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

Julie Marie Vose, Arundathy N. Pandite, Roy A. Beveridge, Robert B. Geller, Michael W. Schuster, Jeanne E. Anderson, Charles F. LeMaistre, Tauseef Ahmed, Alberto Granena, Armand Keating, Jose M. Fernadez Ranada, Patrick J. Stiff, Imad Tabbara, Walter Longo, Edward A. Copelan, Craig Nichols, Anne Smith, David L. Topolsky, Philip Jay Bierman, M. E. Lebsack & 2 others Mary Lange, Leslie Garrison

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1617-1623
Number of pages7
JournalJournal of Clinical Oncology
Volume15
Issue number4
DOIs
StatePublished - Jan 1 1997

Fingerprint

Autologous Transplantation
Interleukin-3
Granulocyte-Macrophage Colony-Stimulating Factor
Bone Marrow Transplantation
Non-Hodgkin's Lymphoma
Bone Marrow
Transplants
Platelet Transfusion
Proteins
Neutrophils
Logistic Models
Body Surface Area
Exanthema
Intravenous Infusions
Blood Platelets
Drug Therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Vose, Julie Marie; Pandite, Arundathy N.; Beveridge, Roy A.; Geller, Robert B.; Schuster, Michael W.; Anderson, Jeanne E.; LeMaistre, Charles F.; Ahmed, Tauseef; Granena, Alberto; Keating, Armand; Fernadez Ranada, Jose M.; Stiff, Patrick J.; Tabbara, Imad; Longo, Walter; Copelan, Edward A.; Nichols, Craig; Smith, Anne; Topolsky, David L.; Bierman, Philip Jay; Lebsack, M. E.; Lange, Mary; Garrison, Leslie.

In: Journal of Clinical Oncology, Vol. 15, No. 4, 01.01.1997, p. 1617-1623.

Research output: Contribution to journalArticle

Vose, JM, Pandite, AN, Beveridge, RA, Geller, RB, Schuster, MW, Anderson, JE, LeMaistre, CF, Ahmed, T, Granena, A, Keating, A, Fernadez Ranada, JM, Stiff, PJ, Tabbara, I, Longo, W, Copelan, EA, Nichols, C, Smith, A, Topolsky, DL, Bierman, PJ, Lebsack, ME, Lange, M & Garrison, L 1997, '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', Journal of Clinical Oncology, vol. 15, no. 4, pp. 1617-1623. https://doi.org/10.1200/JCO.1997.15.4.1617
Vose, Julie Marie ; Pandite, Arundathy N. ; Beveridge, Roy A. ; Geller, Robert B. ; Schuster, Michael W. ; Anderson, Jeanne E. ; LeMaistre, Charles F. ; Ahmed, Tauseef ; Granena, Alberto ; Keating, Armand ; Fernadez Ranada, Jose M. ; Stiff, Patrick J. ; Tabbara, Imad ; Longo, Walter ; Copelan, Edward A. ; Nichols, Craig ; Smith, Anne ; Topolsky, David L. ; Bierman, Philip Jay ; Lebsack, M. E. ; Lange, Mary ; Garrison, Leslie. / 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. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 4. pp. 1617-1623.
@article{95e318345c8e4ae1b3775913396196a3,
title = "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",
abstract = "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.",
author = "Vose, {Julie Marie} and Pandite, {Arundathy N.} and Beveridge, {Roy A.} and Geller, {Robert B.} and Schuster, {Michael W.} and Anderson, {Jeanne E.} and LeMaistre, {Charles F.} and Tauseef Ahmed and Alberto Granena and Armand Keating and {Fernadez Ranada}, {Jose M.} and Stiff, {Patrick J.} and Imad Tabbara and Walter Longo and Copelan, {Edward A.} and Craig Nichols and Anne Smith and Topolsky, {David L.} and Bierman, {Philip Jay} and Lebsack, {M. E.} and Mary Lange and Leslie Garrison",
year = "1997",
month = "1",
day = "1",
doi = "10.1200/JCO.1997.15.4.1617",
language = "English (US)",
volume = "15",
pages = "1617--1623",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "4",

}

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 Marie

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 Jay

AU - Lebsack, M. E.

AU - Lange, Mary

AU - Garrison, Leslie

PY - 1997/1/1

Y1 - 1997/1/1

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.

UR - http://www.scopus.com/inward/record.url?scp=0031003466&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031003466&partnerID=8YFLogxK

U2 - 10.1200/JCO.1997.15.4.1617

DO - 10.1200/JCO.1997.15.4.1617

M3 - Article

VL - 15

SP - 1617

EP - 1623

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 4

ER -