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

Abstract

BackgroundThe 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.MethodsPatients >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.ResultsOverall, 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.ConclusionsEpoetin zeta was effective and well tolerated in the management of CIA in patients with solid tumours, lymphoma and myeloma.Trial registrationTrial registration number: NCT02140736 (date of registration: 14 May 2014).

Biosimilar epoetin for the management of chemotherapy-induced anemia in elderly patients

“…ORHEO was a large observational, noninterventional, longitudinal, national, multicenter study (NCT02140736) 12. Inclusion criteria included patients at least 18 years of age presenting with CIA (irrespective of chemotherapy cycle) associated with solid tumors, lymphomas, or myelomas and eligible for treatment with an epoetin alfa biosimilar.…”

“…For the reasons presented regarding the importance of managing CIA in the elderly patient and the lack of studies, an exploratory subanalysis was performed on the results of the ORHEO observational study12 to compare the tolerability and effectiveness of epoetin biosimilars in the management of CIA in younger patients (<70 years old) versus elderly patients (≥70 years old). A description of the ORHEO trial is presented in the following sections.…”

Hematopoietic growth factors in lung cancer

“…In fact, the most recent updates involving biosimilar filgrastim come from preclinical data [81] and comparisons with its originator in solid tumors, with particular focus on breast cancer [82][83][84][85]; globally, such comparative studies did not show substantial differences between the products. Similarly, although most comparative data on biosimilar epoetin come from nephrology [86], a recent, large observational study in the clinical setting of solid and hematologic malignancies [87] favored its use.…”

Biosimilars in Oncology

“…28 There is now extensive clinical experience with biosimilar epoetin and filgrastim in patients with cancer, and many studies have reported that efficacy is comparable to that of originator products, with no unexpected safety concerns, and substantial economic savings. [29][30][31] A European retrospective review of patients who switched from originator filgrastim to biosimilar filgrastim showed that the latter was effective, clinically comparable to the originator product and prevented dose reductions/ discontinuation in the majority of patients. 31 In the US, the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, was passed in 1984.…”