Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin Beta, in hematologic malignancies.

Abstract

PURPOSE:

To investigate the effect of recombinant human erythropoietin (epoetin beta) on anemia, transfusion need, and quality of life (QOL) in severely anemic patients with low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), or multiple myeloma (MM).

PATIENTS AND METHODS:

Transfusion-dependent patients with NHL (n = 106), CLL (n = 126), or MM (n = 117) and a low serum erythropoietin concentration were randomized to receive epoetin beta 150 IU/kg or placebo subcutaneously three times a week for 16 weeks. Primary efficacy criteria were transfusion-free and transfusion- and severe anemia-free survival (hemoglobin [Hb] > 8.5 g/dL) between weeks 5 to 16. Response was defined as an increase in Hb > or = 2 g/dL with elimination of transfusion need. QOL was assessed by the Functional Assessment of Cancer Therapy scale.

RESULTS:

Transfusion-free (P =.0012) survival and transfusion- and severe anemia-free survival (P =.0001) were significantly greater in the epoetin beta group versus placebo (Wald chi(2) test), giving a relative risk reduction of 43% and 51%, respectively. The response rate was 67% and 27% in the epoetin beta versus the placebo group, respectively (P <.0001). After 12 and 16 weeks of treatment, QOL significantly improved in the epoetin beta group compared with placebo (P <.05); this improvement correlated with an increase in Hb concentration (> or = 2 g/dL). A target Hb that could be generally recommended could not be identified.

CONCLUSION:

Many severely anemic and transfusion-dependent patients with advanced MM, NHL, and CLL and a low performance status benefited from epoetin therapy, with elimination of severe anemia and transfusion need, and improvement in QOL.

• Authors: Anders Osterborg, Y Brandberg, V Molostova, G Iosava, K Abdulkadyrov, M Hedenus, D Messinger, Epoetin Beta Hematology Study Group
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 20 Issue 10 Pg. 2486-94 (May 15 2002) ISSN: 0732-183X [Print] United States
• PMID: 12011126 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• epoetin beta
• Erythropoietin
• Iron

Topics

• Adult
• Aged
• Aged, 80 and over
• Anemia (drug therapy, etiology)
• Double-Blind Method
• Erythropoietin (therapeutic use)
• Female
• Humans
• Injections, Subcutaneous
• Iron (metabolism)
• Leukemia, Lymphocytic, Chronic, B-Cell (complications, drug therapy)
• Lymphoma, Non-Hodgkin (complications, drug therapy)
• Male
• Middle Aged
• Multiple Myeloma (complications, drug therapy)
• Quality of Life
• Recombinant Proteins
• Surveys and Questionnaires
• Survival Rate
• Treatment Outcome