Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo‐mobilization with vinorelbine in multiple myeloma patients

Abstract

Biosimilars are increasingly being licensed as equipotent drugs, although efficacy and safety data are not available for all clinical indications. Accordingly, the efficacy of the biosimilar filgrastim Zarzio® combined with vinorelbine for chemo-mobilization of CD34+ hematopoietic progenitor cells (HPC) in patients with multiple myeloma has not been evaluated yet. We compared the efficacy of vinorelbine combined with this biosimilar filgrastim for HPC mobilization to vinorelbine plus original filgrastim (Neupogen®). Overall, 105 multiple myeloma patients received vinorelbine 35 mg/m intravenously on day 1 and either original filgrastim (n = 61;58%) or biosimilar filgrastim (n = 44;42%) at a dose of 5 µg per kg body weight (BW) twice daily subcutaneously starting day 4 until the end of the collection procedure. Leukapheresis was scheduled to start on day 8 and performed for a maximum of three consecutive days until at least 4 × 10 HPC/kg BW were collected. All patients proceeded to leukapheresis. In 102 (97%) patients the leukapheresis sessions were started as planned at day 8. The median number of collected HPC was 7.3 × 10 /kg BW (0.2-18.3) with original filgrastim compared to 9 × 10 /kg BW (4.2-23.8) with the biosimilar filgrastim (P = 0.16). HPC collection was successful in 57 (93%) of 61 patients of the original group and in all 44 (100%) patients of the biosimilar group (P = 0.14). No differences were observed regarding side effects. Duration of neutrophil engraftment after autologous HPC transplantation was similar between the two groups (P = 0.17). Biosimilar and original filgrastim achieve comparable results in combination with vinorelbine regarding HPC mobilization and transplantation outcome in multiple myeloma patients. J. Clin. Apheresis 32:21-26, 2017. © 2016 Wiley Periodicals, Inc.

Comparison of biosimilar filgrastim, originator filgrastim, and lenograstim for autologous stem cell mobilization in patients with multiple myeloma

“…Also, analyzing the overall collected number of CD341 cells, the number of LP sessions and the application of plerixafor revealed no differences between the subgroups. This is in line with the findings of Maul and colleagues 16 as well as Martino and colleagues, 17 who evaluated the CD341 collection results in MM patients after chemomobilization with cyclophosphamide and vinorelbine, respectively, and found comparable mobilization efficacies of the biosimilar filgrastim and reference filgrastim. Recently, Becker and coworkers 24 found the use of biosimilar filgrastim for healthy-donor stem cell mobilization to be safe and effective in a twocenter safety surveillance study (n 5 245).…”

“…On the other hand, this is a limitation of this study, as the findings cannot be easily translated into other patient collectives. While we are confident that in the light of the above-mentioned literature 16,17,23,24 the results would be similar in case of other cyclophosphamide-based chemomobilization regimens or even steady-state mobilization, future studies are warranted to comparatively analyze different mobilization strategies and include malignancies other than MM. Furthermore, the results might be different for pediatric patients.…”

“…In the Filgrastim Hexal cohort eight patients received more than four induction therapy cycles based on different therapeutic approaches in other medical institutions, in particularly abroad, before the patient presented in our center for further treatment. The median disease duration until PBSC collection was 5 (range, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] months. The upper range of 22 months resulted from the fact that some few patients underwent orthopedic surgery or local radiation before receiving systemic therapy.…”

“…[11][12][13][14][15] However, in previous studies PBSC mobilization outcomes were analyzed in heterogeneous and/or small cancer patient cohorts. [16][17][18][19][20] Moreover, no direct comparison of all three G-CSF variants-filgrastim, lenograstim, and the biosimilar Zarzio/Filgrastim Hexalin one single study population was performed so far.…”

A phase I study of different doses and frequencies of pegylated recombinant human granulocyte-colony stimulating factor (PEG rhG-CSF) in patients with standard-dose chemotherapy-induced neutropenia

“…rhG-CSF is an effective prevention and management of chemotherapy-induced neutropenia and it can improve the patients' quality of life (20)(21)(22). As its pegylated form, PEG rhG-CSF was reported to have a reduced clearance, increased plasma half-life, and sustained biologic activity, developing increased ANCs for substantially longer periods of time (23,24).…”