Abstract
Anaemia is a common haematologic disorder in patients with cancer and has a multifactorial aetiology, including the effects of the malignancy itself and residual effects from previous therapy. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa), a protein with additional sialic acid compared with erythropoietin (EPO), stimulates erythropoiesis by the same mechanism 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 with chronic renal failure and do so with less frequent dosing. We investigated the ability of NESP to safely increase haemoglobin levels of anaemic patients with non-myeloid malignancies not receiving chemotherapy. NESP was administered under the supervision of a physician at doses of 0.5, 1.0, 2.25 or 4.5 mcg kg−1wk−1for a maximum of 12 weeks. This report includes 89 patients completing the study by November 2000. NESP was well tolerated, with no reported dose-limiting toxicities or treatment-related severe adverse events. Increasing doses of NESP corresponded with increased efficacy. The percentage (95% confidence interval) of patients responding ranged from 61% (42%, 77%) in the 1.0 mcg kg−1wk−1group to 83% (65%, 94%) in the 4.5 mcg kg−1wk−1group. © 2001 Cance Cancer Research Campaign
Keywords: anaemia, cancer, chemotherapy, chronic disease, darbepoetin alfa, erythropoietin
Full Text
The Full Text of this article is available as a PDF (436.4 KB).
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.
- Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13–19. [PubMed] [Google Scholar]
- Henry D. H., Abels R. I. Recombinant human erythropoietin in the treatment of cancer and chemotherapy-induced anemia: results of double-blind and open-label follow-up studies. Semin Oncol. 1994 Apr;21(2 Suppl 3):21–28. [PubMed] [Google Scholar]
- Jelkmann W. Proinflammatory cytokines lowering erythropoietin production. J Interferon Cytokine Res. 1998 Aug;18(8):555–559. doi: 10.1089/jir.1998.18.555. [DOI] [PubMed] [Google Scholar]
- Ludwig H., Fritz E. Anemia in cancer patients. Semin Oncol. 1998 Jun;25(3 Suppl 7):2–6. [PubMed] [Google Scholar]
- Ludwig H., Fritz E., Leitgeb C., Pecherstorfer M., Samonigg H., Schuster J. Prediction of response to erythropoietin treatment in chronic anemia of cancer. Blood. 1994 Aug 15;84(4):1056–1063. [PubMed] [Google Scholar]
- Ludwig H., Sundal E., Pecherstorfer M., Leitgeb C., Bauernhofer T., Beinhauer A., Samonigg H., Kappeler A. W., Fritz E. Recombinant human erythropoietin for the correction of cancer associated anemia with and without concomitant cytotoxic chemotherapy. Cancer. 1995 Dec 1;76(11):2319–2329. doi: 10.1002/1097-0142(19951201)76:11<2319::aid-cncr2820761121>3.0.co;2-u. [DOI] [PubMed] [Google Scholar]
- Macdougall I. C., Gray S. J., Elston O., Breen C., Jenkins B., Browne J., Egrie J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol. 1999 Nov;10(11):2392–2395. doi: 10.1681/ASN.V10112392. [DOI] [PubMed] [Google Scholar]
- Miller C. B., Jones R. J., Piantadosi S., Abeloff M. D., Spivak J. L. Decreased erythropoietin response in patients with the anemia of cancer. N Engl J Med. 1990 Jun 14;322(24):1689–1692. doi: 10.1056/NEJM199006143222401. [DOI] [PubMed] [Google Scholar]
- Ozguroglu M., Arun B., Demir G., Demirelli F., Mandel N. M., Buyukunal E., Serdengecti S., Berkarda B. Serum erythropoietin level in anemic cancer patients. Med Oncol. 2000 Feb;17(1):29–34. doi: 10.1007/BF02826213. [DOI] [PubMed] [Google Scholar]