Preferences help
enabled [disable] Abstract
Number of results
2016 | 6 | 2 | A66-71
Article title

The effect of lipegfilgrastim on hematopoietic reconstitution and supportive treatment after megachemotherapy with autologous peripheral blood stem cell transplantation in patients with lymphoproliferative malignancies

Title variants
Languages of publication
Megachemotherapy with autologous peripheral blood stem cell transplantation (auto-PBSCT) is a standard treatment option in patients below 70 years of age with multiple myeloma (MM) as well as with relapsed and refractory lymphomas. Recombinant granulocyte colony-stimulating factors (G-CSF) are commonly used to accelerate bone marrow recovery after chemotherapy and reduce the duration of severe neutropenia. Lipegfilgrastim is a glicopegylated G-CSF with prolonged action registered for adult patients with malignant neoplasms in order to reduce the duration of neutropenia and the incidence of febrile neutropenia (FN). So far, there is not enough data to confirm the effectiveness and safety of this drug in patients with hematological malignancies including those undergoing auto-PBSCT. The aim of this study was to determine the effect of lipegfilgrastim on hematopoietic regeneration and supportive care after auto-PBSCT in patients with lymphoproliferative malignancies. The study population consisted of 30 patients (12 female and 18 male; median age: 50 years ± 13), including 13 patients with MM, 5 with Hodgkin’s lymphoma (HL) and 12 with non-Hodgkin’s lymphoma (nHL). The median number of transplanted CD34+ cells was 3.96 ± 1.56 × 10^6/kg of body mass. On day +1 after auto-PBSCT, the patients received lipegfilgrastim in a single 6 mg subcutaneous injection. The control group consisted of 32 patients (13 female and 19 male; median age: 50 years ± 6.4), including 13 with MM, 8 with HL and 11 with nHL, who received subcutaneous filgrastim in a dose of 5 μg/kg/day from day +1 after transplantation and continued to an absolute neutrophil count (ANC) > 1.5 × 10^9/L. There was no significant difference in the time of regeneration ANC > 0.5 × 10^9/L which was 10.65 ± 1.00 vs. 11.51 ± 2.29 days respectively in the study and control group. Similar observations were noted regarding the duration of febrile neutropenia (2.16 ± 2.22 vs. 1.70 ± 4.17 days; p = 0.998), regeneration of platelets (PLT) > 20 × 10^9/L (12.41 ± 2.41 vs. 13.82 ± 4.48 days; p = 0.233) and demand for transfusion of red blood cells (0.76 ± 1.07 vs. 1.33 ± 2.33 units; p = 0.414) and platelets (11.5 ± 6.9 vs. 19.2 ± 17.7 units; p = 0.08). Different results were observed for the length of hospitalization, which was significantly shorter in the lipegfilgrastim group (16.14 ± 14 vs. 24.46 ± 6.79 days; p = 0.000). Lipegfilgrastim is as effective as filgrastim with regards to the regeneration of the hematopoietic system, duration of febrile neutropenia, demand for transfusion of blood products and significantly reduces hospitalization in patients with lymphoproliferative malignancies after auto-PBSCT.
Physical description
  • 1. Mendler JH, Friedberg JW. Salvage therapy in Hodgkin’s lymphoma. Oncologist 2009; 14: 425-432.
  • 2. Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M et al. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone Marrow Transplant 2006; 37: 439-449.
  • 3. Blade J, Rosinol L, Sureda A et al. High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy: long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA. Blood 2005; 106: 3755-3759.
  • 4. Child JA, Morgan GJ, Davies FE et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 2003; 348: 1875-1883.
  • 5. Crawford J, Armitage J, Balducci L et al. Myeloid growth factors. J Natl Compr Canc Netw 2013; 11: 1266-1290.
  • 6. Toor AA, van Burik JA, Weisdorf DJ. Infections during mobilizing chemotherapy and following autologous stem cell transplantation. Bone Marrow Transplant 2001; 28: 1129-1134.
  • 7. Tarella C, Castellino C, Locatelli F et al. G-CSF administration following peripheral blood progenitor cell (PBPC) autograft in lymphoid malignancies: evidence for clinical benefits and reduction of treatment costs. Bone Marrow Transplant 1998; 21: 401-407.
