Efficacy and safety of epoetin beta 30,000 IU once weekly in patients with solid tumors and chemotherapy-induced anemia

Abstract

18620 Background: Anemia is common in patients receiving chemotherapy, causing a multitude of symptoms which have a major impact on quality of life (QoL). Epoetin beta rapidly increases hemoglobin (Hb) levels and improves QoL in anemic patients with a variety of tumors. In patients with lymphoid malignancies, once-weekly epoetin beta 30,000 IU has comparable efficacy to the three-times weekly 10,000 IU regimen (Cazzola et al. Br J Haematol 2003; 122: 386–393). Methods: This was a randomized, double-blind, dose-finding study assessing the efficacy and safety of once-weekly epoetin beta in patients with solid tumors receiving chemotherapy. Adult patients with anemia (Hb levels <11 g/dl) were randomized to receive epoetin beta 30,000 IU or 20,000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Hb levels, transfusion need and QoL (Functional Assessment of Cancer Therapy-fatigue subscale score [FACT-fatigue]) were assessed at regular intervals. Results: Fifty patients were randomized; 30 patients received epoetin beta 30,000 IU once weekly and 20 received 20,000 IU once weekly. Mean (± SD) increase in Hb from baseline to week 12 was 1.75 ± 2.15 g/dl in the 30,000 IU group (p = 0.008 vs baseline) and 1.04 ± 1.75 g/dl in the 20,000 IU group (p = non-significant). Hb response (increase in Hb level ≥2 g/dl from baseline) was observed in 78.3% of patients receiving epoetin beta 30,000 IU and 66.7% receiving epoetin beta 20,000 IU. Improvements in FACT-fatigue were significantly (p < 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both epoetin beta regimens were well tolerated and there were no dose-dependent adverse events. Conclusion: Epoetin beta 30,000 IU once weekly is an effective and well-tolerated treatment of anemia in patients with solid tumors. No significant financial relationships to disclose.