title: Management of anaemia in oncohaematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study.
abstract: BACKGROUND
  Many patients with solid tumours or nonmyeloid haematopoietic tumours develop symptomatic anaemia, which has a major impact on quality of life (QoL). The efficacy of erythropoiesis-stimulating agents (ESAs) in improving QoL and reducing blood transfusions has been widely demonstrated. Binocrit® (biosimilar epoetin alfa) is an ESA indicated in the European Union for treating chemotherapy-induced anaemia. The aim of this study was to investigate the effect of Binocrit® on haemoglobin (Hb) levels in anaemic cancer patients in Italian clinical practice.
  
  
  METHODS
  The ANEMONE study was a national, longitudinal, retrospective, multicentre observational study. Patients had to be 18 years or older, with a solid tumour or non-Hodgkin's lymphoma, Hodgkin's disease or multiple myeloma, receiving chemotherapy, and treated with Binocrit® to manage chemotherapy-induced anaemia. The primary outcomes were the proportion of patients with a Hb increase ⩾1 g/dl during the first 4 weeks and with a Hb increase ⩾2 g/dl during the first 12 weeks.
  
  
  RESULTS
  A total of 245 patients were enrolled and 215 patients were evaluable for statistical analysis. In the first 4 weeks, 49.3% of patients showed an increase in Hb of ⩾1 g/dl: 45.5% in patients with solid tumours and 52.1% in patients with haematological malignancies. In the first 12 weeks, 51.6% of patients showed an increase in Hb of ⩾2 g/dl (48.4% solid tumours, 54.2% haematological diseases). Treatment with Binocrit® was well tolerated.
  
  
  CONCLUSIONS
  These results confirm the effectiveness and safety of Binocrit® for chemotherapy-induced anaemia in routine practice in patients with solid tumours, lymphoma and myeloma.
authors.affiliation: Oncologia, Policlinico San Matteo IRCCS, Pavia, Via Scarpa 1, 31100 Treviso, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rosti
authors.affiliation: Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Petrini
authors.affiliation: Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
authors.affiliation: Ospedale C. e G. Mazzoni, Ascoli Piceno, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Galieni
authors.affiliation: ULSS 10 'Veneto Orientale', San Donà di Piave, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Bernardi
authors.affiliation: Ospedale Cardarelli, Campobasso, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Giglio
authors.affiliation: Ospedale Riuniti Padova Sud, Monselice, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Dorotea
authors.affiliation: Ospedale Santa Maria della Misericordia, Perugia, Italy.
authors.forename: Brunangelo
authors.initials: B
authors.lastname: Falini
authors.affiliation: Ospedale di Castelfranco Veneto (ULSS), Castelfranco Veneto, Italy.
authors.forename: Elvira
authors.initials: E
authors.lastname: Scelzi
authors.affiliation: Ospedale S. Maria Goretti, Latina, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Veltri
authors.affiliation: Fondazione Cà Granda Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Castelli
authors.affiliation: MediNeos surl, Modena, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Longagnani
authors.affiliation: Sandoz S.p.A., Origgio, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Raggi
authors.affiliation: Versilia Azienda ULSS 12, Lido di Camaiore, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Simonetti
keywords: biosimilar; chemotherapy-induced anaemia; epoetin alfa; erythropoiesis-stimulating agents; erythropoietin