Giovanni Rosti1, Mario Petrini2, Alberto Bosi3, Piero Galieni4, Daniele Bernardi5, Gianfranco Giglio6, Laura Dorotea7, Brunangelo Falini8, Elvira Scelzi9, Enzo Veltri10, Roberto Castelli11, Chiara Longagnani12, Tommaso Raggi13, Federico Simonetti14. 1. Oncologia, Policlinico San Matteo IRCCS, Pavia, Via Scarpa 1, 31100 Treviso, Italy. 2. Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 3. Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy. 4. Ospedale C. e G. Mazzoni, Ascoli Piceno, Italy. 5. ULSS 10 'Veneto Orientale', San Donà di Piave, Italy. 6. Ospedale Cardarelli, Campobasso, Italy. 7. Ospedale Riuniti Padova Sud, Monselice, Italy. 8. Ospedale Santa Maria della Misericordia, Perugia, Italy. 9. Ospedale di Castelfranco Veneto (ULSS), Castelfranco Veneto, Italy. 10. Ospedale S. Maria Goretti, Latina, Italy. 11. Fondazione Cà Granda Ospedale Maggiore Policlinico, Milano, Italy. 12. MediNeos surl, Modena, Italy. 13. Sandoz S.p.A., Origgio, Italy. 14. Versilia Azienda ULSS 12, Lido di Camaiore, Italy.
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.
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 cancerpatients 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.
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