Abstract
Plerixafor (Mozobil®) is a CXCR4 chemokine receptor antagonist that is indicated for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize stem cells to the peripheral blood for collection and subsequent autologous stem-cell transplantation in patients who have non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM) [US] and in patients who have lymphoma or MM and are poor mobilizers (EU). This article reviews the clinical efficacy and tolerability of subcutaneous plerixafor for stem-cell mobilization in patients with lymphoma or MM, as well as summarizing its pharmacological properties. Pharmacoeconomic analyses of plerixafor and decision-making algorithms intended to optimize its use are also discussed.
Plerixafor plus G-CSF mobilized stem cells more efficiently than placebo plus G-CSF in adults with NHL or MM, according to the results of two randomized, double-blind, multicentre trials. In these trials, significantly more plerixafor plus G-CSF recipients than placebo plus G-CSF recipients reached primary apheresis targets in significantly fewer apheresis days. In the trial in patients with NHL, significantly more plerixafor plus G-CSF than placebo plus G-CSF recipients proceeded to transplantation.
Results of compassionate-use studies in patients with lymphoma or MM demonstrated that plerixafor plus G-CSF successfully mobilized stem cells in the majority of patients who were poor mobilizers (i.e. sufficient CD34+ cells had not been collected during apheresis or apheresis had not occurred because of low peripheral blood CD34+ cell counts). Results of compassionate-use studies and additional studies in patients with lymphoma or MM also demonstrated that plerixafor plus G-CSF successfully mobilized stem cells in predicted poor mobilizers, such as heavily pretreated patients considered to be at high risk of mobilization failure. In addition, a small study showed mobilization with preemptive plerixafor to be effective.
Subcutaneous plerixafor was generally well tolerated during stem-cell mobilization in patients with NHL or MM; the most commonly occurring treatment-related adverse events in plerixafor plus G-CSF recipients included injection-site reactions and gastrointestinal adverse events.
Preliminary results of a US cost-effectiveness analysis suggest that plerixafor plus G-CSF is a cost-saving option compared with cyclophosphamide plus G-CSF. A retrospective US cost analysis found no significant difference between plerixafor plus G-CSF and cyclophosphamide plus G-CSF recipients in the median total cost of initial mobilization, suggesting that the cost of plerixafor may be offset by increased utilization of other resources in patients receiving alternative mobilization regimens. Additional cost analyses examined the use of preemptive plerixafor; institutions have developed decision-making algorithms, mainly relating to the use of pre-emptive plerixafor, to help optimize its use.
In conclusion, plerixafor is a valuable stem-cell mobilizer for use in combination with G-CSF in patients with lymphoma or MM, particularly in patients who are poor mobilizers or predicted poor mobilizers.
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Various sections of the manuscript reviewed by: L. Arcaini, Division of Hematology, Department of Oncohematology, University of Pavia Medical School, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; H.E. Broxmeyer, Department of Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN, USA; K. Douglas, HPC Transplant Programme, Beatson West of Scotland Cancer Centre, Glasgow, Scotland; R.F. Duarte, Department of Hematology, ICO-Hospital Duran i Reynals, Hospitalet de Llobregat, Barcelona, Spain; E. Jantunen, University of Eastern Finland/Institute of Clinical Medicine and Department of Medicine, Kuopio University Hospital, Kuopio, Finland; E.K. Waller, Winship Cancer Institute, Department of Hematology/Oncology, Emory University School of Medicine, Atlanta, GA, USA; N. Worel, Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria.
Data Selection
Sources: Medical literature (including published and unpublished data) on ‘plerixafor’ was identified by searching databases since 1995 (including MEDLINE and 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 ‘plerixafor’ and (‘myeloma’ or ‘lymphoma’ or ‘lymphoma, non-Hodgkin’ or ‘nonhodgkin lymphoma’ or ‘stem cell mobilisation’ or ‘stem cell mobilization’). Searches were last updated 8 August 2011.
Selection: Studies in patients with lymphoma or multiple myeloma who received plerixafor for 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: Plerixafor, lymphoma, multiple myeloma, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability, pharmacoeconomics.
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Keating, G.M. Plerixafor. Drugs 71, 1623–1647 (2011). https://doi.org/10.2165/11206040-000000000-00000
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DOI: https://doi.org/10.2165/11206040-000000000-00000