Granulocyte-macrophage colony-stimulating factor/interleukin-3 fusion protein versus granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for non-Hodgkin's lymphoma: results of a randomized double-blind trial.
OBJECTIVE
A phase III trial to compare PIXY321 with granulocyte-macrophage colony-stimulating factor (GM-CSF) following high-dose therapy and autologous bone marrow transplant (ABMT) was conducted to evaluate the time to hematopoietic recovery.


METHODS
One hundred seventy-seven patients with non-Hodgkin's lymphoma (NHL) receiving ABMT were randomized to receive either PIXY321 750 micrograms/m2/d divided into two subcutaneous (SC) doses or GM-CSF 250 micrograms/m2/d as a 2-hour intravenous (IV) infusion starting on day 0 post-ABMT for a maximum of 28 days.


RESULTS
The median time to reach an absolute neutrophil count (ANC) > or = 500/microL in the PIXY321 group was 17 days versus 19 days in the GM-CSF group (P = .07) and the median time to reach platelet transfusion independence in the PIXY321 group was 25 days versus 23 days in the GM-CSF group (P = .30). The toxicity profiles of the two agents appeared to be equivalent with the exception of more patients in the PIXY321 group with a rash (64%) compared with the GM-CSF group (48%) (P = .028). A logistic regression model identified the use of a non-total-body irradiation (TBI) regimen and/or receipt of unpurged marrow and a body-surface area greater than 2.0 m2 as predictive of faster neutrophil engraftment, and those three factors, as well as the receipt of < or = two prior chemotherapy regimens as predictive for rapid platelet engraftment.


CONCLUSIONS
There was a trend toward a slight improvement in neutrophil engraftment post-ABMT with the PIXY321 administered by an SC route compared with GM-CSF administered by an IV route. However, no differences could be identified between the two agents with respect to the time to platelet transfusion independence. Patient, regimen, and graft characteristics were most predictive of the engraftment tempo.
Vose
J M
JM
University of Nebraska Medical Center, Omaha 68198-3330, USA. jmvose@mail.unmc.edu
Pandite
A N
AN
Beveridge
R A
RA
Geller
R B
RB
Schuster
M W
MW
Anderson
J E
JE
LeMaistre
C F
CF
Ahmed
T
T
Granena
A
A
Keating
A
A
Fernandez Ranada
J M
JM
Stiff
P J
PJ
Tabbara
I
I
Longo
W
W
Copelan
E A
EA
Nichols
C
C
Smith
A
A
Topolsky
D L
DL
Bierman
P J
PJ
Lebsack
M E
ME
Lange
M
M
Garrison
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001830:Body Surface Area; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006410:Hematopoiesis; D006801:Humans; D007377:Interleukin-3 / Q000627:therapeutic use*; D016015:Logistic Models; D008228:Lymphoma, Non-Hodgkin / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010976:Platelet Count; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D007377:Interleukin-3; D011993:Recombinant Fusion Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor