CD4+CD28+ T Lymphoctye Subsets Decreased in Healthy Donors after G-CSF Mobilization.
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Granulocyte transfusion therapy has been used infrequently in the last 10 to 15 years, in large part because its efficacy in the treatment of infected neutropenic patients has not been impressive. This perceived lack of efficacy has been attributed primarily to the fact that the dose of granulocytes obtainable with standard leukapheresis techniques has been inadequate. With the availability of recombinant granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophilia in normal donors and increase the number of granulocytes that can be collected, there is now renewed interest in this form of transfusion therapy. Recent studies have shown that stimulation with G-CSF, with or without corticosteroids, is well tolerated by normal donors and that granulocyte yields are increased three- to four-fold. Blood neutrophil counts in patients receiving these large cell doses rise substantially, often to normal or near normal levels, and commonly remain elevated for 24 hours or more. In vitro and in vivo measurements have shown that the functional capabilities of granulocytes collected from G-CSF stimulated donors appear to be normal. Although early reports have been encouraging, the clinical efficacy of this new level of granulocyte transfusion therapy has been yet to be determined.
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BACKGROUND: The use of peripheral blood progenitor cells (PBPCs) instead of autologous bone marrow leads to more rapid engraftment following high‐dose chemotherapy. Mobilization regimens differ with respect to toxicity, efficiency, and cost. STUDY DESIGN AND METHODS: Two cohorts of patients with breast cancer received one of two mobilization regimens: granulocyte‐colony‐stimulating factor (G‐CSF) at 10 micrograms per kg was given subcutaneously for 5 days, with leukapheresis begun on Day 6, or low‐dose cyclophosphamide followed by sequential granulocyte‐macrophage‐CSF (GM‐CSF) at 5 micrograms per kg for 5 days and by G‐CSF at 10 micrograms per kg, with leukapheresis begun on Day 11. Results of CD34+ cell collection, engraftment, and costs of mobilization were determined. RESULTS: The combination chemotherapy and growth factor regimen was more efficient in mobilizing CD34+ cells. Sixty‐six percent of patients reached a target 4 × 10(6) CD34+ cells per kg in a single leukapheresis session with the combination regimen, compared to 14 percent who received G‐CSF alone (p < 0.01). The mean number of leukapheresis sessions required to reach a target of 4 × 10(6) CD34+ cells per kg was 1.3 for the combination regimen and 2.7 for the regimen of G‐CSF alone (p < 0.01). One patient in the chemotherapy and growth factor group developed febrile neutropenia. Engraftment was similar in both cohorts of patients. The cost of mobilization, including all supplies and cryopreservation, was $7381 for the G‐CSF regimen and $5508 for the chemotherapy regimen (p < 0.05). This reduction was attributed to the lower number of leukapheresis and cryopreservation sessions, which outweighed the slight increase in expense for chemotherapy and growth factor in the combination regimen. CONCLUSION: This combination mobilization regimen allowed the predictable and efficient collection of CD34+ cells from the peripheral blood in a limited number of leukapheresis sessions, which reduced the cost of mobilization by approximately 25 percent.
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The use of peripheral hematopoietic progenitor cells (HPCs) is the cell choice in autologous transplantation. The classic dose of granulocyte-colony stimulating factor (G-CSF) for mobilization is a single daily dose of 10μg/kg of patient body weight. There is a theory that higher doses of granulocyte-colony stimulating factor applied twice daily could increase the number of CD34(+) cells collected in fewer leukapheresis procedures.The aim of this study was to compare a fractionated dose of 15μg G-CSF/kg of body weight and the conventional dose of granulocyte-colony stimulating factor in respect to the number of leukapheresis procedures required to achieve a minimum collection of 3×10(6) CD34(+) cells/kg body weight.Patients were divided into two groups: Group 10 - patients who received a single daily dose of 10μg G-CSF/kg body weight and Group 15 - patients who received a fractioned dose of 15μg G-CSF/kg body weight daily. The leukapheresis procedure was carried out in an automated cell separator. The autologous transplantation was carried out when a minimum number of 3×10(6) CD34(+) cells/kg body weight was achieved.Group 10 comprised 39 patients and Group 15 comprised 26 patients. A total of 146 apheresis procedures were performed: 110 (75.3%) for Group 10 and 36 (24.7%) for Group 15. For Group 10, a median of three (range: 1-7) leukapheresis procedures and a mean of 8.89×10(6) CD34(+) cells/kg body weight (±9.59) were collected whereas for Group 15 the corresponding values were one (range: 1-3) and 5.29×10(6) cells/kg body weight (±4.95). A statistically significant difference was found in relation to the number of apheresis procedures (p-value <0.0001).To collect a minimum target of 3×10(6) CD34(+) cells/kg body weight, the administration of a fractionated dose of 15μg G-CSF/kg body weight significantly decreased the number of leukapheresis procedures performed.
