TY - JOUR
T1 - 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
T2 - Results of a randomized double-blind trial
AU - Vose, Julie M.
AU - Pandite, Arundathy N.
AU - Beveridge, Roy A.
AU - Geller, Robert B.
AU - Schuster, Michael W.
AU - Anderson, Jeanne E.
AU - LeMaistre, Charles F.
AU - Ahmed, Tauseef
AU - Granena, Alberto
AU - Keating, Armand
AU - Fernadez Ranada, Jose M.
AU - Stiff, Patrick J.
AU - Tabbara, Imad
AU - Longo, Walter
AU - Copelan, Edward A.
AU - Nichols, Craig
AU - Smith, Anne
AU - Topolsky, David L.
AU - Bierman, Philip J.
AU - Lebsack, M. E.
AU - Lange, Mary
AU - Garrison, Leslie
PY - 1997/4
Y1 - 1997/4
N2 - Purpose: 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. Patients and Methods: One hundred seventy-seven patients with non-Hodgkin's lymphoma (NHL) receiving ABMT were randomized to receive either PIXY321 750 μg/m2/d divided into two subcutaneous (SC) doses or GM-CSF 250 μg/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) ≤ 500/μL 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 ≤ two prior chemotherapy regimens as predictive for rapid platelet engraftment. Conclusion: 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.
AB - Purpose: 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. Patients and Methods: One hundred seventy-seven patients with non-Hodgkin's lymphoma (NHL) receiving ABMT were randomized to receive either PIXY321 750 μg/m2/d divided into two subcutaneous (SC) doses or GM-CSF 250 μg/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) ≤ 500/μL 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 ≤ two prior chemotherapy regimens as predictive for rapid platelet engraftment. Conclusion: 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.
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U2 - 10.1200/JCO.1997.15.4.1617
DO - 10.1200/JCO.1997.15.4.1617
M3 - Article
C2 - 9193361
AN - SCOPUS:0031003466
SN - 0732-183X
VL - 15
SP - 1617
EP - 1623
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 4
ER -