1563P - The use of biosimilars in the management of chemotherapy-induced anaemia (CIA) in solid tumours, lymphoma and myeloma: the ORHEO study

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Lymphomas
Supportive Care
Myeloproliferative Neoplasms
Presenter Mauricette Michallet
Authors M. Michallet1, P. Soubeyran2, E. Luporsi3, H. Albrand4
  • 1Centre Hospitalier Lyon Sud, 69495 - Lyon-Pierre Bénite/FR
  • 2Department Of Medical Oncology, Institut Bergonié and Université Bordeaux Segalen, 33000 - Bordeaux/FR
  • 3Medical Oncology, Centre Alexis Vautrin, 54500 - Vandœuvre-lès-Nancy/FR
  • 4Medical Director, Laboratoire HOSPIRA France, 92360 - Meudon La Forêt/FR

Abstract

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 CIA in the clinical setting. Patients >18 years with CIA (haemoglobin [Hb] <11g/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. Analyses included adverse events, achievement of target Hb and Hb response (defined as Hb reaching ≥10 g/dL, an increase in Hb levels of at least 1 g/dL since inclusion visit or reaching target Hb set by doctor at start of study, without any blood transfusions in the 3 weeks prior to measurement).

2310 patients (mean age 66.5 years) from 232 centres were included, of whom 79.6% had solid tumours, 13.0% had lymphoma and 7.4% myeloma. Of those patients with solid tumours, 30.1% of patients had a stage III and 21.6% had a stage IV tumour. Almost all patients received the biosimilar epoetin zeta (Retacrit®, Hospira UK Ltd., median dose 30,000 IU/week). Mean baseline Hb level across all patients was 9.6 g/dL, with 35.6% of patients having moderate anaemia (Hb 8–9.5 g/dL). Following treatment, Hb response was achieved in 81.6% and 86.5% of patients at 3 and 6 months, respectively. The overall mean change in Hb level was 1.5 ± 1.6 g/dL at 3 months and 1.72 ± 1.61 g/dL at 6 months. Transfusion rates were 9.4% and 5.8%, while the rate of thromboembolic events was 2.4% and 1.5%, at 3 and 6 months respectively. In conclusion, Retacrit was effective and well tolerated in the management of CIA in patients with solid tumours, lymphoma and myeloma.

Disclosure

M. Michallet: I received honoraria from Hospira for advisory boards and consulting,

P. Soubeyran: I received honoraria from Hospira for advisory boards and consulting,

H. Albrand: Employed by Hospira,

E. Luporsi: I received honoraria from Hospira for advisory boards and consulting.