00040: HIGHER RATE OF THROMBOSIS IN ERYTHROPOIETIN ß TWICE WEEKLY VERSUS STANDARD THERAPY IN PATIENTS WITH GYNECOLOGIC MALIGNANCY: AN AUSTRIAN AGO TRIAL

Background: We assessed the influence of two different dosages of erythropoietin b on haemoglobin level, quality of life (QoL) and side effects. Methods: 119 anaemic study patients under therapy for gynaecologic malignancy were randomised to either standard therapy with 10 000 UI erythropoietin b three times weekly (Arm A) versus 20 000 UI erythropoietin b two times weekly (Arm B). Changes in haemoglobin level and QoL were measured. Characteristics of the study population were analysed with descriptive statistical methods. Analysis of variance for repeated measurements (general linear model) was performed, with haemoglobin level as dependent variable and time and study arm as factors. Results: Improvement in haemoglobin in both arms was significant (Arm A 10.30 to 11.90g/dl versus Arm B 10.50 to 12.20g/dl) as was QoL, without significant difference between the study arms. Significant more thromboses in Arm B than in Arm A (7; 12% versus 0; p = 0.006) were seen. Conclusions: Our results show similar improvements in haemoglobin level and QoL but significant more thromboses in Arm B which might be due to the higher dosage (2x20.000 UI versus 3x10.000 UI) compared to standard therapy of erythropoietin b.