Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: A randomized, double-blind, placebo-controlled study

Michael Hedenus, Magnus Adriansson, Jesus San Miguel, Mark H H Kramer, Martin R. Schipperus, Eeva Juvonen, Kerry Taylor, Andrew Belch, Albert Altés, Giovanni Martinelli, David Watson, James Matcham, Gregory Rossi, Timothy J. Littlewood

Research output: Contribution to journalArticle

Abstract

This phase 3, randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Patients (n = 344) with lymphoma or myeloma received darbepoetin alfa 2.25 μg/kg or placebo s.c., once weekly for 12 weeks. The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group (60%) than in the placebo group (18%) (P <0.001), regardless of baseline endogenous erythropoietin level. However, increased responsiveness was observed in patients with lower baseline erythropoietin levels. Darbepoetin alfa also resulted in higher mean changes in haemoglobin than placebo from baseline to the last value during the treatment phase (1.80 g/dl vs 0.19 g/dl) and after 12 weeks of treatment (2.66 g/dl vs 0.69 g/dl). A significantly lower percentage of patients in the darbepoetin alfa group received red blood cell transfusions than in the placebo group (P <0.001). The efficacy of darbepoetin alfa was consistent for patients with lymphoma or myeloma. Improvements in quality of life were also observed with darbepoetin alfa. The overall safety profile of darbepoetin alfa was consistent with that expected for this patient population. Darbepoetin alfa significantly increased haemoglobin and reduced red blood cell transfusions in patients with lymphoproliferative malignancies receiving chemotherapy.

Original languageEnglish
Pages (from-to)394-403
Number of pages10
JournalBritish Journal of Haematology
Volume122
Issue number3
DOIs
Publication statusPublished - Aug 2003

Keywords

  • Anaemia
  • Cancer
  • Erythropoietin
  • Lymphoma
  • Myeloma

ASJC Scopus subject areas

  • Hematology

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