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Open Access Highly Accessed Research article

BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study

Mauricette Michallet1*, Elisabeth Luporsi2, Pierre Soubeyran3, Nadia Ali Amar4, Vincent Boulanger5, Miguel Carreiro6, Louis-Marie Dourthe7, Jean-Luc Labourey58, Daniel Lepille9, Frédéric Maloisel7, Jean-Loup Mouysset10, Sophie Nahon11, Bérengère Narciso12, Pierre Nouyrigat13, Raouf Radji14, Nacéra Sakek15, Hélène Albrand16 and The ORHEO study group

Author Affiliations

1 Service d’Hématologie, Pavillon Marcel Bérard 1G, Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet, Lyon- Pierre Bénite 69495, France

2 Centre Alexis Vautrin, Vandoeuvre-les-Nancy, France

3 Institut Bergonie, Bordeaux, France

4 Centre Hospitalier de Troyes, Troyes, France

5 Centre Hospitalier de Carcassonne, Carcassonne, France

6 Centre Hospitalier de Montauban, Montauban, France

7 Clinique Sainte Anne, Strasbourg, France

8 Polyclinique Montréal, Carcassonne, France

9 Clinique Pasteur, Evreux, France

10 Clinique Rambot-Provencale, Aix en Provence, France

11 Centre Hospitalier d'Aix en Provence, Aix en Provence, France

12 Centre Hospitalier Régional Universitaire de Tours, Tours, France

13 Clinique du Cap d’Or, La Seyne sur Mer, France

14 Centre Frédéric JOLLIOT, Rouen, France

15 Centre Hospitalier de Montbéliard, Montbeliard, France

16 Laboratoire HOSPIRA France, Meudon La Foret, France

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BMC Cancer 2014, 14:503  doi:10.1186/1471-2407-14-503

Published: 10 July 2014

Abstract

Background

The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation and stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar epoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting.

Methods

Patients >18 years with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for treatment with an epoetin biosimilar were included in this study. Patient characteristics were recorded at baseline along with anaemia-related information, such as observed and target Hb (as chosen by the treating clinician), brand and dose of epoetin biosimilar prescribed, and details of any other treatments. Patients were then followed-up at 3 and 6 months. The primary endpoint was Hb response (defined as Hb reaching ≥10 g/dL, an increase of Hb ≥1 g/dL since inclusion visit or reaching physician-defined target Hb, with no blood transfusions in the 3 weeks prior to measurement). Other endpoints included adverse events, achievement of target Hb and associated treatments.

Results

Overall, 2333 patients >18 years (mean age 66.5 years) with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for biosimilar epoetin treatment were included. 99.9% of patients received epoetin zeta (median dose 30,000 IU/week). Mean baseline Hb was 9.61 g/dL, with 35.6% of patients having moderate anaemia (Hb 8–9.5 g/dL). Hb response was achieved in 81.6% and 86.5% of patients at 3 and 6 months, respectively. Overall mean change in Hb level was 1.52 ± 1.61 and 1.72 ± 1.61 g/dL at 3 and 6 months, respectively. Transfusion and thromboembolic event rates were 9.4% and 2.4% at 3 months, and 5.8% and 1.5% at 6 months, respectively.

Conclusions

Epoetin zeta was effective and well tolerated in the management of CIA in patients with solid tumours, lymphoma and myeloma.

Trial registration

Trial registration number: NCT02140736 (date of registration: 14 May 2014).

Keywords:
Epoetin; ESA; Anaemia; Chemotherapy; Biosimilar