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BACKGROUND: AMD3100, a selective antagonist of CXCR4, rapidly mobilizes CD34+ hematopoietic progenitor cells (HPCs) from marrow to peripheral blood with minimal side effects. STUDY DESIGN AND METHODS: To further investigate potential clinical utility of AMD3100 for CD34+ cell mobilization and collection, a Phase I study in normal volunteers was performed examining single‐dose administration of AMD3100 alone and in combination with a standard 5‐day granulocyte–colony‐stimulating factor (G–CSF) regimen. RESULTS: AMD3100 (160 µg/kg × 1 on Day 5) significantly increased both G–CSF‐stimulated (10 µg/kg/day) mobilization of CD34+ cells (3.8‐fold) and leukapheresis yield of CD34+ cells. Moreover, collection of CD34+ cells was comparable between individuals mobilized by a single‐dose regimen of AMD3100 (240 µg/kg) and individuals mobilized with a 5‐day regimen of G–CSF. AMD3100‐mobilized leukapheresis products contained significantly greater numbers of T and B cells compared to G–CSF‐stimulated leukapheresis products. CONCLUSION: These findings indicate that AMD3100 can be used alone or as an adjunct to G–CSF to mobilize cells for HPC transplantation.
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The optimal dose of post-chemotherapy granulocyte-colony-stimulating factor (G-CSF) administration before peripheral blood progenitor cell (PBPC) collection has not been determined as yet, although 5 microg per kg per day has been recommended as the standard dose. This study retrospectively analyzed the effect of G-CSF dose on peripheral blood CD34+ cell collection from 91 patients with hematologic malignancies.Various doses of G-CSF were administered after several chemotherapeutic PBPC mobilization regimens. According to the dose of G-CSF administered, patients were assigned to two groups. Group 1 included 46 patients who received a low dose of G-CSF (median, 3.6 [range, 2.8-4.6] microg/kg/day). Group 2 included 45 patients who received a standard G-CSF dose of 6.0 (5.5-8. 1) microg per kg per day. Patients in the two groups were matched for age, diagnosis, previous therapy, and chemotherapeutic PBPC mobilization regimens.No difference was observed in the median number of CD34+ cells harvested from each group. The number of leukapheresis procedures necessary to obtain a minimum of 3 x 10(6) CD34+ cells per kg was the same in both groups, and the percentage of patients who failed to achieve adequate PBPC collections was similar in the two groups.The administration of low-dose G-CSF after chemotherapy appears equivalent to administration of the standard dose in achieving satisfactory PBPC collection. This approach could allow significant savings in medical cost. A randomized and prospective study is necessary, however, to assess the validity of these conclusions.
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Mobilization of peripheral blood stem cells (PBSC) by granulocyte colony-stimulating factor (G-CSF), at 10 micrograms/kg/day vs. 20 micrograms/kg/day (in 42 and 29 patients, respectively), was compared in children with solid tumors or leukemias. During mobilization, differences were noted in the peak values of CD34+ cells in peripheral blood (PB) in these two groups (median 28 x 10(6)/L for 10 micrograms/kg/day vs. 61 x 10(6)/L for 20 micrograms/kg/day; p = 0.025). Similar numbers of progenitor cells were harvested for the two concentrations of G-CSF. However, similar CD34+ cell levels in the leukapheresis product were obtained after only the third dose of G-CSF at 20 micrograms/kg/day compared with the fourth dose of G-CSF at 10 micrograms/kg/day (1.7 and 1.2 x 10(6) CD34+ cells/kg/one patient's blood volume processed, respectively). Of note is the impact of diagnosis on PB CD34+ cell levels. We conclude that, in children, mobilization with G-CSF at 20 micrograms/kg/day could minimize the duration of priming but not reduce the number of leukaphereses. Thus, the impact on outcome, clinical practice, bed utilization, and health economics is uncertain.
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Recently, several groups have begun to administer granulocyte colony-stimulating factor (G-CSF), a hematopoietic growth factor, with or without dexamethasone to mobilize peripheral blood neutrophils. Granulocyte colony-stimulating factor (600 μg subcutaneously) and dexamethasone (8 mg orally) given 12 hours before standard leukapheresis routinely results in the collection of approximately 80 × 109 granulocytes. This number of cells is sufficient to increase the neutrophil count of a severely neutropenic patient to normal and restore the recipients' ability to develop a neutrophil response in tissues. Several trials are ongoing to establish the clinical benefit of this new approach to supportive care for neutropenic patients.
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