Comparative Efficacy of Different Doses of Lenograstim for PBSC Mobilisation and Transplantation
Table 1: Data Published to Date on the Use of Lenograstim for Autologous Stem Cell Transplantation
Author, Reference,
n Mb PT
Type of Study
De Arriba et al.,9 prospective, randomised
Ria et al.,10 prospective, randomised
Ataergin et al.,11 prospective, randomised
Öztürk et al.,12 prospective, randomised Kopf et al.,13 prospective, randomised
30 + –
Lenograstism Dose Control Group (µg/kg/day)
Lenograstism 6.4
(µg/kg/day)
Filgrastim 8.4
Number of CD34+ Cells, Engraftment Parameters
To achieve the same number of CD34+ cells
Other
Information
*31% more
filgrastim was
needed to achieve the same result
86 40 49 + + + 103 + – + + – Cy + lenograstim 5 Cy + filgrastim 5 Lenograstim 7.5 Lenograstim 7.5 Filgrastim 10 Lenograstim 10
Disease-specific Disease-specific regimen CT
plus lenograstim
disease-specific regimen CT
Karanth et al.,14 prospective, randomised
Lefrère et al.,15 retrospective
Linch et al.,20 prospective, randomised Brice et al.,21 prospective,
randomised Schmitz et al.,22 double-blind, randomised Suh et al.,23 prospective, randomised
79 + 126 + – –
Cy (2g/m²) + prospective lenograstim 5 Lenograstim 10
plus molgramostim Lenograstim alone at 10
Filgrastim 10
>3x106 CD34+/kg *Lenograstim (in two LPs)
Successful mobilisation in first LP 46% versus 50% patients
Successful mobilisation in first LP 42% versus 56% patients
regimen CT plus filgrastim and
mobilised more CD34+ cells NS
NS
CD34+ cells 5.8x106/kg NS lenograstim versus 8.4x106/kg filgrastim versus 4.0x106/kg molgramostim
Successful mobilisation in 56.4% versus 70%
Difference to obtain a
minimal number of 3x106 CD34+ cells/kg between groups
90 16 + – 192 – 33 – + + + +
Lenograstim Placebo 263µg/day SC
Lenograstim 150µg/day SC
Lenograstim 5
Lenograstim 100µg/day SC
Placebo Placebo
Lenograstim 250µg/day SC
Neutrophil engraftment 9 days lenograstim versus 12.5 days placebo
*p=0.0001
Less frequent hospitalisation * in lenograstim-treated group
Improved neutrophil
recovery 11 days versus 15 days
For both lenograstim doses, neutrophil
engraftment was 9 days and PLT engraftment was 11 days
Nolan et al.,24 double-blind,
placebo-controlled, randomised
Jang et al.,25 prospective randomised
40 – + 61 – +
Lenograstim Lenograstim 105µg/day SC (Short-course, low-dose)
263µg/day and placebo
Lenograstim 5 (single dose)
Lenograstim 2.5 twice daily (split dose)
Neutrophil engraftment 10 days versus 11 days versus 14 days (*p<0.001 compared with placebo)
Neutrophil engraftment 10 days for both
groups, PLT engraftment 11 days for the single-dose group versus 14 days for the the split-dose group
*Difference significant; CT = chemotherapy; Cy = cyclophosphamide; LP = leukapheresis; Mb = mobilisation; N = number of patients; NS = not significant; PT = post-transplant; PLT = platelet.
collection level of >3x106 CD34+/kg bodyweight in two leukaphereses.10 Ataergin et al. showed in a randomised study that filgrastim 10µg/kg/day and lenograstim 7.5µg/kg/day resulted in successful mobilisation of CD34+ cells in patients undergoing high-dose chemotherapy (HDC) and PBSC transplantation. Successful mobilisation with the first apheresis was achieved in 10 of 20 patients (50%) in the
EUROPEAN ONCOLOGY
filgrastim group versus nine of 20 patients (46%) in the lenograstim group. No significant difference was seen in the median number of CD34+ cells mobilised, the median number of aphereses, the median volume of apheresis, the percentage of CD34+ cells or CD34+ cell number. This study showed that lenograstim at a 25% lower dose does not negatively affect the number of CD34+ stem cells harvested.11
77
Short-course low-dose lenograstim is as
effective as standard
dose in reducing neutrophil engraftment NS
NS *p<0.001 NS NS
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