期刊
ONKOLOGIE
卷 32, 期 4, 页码 168-174出版社
KARGER
DOI: 10.1159/000200783
关键词
Chemotherapy; Epoetin alfa; Erythropoiesis; Haemoglobin; Reticulocytes
类别
资金
- Hexal Biotech Forschungs GmbH/Sandoz Pharmaceuticals GmbH [HX575]
Background: Recombinant human epoetin alfa, HX575, is the first biosimilar erythropoiesis-stimulating agent (ESA) with European marketing authorisation. The primary objective of this double-blind, randomised, multicentre study was to assess the efficacy and safety of HX575 in treating chemotherapy-associated symptomatic anaemia in patients with solid tumours. Patients and Methods: The patients (n = 114) were treated with HX575 or active control (epoetin alfa) at 150 IU/kg body weight 3 times weekly for 12 weeks, increased to 300 IU/kg body weight 3 times weekly if the haemoglobin/reticulocyte increase was insufficient after 4 or 8 weeks. Results: With HX575, haemoglobin increased by >= 20 g/l in 62% (37/60 patients). The confidence interval (48.2%, 73.9%) was entirely above the pre-defined 30% threshold. Both groups showed similar results for safety profiles and secondary efficacy parameters. Transfusion requirements were 32% (19/60) (HX575) and 38% (13/34) (epoetin alfa). Conclusions: In treating chemotherapy-associated symptomatic anaemia in patients with solid tumours, the biosimilar ESA, HX575, is efficacious with a safety profile as expected for the therapeutic area.
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