A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer

R. E. Smith, N. S. Tchekmedyian, D. Chan, L. A. Meza, D. W. Northfelt, R. Patel, M. Austin, A. B. Colowick, G. Rossi, J. Glaspy

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Abstract

A multicentre study evaluated the efficacy and safety of darbepoetin alpha administered weekly (QW), every 3 weeks (Q3W), and every 4 weeks (Q4W) to anaemic patients with cancer not concurrently receiving chemotherapy or radiotherapy. The QW portion (n = 102) was an open-label, sequential, dose-escalation design; cohorts received darbepoetin alpha QW by subcutaneous (s.c.) injection at 0.5, 1.0, 2.25, or 4.5 μg kg-1 week-1 for 12 weeks. The 12-week placebo-controlled, double- blind Q3W (6.75 μg kg-1) and Q4W (6.75 or 10.0 μg kg-1) schedules (n = 86), which enrolled different patients, took place after the QW schedule and were followed by a 12-week, open-label phase. Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety. Selected domains of health-related quality of life (HRQOL) were measured. With QW dosing, at least 70% of each cohort had a haemoglobin increase from baseline of > 2 gdl-1 or a concentration > 12g dl-1 (haematopoietic response). In the 4.5 μg kg-1 QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (Cl)= 100, 100). In the Q3W and Q4W schedules, all cohorts had at least 60% of patients who achieved a haematopoietic response. Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W. Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

Original languageEnglish (US)
Pages (from-to)1851-1858
Number of pages8
JournalBritish journal of cancer
Volume88
Issue number12
DOIs
StatePublished - Jun 16 2003

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Keywords

  • Anaemia
  • Chronic disease
  • Darbepoetin alpha
  • Erythropoietin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Smith, R. E., Tchekmedyian, N. S., Chan, D., Meza, L. A., Northfelt, D. W., Patel, R., Austin, M., Colowick, A. B., Rossi, G., & Glaspy, J. (2003). A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. British journal of cancer, 88(12), 1851-1858. https://doi.org/10.1038/sj.bjc.6600994