Background: The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation\nand stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the\ntherapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an\nobservational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar\nepoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting.\nMethods: Patients >18 years with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or\nmyeloma and eligible for treatment with an epoetin biosimilar were included in this study. Patient characteristics were\nrecorded at baseline along with anaemia-related information, such as observed and target Hb (as chosen by the\ntreating clinician), brand and dose of epoetin biosimilar prescribed, and details of any other treatments. Patients were\nthen followed-up at 3 and 6 months. The primary endpoint was Hb response (defined as Hb reaching ?10 g/dL, an\nincrease of Hb ?1 g/dL since inclusion visit or reaching physician-defined target Hb, with no blood transfusions in the\n3 weeks prior to measurement). Other endpoints included adverse events, achievement of target Hb and associated\ntreatments.\nResults: Overall, 2333 patients >18 years (mean age 66.5 years) with CIA (haemoglobin [Hb] <11 g/dL) in association\nwith solid tumours, lymphoma or myeloma and eligible for biosimilar epoetin treatment were included. 99.9% of\npatients received epoetin zeta (median dose 30,000 IU/week). Mean baseline Hb was 9.61 g/dL, with 35.6% of patients\nhaving moderate anaemia (Hb 8ââ?¬â??9.5 g/dL). Hb response was achieved in 81.6% and 86.5% of patients at 3 and\n6 months, respectively. Overall mean change in Hb level was 1.52 Ã?± 1.61 and 1.72 Ã?± 1.61 g/dL at 3 and 6 months,\nrespectively. Transfusion and thromboembolic event rates were 9.4% and 2.4% at 3 months, and 5.8% and 1.5% at\n6 months, respectively.\nConclusions: Epoetin zeta was effective and well tolerated in the management of CIA in patients with solid tumours,\nlymphoma and myeloma.
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