Erythropoetin beta twice weekly versus standard therapy in patients with gynaecological malignancies--a randomised Austrian AGO trial.
BACKGROUND
The influence of two regimens of erythropoetin beta on haemoglobin level, quality of life (QoL) and side-effects in patients with gynaecological malignancies was assessed.


METHODS
A total of 119 patients during chemotherapy were randomised 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).


CONCLUSIONS
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.
Volgger
Birgit
B
Department Obstetrics and Gynaecology, Innsbruck Medical University, Anichstrasse 35, 6020 Innsbruck, Austria. birgit.volgger@i-med.ac.at
Petru
Edgar
E
Angleitner-Boubenizek
Lukas
L
Weigert
Monika
M
Reinthaller
Alexander
A
Lass
Harald
H
Stempfl
Anita
A
Gamper
Christian
C
Deibl
Martina
M
Marth
Christian
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D005833:Genital Neoplasms, Female / Q000097:blood*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins
D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin