Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study.

ABSTRACT

OBJECTIVE: Erythropoietin is shown to be an effective treatment for anemia in various types of cancers, however only limited studies have evaluated its benefits in advanced hormone-refractory prostate cancer (HRPC). This multi-center study investigated the influence of 2 different doses of epoetin beta on quality of life, hemoglobin level, need for blood transfusion, and safety, in the treatment of anemia in patients with metastatic HRPC. MATERIALS AND METHODS: This study randomized 180 patients to receive either epoetin beta 1000 IU or 5000 IU subcutaneously 3 times per week for 12 weeks. Hemoglobin was evaluated at study start and 6 time-points during the study. Quality of life (QoL) was assessed by the European Organization for Research and Treatment of Cancer questionnaire, QLC-C30, before treatment start and after 6 and 12 weeks of treatment. Best supportive care and blood transfusions were given, if clinically indicated. Additional laboratory values and adverse events were followed for safety. RESULTS: Hemoglobin increased significantly (>20 g/l) in 43% in the high dose (HD) group and 25% in the low dose (LD) group in response to treatment. Levels were significantly higher in the HD group than the LD group (p < 0.001) after 8 and 12 weeks. QoL improved significantly if the increase in hemoglobin was >20 g/l. Significantly more patients in the LD group received blood transfusions than the HD group (p < 0.005). There were no differences between the groups regarding overall quality of life and fatigue. The treatment was well tolerated in both groups. CONCLUSIONS: Epoetin beta is shown to be safe and effective for the treatment of anemia in many patients with HRPC. It is found to improve QoL and physical functioning, and relieve fatigue symptoms, in many of these critically ill patients.