演題詳細

一般口演 / Oral Session

一般口演 108 (Oral Session 108) :感染症・その他

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日程
2013年10月13日(日)
時間
16:00 - 17:00
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
岩崎 博道 (Hiromichi Iwasaki):1
1:福井大学医学部 感染制御部
 
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A multicenter, open-label, randomized study comparing KRN125 with filgrastim in elderly NHL

演題番号 : OS-3-186

吉田 功 (Isao Yoshida):1、品川 篤司 (Atsushi Shinagawa):2、澤 正史 (Masashi Sawa):3、日高 道弘 (Michihiro Hidaka):4、薄井 紀子 (Noriko Usui):5、浦部 晶夫 (Akio Urabe):6、田村 和夫 (Kazuo Tamura):7

1:Department of Hematologic Oncology, Shikoku Cancer Center, Ehime, Japan、2:Department of Hematology, Hitachi General Hospital, Ibaraki, Japan、3:Department of Hematology and Oncology, Anjo Kosei Hospital, Aichi, Japan、4:Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan、5:Division of Hematology and Oncology, Jikei University School of Medicine, Tokyo, Japan、6:Center for Preventive Medicine, NTT Kanto Medical Center, Tokyo, Japan、7:Division of Medical Oncology, Hematology, and Infectious Disease, Fukuoka University, Fukuoka, Japan

 

[Background] KRN125(pegfilgrastim) is a pegylated derivative of filgrastim, a human G-CSF, which remains in circulation for a prolonged duration. We conducted a multicenter, open-label, randomized study comparing KRN125 with filgrastim in elderly NHL patients treated with chemotherapy .[Methods] To assess the efficacy and safety of KRN125 versus filgrastim in elderly NHL patients, patients randomized to two groups where they receive KRN125 or filgrastim after (R)CHOP ((rituximab) CPA, ADR, VCR and PDN) chemotherapy. The primary endpoint was the duration of severe neutropenia (DSN) in the first cycle of (R)CHOP. Major eligibility criteria were as follows; age of 65 years or more, expectation to receiving full dose of (R)CHOP therapy and PS 0-2 (ECOG). [Results] A total number of 52 patients were enrolled and randomized into this study. Among those, 27 patients received KRN125 and 25 patients received filgrastim. All patients were evaluable for efficacy and safety analysis. Patient's characteristics were well balanced. Mean DSN(±S.D.) in the first cycle was 1.6±1.0 and 1.3±1.3 days in the pegfilgrastim, filgrastim groups respectively. Adverse events (AEs) occurred in all patients, mostly which were related to chemotherapy or primary disease. Safety data were not so much different in both groups.[Conclusion] This randomized study showed that in elderly NHL a single administration of KRN125 provided efficacy and safety profile comparable to daily filgrastim.

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