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

G. Rosti, M. Petrini, A. Bosi, P. Galieni, D. Bernardi, G. Giglio, L. Dorotea, B. Falini, E. Scelzi, E. Veltri, R. Castelli, C. Longagnani, T. Raggi, F. Simonetti

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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(R) (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(R) 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(R) 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(R) was well tolerated. CONCLUSIONS: These results confirm the effectiveness and safety of Binocrit(R) for chemotherapy-induced anaemia in routine practice in patients with solid tumours, lymphoma and myeloma.
Original languageEnglish
Pages (from-to)22-32
Number of pages11
JournalTherapeutic Advances in Medical Oncology
Volume9
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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Epoetin Alfa
Biosimilar Pharmaceuticals
Observational Studies
Anemia
Retrospective Studies
Hemoglobins
Neoplasms
Hematinics
Drug Therapy
Quality of Life

Keywords

  • biosimilar
  • chemotherapy-induced anaemia
  • epoetin alfa
  • erythropoiesis-stimulating agents
  • erythropoietin

Cite this

Management of anaemia in oncohaematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study. / Rosti, G.; Petrini, M.; Bosi, A.; Galieni, P.; Bernardi, D.; Giglio, G.; Dorotea, L.; Falini, B.; Scelzi, E.; Veltri, E.; Castelli, R.; Longagnani, C.; Raggi, T.; Simonetti, F.

In: Therapeutic Advances in Medical Oncology, Vol. 9, No. 1, 01.01.2017, p. 22-32.

Research output: Contribution to journalArticle

Rosti, G, Petrini, M, Bosi, A, Galieni, P, Bernardi, D, Giglio, G, Dorotea, L, Falini, B, Scelzi, E, Veltri, E, Castelli, R, Longagnani, C, Raggi, T & Simonetti, F 2017, 'Management of anaemia in oncohaematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study', Therapeutic Advances in Medical Oncology, vol. 9, no. 1, pp. 22-32. https://doi.org/10.1177/1758834016670554 [doi]
Rosti, G. ; Petrini, M. ; Bosi, A. ; Galieni, P. ; Bernardi, D. ; Giglio, G. ; Dorotea, L. ; Falini, B. ; Scelzi, E. ; Veltri, E. ; Castelli, R. ; Longagnani, C. ; Raggi, T. ; Simonetti, F. / Management of anaemia in oncohaematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study. In: Therapeutic Advances in Medical Oncology. 2017 ; Vol. 9, No. 1. pp. 22-32.
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AU - Petrini, M.

AU - Bosi, A.

AU - Galieni, P.

AU - Bernardi, D.

AU - Giglio, G.

AU - Dorotea, L.

AU - Falini, B.

AU - Scelzi, E.

AU - Veltri, E.

AU - Castelli, R.

AU - Longagnani, C.

AU - Raggi, T.

AU - Simonetti, F.

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N2 - 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(R) (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(R) 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(R) 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(R) was well tolerated. CONCLUSIONS: These results confirm the effectiveness and safety of Binocrit(R) for chemotherapy-induced anaemia in routine practice in patients with solid tumours, lymphoma and myeloma.

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KW - erythropoiesis-stimulating agents

KW - erythropoietin

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DO - 10.1177/1758834016670554 [doi]

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JO - Therapeutic Advances in Medical Oncology

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