Portal de Periódicos da CAPES

Randomised, phase III trial of epoetin-β to treat chemotherapy-induced anaemia according to the EU regulation

2011; Springer Nature; Volume: 105; Issue: 9 Linguagem: Inglês

10.1038/bjc.2011.395

1532-1827

Yasuhito Fujisaka, Toru Sugiyama, Hiroshi Saito, Satoko Nagase, Satoshi Kudoh, Masahiro Endo, Hiroshi Sakai, Yasuo Ohashi, Nagahiro Saijo,

Iron Metabolism and Disorders

Erythropoietin-stimulating agents (ESAs) effectively decrease the transfusion requirements of patients with chemotherapy-induced anaemia (CIA). Recent studies indicate that ESAs increase mortality and accelerate tumour progression. The studies also identify a 1.6-fold increased risk of venous thromboembolism. The ESA labelling was thus revised in Europe and the United States in 2008. This is the first randomised, phase III trial evaluating the efficacy and safety of epoetin-β (EPO), an ESA, dosed in accordance with the revised labelling, which specifies that ESAs should be administered to CIA patients with a haemoglobin level of ≤ 10 g dl⁻¹ and that a sustained haemoglobin level of > 12 g dl⁻¹ should be avoided.