Therapeutic effects of epoetin zeta in the treatment of chemotherapy-induced anaemia.

Abstract:

OBJECTIVE:To perform an open, non-controlled, multiple-dose, international, multicentre, phase III study to evaluate epoetin zeta, a biosimilar epoetin referenced to epoetin alfa, for the treatment of chemotherapy-induced anaemia in patients with cancer. METHODS:Safety, tolerability and efficacy of subcutaneously administered epoetin zeta were assessed in 216 patients with solid tumours or non-myeloid haematological malignancies receiving chemotherapy and at risk of transfusion. RESULTS:A significant (p < 0.0001) increase in mean haemoglobin (Hb) level (1.8 g/dL) was observed between baseline and week 12 (intent-to-treat population); 176/216 (81.5%) patients achieved a response (increase in Hb > or = 1 g/dL or reticulocyte count > or = 40,000 cells/microL) by week 8. Over the treatment period, 231 treatment-emergent adverse events were experienced by 91 patients; 9/216 (4.2%) experienced a clinically significant thrombotic event within the first 12 weeks of epoetin zeta treatment, significantly lower than the assumed 18% baseline incidence (p < 0.0001) based on historical data from epoetin trials. No transfusion was necessary for 175/216 patients (81.0%) and quality of life improved over the study. No patients developed anti-erythropoietin antibodies. Sponsor trial no: CT-830-05-0009. CONCLUSION:This study demonstrates that subcutaneously administered epoetin zeta is well-tolerated and has efficacy in the treatment of anaemia in patients with cancer receiving chemotherapy and at risk of transfusion.

journal_name

Curr Med Res Opin

authors

Tzekova V,Mihaylov G,Elezovic I,Koytchev R,Epoetin Zeta Oncology Study Group.

doi

10.1185/03007990903050876

subject

Has Abstract

pub_date

2009-07-01 00:00:00

pages

1689-97

issue

7

eissn

0300-7995

issn

1473-4877

journal_volume

25

pub_type

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