The comparison of Filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) as a first line peripheral blood stem cell mobilization strategy in autologous hematopoieitic stem cell transplantation: a single center experience from Turkey.

OBJECTIVES AND AIM: Patients affected by hematological malignancies can often benefit from high dose chemotherapy followed by peripheral blood stem cells (PBSCs) transplantation. Different strategies have been used to mobilize an adequate number of PBSC, including granulocyte colony-stimulating factor (G-CSF) alone or chemotherapy plus G-CSF. In this study, we aimed to compare the efficacy profile of different G-CSF agents including filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) mobilization in patients who underwent autologous hematopoietic stem cell transplantation (autoHSCT).

MATERIALS AND METHODS: We retrospectively analysed data of patients who underwent autoHSCT diagnosed with multiple myeloma (MM), Hodgkin Lymphoma (HL), non-Hodgkin Lymphoma (NHL) and others. Data for stem cell mobilization has been obtained from patients' files. Patients who received Filgrastim (Neupogen®), biosimilar Filgrastim (Leucostim®, Group) and Lenograstim (Granocyte®) were evaluated mainly for total CD34(+) cell count at the end of mobilization procedure.

RESULTS: A total of 96 patients who underwent autoHSCT were retrospectively analyzed. 27 (28.2%) of the patients were female, and 69 (71.8%) were male. The diagnosis of the patients were; multiple myeloma (39 patients, 40.6%), Hodgkin Lyphoma (23 patients, 23.9%), non-Hodgkin lymphoma (16 patients, 16.6%), and others (18 patients, 18.9%). The median number of leukapheresis cycle necessary to harvest a minimal count of 3×10(6) CD34(+)/kg was 2 in Neupogen® (min-max: 1-4) and Granocyte® (min-max: 1-3) groups and 1 (min-max: 1-2) in Leucostim® group. The median doses of G-CSF agents (μg/kg/day) in PBSC collection procedure were; 10.00 (min-max: 7.00-12.00) in the Neupogen® group, 8.00 (min-max: 7.25-9.00) in the Leucostim® group and 8.50 (6.00-9.50) in the Granocyte® group. There was no statistical significance among groups (p=0.067). The number of total collected PB CD34(+) cells (×10(6)/kg) was 7.64 (min-max: 4.09-13.86) in the Neupogen® group, 13.43 (min-max: 8.15-23.38) in the Leucostim® group and 5.45 (min-max: 4.28-9.40) in the Granocyte® group. The data showed that patients in the leucostim group had significantly higher PB CD34(+) cells compared to patients in the Granocyte® group (p=0.013).

CONCLUSION: Leucostim® was comparable to Neupogen® for PBSC mobilization in patients who underwent autoHSCT.