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Erythropoetin beta twice weekly versus standard therapy in patients with gynaecological malignancies–a randomised Austrian AGO trial.

Zusammenfassung: Hämoglobin-Werte (Blutwerte) und Lebensqualität verbessern sich gleichermassen mit 3x10000IE oder 2x 20000 IE wöchentlicher Gabe eines gerinnungshemmdenden Medikaments. Möglicherweise erhöht jedoch die 2malige Gabe das Thromboserisiko.

Anticancer Res. 2008 Nov-Dec;28(6B):3977-84

Volgger B(1), Petru E, Angleitner-Boubenizek L, Weigert M, Reinthaller A, Lass H, Stempfl A, Gamper C, Deibl M, Marth C.

BACKGROUND: The influence of two regimens of erythropoetin beta on haemoglobin level, quality of life (QoL) and side-effects in patients with gynecological malignancies was assessed.

PATIENTS AND METHODS: A total of 119 patients during chemotherapy were randomized to either standard therapy with 10,000 IU erythropoetin beta 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.