Japanese Journal of Clinical Oncology Advance Access published online on January 22, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn151
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© The Author (2009). Published by Oxford University Press. All rights reserved
Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study
1 Department of General Thoracic and Thyroid Surgery, Tokyo Medical University Hospital, Tokyo
2 Department of Internal Medicine, Fujita Health University School of Medicine, Aichi
3 Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo
4 Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo
5 National Cancer Center Hospital East, Chiba, Japan
For reprints and all correspondence: Masahiro Tsuboi, Department of Thoracic Surgery and Oncology, Tokyo Medical University and Hospital 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. E-mail: mtsuboi{at}za2.so-net.ne.jp
Received September 24, 2008; accepted December 14, 2008
Objective: The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated.
Methods: One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire.
Results: Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 ± 1.9 g/dl versus –0.8 ± 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level 
2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94.
Conclusion: Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.
Key Words: anemia • erythropoietin • cancer • chemotherapy-induced anemia • quality of life • survival