Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells
| Autor: | Alfred Rademaker, Maurice R.G. O'Gorman, M. Villa, Edward A. Stadtmauer, Nancy Horvath, Ed Crum, James Bender, Elizabeth Conklin, Leo I. Gordon, Karen Byrd, Hillard M. Lazarus, Jane N. Winter, James Martin, Anne Bauman, Lynne Jahnke, Steven Newman, Charles L. Goolsby, Martin S. Tallman, C. Mangan, Brenda W. Cooper, Stanton L. Gerson |
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| Rok vydání: | 1996 |
| Předmět: |
Adult
Male Cancer Research Adolescent Lymphoma Neutrophils Vomiting Injections Subcutaneous Microgram medicine.medical_treatment Pain Breast Neoplasms Granulocyte Pharmacology Infections Leukocyte Count Catheters Indwelling Predictive Value of Tests Granulocyte Colony-Stimulating Factor medicine Humans Bone pain Bone Marrow Transplantation Analysis of Variance Platelet Count business.industry Granulocyte-Macrophage Colony-Stimulating Factor Nausea Middle Aged Flow Cytometry Hematopoietic Stem Cells Thrombocytopenia Granulocyte colony-stimulating factor medicine.anatomical_structure Cytokine Granulocyte macrophage colony-stimulating factor Oncology Toxicity Immunology Blood Component Removal Female Stem cell medicine.symptom Multiple Myeloma business medicine.drug |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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 micrograms/kg on days 1 to 12 and GM-CSF at .5, 1, or 5 micrograms/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 micrograms/kg on days 1 to 12 and G-CSF 5 micrograms/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 micrograms/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. |
| Databáze: | OpenAIRE |
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