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), 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...

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Bibliographic Details
Published in:British journal of cancer 2001-04, Vol.84 (S1), p.17-23
Main Authors: Glaspy, J, Jadeja, J S, Justice, G, Kessler, J, Richards, D, Schwartzberg, L, Rigas, J, Kuter, D, Harmon, D, Prow, D, Demetri, G, Gordon, D, Arseneau, J, Saven, A, Hynes, H, Boccia, R, O'Byrne, J, Colowick, A B
Format: Article
Language:English
Subjects:
Adult
Aged
Anemia - drug therapy
Anemia - etiology
Anemia - therapy
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Blood Transfusion - statistics & numerical data
Cohort Studies
Combined Modality Therapy
Darbepoetin alfa
Dose-Response Relationship, Drug
Drug Administration Schedule
Erythrocyte Transfusion - statistics & numerical data
Erythropoiesis - drug effects
Erythropoietin - administration & dosage
Erythropoietin - adverse effects
Erythropoietin - analogs & derivatives
Erythropoietin - chemistry
Erythropoietin - immunology
Erythropoietin - therapeutic use
Female
Half-Life
Hemoglobins - analysis
Humans
Injections, Subcutaneous
Male
Middle Aged
N-Acetylneuraminic Acid - chemistry
Neoplasms - blood
Neoplasms - complications
Neoplasms - drug therapy
Recombinant Proteins - administration & dosage
Recombinant Proteins - adverse effects
Recombinant Proteins - chemistry
Recombinant Proteins - immunology
Recombinant Proteins - therapeutic use
Regular
Safety
Treatment Outcome
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Summary: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(-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 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(-1)wk(-1)cohorts (mean change in haemoglobin at end of treatment was 1.24, 1.73 and 2.15 g dl(-1)respectively). Controlled studies of this agent at higher doses and less frequent schedules of administration are ongoing.
ISSN:0007-0920
1532-1827
1532-1827
DOI:10.1054/bjoc.2001.1748