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

BMC Cancer

Hélène Albrand⁴  Nacéra Sakek^1,12  Raouf Radji^1,15  Pierre Nouyrigat⁸  Bérengère Narciso^1,13  Sophie Nahon^1,16  Jean-Loup Mouysset^1,10  Frédéric Maloisel⁵  Daniel Lepille¹  Jean-Luc Labourey^1,11  Louis-Marie Dourthe⁵  Miguel Carreiro²  Vincent Boulanger⁹  Nadia Ali Amar³  Pierre Soubeyran^1,14  Elisabeth Luporsi⁶  Mauricette Michallet⁷ 

[1]Clinique Pasteur, Evreux, France

[2]Centre Hospitalier de Montauban, Montauban, France

[3]Centre Hospitalier de Troyes, Troyes, France

[4]Laboratoire HOSPIRA France, Meudon La Foret, France

[5]Clinique Sainte Anne, Strasbourg, France

[6]Centre Alexis Vautrin, Vandoeuvre-les-Nancy, France

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

[8]Clinique du Cap d’Or, La Seyne sur Mer, France

[9]Centre Hospitalier de Carcassonne, Carcassonne, France

[10]Clinique Rambot-Provencale, Aix en Provence, France

[11]Polyclinique Montréal, Carcassonne, France

[12]Centre Hospitalier de Montbéliard, Montbeliard, France

[13]Centre Hospitalier Régional Universitaire de Tours, Tours, France

[14]Institut Bergonie, Bordeaux, France

[15]Centre Frédéric JOLLIOT, Rouen, France

[16]Centre Hospitalier d'Aix en Provence, Aix en Provence, France

关键词: Biosimilar;    Chemotherapy;    Anaemia;    ESA;    Epoetin;   

Others  :  1125350
DOI  :  10.1186/1471-2407-14-503

 received in 2014-02-04, accepted in 2014-07-01,  发布年份 2014

【 摘 要 】

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).

【 授权许可】

   
2014 Michallet et al.; licensee BioMed Central Ltd.

【 图 表 】

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