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

Şıvgın, Serdar; Karakus, Esen; Kaynar, Leylagül; Kurnaz, Fatih; Pala, Çiğdem; Keklik, Muzaffer; Zararsız, Gökmen; Eser, Bülent; Çetın, Mustafa; Ünal, Ali

doi:10.1016/j.transci.2013.04.007

Cited by 27 publications

(22 citation statements)

References 23 publications

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“…Other studies have reported that no significant differences were observed between lenograstim and filgrastim in patients or healthy donors undergoing PBSC mobilization [Lefrère et al 1999;Huttmann et al 2005;Sivgin et al 2013;Pórez-López et al 2013].…”

Section: Discussionmentioning

confidence: 98%

Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant

Uddin

Russell

Farrell

et al. 2015

Therapeutic Advances in Hematology

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Objectives: Biosimilar filgrastim was compared with lenograstim for autologous haematopoietic stem-cell transplant (HSCT) in patients with haematological malignancies. Data from a separate group of sibling donors who underwent allogeneic HSCT are also reported. Methods: Patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT with biosimilar filgrastim were compared with a historical control group of patients who received lenograstim. Peripheral blood (PB) cells counts were monitored after 7-8 consecutive days of granulocyte-colony stimulating factor (G-CSF) injection and apheresis was performed on day 8 if PB CD34+ cell count was ⩾10 cells/µl. The target PB CD34+ cell doses were ⩾2.0 × 10 6 /kg (lymphoma), ⩾4.0 × 10 6 /kg (MM ⩾60 years old) or ⩾8.0 × 10 6 /kg (MM <60 years old). Results: A total of 259 patients were included in the autologous HSCT comparison (biosimilar filgrastim, n = 104; lenograstim, n = 155). In patients with lymphoma and older MM patients (⩾60 years old), no significant differences were observed between groups with regard to stem-cell mobilization parameters. However, in MM patients <60 years old, all parameters were significantly superior in the biosimilar filgrastim group, including the need for 1 rather than 2 apheresis procedures. No significant differences were observed between groups in median number of days to absolute neutrophil count (ANC) or platelet recovery. In the allogeneic setting, 47 sibling donors received biosimilar filgrastim. Mean CD34+ count at the first apheresis was 6.1 × 10 6 /kg. A total of 13 donors needed a second apheresis and 4 required a third. Among recipients, median days to ANC recovery was 16 (10-28) and to platelet recovery was 13 (9-54). Conclusions: Biosimilar filgrastim is as effective as lenograstim for autologous HSCT in patients with lymphoma or MM patients ⩾60 years old. However, mobilization with biosimilar filgrastim appeared to be superior to that with lenograstim in younger MM patients.

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Section: Discussionmentioning

confidence: 98%

Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant

Uddin

Russell

Farrell

et al. 2015

Therapeutic Advances in Hematology

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show abstract

“…These findings correlated with previous studies comparing G-CSF agents Continuous values reported as median (minimum-maximum), discrete values reported as mean AE standard deviation. [19][20][21][22][23][24][25][26][27]. Although patients in the filgrastim arm were older, a subanalysis determined that age had no effect on total CD34 þ cells/kg collected.…”

Section: Discussionmentioning

confidence: 99%

“…Although the guidelines' authors recognize the potential contribution of biosimilars in PBSC mobilization, additional studies were recommended. Limited reports demonstrate equivalence utilizing biosimilars in the mobilization and post-transplantation setting; however, no consistent evidence to guide definitive practice changes has emerged [19][20][21][22][23][24][25][26][27].…”

Section: Introductionmentioning

confidence: 99%

Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation

Elayan

Horowitz

Magraner

et al. 2015

Biology of Blood and Marrow Transplantation

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There are limited data available supporting the use of the recombinant granulocyte colony-stimulating factor (G-CSF), tbo-filgrastim, rather than traditionally used filgrastim to mobilize peripheral blood stem cells (PBSC) or to accelerate engraftment after autologous stem cell transplantation (ASCT). We sought to compare the efficacy and cost of tbo-filgrastim to filgrastim in these settings. Patients diagnosed with lymphoma or plasma cell disorders undergoing G-CSF mobilization, with or without plerixafor, were included in this retrospective analysis. The primary outcome was total collected CD34(+) cells/kg. Secondary mobilization endpoints included peripheral CD34(+) cells/μL on days 4 and 5 of mobilization, adjunctive use of plerixafor, CD34(+) cells/kg collected on day 5, number of collection days and volumes processed, number of collections reaching 5 million CD34(+) cells/kg, and percent reaching target collection goal in 1 day. Secondary engraftment endpoints included time to neutrophil and platelet engraftment, number of blood product transfusions required before engraftment, events of febrile neutropenia, and length of stay. A total of 185 patients were included in the final analysis. Patients receiving filgrastim (n = 86) collected a median of 5.56 × 10(6) CD34(+) cells/kg, compared with a median of 5.85 × 10(6) CD34(+) cells/kg in the tbo-filgrastim group (n = 99; P = .58). There were no statistically significant differences in all secondary endpoints with the exception of apheresis volumes processed (tbo-filgrastim, 17.0 liters versus filgrastim, 19.7 liters; P < .01) and mean platelet transfusions (tbo-filgrastim, 1.7 units versus filgrastim, 1.4 units; P = .04). In conclusion, tbo-filgrastim demonstrated similar CD34(+) yield compared with filgrastim in mobilization and post-transplantation settings, with no clinically meaningful differences in secondary efficacy and safety endpoints. Furthermore, tbo-filgrastim utilization was associated with cost savings of approximately $1406 per patient utilizing average wholesale price.

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“…Sivgin et al [28] retrospectively analyzed data of 96 patients who underwent ASCT diagnosed with MM, Hodgkin's lymphoma, non-Hodgkin's lymphoma and others. The authors showed that the biosimilar filgrastim administered after chemotherapy was equivalent to originator for mobilization and PBSC collection when used with the same schedules and doses.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Martino¹,

Recchia

Moscato³

et al. 2015

Cytotherapy

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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

Cited by 27 publications

References 23 publications

Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant

Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant

Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation

Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

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