[Epoetin beta for the treatment of chemotherapy-induced anaemia in solid and haematological malignancies. Results of an open-label, multicentric clinical trial]

Abstract

Aim: Evaluate efficacy and safety of epoetin beta in anaemic patients receiving chemotherapy for a non-myeloid malignancy.

Patients and methods: This open-label, multicentric, clinical trial was conducted in France among 691 anaemic patients (haemoglobin < or = 12 g/dL) with a solid or haematological malignancy to evaluate the benefit of epoetin beta 30,000 IU/week subcutaneously for 16 weeks. The primary endpoint was the rate of therapeutic response.

Results: The overall response rate was 60.4% (CI 95%: [56.6%-64.1]). According to initial haemoglobin level < 11 g/dL or between 11 and 12 g/dL, it was 61.2% and 57.5% respectively. Response rates by tumour type (solid and haematological) were similar. The mean haemoglobin level increases were respectively 1.1 g/dL, approximately 2 and 2.2 g/dL at 4, 9, and 12 weeks after treatment initiation. In patients with haemoglobin level < 11 g/dL at inclusion the mean increases in haemoglobin level were respectively 1.17, 2.03 and 2.45 g/dL at 4, 9 and 12 weeks. During study period, 23% of patients required red blood cell transfusion. Overall treatment with epoetin beta was well-tolerated and 7.1% of patients only experienced thromboembolic events.

Conclusion: For treating chemotherapy-induced anaemia in patients with solid or haematological malignancy (especially if haemoglobin level < 11 g/dL), epoetin beta 30.000 IU subcutaneously once-weekly (450 IU/kg/week) is rapidly effective and overall well-tolerated.