title: Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study).
abstract: OBJECTIVE
  The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (febrile) neutropenia (chemotherapy-induced (CIN)/febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®).
  
  
  METHODS
  MONITOR-GCSF is an international (12 countries), multi-center (140), prospective (max. six cycles), observational, open-label, pharmaco-epidemiologic study of cancer patients (n = 1447) treated with myelosuppressive chemotherapy across a total of 6,213 cycles and receiving prophylaxis with Zarzio®. Data were analyzed using both the patient and cycle as unit of analysis.
  
  
  RESULTS
  Most (72.3 %) received primary prophylaxis; dosed mainly (53.2 %) at 30 MIU but differentiated by weight, chemotoxicity, and tumor type; and mainly (53.2 %) initiated in the 24-72h post-chemotherapy window but differentiated by prophylaxis type, tumor type, and chemotoxicity and for modal/median duration of 5 days. Relative to European Organisation for Research and Treatment of Cancer (EORTC) guidelines, 56.6 % were correctly prophylacted, 17.4 % under-prophylacted, and 26.0 % over-prophylacted. The following incidence rates were recorded: CIN grade 4 13.2 % of patients and 3.9 % of cycles, FN 5.9 % of patients and 1.4 % of cycles, CIN/FN-related hospitalizations 6.1 % of patients and 1.5 % of cycles, CIN/FN-related chemotherapy disturbances 9.5 % of patients and 2.8 % of cycles, and composite outcomes index 22.3 % of patients and 6.7 % of cycles. Rates varied by type of prophylaxis and tumor, chemotoxicity, initiation day, and prophylaxis duration. There were 1834 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients.
  
  
  CONCLUSIONS
  The clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice.
authors: Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.
authors: Pere
authors: P
authors: Gascón
authors: Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland.
authors: Matti
authors: M
authors: Aapro
authors: Medizinische Abteilung I-Onkologie und Haematologie, Wilhelminenspital, Wien, Austria.
authors: Heinz
authors: H
authors: Ludwig
authors: Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany.
authors: Carsten
authors: C
authors: Bokemeyer
authors: Dipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy.
authors: Mario
authors: M
authors: Boccadoro
authors: Sandoz Biopharmaceuticals, Holzkirchen, Germany.
authors: Matthew
authors: M
authors: Turner
authors: Matrix45, Tucson, AZ, USA.
authors: Kris
authors: K
authors: Denhaerynck
authors: Matrix45, Tucson, AZ, USA.
authors: Karen
authors: K
authors: MacDonald
authors: Matrix45, Tucson, AZ, USA. abraham@pharmacy.arizona.edu.|Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Drachman Hall B306H, 1295 N Martin, Tucson, AZ, 85721, USA. abraham@pharmacy.arizona.edu.
authors: Ivo
authors: I
authors: Abraham
mesh_terms: D000328:Adult; D000368:Aged; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000188:drug therapy* / Q000517:prevention & control*; D005260:Female; D005334:Fever / Q000139:chemically induced; D000069585:Filgrastim / Q000627:therapeutic use*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim
keywords: Biosimilar; Chemotherapy-induced neutropenia; Febrile neutropenia; Filgrastim; Granulocyte colony-stimulating factor; Prophylaxis