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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.
Afiliación
  • Winter JN; Robert Lurie Cancer Center, Northwestern University, Chicago, IL 60611, USA.
J Clin Oncol ; 14(1): 277-86, 1996 Jan.
Article en En | MEDLINE | ID: mdl-8558209
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.
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Bases de datos: MEDLINE Asunto principal: Células Madre Hematopoyéticas / Factor Estimulante de Colonias de Granulocitos / Factor Estimulante de Colonias de Granulocitos y Macrófagos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 1996 Tipo del documento: Article País de afiliación: Estados Unidos
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Bases de datos: MEDLINE Asunto principal: Células Madre Hematopoyéticas / Factor Estimulante de Colonias de Granulocitos / Factor Estimulante de Colonias de Granulocitos y Macrófagos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 1996 Tipo del documento: Article País de afiliación: Estados Unidos