1568P - The use of biosimilar epoetins in the management of chemotherapy-induced anaemia (CIA) in patients with breast cancer: a subanalysis of the ORHEO st...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive Care
Breast Cancer
Presenter Mauricette Michallet
Authors M. Michallet1, E. Luporsi2, P. Soubeyran3, H. Albrand4
  • 1Centre Hospitalier Lyon Sud, 69495 - Lyon-Pierre Bénite/FR
  • 2Medical Oncology, Centre Alexis Vautrin, 54500 - Vandœuvre-lès-Nancy/FR
  • 3Department Of Medical Oncology, Institut Bergonié and Université Bordeaux Segalen, 33000 - Bordeaux/FR
  • 4Medical Director, Laboratoire HOSPIRA France, 92360 - Meudon La Forêt/FR


ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) is 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. The study included a total of 2310 patients (mean age 66.5 years) of whom 79.6% (n = 1838) had solid tumours, 13.0% (n = 171) had lymphoma and 7.4% (n = 301) myeloma. Here we report a subanalysis of the study assessing the efficacy and safety of biosimilar epoetins in patients with breast cancer. A total of 266 patients >18 years with CIA (haemoglobin [Hb] <11g/dL) in association with breast cancer and eligible for treatment with an epoetin biosimilar were included in this subanalysis. 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 biosimilar epoetin prescribed, and details of parallel treatments. Patients were 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). Of the patients included in this cohort, 38.8% had a stage II tumour and 18.7% a stage III tumour. Metastases were identified in 56.0% of patients. At baseline, average Hb levels were 9.9 g/dL, with 24.1% of patients classed as having moderate anaemia. 99.6% patients received epoetin zeta (Retacrit®, Hospira UK Ltd.) Response to treatment with biosimilar epoetin was achieved in 86.8% and 91.7% of patients with breast cancer after 3 and 6 months, respectively, while average Hb levels had increased by 1.3 and 1.8 g/dL at 3 and 6 months, respectively. At 6 months, the transfusion rate was 0.7%, the rate of clinically significant adverse events was 9.9%, while the rate of thrombotic events was 0.8%. In conclusion, Retacrit was effective and well tolerated in the treatment of CIA in patients with breast cancer.


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

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

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

H. Albrand: Employed by Hospira.