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Granulocyte colony stimulating factors (G-CSF, Filgrastim, Neupogen) are routinely used after autologous HSCT to reduce the duration of severe neutropenia. Clinical studies have not directly compared the effects of different G-CSF doses on engraftment, thus the optimal G-CSF dose remains unknown. A clinical initiative of dose-escalated GCSF was instituted at NMH to determine if the duration of neutropenia could be reduced with increased G-CSF dose. Herein are the results of an observational study comparing standard dose to dose-escalated G-CSF for resolution of neutropenia following auto-HSCT.
NMH electronic database was used to identify consecutive autologous HSCT recipients treated at Northwestern Memorial Hospital between 2008-9 (single daily dose Filgrastim 5mcg/kg) and 2010-11 (twice daily dose of Filgrastim-total dose=10mcg/kg/day) All patients started G-CSF 5 days after stem cell infusion .Resolution of neutropenia was defined as the 1st day ANC > 500cells/ml. Most patients received a minimum of 5mcg/kg/dose total body weight rounded up to the nearest vial size.
172 single-dose and 162 twice daily dose auto-HSCT recipients were included in this study. There was no statistical difference between study arms for age, weight, gender, diagnosis, or G-CSF dose, the number of patients who received a 480mcg doses of G-CSF. The number of CD34+ stem cells infused was significantly higher in the twice daily study arm.
Table 2 shows study results. Time to engraftment and the number of treatment days needed to reach engraftment was the same for both study arms. No difference was observed for length of stay or hospital mortality. A trend towards higher microbiologically confirmed infections was seen.
In this study, a single 5mcg/kg G-CSF dose was as effective as twice daily 5mcg/kg G-CSF doses for accelerating stem cell engraftment. A randomized prospective study is needed to confirm these results.
TABLE 1. Single vs Twice Daily G-CSF | |||
Demographics | Single Daily Dose | Twice Daily Dose | P-value |
Number | 172 | 163 | |
Age (range) | 56(22-77) | 57(24-77) | 0.4343 |
Weight (median/kg) | 82.77 | 85.43 | 0.2228 |
G-CSF dose (mcg/kg) | 148(86) | 1622 | 0.4955 |
Male | 101(59) | 120(66) | 0.8711 |
Diagnosis | |||
Myeloma | 135(78) | 136(75) | 0.3787 |
NHL | 24(14) | 24(13) | 0.877 |
Other | 13(8) | 22(12) | 0.2199 |
CD34 cells infused(mean-mil/kg) | 6.03 | 6.72 | 0.0395 |
Table 2 Results | Single | Twice daily | P-value |
Time to engraftment (days) | 12(9-27) | 11(9-24) | 0.9126 |
Length of stay (range) | 16(7-45) | 16(9-115) | 0.4777 |
Number of patients with microbiologically confirmed infection | 26 | 42 | 0.0787 |
Hospital mortality | 3(1.7) | 4(2.2) | 0 99 |