  • 8. Linch DC, Milligan DW, Winfield DA et al. G-CSF after peripheral blood stem cell transplantation in lymphoma patients significantly accelerated neutrophil recovery and shortened time in hospital: results of a randomized BNLI trial. Br J Haematol 1997; 99: 933-938.
  • 9. Hornedo J, Sola C, Solano C et al. The role of granulocyte colony-stimulating factor (G-CSF) in the post-transplant period. Bone Marrow Transplant 2002; 29: 737-743.
  • 10. Aapro MS, Bohlius J, Cameron DA et al; European Organization for Research and Treatment of Cancer. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer 2011; 47: 8-32.
  • 11. Ziakas PD, Kourbeti IS. Pegfilgrastim vs. filgrastim for supportive care after autologous stem cell transplantation: can we decide? Clin Transplant 2012; 26: 16-22.
  • 12. Perrier L, Lefranc A, Pérol D et al. Cost effectiveness of pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous stem cell transplantation in patients with lymphoma and myeloma: an economic evaluation of the PALM Trial. Appl Health Econ Health Policy 2013; 2: 129-138.
  • 13. Cesaro S, Nesi F, Tridello G et al. A randomized, non-inferiority study comparing efficacy and safety of a single dose of pegfilgrastim versus daily filgrastim in pediatric patients after autologous peripheral blood stem cell transplant. PLoS One 2013; 8(1): e53252.
  • 14. Sebban C, Lefranc A, Perrier L et al. A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study). Eur J Cancer 2012; 5: 713-720.
  • 15. Kahl C, Sayer HG, Hinke A et al. Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. J Cancer Res Clin Oncol 2012; 3: 513-517.
  • 16. Kohler E, Lubenau H, Buchner A et al. Lipegfilgrastim – a long-acting, once-per-cycle filgrastim: pharmacokinetics and pharmacodynamics in healthy volunteers. Support Care Cancer 2012; 1: S238.
  • 17. Buchner A, Elsässer R, Bias P. A randomized, double-blind, active control, multicenter, dose-finding study of lipegfilgrastim (XM22) in breast cancer patients receiving myelosuppressive therapy. Breast Cancer Res Treat 2014; 1: 107-116.
  • 18. Trivedi M, Martinez S, Corringham S et al. Optimal use of G-CSF administration after hematopoietic SCT. Bone Marrow Transplant 2009; 43: 895-908.
  • 19. Castagna L, Bramanti S, Levis A et al. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol 2010; 21: 1482-1485.
  • 20. Gerds A, Fox-Geiman M, Dawravoo K et al. Randomized phase III trial of pegfilgrastim versus filgrastim after autologus peripheral blood stem cell transplantation. Biol Blood Marrow Transplant 2010; 16: 678-685.
  • 21. Rifkin R, Spitzer G, Orloff G et al. Pegfilgrastim appears equivalent to daily dosing of filgrastim to treat neutropenia after autologous peripheral blood stem cell transplantation in patients with non-Hodgkin lymphoma. Clin Lymphoma Myeloma Leuk 2010; 10: 186-191.
  • 22. Mathew S, Adel N, Rice RD et al. Retrospective comparison of the effects of filgrastim and pegfilgrastim on the pace of engraftment in auto-SCT patients. Bone Marrow Transplant 2010; 45: 1522-1527.
  • 23. Green MD, Koelbl H, Baselga J et al; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed- -dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003; 1: 29-35.
  • 24. Vose JM, Crump M, Lazarus H et al. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 2003; 3: 514-519.
  • 25. Samaras P, Blickenstorfer M, Siciliano RD et al. Pegfilgrastim reduces the length of hospitalization and the time to engraftment in multiple myeloma patients treated with melphalan 200 and auto-SCT compared with filgrastim. Ann Hematol 2011; 1: 89-94.
  • 26. Volovat C, Bondarenko IM, Gladkov OA et al. Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non-small cell lung cancer receiving myelosuppressive therapy. Springerplus 2015; 4: 316.
  • 27. Bondarenko I, Gladkov OA, Elsaesser R et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer 2013; 13: 386.
  • 28. Kurbacher CM, Fietz T, Diel IJ et al. NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim – First Interim Analysis. Oncol Res Treat 2015; 5: 221-229.
Document Type
Publication order reference
YADDA identifier
JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.