Haematological Malignancies
Comparative Efficacy of Reduced or Standard Doses of Lenograstim for Peripheral Blood Stem Cell Mobilisation and Transplantation – A Review
Mustafa Öztürk1 and Fikret Arpaci2
1. Assistant Professor; 2. Chief, Department of Medical Oncology, Gulhane Military Medical Academy
Abstract
Recombinant human granulocyte colony-stimulating factors (G-CSFs) are used for mobilisation of peripheral blood stem cells (PBSCs) and their subsequent infusion. Lenograstim is the glycosylated recombinant form of human G-CSF. Compared with filgrastim, lenograstim has a greater capacity to stimulate the colony growth in vitro of both purified CD34 and unmanipulated PBSCs. Due to the increased potency of lenograstim, several clinical studies were carried out to show the comparative efficacy of reduced or standard doses of lenograstim for PBSC mobilisation and transplantation. In vivo prospective randomised studies indicate that lenograstim is more potent than filgrastim. Short- course low-dose lenograstim was found to be as effective as the standard dose in reducing neutrophil engraftment time following high-dose chemotherapy and PBSC recovery. Lenograstim at a 25% lower dose does not negatively affect the number of CD34+ stem cells harvested or the engraftment results.
Keywords
Granulocyte colony-stimulating factor, aphaeresis, lenograstim, filgrastim, peripheral blood stem cell mobilisation, transplantation
Disclosure: The authors have no conflicts of interest to declare. Received: 3 October 2009 Accepted: 26 February 2010 Citation: European Oncology, 2010;6(1):76–9 Correspondence: Mustafa Öztürk, Gulhane Medical Academy, Department of Medical Oncology, General Tevfik Saglam Caddesi, 06018 Etlik/Ankara, Turkey. E:
drmustafaozturk@yahoo.com
Recombinant human granulocyte colony-stimulating factors (G-CSFs) are the only currently available agents that are used for mobilisation of peripheral blood stem cells (PBSCs) and their subsequent infusion. Lenograstim is the glycosylated recombinant form of human G-CSF. Compared with filgrastim, lenograstim has a greater capacity to stimulate the colony growth in vitro of both purified CD34 and unmanipulated PBSCs.1
more potent than filgrastim on a weight-for-weight basis.2–4
Other in vitro studies indicate that lenograstim is It has been
shown that 1µg of filgrastim was equivalent to 100,000 units of activity, whereas 1µg of lenograstim was equivalent to 127,750 units of activity, demonstrating that lenograstim is 27% more potent than filgrastim in
vitro.5,6
Lenograstim also mobilises CD34+ cells more efficiently in unit
dose terms than filgrastim and has been used successfully to mobilise PBSCs from healthy donors for allogeneic transplantation.7
However,
both products are recommended at the same dosage of 10µg/kg for PBSC mobilisation if used without chemotherapy.8
Due to the increased
potency of lenograstim, several clinical studies were performed to show the comparative efficacy of reduced or standard doses of lenograstim for PBSC mobilisation and transplantation. In this review, data were collected to show the comparative efficacy of reduced or standard doses of lenograstim for PBSC mobilisation and transplantation.
Methodology
Computerised literature searches of MEDLINE, PreMEDLINE and PubMed were undertaken to identify reports of relevant clinical studies. The studies were required to be published in the English language between 31 December 1993 and 30 August 2009. Studies with reduced- and standard-dose lenograstim were examined
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De Arriba et al. conducted an in vivo prospective randomised study in 30 patients and compared the efficacy of bioequivalent doses in terms of biological activity of lenograstim and filgrastim for mobilisation of PBSCs (0.82MU/kg/day lenograstim or 0.84MU/kg/day filgrastim for four days or until completion of leukapheresis). When they compared the effect of the administration of the same number of IU of each product, they saw that 31% more filgrastim was needed to achieve the same result (8.4 versus 6.4µg/kg/day).9
Ria et al. compared the efficiency of lenograstim and filgrastim in mobilising PBSCs in a total of 86 patients who were consecutively enrolled for mobilisation with cyclophosphamide plus either lenograstim or filgrastim, and underwent leukapheresis. Lenograstim mobilised more CD34+ cells than did filgrastim in terms of reaching a
© T O UCH BRIEFINGS 2010
involving adults >18 years of age. Details of this search, which included data published to date on the use of lenograstim for autologous and allogeneic stem cell transplantation, can be found in
Tables 1 and 2.
Results and Discussion
Studies with Lenograstim on Peripheral Blood Stem Cell Mobilisation in Autologous Transplantation
Prospective randomised clinical trials were carried out to find the optimal dosage of lenograstim in autologous stem cell transplantation (ASCT) patients. Some studies compared different GCSFs; others compared reduced doses of lenograstim with standard doses in terms of mobilisation and engraftmant kinetics.
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