Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells

J. N. Winter, H. M. Lazarus, A. Rademaker, M. Villa, C. Mangan, M. Tallman, L. Jahnke, L. Gordon, S. Newman, K. Byrd, B. W. Cooper, N. Horvath, E. Crum, E. A. Stadtmauer, E. Conklin, A. Bauman, J. Martin, C. Goolsby, S. L. Gerson, J. BenderM. O'Gorman

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Abstract

Purpose: To study the toxicity and efficacy of combined granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) administration for mobilization of hematopoietic progenitor cells (HPCs). Materials and Methods: Cohorts of a minimum of five patients each were treated subcutaneously as follows: G-CSF 5 μg/kg an days 1 to 12 and GM-CSF at .5, 1, or 5 μg/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 μg/kg on days 1 to 12 and G-CSF 5 μg/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 μg/kg each on days 1 to 12 (cohort 5). Ten-liter aphereses were performed on days 1 (baseline, pre-CSF), 5, 7, 11, and 13. Colony assays for granulocyte-macrophage colony-forming units (CFU- GM) and erythroid burst-forming units (BFU-E) were performed on each harvest. Results: The principal toxicities were myalgias, bone pain, fever, nausea, and mild thrombocytopenia, but none was dose-limiting. Four days of treatment with either G-CSF or GM-CSF resulted in dramatic and sustained increases in the numbers of CFU-GM per kilogram collected per harvest that represented 35.6 ± 8.9- and 33.7 ± 13.0-fold increases over baseline, respectively. This increment was attributable both to increased numbers of mononuclear cells collected per 10-L apheresis and to increased concentrations of progenitors within each collection. The administration of G-CSF to patients already receiving GM-CSF (cohort 4) caused the HPC content to surge to nearly 80-fold the baseline (P = .024); the reverse sequence, ie, the addition of GM-CSF to G-CSF, was less effective. The CFU-GM content of the baseline aphereses correlated with the maximal mobilization achieved (r = .74, P = .001). Conclusion: Combined G-CSF and GM-CSF administration effectively and predictably mobilizes HPCs and facilitates apheresis.

Original languageEnglish
Pages (from-to)277-286
Number of pages10
JournalJournal of Clinical Oncology
Volume14
Issue number1
StatePublished - Jan 1 1996
Externally publishedYes

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Granulocyte Colony-Stimulating Factor
Granulocyte-Macrophage Colony-Stimulating Factor
Hematopoietic Stem Cells
Granulocyte-Macrophage Progenitor Cells
Blood Component Removal
Erythroid Precursor Cells
Myalgia
Thrombocytopenia
Nausea
Fever
Cell Count
Bone and Bones
Pain

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells. / Winter, J. N.; Lazarus, H. M.; Rademaker, A.; Villa, M.; Mangan, C.; Tallman, M.; Jahnke, L.; Gordon, L.; Newman, S.; Byrd, K.; Cooper, B. W.; Horvath, N.; Crum, E.; Stadtmauer, E. A.; Conklin, E.; Bauman, A.; Martin, J.; Goolsby, C.; Gerson, S. L.; Bender, J.; O'Gorman, M.

In: Journal of Clinical Oncology, Vol. 14, No. 1, 01.01.1996, p. 277-286.

Research output: Contribution to journalArticle

Winter, JN, Lazarus, HM, Rademaker, A, Villa, M, Mangan, C, Tallman, M, Jahnke, L, Gordon, L, Newman, S, Byrd, K, Cooper, BW, Horvath, N, Crum, E, Stadtmauer, EA, Conklin, E, Bauman, A, Martin, J, Goolsby, C, Gerson, SL, Bender, J & O'Gorman, M 1996, 'Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells', Journal of Clinical Oncology, vol. 14, no. 1, pp. 277-286.
Winter, J. N. ; Lazarus, H. M. ; Rademaker, A. ; Villa, M. ; Mangan, C. ; Tallman, M. ; Jahnke, L. ; Gordon, L. ; Newman, S. ; Byrd, K. ; Cooper, B. W. ; Horvath, N. ; Crum, E. ; Stadtmauer, E. A. ; Conklin, E. ; Bauman, A. ; Martin, J. ; Goolsby, C. ; Gerson, S. L. ; Bender, J. ; O'Gorman, M. / Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 1. pp. 277-286.
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abstract = "Purpose: To study the toxicity and efficacy of combined granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) administration for mobilization of hematopoietic progenitor cells (HPCs). Materials and Methods: Cohorts of a minimum of five patients each were treated subcutaneously as follows: G-CSF 5 μg/kg an days 1 to 12 and GM-CSF at .5, 1, or 5 μg/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 μg/kg on days 1 to 12 and G-CSF 5 μg/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 μg/kg each on days 1 to 12 (cohort 5). Ten-liter aphereses were performed on days 1 (baseline, pre-CSF), 5, 7, 11, and 13. Colony assays for granulocyte-macrophage colony-forming units (CFU- GM) and erythroid burst-forming units (BFU-E) were performed on each harvest. Results: The principal toxicities were myalgias, bone pain, fever, nausea, and mild thrombocytopenia, but none was dose-limiting. Four days of treatment with either G-CSF or GM-CSF resulted in dramatic and sustained increases in the numbers of CFU-GM per kilogram collected per harvest that represented 35.6 ± 8.9- and 33.7 ± 13.0-fold increases over baseline, respectively. This increment was attributable both to increased numbers of mononuclear cells collected per 10-L apheresis and to increased concentrations of progenitors within each collection. The administration of G-CSF to patients already receiving GM-CSF (cohort 4) caused the HPC content to surge to nearly 80-fold the baseline (P = .024); the reverse sequence, ie, the addition of GM-CSF to G-CSF, was less effective. The CFU-GM content of the baseline aphereses correlated with the maximal mobilization achieved (r = .74, P = .001). Conclusion: Combined G-CSF and GM-CSF administration effectively and predictably mobilizes HPCs and facilitates apheresis.",
author = "Winter, {J. N.} and Lazarus, {H. M.} and A. Rademaker and M. Villa and C. Mangan and M. Tallman and L. Jahnke and L. Gordon and S. Newman and K. Byrd and Cooper, {B. W.} and N. Horvath and E. Crum and Stadtmauer, {E. A.} and E. Conklin and A. Bauman and J. Martin and C. Goolsby and Gerson, {S. L.} and J. Bender and M. O'Gorman",
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T1 - Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells

