Pegfilgrastim compared with filgrastim for cytokine-alone mobilization of autologous haematopoietic stem and progenitor cells

Abstract

Haematopoietic stem and progenitor cells (HSPC) mobilization, using cytokine-alone, is a well-tolerated regimen with predictable mobilization kinetics. Single-dose pegfilgrastim mobilizes HSPC efficiently; however, there is surprisingly little comparative data on its use without chemotherapy for HSPC mobilization. Pegfilgrastim-alone and filgrastim-alone mobilization regimens were compared in 52 patients with haematological malignancy. Pegfilgrastim 12 mg (n ¼ 20) or 6 mg (n ¼ 2) was administered Day 1 (D1) in 22 patients (lymphoma n ¼ 17; myeloma n ¼ 5). Thirty historical controls (lymphoma n ¼ 18; myeloma n ¼ 12) received filgrastim 10 mcg/kg daily from D1. Peripheral blood (PB) CD34 þ counts reached threshold (X5 Â 10 6 /L) and apheresis commenced on D4(4-5) and D4(4-6). Median PB CD34 þ cell count on D1 of apheresis was similar (26.0 Â 10 6 /L (2.5-125.0 Â 10 6 /L) and 16.2 Â 10 6 /L (2.6-50.7 Â 10 6 /L); P ¼ 0.06), for pegfilgrastim and filgrastim groups, respectively. Target yield (X2 Â 10 6 per kg CD34 þ cells) was collected in 20/22 (91%) pegfilgrastim patients and 24/30 (80%) in the filgrastim group (P ¼ 0.44), in a similar median number of aphereses (3(1-4) versus 3(2-6), respectively; P ¼ 0.85). A higher proportion of pegfilgrastim patients tended to yield X4 Â 10 6 per kg CD34 þ cells; 16/22 (73%) versus 14/30 (47%) filgrastim patients (P ¼ 0.09). One pegfilgrastim patient developed hyperleukocytosis that resolved without incident. Pegfilgrastim-alone is a simple, well-tolerated, and attractive option for outpatient-based HSPC mobilization with similar mobilization kinetics and efficacy to regular filgrastim. (2013) 48, 351-356; doi:10.1038/bmt.2012.145; published online 30 July 2012 Bone Marrow TransplantationKeywords: CD34; pegfilgrastim; mobilization; filgrastim; autologous transplantation INTRODUCTIONThe emergence of recombinant human cytokines for the mobilization of haematopoietic stem and progenitor cells (HSPC) is one of the critical milestones in the history of haematopoietic SCT. The isolation and purification of G-CSF (filgrastim) and the discovery of its potent effect in mobilizing stem and progenitor cells into the PB has provided an alternative to harvesting BM as a source of HSPC for transplantation. Indeed, transplantation using mobilized PB HSPC has been found to result in superior engraftment rates than BM-derived HSPC for transplantation, especially with respect to platelet recovery. 1,2 HSPC mobilization is routinely achieved either using cytokine-alone or cytokine following myelosuppressive chemotherapy (chemo-cytokine mobilization).Chemo-cytokine mobilization results in superior HSPC yields overall, 3-5 however there is increasing interest in outpatient-based cytokine-only regimens for mobilization owing to the improved acceptability to patients, the absence of risk of neutropenic complications and possibly more predictable mobilization kinetics compared with chemo-cytokine mobilization. In chemo-cytokine mobilization, the cytokine effect of filgrastim makes use of the wave of i...

Peripheral Blood Progenitor Cell Mobilization for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation

“…No advantage has been shown by split dosing G-CSF [45,46]. There is emerging data on the efficacy of 12 mg pegfilgrastim as a single subcutaneous dose [47]. However, pegfilgrastim has not been adopted by many centers, likely because of ease and familiarity of use with G-CSF and cost.…”

Plerixafor plus pegfilgrastim is a safe, effective mobilization regimen for poor or adequate mobilizers of hematopoietic stem and progenitor cells: a phase I clinical trial

“…There was a theoretical concern regarding the risk of hyperleukocytosis with pegfilgrastim plus plerixafor, which was not borne out in this study. One historical control patient mobilized with pegfilgrastim alone at our institution 20 had developed hyperleukocytosis after a dose of pegfilgrastim 12 mg for the purposes of cytokine-alone mobilization. Although this case resolved without incident, a dose of pegfilgrastim 6 mg was chosen prospectively for this study and no cases of hyperleukocytosis were observed.…”

How we manage autologous stem cell transplantation for patients with multiple myeloma

“…[68][69][70] A single dose of pegfilgrastim also may be used for mobilization; although extensively used elsewhere, it has not been adopted by our group. 71 BLOOD…”