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

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

Abstract

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.

Patients and 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).

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anemia / complications
  • Anemia / drug therapy*
  • Drug Administration Schedule
  • Erythropoietin / administration & dosage*
  • Female
  • Genital Neoplasms, Female / blood*
  • Hemoglobins / metabolism
  • Humans
  • Middle Aged
  • Quality of Life
  • Recombinant Proteins

Substances

  • Hemoglobins
  • Recombinant Proteins
  • Erythropoietin