title: Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.
abstract: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy.
  
  
  
  This was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled.
  
  
  
  Among the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22-92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment.
  
  
  
  Biosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies.
  
  
  
  ClinicalTrials.gov identifier, NCT01627990.
  
  
  
  Hospira Inc, A Pfizer Company, Lake Forest, IL, USA.
authors.affiliation: Klinik Dr. Hancken, Hämatologie, Onkologie und Palliativmedizin, Stade, Germany. stefan_fruehauf@urz.uni-heidelberg.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Fruehauf
authors.affiliation: Onkologische Praxis Oldenburg/Delmenhorst, Standort Oldenburg, Oldenburg, Germany.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Otremba
authors.affiliation: Hämato-Onkologische Schwerpunktpraxis, Praxis München, Munich, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Stötzer
authors.affiliation: Hospira Deutschland GmbH, A Pfizer Company, Medical Affairs, Munich, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Rudolph
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects; D003603:Cytotoxins; D064147:Febrile Neutropenia / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage / Q000009:adverse effects; D006401:Hematologic Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D065129:Pre-Exposure Prophylaxis / Q000379:methods; D011446:Prospective Studies; D055502:Secondary Prevention / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D003603:Cytotoxins; D006401:Hematologic Agents; D000069585:Filgrastim
keywords: Biosimilar; Chemotherapy; Filgrastim; Granulocyte-colony stimulating factor; Hematology; Neutropenia; Nivestim; Oncology