Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies
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Abstract
Pegfilgrastim (PEGFIL) has been found to be comparable to daily filgrastim (FIL) in managing chemotherapy-induced neutropenia. In the present study, we evaluated the ability of PEGFIL to mobilize stem cells in 38 consecutive patients with lymphoproliferative diseases (multiple myeloma, n = 18; lymphomas, n = 15; chronic lymphocytic leukemia, n = 5). Patients were mobilized using PEGFIL (6–18 mg as a single dose) during 2005–2006; 32 then received high-dose chemotherapy followed by autologous stem cell transplantation. PEGFIL-mobilized patients were matched by age, disease, and treatment line at a ratio of 1:2 to historical FIL-mobilized controls. The primary study endpoint was the blood CD34+ concentration at onset of leukapheresis. Leukapheresis began a median of 10 days from the beginning of mobilization chemotherapy in both groups. At the onset of leukapheresis, median blood CD34+ cell counts did not differ significantly in the FIL group compared with the PEGFIL group (79 × 106/L vs 64 × 106/L, respectively; p = 0.44). In the different disease categories, the respective CD34+ cell counts after FIL and PEGFIL mobilization were 72 × 106/L vs 123 × 106/L (p = 0.08) in myeloma, 51 × 106/L vs 62 × 106/L (p = 0.6) in lymphomas, and 27 × 106/L vs 30 × 106/L (p = 0.62) in CLL, respectively. The target CD34+ cell yield was harvested with one leukapheresis in 53% of PEGFIL-mobilized patients. Engraftment after autografting did not differ significantly in the two groups. Stem cell mobilization with a single dose of PEGFIL was, therefore, comparable to that achieved using daily FIL in patients with lymphoproliferative diseases. PEGFIL is a more practical way to mobilize stem cells than daily FIL.
Keywords
Autologous stem cell transplant Filgrastim Pegfilgrastim Mobilization Lymphoproliferative diseaseReferences
- 1.Siena S, Bregni M, Brando B, Ravagnani F, Bonadonna G, Gianni AM (1989) Circulation of CD34+ hematopoietic stem cells in the peripheral blood of high-dose cyclophosphamide-treated patients: enhancement by intravenous recombinant human granulocyte-macrophage colony-stimulating factor. Blood 74:1905–1914PubMedGoogle Scholar
- 2.Alegre A, Tomas JF, Martinez-Chamorro C, Gil-Fernandez JJ, Fernandez-Villalta MJ, Arranz R, Diaz MA, Granada A, Bernardo MR, Escudero A, Lopez-Lorenzo JL, Fernandez-Ranada JM (1997) Comparison of peripheral blood progenitor cell mobilization in patients with multiple myeloma: high-dose cyclophosphamide plus GM-CSF vs G-CSF alone. Bone Marrow Transplant 20:211–217 doi: 10.1038/sj.bmt.1700867 PubMedCrossRefGoogle Scholar
- 3.Desikan KR, Barlogie B, Jagannath S, Vesole DH, Siegel D, Fassas A et al (1998) Comparable engraftment kinetics following peripheral-blood stem-cell infusion mobilized with granulocyte colony-stimulating factor with or without cyclophosphamide in multiple myeloma. J Clin Oncol 16:1547–1553PubMedGoogle Scholar
- 4.Curran MP, Goa KL (2002) Pegfilgrastim. Drugs 62:1207–1213 doi: 10.2165/00003495-200262080-00012 PubMedCrossRefGoogle Scholar
- 5.Zamboni WC (2003) Pharmacokinetics of pegfilgrastim. Pharmacotherapy 23:9S–14S doi: 10.1592/phco.23.9.9S.32888 PubMedCrossRefGoogle Scholar
- 6.Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J et al (2003) Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 21:514–519 doi: 10.1200/JCO.2003.03.040 PubMedCrossRefGoogle Scholar
- 7.Siena S, Piccart MJ, Holmes FA, Glaspy J, Hackett J, Renwick JJ (2003) A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily filgrastim in patients with stage II–IV breast cancer. Oncol Rep 10:715–724PubMedGoogle Scholar
- 8.Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P et al (2003) A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 14:29–35 doi: 10.1093/annonc/mdg019 PubMedCrossRefGoogle Scholar
- 9.Molineux G, Kinstler O, Briddell B, Hartley C, McElroy P, Kerzic P et al (1999) A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp Hematol 27:1724–1734 doi: 10.1016/S0301-472X(99)00112-5 PubMedCrossRefGoogle Scholar
