Japanese Journal of Clinical Oncology Advance Access published online on September 20, 2006
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl097
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1 Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan
* To whom correspondence should be addressed. Objective: To determine a recommended dose of once-weekly epoetin-beta administration for anemic cancer patients receiving myelosuppressive chemotherapy, we conducted a multicenter, randomized, double-blind trial. Methods: A total of 86 patients with malignant lymphoma or lung cancer who received chemotherapy containing platinum, taxanes or anthracyclines were enrolled in the study. Patients were randomly assigned into groups that received three dose levels of epoetin-beta (9000, 18 000 or 36 000 IU) administered subcutaneously once a week for 12 weeks. The primary endpoint was change in hemoglobin, while the secondary endpoints were quality of life (QOL) assessed by Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire and transfusion requirements. Results: Among the 69 patients (per protocol set population) assessable for efficacy, hemoglobin level change in the 36 000 IU group was significantly greater than that in the 9000 IU group (1.75 ± 2.15 versus 0.04 ± 1.98 g/dl; P = 0.009), and a significant dose-response relationship was observed for the change in hemoglobin level (P = 0.003). Although changes in FACT-An Total Fatigue subscale (Fatigue subscale) scores were similar for the three dosage groups, there was a statistically significant correlation (r = 0.435, P < 0.001) between the change in hemoglobin levels and the change in Fatigue subscale scores. The proportion of transfused patients was significantly smaller in the 36 000 IU group compared with that in the 9000 IU group (P = 0.022, not adjusted for pre-study transfusions). The incidence of adverse events was similar in the three dosage groups. Conclusions: Once-weekly epoetin-beta 36 000 IU for 12 weeks was well tolerated and significantly increased hemoglobin levels in anemic cancer patients receiving chemotherapy.
Received February 4, 2006
Accepted June 16, 2006
Original Article
Once-Weekly Epoetin-Beta Improves Hemoglobin Levels in Cancer Patients with Chemotherapy-Induced Anemia: A Randomized, Double-Blind, Dose-Finding Study
Yasuo Morishima 1 *, Michinori Ogura 1, Shuichi Yoneda 2, Hiroshi Sakai 2, Kensei Tobinai 3, Yutaka Nishiwaki 4, Hironobu Minami 5, Tomomitsu Hotta 6, Kohji Ezaki 7, Yuichiro Ohe 8, Akira Yokoyama 9, Masahiro Tsuboi 10, Kiyoshi Mori 11, Koshiro Watanabe 12, Yasuo Ohashi 13, Kunitake Hirashima 14, and Nagahiro Saijo 15, Japan Erythropoietin Study Group
2 Department of Pulmonary Medicine, Saitama Cancer Center, Saitama, Japan
3 Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Nagoya, Japan
4 Thoracic Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
5 Division of Oncology/Hematology, Department of Medicine, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
6 Division of Hematology and Oncology, Department of Medicine, Tokai University School of Medicine, Isehara, Kanagawa, Japan
7 Department of Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
8 Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
9 Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
10 Department of General Thoracic and Thyroid Surgery, Tokyo Medical University Hospital, Tokyo, Japan
11 Department of Thoracic Diseases, Tochigi Cancer Center, Utsunomiya, Japan
12 Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan
13 Department of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan
14 Saitama Medical School, Iruma-gun, Saitama, Japan
15 National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Yasuo Morishima, E-mail: ymorisim{at}aichi-cc.jp
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