Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR)

Alberto Bongiovanni, Manuela Monti, Flavia Foca, Federica Recine, Nada Riva, Valentina Di Iorio, Chiara Liverani, Alessandro de Vita, Giacomo Miserocchi, Laura Mercatali, Dino Amadori, Toni Ibrahim

Research output: Contribution to journalArticle

Abstract

Purpose: Anthracycline and ifosfamide-based chemotherapy represents a widely used regimen both in early and advanced settings in soft tissue sarcoma (STS). Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. The aim of this study was to assess the efficacy and safety of biosimilar G-CSF in these patients. Methods: Between 2003 and 2013, 67 patients with soft tissue tumors under epirubicin and ifosfamide (EI) treatment receiving biosimilar filgrastim (Zarzio®), originator filgrastim (Granulokine®, Neupogen®), and lenograstim (only originator Myelostim®) as primary prophylaxis for a total of 260 cycles of therapy were retrospectively analyzed. Baseline patient characteristics were summarized in a propensity score (PS). Results: The incidence of febrile neutropenia (FN) was 44.0 % in biosimilar filgrastim, 40.0 % in originator filgrastim, and 45.5 % in the lenograstim groups (p = 0.935). All grade and G4 neutropenia were similar in the three groups with the same safety profile. The use of biosimilar filgrastim achieved cost savings of €225.25 over originator filgrastim and €262.00 over lenograstim. Conclusion: Biosimilar G-CSF was effective in preventing FN and in reducing the need for hospitalization in STS patients undergoing EI treatment. It also proved comparable to its reference products from both a clinical and cost-effective standpoint.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalSupportive Care in Cancer
DOIs
Publication statusAccepted/In press - Aug 27 2016

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Biosimilar Pharmaceuticals
Ifosfamide
Anthracyclines
Granulocyte Colony-Stimulating Factor
Neutropenia
Sarcoma
Febrile Neutropenia
Epirubicin
Safety
Drug Therapy
Propensity Score
Cost Savings
Filgrastim
Hospitalization
Therapeutics
Costs and Cost Analysis
Incidence

Keywords

  • Anthracycline
  • Biosimilar filgrastim
  • Epirubicin
  • Ifosfamide
  • Neutropenia
  • rG-CSF
  • Sarcoma

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology

Cite this

@article{0671d47cbd9344faac29c03e165d6470,
title = "Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR)",
abstract = "Purpose: Anthracycline and ifosfamide-based chemotherapy represents a widely used regimen both in early and advanced settings in soft tissue sarcoma (STS). Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. The aim of this study was to assess the efficacy and safety of biosimilar G-CSF in these patients. Methods: Between 2003 and 2013, 67 patients with soft tissue tumors under epirubicin and ifosfamide (EI) treatment receiving biosimilar filgrastim (Zarzio{\circledR}), originator filgrastim (Granulokine{\circledR}, Neupogen{\circledR}), and lenograstim (only originator Myelostim{\circledR}) as primary prophylaxis for a total of 260 cycles of therapy were retrospectively analyzed. Baseline patient characteristics were summarized in a propensity score (PS). Results: The incidence of febrile neutropenia (FN) was 44.0 {\%} in biosimilar filgrastim, 40.0 {\%} in originator filgrastim, and 45.5 {\%} in the lenograstim groups (p = 0.935). All grade and G4 neutropenia were similar in the three groups with the same safety profile. The use of biosimilar filgrastim achieved cost savings of €225.25 over originator filgrastim and €262.00 over lenograstim. Conclusion: Biosimilar G-CSF was effective in preventing FN and in reducing the need for hospitalization in STS patients undergoing EI treatment. It also proved comparable to its reference products from both a clinical and cost-effective standpoint.",
keywords = "Anthracycline, Biosimilar filgrastim, Epirubicin, Ifosfamide, Neutropenia, rG-CSF, Sarcoma",
author = "Alberto Bongiovanni and Manuela Monti and Flavia Foca and Federica Recine and Nada Riva and {Di Iorio}, Valentina and Chiara Liverani and {de Vita}, Alessandro and Giacomo Miserocchi and Laura Mercatali and Dino Amadori and Toni Ibrahim",
year = "2016",
month = "8",
day = "27",
doi = "10.1007/s00520-016-3390-0",
language = "English",
pages = "1--7",
journal = "Supportive Care in Cancer",
issn = "0941-4355",
publisher = "Springer Verlag",

}

TY - JOUR

T1 - Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR)

AU - Bongiovanni, Alberto

AU - Monti, Manuela

AU - Foca, Flavia

AU - Recine, Federica

AU - Riva, Nada

AU - Di Iorio, Valentina

AU - Liverani, Chiara

AU - de Vita, Alessandro

AU - Miserocchi, Giacomo

AU - Mercatali, Laura

AU - Amadori, Dino

AU - Ibrahim, Toni

PY - 2016/8/27

Y1 - 2016/8/27

N2 - Purpose: Anthracycline and ifosfamide-based chemotherapy represents a widely used regimen both in early and advanced settings in soft tissue sarcoma (STS). Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. The aim of this study was to assess the efficacy and safety of biosimilar G-CSF in these patients. Methods: Between 2003 and 2013, 67 patients with soft tissue tumors under epirubicin and ifosfamide (EI) treatment receiving biosimilar filgrastim (Zarzio®), originator filgrastim (Granulokine®, Neupogen®), and lenograstim (only originator Myelostim®) as primary prophylaxis for a total of 260 cycles of therapy were retrospectively analyzed. Baseline patient characteristics were summarized in a propensity score (PS). Results: The incidence of febrile neutropenia (FN) was 44.0 % in biosimilar filgrastim, 40.0 % in originator filgrastim, and 45.5 % in the lenograstim groups (p = 0.935). All grade and G4 neutropenia were similar in the three groups with the same safety profile. The use of biosimilar filgrastim achieved cost savings of €225.25 over originator filgrastim and €262.00 over lenograstim. Conclusion: Biosimilar G-CSF was effective in preventing FN and in reducing the need for hospitalization in STS patients undergoing EI treatment. It also proved comparable to its reference products from both a clinical and cost-effective standpoint.

AB - Purpose: Anthracycline and ifosfamide-based chemotherapy represents a widely used regimen both in early and advanced settings in soft tissue sarcoma (STS). Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. The aim of this study was to assess the efficacy and safety of biosimilar G-CSF in these patients. Methods: Between 2003 and 2013, 67 patients with soft tissue tumors under epirubicin and ifosfamide (EI) treatment receiving biosimilar filgrastim (Zarzio®), originator filgrastim (Granulokine®, Neupogen®), and lenograstim (only originator Myelostim®) as primary prophylaxis for a total of 260 cycles of therapy were retrospectively analyzed. Baseline patient characteristics were summarized in a propensity score (PS). Results: The incidence of febrile neutropenia (FN) was 44.0 % in biosimilar filgrastim, 40.0 % in originator filgrastim, and 45.5 % in the lenograstim groups (p = 0.935). All grade and G4 neutropenia were similar in the three groups with the same safety profile. The use of biosimilar filgrastim achieved cost savings of €225.25 over originator filgrastim and €262.00 over lenograstim. Conclusion: Biosimilar G-CSF was effective in preventing FN and in reducing the need for hospitalization in STS patients undergoing EI treatment. It also proved comparable to its reference products from both a clinical and cost-effective standpoint.

KW - Anthracycline

KW - Biosimilar filgrastim

KW - Epirubicin

KW - Ifosfamide

KW - Neutropenia

KW - rG-CSF

KW - Sarcoma

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SN - 0941-4355

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