Regular Article

British Journal of Cancer (2001) 84, 17–23. doi:10.1054/bjoc.2001.1748 www.bjcancer.com
Published online 3 April 2001

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

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

J Glaspy1, J Singh Jadeja2, G Justice3, J Kessler4, D Richards5, L Schwartzberg6, J Rigas7, D Kuter8, D Harmon8, D Prow9, G Demetri10, D Gordon11, J Arseneau12, A Saven13, H Hynes14, R Boccia15, J O'Byrne16 and A B Colowick16

  1. 1UCLA School of Medicine, 200 Medical Plaza, Suite 120, Los Angeles, CA 90024 USA
  2. 2Hematology-Oncology Associates of Jacksonville, 5742 Booth Road, Jacksonville, FL 32207, US
  3. 3Pacific Coast Hematology Oncology Medical Group, 11190 Warner Avenue, Suite 300, Fountain Valley, CA 92708, USA
  4. 4Virginia Oncology Associates, 895 Middle Ground Blvd, Newport News, VA 2360, USA
  5. 5Tyler Cancer Center, 910 East Houston, Tyler, TX 75702, USA
  6. 6The West Clinic, 1775 Moriah Woods Boulevard, Suite 5, Memphis, TN 38117, USA
  7. 7Dartmouth Medical School, Norris Cancer Center, Lebanon, NH 03756, USA
  8. 8Massachusetts General Hospital, 100 Blossom Street, Boston, MA 02114, USA
  9. 9Texas Cancer Care, Klabzuba Tower, 1300 W. Terrell, Suite 2060, Fort Worth, TX 76104, USA
  10. 10Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA
  11. 11San Antonio Tumor and Blood Clinic, 215 Quincy, Suite 314, San Antonio, TX 78215, USA
  12. 12Albany Regional Cancer Center, 317 South Manning Boulevard, Suite 330, Albany, NY 12208, USA
  13. 13Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037, USA
  14. 14Cancer Center of Kansas, Suite 403, 818 North Emporia, Wichita, KS 67214, USA
  15. 15Associates in Oncology and Hematology, 9707 Medical Center Drive, Shady Grove Medical Building, Rockville, MD, USA
  16. 16Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA 91329, USA
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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 Cancer Research Campaign

Keywords:

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

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