Novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia of chronic disease associated with cancer

Anaemia is a common haematologic disorder in patients with cancer and has a multifactorial aetiology, including the effects of the malignancy itself a nd residual effects from previous therapy. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa), a protein with additional sialic acid co mpared with erythropoietin (EPO), stimulates erythropoiesis by the same mec hanism as recombinant human erythropoietin (rHuEPO) but it is biochemically distinct. NESP, with its approximately 3-fold greater serum half-life, can maintain haemoglobin levels as effectively as rHuEPO in anaemic patients w ith chronic renal failure and do so with less frequent dosing. We investiga ted the ability of NESP to safely increase haemoglobin levels of anaemic pa tients with non-myeloid malignancies not receiving chemotherapy. NESP was a dministered under the supervision of a physician at doses of 0.5, 1.0, 2.25 or 4.5 mcg kg(-1) wk(-1) for a maximum of 12 weeks. This report includes 8 9 patients completing the study by November 2000. NESP was well tolerated, with no reported dose-limiting toxicities or treatment-related severe adver se events. Increasing doses of NESP corresponded with increased efficacy. T he percentage (95% confidence interval) of patients responding ranged from 61% (42%, 77%) in the 1.0 mcg kg(-1) wk(-1) group to 83% (65%, 94%) in the 4.5 mcg kg(-1) wk(-1) group. (C) 2001 Cancer Research Campaign.