Biosimilar epoetin alfa in the management of chemotherapy-induced aneamia: results from ANEMONE observational study

Abstract

Background: A large proportion of patients with solid tumours or nonmyeloid haematopoietic tumours develop symptomatic anaemia, with relevant impact on quality of life (QoL).The efficacy of erythropoiesisstimulating agents (ESA) in improving QoL and reducing blood transfusions has been widely demonstrated. Several biosimilar epoetins have been approved by the European Medicines Agency. Biosimilar is a regulatory term used to describe medicines with similar properties to that of an approved biological medicine for which the patent has expired. Binocrit is a biosimilar epoetin alpha approved by EMA in 2007 for several indications, including the treatment of chemotherapy-induced anaemia (CIA). The aim of this retrospective study was to verify, in the Italian clinical practice, the trend of haemoglobin (Hb) levels in anaemic cancer patients for whom physicians deemed to use Binocrit. Patients and Methods: The ANEMONE study was a national, longitudinal, retrospective, multicentre observational study. Patients had to be 18 years or older, presenting solid tumour or non-Hodgkin's lymphoma, Hodgkin's disease or multiple myeloma, receiving chemotherapy, treated with Binocrit to manage CIA. The primary outcomes were the proportion of patients with an increased level of haemoglobin >=1 g/dL during the first 4 weeks and with an increased level of Hb >=2 g/dL during the first 12 weeks. Result(s): 245 patients were enrolled and 215 patients were evaluable for statistical analysis. In the first 4 weeks, 49.3% of patients showed increased Hb=1 g/dL: 45.5% in patients with solid tumours, 52.1% in patients with haematologic malignancies. In the first 12 weeks, 51.6% of patients showed increased Hb=2 g/dL (48.4% solid tumours, 54.2% haematologic malignancies) (Figure 1). Treatment with Binocrit was well tolerated and no unexpected adverse drug reactions were reported. Interestingly, iron supplementation was adopted less than expected according actual guideline indications. Conclusion(s): Despite the fact that biosimilar epoetins are widely used at European level, few publications currently have reported data about their efficacy and safety in real world clinical practice. This multicentric study represent, therefore, an important step to create and increase awareness of biosimilar epoetin clinical data. These results confirm efficacy and safety on biosimilar epoetin alpha (Binocrit) for the treatment of CIA in routine practice in patients with solid tumors, lymphoma and myeloma. (Figure presented).