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Journal of Clinical Oncology, Vol 20, Issue 10 (May), 2002: 2486-2494
© 2002 American Society for Clinical Oncology

Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Erythropoietin, Epoetin Beta, in Hematologic Malignancies

By A. Österborg, Y. Brandberg, V. Molostova, G. Iosava, K. Abdulkadyrov, M. Hedenus, D. Messinger for the Epoetin Beta Hematology Study Group

From the Departments of Oncology and Hematology, Karolinska Hospital, Stockholm, Sweden; Far-East Medical Center, Khabarovsk, and Research Institute of Hematology and Transfusiology, St Petersburg, Russia; Institute for Hematology and Transfusiology, Tblisi, Georgia; Sundsvall Hospital, Sundsvall, and Sweden; and F. Hoffmann-La Roche Ltd, Mannheim, Germany.

Address reprint requests to A. Österborg, MD, PhD, Department of Oncology (Radiumhemmet), Karolinska Hospital, S-17176 Stockholm, Sweden; email: anders.osterborg{at}ks.se

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 >= 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 (>= 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.


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