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

Support Care Cancer. 2017 Jan;25(1):111-117. doi: 10.1007/s00520-016-3390-0. Epub 2016 Aug 27.

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.

Keywords: Anthracycline; Biosimilar filgrastim; Epirubicin; Ifosfamide; Neutropenia; Sarcoma; rG-CSF.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Chemotherapy-Induced Febrile Neutropenia / etiology
  • Chemotherapy-Induced Febrile Neutropenia / prevention & control*
  • Epirubicin / adverse effects
  • Female
  • Filgrastim / therapeutic use*
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Hematologic Agents / therapeutic use
  • Humans
  • Ifosfamide / administration & dosage
  • Ifosfamide / adverse effects
  • Lenograstim
  • Male
  • Middle Aged
  • Recombinant Proteins / therapeutic use
  • Retrospective Studies
  • Sarcoma / blood
  • Sarcoma / drug therapy*

Substances

  • Hematologic Agents
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Lenograstim
  • Filgrastim
  • Ifosfamide