- 10.Steidl U, Fenk R, Bruns I, Neumann F, Kondakci M, Hoyer B et al (2005) Successful transplantation of peripheral blood stem cells mobilized by chemotherapy and a single dose of pegylated G-CSF in patients with multiple myeloma. Bone Marrow Transplant 35:33–36 doi: 10.1038/sj.bmt.1704702 PubMedCrossRefGoogle Scholar
- 11.Isidori A, Tani M, Bonifazi F, Zinzani P, Curti A, Motta MR et al (2005) Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreated lymphoma patients. Haematologica 90:225–231PubMedGoogle Scholar
- 12.Nosari A, Cairoli R, Ciapanna D, Gargantini L, Intropido L, Barate C et al (2006) Efficacy of single dose pegfilgrastim in enhancing the mobilization of CD34+ peripheral blood stem cells in aggressive lymphoma patients treated with cisplatin-aracytin-containing regimens. Bone Marrow Transplant 38:413–416 doi: 10.1038/sj.bmt.1705459 PubMedCrossRefGoogle Scholar
- 13.Bruns I, Steidl U, Kronenwett R, Fenk R, Graef T, Rohr UP et al (2006) A single dose of 6 or 12 mg of pegfilgrastim for peripheral blood progenitor cell mobilization results in similar yields of CD34+ progenitors in patients with multiple myeloma. Transfusion 46:180–185 doi: 10.1111/j.1537-2995.2006.00699.x PubMedCrossRefGoogle Scholar
- 14.Remes K, Matinlauri I, Grenman S, Itala M, Kauppila M, Pelliniemi TT et al (1997) Daily measurements of blood CD34+ cells after stem cell mobilization predict stem cell yield and posttransplant hematopoietic recovery. J Hematother 6:13–19PubMedGoogle Scholar
- 15.Johnsen HE (1995) Report from a Nordic workshop on CD34+ cell analysis: technical recommendations for progenitor cell enumeration in leukapheresis from multiple myeloma patients. Nordic Myeloma Study Group Laboratories. J Hematother 4:21–28PubMedGoogle Scholar
- 16.Kroschinsky F, Holig K, Poppe-Thiede K, Zimmer K, Ordemann R, Blechschmidt M et al (2005) Single-dose pegfilgrastim for the mobilization of allogeneic CD34+ peripheral blood progenitor cells in healthy family and unrelated donors. Haematologica 90:1665–1671PubMedGoogle Scholar
- 17.Holmes FA, O’Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M et al (2002) Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20:727–731 doi: 10.1200/JCO.20.3.727 PubMedCrossRefGoogle Scholar
- 18.Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL et al (2005) Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant 35:1165–1169 doi: 10.1038/sj.bmt.1704994 PubMedCrossRefGoogle Scholar
- 19.Staber PB, Holub R, Linkesch W, Schmidt H, Neumeister P (2005) Fixed-dose single administration of pegfilgrastim vs daily filgrastim in patients with haematological malignancies undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant 35:889–893 doi: 10.1038/sj.bmt.1704927 PubMedCrossRefGoogle Scholar
- 20.Kroschinsky F, Hoelig K, Platzbecker U, Schleyer E, Ordeman R, Haack A (2004) Single-dose pegfilgrastim after chemotherapy is highly effective in enhancing the mobilization of autologous CD34+PBSC in patients with lymphoid malignancies and solid tumors. Blood 104:788a (abstract 2922)CrossRefGoogle Scholar
- 21.Hosing C, Qazilbash M, Kebriaei P, Giralt S, Davis M, Popat U et al (2006) Fixed-dose single agent pegfilgrastim for peripheral blood prognitor cell mobilisation in patients with multiple myeloma. Br J Haematol 133:533–537 doi: 10.1111/j.1365-2141.2006.06054.x PubMedCrossRefGoogle Scholar
- 22.Fruehauf S, Klaus J, Huesing J, Veldwijk MR, Buss EC, Topaly J, Seeger T, Zeller LWJ, Moehler T, Ho AD, Goldschmidt H (2007) Efficient mobilization of peripheral blood stem cell following CAD chemotherapy and a single dose of pegylated G-CSF in patients with multiple myeloma. Bone Marrow Transplant 39:743–750 doi: 10.1038/sj.bmt.1705675 PubMedCrossRefGoogle Scholar
- 23.Beveridge RA, Rifkin RM, Moleski RJ, Milkovich G, Reitan JF, Paivanas TA et al (2003) Impact of long-acting growth factors on practice dynamics and patient satisfaction. Pharmacotherapy 23:101S–109S doi: 10.1592/phco.23.16.101S.31971 PubMedCrossRefGoogle Scholar
- 24.Kubista E, Glaspy J, Holmes FA, Green MD, Hackett J, Neumann T et al (2003) Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer. Clin Breast Cancer 3:391–398PubMedCrossRefGoogle Scholar