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. 2001 Apr;84(Suppl 1):17–23. doi: 10.1054/bjoc.2001.1748

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

J Glaspy 1, J Singh Jadeja 2, G Justice 3, J Kessler 4, D Richards 5, L Schwartzberg 6, J Rigas 7, D Kuter 8, D Harmon 8, D Prow 9, G Demetri 10, D Gordon 11, J Arseneau 12, A Saven 13, H Hynes 14, R Boccia 15, J O'Byrne 16, A B Colowick 16
PMCID: PMC2363898  PMID: 11308270

Abstract

Darbepoetin alfa is a novel erythropoiesis stimulating protein (NESP), which stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO). NESP has been shown to be safe and efficacious in patients with chronic renal failure. NESP is biochemically distinct from rHuEPO, due to its increased sialic acid content. NESP has an approximately 3-fold 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 chemotherapy for up to 12 weeks. Three dose cohorts are presented in this sequential, unblinded and dose-escalating study. Thirteen to 59 patients received NESP (0.5, 1.5 or 2.25 mcg kg−1wk−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 being studied. No antibody formation was detected over the 16-week study period and follow-up. A dose–response relationship was evident for NESP and multiple 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 mcg kg−1wk−1cohorts (mean change in haemoglobin at end of treatment was 1.24, 1.73 and 2.15 g dl−1respectively). Controlled studies of this agent at higher doses and less frequent schedules of administration are ongoing. © 2001 Cance Cancer Research Campaign

Keywords: anaemia, cancer, chemotherapy, darbepoetin alfa, solid tumours, transfusion

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Footnotes

This study was supported by Amgen Inc, Thousand Oaks, California.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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