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: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy. alberto.bongiovanni@irst.emr.it.
authors: Alberto
authors: A
authors: Bongiovanni
authors: Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Manuela
authors: M
authors: Monti
authors: Oncology Pharmacy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Flavia
authors: F
authors: Foca
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Federica
authors: F
authors: Recine
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Nada
authors: N
authors: Riva
authors: Oncology Pharmacy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Valentina
authors: V
authors: Di Iorio
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Chiara
authors: C
authors: Liverani
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Alessandro
authors: A
authors: De Vita
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Giacomo
authors: G
authors: Miserocchi
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Laura
authors: L
authors: Mercatali
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Dino
authors: D
authors: Amadori
authors: Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli, 40, 47014, Meldola, Italy.
authors: Toni
authors: T
authors: Ibrahim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology / Q000517:prevention & control*; D015251:Epirubicin / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim / Q000627:therapeutic use*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006401:Hematologic Agents / Q000627:therapeutic use; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012509:Sarcoma / Q000097:blood / Q000188:drug therapy*
chemical_list: D006401:Hematologic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D000078224:Lenograstim; D000069585:Filgrastim; D007069:Ifosfamide
keywords: Anthracycline; Biosimilar filgrastim; Epirubicin; Ifosfamide; Neutropenia; Sarcoma; rG-CSF