Plerixafor and Filgrastim XM02 (Tevagastrim ®) as a first line peripheral blood stem cell mobilisation strategy in patients with multiple myeloma and lymphoma candidated to autologous bone marrow transplantation

European Journal of Haematology

Volumn 88, Issue 2, 2012, Pages 154-158

  Andreola, Giovanna ^a   Babic, Aleksandra ^a   Rabascio, Cristina ^a   Negri, Mara ^a   Martinelli, Giovanni ^a   Laszlo, Daniele ^a  

^a EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

Biosimilar granulocyte colony stimulating factor; CD34+ cells; Plerixafor; Stem cell mobilisation

Indexed keywords

PLERIXAFOR; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TEVAGASTRIM; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; AUTOLOGOUS BONE MARROW TRANSPLANTATION; BONE PAIN; CANCER PATIENT; CD34 SELECTION; CLINICAL ARTICLE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; HODGKIN DISEASE; HUMAN; HUMAN CELL; LEUKAPHERESIS; MALE; MULTIPLE MYELOMA; NONHODGKIN LYMPHOMA; PRIORITY JOURNAL; STEM CELL MOBILIZATION; TREATMENT RESPONSE;

ADULT; AGED; ANTIGENS, CD34; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE MARROW TRANSPLANTATION; COMBINED MODALITY THERAPY; FEMALE; GRANULOCYTE COLONY-STIMULATING FACTOR; HEMATOPOIETIC STEM CELL MOBILIZATION; HETEROCYCLIC COMPOUNDS; HUMANS; LYMPHOMA; MALE; MIDDLE AGED; MULTIPLE MYELOMA; RECOMBINANT PROTEINS; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84855836072     PISSN: 09024441     EISSN: 16000609     Source Type: Journal    
DOI: 10.1111/j.1600-0609.2011.01719.x     Document Type: Article

References (24)

1. Jantunen E, Putkonen M, Nousiainen T, Pelliniemi TT, Mahlamaki E, Remes K. Low-dose or intermediate-dose cyclophosphamide plus granulocyte colony-stimulating factor for progenitor cell mobilisation in patients with multiple myeloma. Bone Marrow Transplant 2003;31:347-51.
2. Devine SM, Flomenberg N, Vesole DH, Liesveld J, Weisdorf D, Badel K, Calandra G, DiPersio JF. Rapid mobilization of CD34+ cells following administration of the CXCR4 antagonist AMD3100 to patients with multiple myeloma and non-Hodgkin's lymphoma. J Clin Oncol 2004;22:1095-102.
3. Calandra G, McCarty J, McGuirk J, Tricot G, Crocker SA, Badel K, Grove B, Dye A, Bridger G. AMD3100 plus G-CSF can successfully mobilize CD34+ cells from non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma patients previously failing mobilization with chemotherapy and/or cytokine treatment: compassionate use data. Bone Marrow Transplant 2008;41:331-8.
4. Russell N, Douglas K, Ho A, et al. Plerixafor (Mozobil) and G-CSF for front-line peripheral blood stem cell mobilization for autologous transplantation in lymphoma or multiple myeloma: preliminary results from the EU predic study. Proceedings of the 16th Congress of the European Hematology Association 2011 London; Abstract 0548.
5. del Giglio A, Eniu A, Ganea-Motan D, Topuzov E, Lubenau H. XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC Cancer 2008;8:332.
6. Engert A, Griskevicius L, Zyuzgin Y, Lubenau H, del GA. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma 2009;50:374-9.
7. Engert A, del GA, Bias P, Lubenau H, Gatzemeier U, Heigener D. Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin's lymphoma. Onkologie 2009;32:599-604.
8. Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, del GA. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. J Thorac Oncol 2009;4:736-40.
9. Gascon P, Fuhr U, Sorgel F, Kinzig-Schippers M, Makhson A, Balser S, Einmahl S, Muenzberg M. Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol 2010;21:1419-29.
10. Lubenau H, Sveikata A, Gumbrevicius G, Macijauskiene J, Fokas V, Kazlauskas S, Janulionis V. Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharmacol Ther 2009;47:275-82.
11. Lubenau H, Bias P, Maly AK, Siegler KE, Mehltretter K. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs 2009;23:43-51.
12. Waller CF, Bronchud M, Mair S, Challand R. Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010;89:927-33.
13. Sorgel F, Lerch H, Lauber T. Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product. BioDrugs 2010;24:347-57.
14. Skrlin A, Radic I, Vuletic M, Schwinke D, Runac D, Kusalic T, Paskvan I, Krsic M, Bratos M, Marinc S. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 2010;38:557-66.
15. Lefrere F, Brignier AC, Elie C, Ribeil JA, Bernimoulin M, Aoun C, Dal Cortivo L, Delarue R, Hermine O, Cavazzana-Carlo M. First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor. Adv Ther 2011;28:304-10.
16. Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant 2010;45:39-47.
17. Mendrone A Jr, Arrais CA, Saboya R, Chamone DA, Dulley FL. Factors affecting hematopoietic progenitor cell mobilization: an analysis of 307 patients. Transfus Apher Sci 2008;39:187-92.
18. Moog R. Management strategies for poor peripheral blood stem cell mobilization. Transfus Apher Sci 2008;38:229-36.
19. D'Addio A, Curti A, Worel N, et al. The addition of plerixafor is safe and allows adequate PBSC collection in multiple myeloma and lymphoma patients poor mobilizers after chemotherapy and G-CSF. Bone Marrow Transplant 2011;46:356-63.
20. Mohty M, Duarte RF, Croockewit S, Hubel K, Kvalheim G, Russell N. The role of plerixafor in optimizing peripheral blood stem cell mobilization for autologous stem cell transplantation. Leukemia 2011;25:1-6.
21. Jantunen E, Penttila K, Pyorala M, Mahlamaki E, Kuittinen T, Nousiainen T. Addition of plerixafor to a chemotherapy plus G-CSF mobilization in hard-to-mobilize patients. Bone Marrow Transplant 2011;46:308-9.
22. Barosi G, Bosi A, Abbracchio MP, Danesi R, Genazzani A, Corradini P, Pane F, Tura S. Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica 2011;96:937-42.
23. Laszlo D, Andreola G, Babic A, Rabascio C, Negri M, Martinelli G. Efficacy of mobilization with plerixafor in patients failing a previous mobilization attempot and as first-line mobilitazion therapy in patients affected by multiple myeloma. Proceedings of the 16th Congress of the European Hematology Association 2011; Abstract 0447.
24. Shaughnessy P, Islas-Ohlmayer M, Murphy J, et al. Cost and clinical analysis of autologous hematopoietic stem cell mobilization with G-CSF and plerixafor compared to G-CSF and cyclophosphamide. Biol Blood Marrow Transplant 2011;17:729-36.