AU - Winter, J. N.

AU - Lazarus, H. M.

AU - Rademaker, A.

AU - Villa, M.

AU - Mangan, C.

AU - Tallman, M.

AU - Jahnke, L.

AU - Gordon, L.

AU - Newman, S.

AU - Byrd, K.

AU - Cooper, B. W.

AU - Horvath, N.

AU - Crum, E.

AU - Stadtmauer, E. A.

AU - Conklin, E.

AU - Bauman, A.

AU - Martin, J.

AU - Goolsby, C.

AU - Gerson, S. L.

AU - Bender, J.

AU - O'Gorman, M.

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N2 - Purpose: To study the toxicity and efficacy of combined granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) administration for mobilization of hematopoietic progenitor cells (HPCs). Materials and Methods: Cohorts of a minimum of five patients each were treated subcutaneously as follows: G-CSF 5 μg/kg an days 1 to 12 and GM-CSF at .5, 1, or 5 μg/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 μg/kg on days 1 to 12 and G-CSF 5 μg/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 μg/kg each on days 1 to 12 (cohort 5). Ten-liter aphereses were performed on days 1 (baseline, pre-CSF), 5, 7, 11, and 13. Colony assays for granulocyte-macrophage colony-forming units (CFU- GM) and erythroid burst-forming units (BFU-E) were performed on each harvest. Results: The principal toxicities were myalgias, bone pain, fever, nausea, and mild thrombocytopenia, but none was dose-limiting. Four days of treatment with either G-CSF or GM-CSF resulted in dramatic and sustained increases in the numbers of CFU-GM per kilogram collected per harvest that represented 35.6 ± 8.9- and 33.7 ± 13.0-fold increases over baseline, respectively. This increment was attributable both to increased numbers of mononuclear cells collected per 10-L apheresis and to increased concentrations of progenitors within each collection. The administration of G-CSF to patients already receiving GM-CSF (cohort 4) caused the HPC content to surge to nearly 80-fold the baseline (P = .024); the reverse sequence, ie, the addition of GM-CSF to G-CSF, was less effective. The CFU-GM content of the baseline aphereses correlated with the maximal mobilization achieved (r = .74, P = .001). Conclusion: Combined G-CSF and GM-CSF administration effectively and predictably mobilizes HPCs and facilitates apheresis.

AB - Purpose: To study the toxicity and efficacy of combined granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) administration for mobilization of hematopoietic progenitor cells (HPCs). Materials and Methods: Cohorts of a minimum of five patients each were treated subcutaneously as follows: G-CSF 5 μg/kg an days 1 to 12 and GM-CSF at .5, 1, or 5 μg/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 μg/kg on days 1 to 12 and G-CSF 5 μg/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 μg/kg each on days 1 to 12 (cohort 5). Ten-liter aphereses were performed on days 1 (baseline, pre-CSF), 5, 7, 11, and 13. Colony assays for granulocyte-macrophage colony-forming units (CFU- GM) and erythroid burst-forming units (BFU-E) were performed on each harvest. Results: The principal toxicities were myalgias, bone pain, fever, nausea, and mild thrombocytopenia, but none was dose-limiting. Four days of treatment with either G-CSF or GM-CSF resulted in dramatic and sustained increases in the numbers of CFU-GM per kilogram collected per harvest that represented 35.6 ± 8.9- and 33.7 ± 13.0-fold increases over baseline, respectively. This increment was attributable both to increased numbers of mononuclear cells collected per 10-L apheresis and to increased concentrations of progenitors within each collection. The administration of G-CSF to patients already receiving GM-CSF (cohort 4) caused the HPC content to surge to nearly 80-fold the baseline (P = .024); the reverse sequence, ie, the addition of GM-CSF to G-CSF, was less effective. The CFU-GM content of the baseline aphereses correlated with the maximal mobilization achieved (r = .74, P = .001). Conclusion: Combined G-CSF and GM-CSF administration effectively and predictably mobilizes HPCs and facilitates apheresis.

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