Mobilization of peripheral blood stem cells with chemotherapy and recombinant human granulocyte colony‐stimulating factor (rhG‐CSF): a randomized evaluation of different doses of rhG‐CSF

Abstract

Summary. To date, no randomized study has compared different doses of recombinant human granulocyte colonystimulating factor (rhG-CSF) following submyeloablative mobilization chemotherapy. Therefore, we evaluated the effect of different doses of rhG-CSF following mobilization chemotherapy on yields of CD34 + peripheral blood stem cells (PBSC). Fifty patients were randomized to receive 8 (n 25) versus 16 lg/kg/d (n 25) of rhG-CSF following mobilization chemotherapy. The median number of CD34 + cells collected after 8 lg/kg/d of rhG-CSF was 2á36´10 6 /kg (range, 0á21±7á80), compared with 7á99 (2á76±14á89) after 16 lg/kg/d (P < 0á001). Twenty out of 25 (80%) patients in the low-dose and 23 out of 25 (92%) in the high-dose rhG-CSF arm underwent high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Median days to white blood cell engraftment in patients mobilized with 8 lg/kg and 16 lg/kg of rhG-CSF were 12 (10±20) and 9 (8±11) respectively (P < 0á001). There was no difference between the two groups regarding the other parameters of peritransplant morbidity: days to platelet engraftment (P 0á10), number of red blood cell (P 0á56) and platelet transfusions (P 0á22), days of total parenteral nutrition requirement (P 0á84), fever (P 0á93) and antibiotics (P 0á77), and number of different antibiotics used (P 0á58). These data showed that higher doses of rhG-CSF following submyeloablative mobilization chemotherapy were associated with a clear dose±response effect based on the collected cell yields. Based on the parameters of peritransplant morbidity, 8 lg/kg/d was as effective as 16 lg/kg/d except for a rapid neutrophil engraftment in the high-dose arm. Therefore, in routine clinical practice, despite some advantage in the use of higher doses of rhG-CSF, lower doses may be used for PBSC collections following chemotherapy-based mobilization regimens in this cost-conscious era.

International myeloma working group (IMWG) consensus statement and guidelines regarding the current status of stem cell collection and high-dose therapy for multiple myeloma and the role of plerixafor (AMD 3100)

“…These targets would allow most patients with myeloma to undergo at least two autografts with an optimal CD34 dose during the course of their disease. Table 3 Representative studies of various mobilization strategies [13][14][15][16][17][18][19][20][21][22][23][24] IMWG Conclusion/assessment (a) Both GCSF alone (non-pegylated) or chemotherapy followed by GCSF are reasonable strategies for stem cell collection. The data regarding stem cell collection after single agent pegylated GCSF is much more limited than for non-pegylated GCSF, but supports the use of this agent for stem cell collection.…”

Mobilization of PBSCs with chemotherapy and recombinant human G-CSF: a randomized evaluation of early vs late administration of recombinant human G-CSF

“…twice daily was started at two time points after chemotherapy: on day 4 (early) and on day 7 (late) and continued until the last day of apheresis. 6,7,11 PBSC collection was started when the peripheral blood CD34 þ cell count reached 20/ml. CD34 þ cells/kg of 4 Â 10 6 /kg were considered an adequate harvest.…”

“…The quantities of these cell populations in each product before and after freezing were determined. 6,7,11 Statistics Data analyses were carried out using SPSS, version 15.00. w 2 and Student's t-tests were used to compare proportions and means of continuous variables, respectively. Variables that did not fit a normal distribution were compared with the Mann-Whitney U-test.…”

“…11,14 However, sparse data exist about the use of late rhG-CSF after mobilization chemotherapy despite its potential for cost reduction and patient convenience. To our knowledge, to date, there is also no randomized study comparing different time schedules of rhG-CSF after mobilization chemotherapy.…”

“…[2][3][4][5][6][7][8][9] Growth factors alone or in combination with chemotherapy have been used in daily doses of 5-40 mg/kg, and recombinant human (rh)G-CSF at a dose of 10 mg is the most commonly used and recommended dose. [10][11][12][13] However, the optimal timing for rhG-CSF initiation after chemotherapy has not been determined as conclusively as has the rhG-CSF dose.…”