A dose-finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy

Darbepoetin alfa is a novel erythropoiesis stimulating protein (NESP), whic h stimulates erythropoiesis by the same mechanism as recombinant human eryt hropoietin (rHuEPO). NESP has been shown to be safe and efficacious in pati ents with chronic renal failure. NESP is biochemically distinct from FHuEPO , due to its increased sialic acid content. NESP has an approximately 3-fol d greater half-life, rHuEPO has been shown to be safe and effective for the treatment of chemotherapy-induced anaemia. This study assessed the safety and efficacy of NESP administered once per week, under the supervision of a physician, to patients with solid tumours who were receiving multicycle ch emotherapy for up to 12 weeks. Three dose cohorts are presented in this seq uential, unblinded and dose-escalating study. Thirteen to 59 patients recei ved NESP (0.5, 1.5 or 2.25 mcg kg(-1) wk(-1)) in each cohort, Patients were monitored for adverse events? including antibody formation to NESP and for effects on haemoglobin. NESP appeared to be well tolerated. Adverse events were similar across all cohorts and were consistent with the population be ing studied. No antibody formation was detected over the 16-week study peri od and follow-up, A dose-response relationship was evident for NESP and mul tiple measures of efficacy, including proportion of patients responding to NESP and the mean change in haemoglobin by week 4 and end of treatment for NESP 0.5, 1.5 and 2.25 meg kg(-1) wk(-1) cohorts (mean change in haemoglobi n at end of treatment was 1.24, 1.73 and 2.15 g dl(-1) respectively). Contr olled studies of this agent at higher doses and less frequent schedules of administration are ongoing. (C) 2001 Cancer Research Campaign.