, Volume 71, Issue 6, pp 679-707
Date: 18 Nov 2012

Lenograstim

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Abstract

Lenograstim (Granocyte®, Neutrogin®, Myelostim®) is a glycosylated recombinant human granulocyte colony-stimulating factor. This article reviews the pharmacological properties, therapeutic efficacy and tolerability of lenograstim, mainly focusing on its use in chemotherapy-induced neutropenia, acceleration of neutrophil recovery following haematopoietic stem cell transplantation (HSCT), and peripheral blood stem cell (PBSC) mobilization in patients with cancer and healthy donors.

In randomized, multicentre trials in patients with solid tumours, lymphoma or multiple myeloma, the durations of chemotherapy-induced neutropenia, hospitalization for infection and intravenous antibacterial therapy were significantly shorter in patients receiving lenograstim prophylaxis than in those receiving placebo. The time to neutrophil recovery was also significantly shorter in patients with acute myeloid leukaemia or acute lymphoblastic leukaemia who received lenograstim than in those who received placebo or no treatment, according to the results of randomized, multicentre trials. In addition, lenograstim prophylaxis facilitated the administration of dose-intense or dose-dense chemotherapy regimens, with improved clinical outcomes seen in some trials.

In patients with cancer undergoing HSCT, lenograstim accelerated neutrophil recovery post-HSCT and shortened the duration of hospitalization, according to the results of randomized, multicentre trials.

Lenograstim effectively mobilized PBSCs in patients with cancer, demonstrating generally similar efficacy to filgrastim or molgramostim in five randomized trials (although lower dosages of lenograstim than filgrastim were administered in four of the trials). Lenograstim also provided effective PBSC mobilization in healthy donors and was more effective than filgrastim when both drugs were administered at a dosage of 10mg/kg/day. The efficacy and safety of lenograstim for PBSC mobilization in healthy donors was supported by the results of a prospective, longer-term study involving almost 4000 healthy donors.

Lenograstim was generally well tolerated across a variety of treatment settings, including PBSC mobilization in healthy donors, with bone pain being one of the most commonly reported adverse events. In conclusion, lenograstim remains an important option for use in chemotherapy-induced neutropenia, acceleration of neutrophil recovery following HSCT, and PBSC mobilization.

Various sections of the manuscript reviewed by: A.G. Favaretto, Oncologia Medica II, Istituto Oncologico Veneto IRCCS, Padova, Italy; D.F. Heigener, Department of Thoracic Oncology, Krankenhaus Grosshansdorf, Grosshansdorf, Schleswig-Holstein, Germany; K. Hölig, Department of Internal Medicine I, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; K. Itoh, Division of Oncology and Hematology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan; D.C. Linch, Department of Haematology, UCL Cancer Institute, London, UK; C. Suh, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Data Selection

Sources: Medical literature (including published and unpublished data) on lenograstim was identified by searching databases since 1986 (including MEDLINE, EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.
Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘lenograstim’ and ‘neutropenia’. Searches were last updated 28 March 2011.
Selection: Studies in patients who received lenograstim for prophylaxis of chemotherapy-induced neutropenia, acceleration of neutrophil recovery following haematopoietic stem cell transplantation and peripheral blood stem cell mobilization. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.
Index terms: Lenograstim, chemotherapy-induced neutropenia, haematopoietic stem cell transplantation, peripheral blood stem cell mobilization, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.