演題詳細

一般口演 / Oral Session

【E】一般口演 16 (Oral Session 16) :MDS:Clinical Research 3

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日程
2013年10月11日(金)
時間
10:00 - 11:30
会場
第14会場 / Room No.14 (札幌市教育文化会館 3F 研修室305)
座長・司会
石川 隆之 (Takayuki Ishikawa):1
1:Department of Hematology, Kobe City Medical Center General Hospital, Japan
 
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Preliminary results of a randomized dose-finding study of darbepoetin alfa in MDS in Japan and Korea

演題番号 : OS-1-84

柴山 浩彦 (Hirohiko Shibayama):1、原田 浩徳 (Hironori Harada):2、Jun Ho Jang:3、鈴木 憲史 (Kenshi Suzuki):4、通堂 満 (Mitsuru Tsudo):5、石川 隆之 (Takayuki Ishikawa):6、鵜池 直邦 (Naokuni Uike):7、日高 道弘 (Michihiro Hidaka):8、臼杵 憲祐 (Kensuke Usuki):9、清水 誠一 (Seiichi Shimizu):10、Yoo-Jin Kim:11、Hawk Kim:12、木崎 昌弘 (Masahiro Kizaki):13、千葉 滋 (Shigeru Chiba):14、南谷 泰仁 (Yasuhito Nannya):15、米村 雄士 (Yuji Yonemura):16、澤 正史 (Masashi Sawa):17、小倉 秀充 (Hidemi Ogura):18、仲里 朝周 (Tomonori Nakazato):19、熊谷 隆志 (Takashi Kumagai):20、木口 亨 (Toru Kiguchi):21、髙橋 健 (Takeshi Takahashi):22、入江 誠治 (Seiji Irie):23、Sung-Soo Yoon:24、Ho-Jin Shin:25、Young Don Joo:26、Yoo Hong Min:27、Sang Kyun Sohn:28、三谷 絹子 (Kinuko Mitani):29、澤田 賢一 (Kenichi Sawada):30、Je-Hwan Lee:31、Hyeoung-Joon Kim:32

1:Department of Hematology and Oncology, Osaka University, Osaka, Japan、2:Department of Hematology, Juntendo University School of Medicine, Tokyo, Japan、3:Division of Hematology/Oncology, Sungkyunkwan University Samsung Medical Center, Seoul, Korea、4:Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan、5:Department of Hematology, Osaka Red Cross Hospital, Osaka, Japan、6:Department of Hematology, Kobe City Medical Center General Hospital, Hyogo, Japan、7:Department of Hematology, Kyushu Cancer Center, Fukuoka, Japan、8:Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan、9:Department of Hematology, NTT Medical Center Tokyo, Tokyo, Japan、10:Department of Internal Medicine, Tsuchiura Kyodo General Hospital, Ibaraki, Japan、11:Department of Hematology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea、12:Department of Hemato-Oncology, Ulsan University Hospital, Ulsan, Korea、13:Department of Hematology, Saitama Medical Center, Saitama Medical University, Saitama, Japan、14:Department of Hematology, University of Tsukuba, Tsukuba, Ibaraki, Japan、15:Department of Hematology & Oncology, The University of Tokyo Hospital, Tokyo, Japan、16:Department of Hematology, Kumamoto University School of Medicine, Kumamoto, Japan、17:Department of Hematology and Oncology, Anjo Kosei Hospital, Aichi, Japan、18:Division of Hematology, Maebashi Red Cross Hospital, Gunma, Japan、19:Department of Hematology, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan、20:Department of Hematology, Ohme Municipal General Hospital, Tokyo, Japan、21:Hematology, Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital, Hiroshima, Japan、22:Hematologic Disease Center, Gifu Municipal Hospital, Gifu, Japan、23:Department of Hematology, Japan Labour Health and Welfare Organization, Kanto Rosai Hospital, Kanagawa, Japan、24:Department of Internal Medicine, Hematology/Oncology, Seoul National University Hospital, Seoul, Korea、25:Department of Hematology / Oncology, Pusan National University Hospital, Busan, Korea、26:Department of Hemato-Oncology, InJe University Haeundae Paik Hospital, Busan, Korea、27:Department of Internal Medicine, Division of Hematology, Yonsei University Severance Hospital, Seoul, Korea、28:Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea、29:Department of Hematology and Oncology, Dokkyo Medical University Hospital, Tochigi, Japan、30:Department of Hematology, Nephrology, and Rheumatology, Akita University Hospital, Akita, Japan、31:Department of Hematology, Ulsan University Asan Medical Center, Seoul, Korea、32:Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Jeollanam-do, Korea

 

Background: Darbepoetin alfa (DA) is defined as the first-line therapy for anemia in low/int-1 MDS patients with serum EPO<500 mIU/mL in MDS treatment guidelines. However, there is no randomized study to justify the optimal dose. We thus started the first randomized study of DA to find the optimal initial dose. Overall survival and AML progression in the long-term treatment of DA will also be assessed. This is a preliminary report for the first 16 weeks of the whole study period (48 weeks).
Methods: A parallel-group, randomized, multicenter (41 sites) study was conducted in low/int-1 MDS patients with Hb<9.0 g/dL, serum<500 mIU/mL and RBC transfusion (TF) dependency. Subjects were randomized to receive a fixed dose of DA either at 60, 120 or 240 μg/week for 16 weeks. The primary endpoint was rate of Major Response (MaR; patients who became TF free and whose Hb increased by >1.0g/dL) or Minor Response (MiR; patients whose TF decreased by >50%) in the first 16 weeks.
Results: As of the data cut-off date (01 April, 2013), 49 subjects were included in the analysis. Median Hb was 8.1 g/dL and median serum EPO was 231.0 mIU/mL. MaR and MiR in the 60, 120 and 240 μg groups were 17.6, 11.1 and 35.7% and 52.9, 38.9 and 64.3%, respectively. Safety concerns arose in neither of the groups.
Conclusions: All doses of DA treatment in Asian MDS patients demonstrated a high response rate which is consistent with studies referred in MDS treatment guidelines. Especially, the 240 μg group showed a higher MaR rate. The study is ongoing and the final data will be reported.

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