Erythropoetin β Twice Weekly Versus Standard Therapy in Patients with Gynaecological Malignancies - A Randomised Austrian AGO Trial

Background: The influence of two regimens of erythropoetin β on haemoglobin level, quality of life (QoL) and side-effects in patients with gynaecological malignancies was assessed. Patients and Methods: A total of 119 patients during chemotherapy were randomised to either standard therapy with 10,000 IU erythropoetin β three times a week (group A) or 20,000 IU twice a week (group B). Haemoglobin level and QoL were measured. Characteristics of the study population were analysed with descriptive statistical methods. Analysis of variance for repeated measurements was performed with haemoglobin level as dependent variable, and time and study arms as factors. Results: The rise in haemoglobin levels and QoL improvement were significant, without any difference between study arms. Adverse events were similar, except significantly more thromboembolic events in group B (0 vs. 8 events; p=0.003). Conclusion: Our results show similar improvements in haemoglobin level and QoL, but raise the question whether less frequent dosing regimes may result in increased rates of thromboembolic events. Of all paraneoplastic syndromes, anaemia is one of the most common. The incidence of anaemia varies with tumour type, stage and patient age; up to 40% of cancer patients are anaemic at diagnosis (1, 2), and this frequency increases to 80% following chemotherapy (3).