Effectiveness Of Biosimilar Epoetin Alfa For The Treatment Of Chemotherapy-Induced Anemia In Patients With Hematological Malignancies

Epoetin and intravenous iron are used at St. Bartholomew's Hospital (Barts Health NHS Trust) for the treatment of patients with non-myeloid malignancy and chemotherapy-induced anemia. Modified American Society of Hematology/American Society of Clinical Oncology guidelines are used to guide epoetin use. This is combined with a systematic approach to iron supplementation based on iron status markers, including zinc protoporphyrin (ZPP). Using this approach, we have previously reported very high hemoglobin response rates of up to 92% with epoetin beta (Agrawal et al. Blood 2005; 106: Abs 588). Biosimilar versions of epoetin alfa are now approved in Europe to treat chemotherapy-induced anemia in patients with cancer. These agents offer potentially substantial cost savings to healthcare payers, and their greater affordability may increase patient access to treatments. We performed a pilot study of the effectiveness of biosimilar epoetin alfa (Sandoz, Germany) in our protocol for the management of chemotherapy-induced anemia in patients with hematological malignancies.

Patients with chronic lymphocytic leukemia (CLL), myeloma or lymphoma, receiving chemotherapy and with Hb<10 g/dL, were treated with biosimilar epoetin alfa (30,000 IU subcutaneously once weekly, increased to 60,000 IU at 4 weeks if no response [Hb increase<1 g/dL over baseline]). Minor and major responses to epoetin were defined as a Hb increase of 1–2 g/dL and >2 g/dL, respectively. Iron support was given in the form of intravenous (i.v.) iron sucrose 200 mg weekly if indicated based on iron status markers (serum ferritin, transferring saturation [TSAT], mean corpuscular Hb [MCH] and ZPP).

Nineteen patients treated with biosimilar epoetin alfa were included in this analysis (9 with CLL, 7 with myeloma, 3 with lymphoma). Ages ranged from 25 to 84 years. 18 patients had a response to biosimilar epoetin alfa (95%); of these, 12 had a major response and 6 a minor response. Only one patient required an epoetin dose increase. Four patients were transfusion-dependent at baseline, 3 of whom became transfusion-independent on epoetin therapy. Seven of the 19 patients were ineligible for iron supplementation because of a serum ferritin >1000 μg/L. Of the remaining 12 patients, five (43%) received i.v. iron support based on their iron status markers at baseline and during epoetin therapy. In all five, the trigger for iron support was a raised ZPP in combination with a low/normal serum ferritin; TSAT was low in only 2/5and the MCH was normal in 5/5. All five patients achieved a response to epoetin. In contrast, five other patients who had a raised ZPP did not receive iron support because of markedly raised serum ferritin (>750 μg/L) with raised TSAT.

This pilot study indicates that biosimilar epoetin alfa is effective for the treatment of chemotherapy-induced anemia in patients with hematological malignancies. Although this is a small data set, response rates using biosimilar epoetin alfa in our epoetin/iron supplementation protocol (95%) are very high and similar to historical data using epoetin beta (92%). While ZPP appears to be a useful parameter to guide iron support in patients with hematological malignancies, it cannot be used in isolation and must be correlated with serum ferritin. Appropriate use of iron support, based on assessment of readily available laboratory parameters, may increase response rates to epoetin therapy.

Agrawal:Sandoz Biopharmaceuticals: Consultancy, Honoraria, Research Funding. Turner:Sandoz Biopharmaceuticals: Employment.