D007958:Leukocyte Count; D008223:Lymphoma / Q000601:surgery* / Q000628:therapy; D008228:Lymphoma, Non-Hodgkin / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000628:therapy; D011183:Postoperative Complications / Q000628:therapy; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000601:surgery; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D014182:Transplantation, Autologous
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor