Management of anaemia in onco-haematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study

Objectives: Many patients with solid tumours or non-myeloid 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 for treating chemotherapy-induced anaemia. The aim of this
study was to investigate the effect of Binocrit® on 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 haemoglobin (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, 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.