演題詳細

一般口演 / Oral Session

一般口演 11 (Oral Session 11) :低悪性度B細胞リンパ腫:治療研究

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日程
2013年10月11日(金)
時間
09:30 - 10:30
会場
第8会場 / Room No.8 (ロイトン札幌 2F ハイネス)
座長・司会
小宅 達郎 (Tatsuo Oyake):1
1:岩手医科大学 血液・腫瘍内科
 
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Phase 2 study of bendamustine plus rituximab for relapsed or refractory follicular lymphoma

演題番号 : OS-1-52

佐野 文明 (Fumiaki Sano):1,10、瀧本 円 (Madoka Takimoto):1,10、三浦 偉久男 (Ikuo Miura):2,10、萩原 真紀 (Maki Hagiwara):3,10、富田 直人 (Naoto Tomita):3,10、渡辺 玲奈 (Rena Watanabe):4,10、高橋 寛之 (Hiroyuki Takahashi):4,10、酒井 リカ (Rika Sakai):4,10、本村 茂樹 (Shigeki Motomura):4,10、藤澤 信 (Shin Fujisawa):5,10、宮崎 浩二 (Koji Miyazaki):6,10、田中 江里 (Eri Tanaka):7,10、山本 晃 (Ko Yamamoto):8,10、大間知 謙 (Ken Ohmachi):9,10、安藤 潔 (Kiyoshi Ando):9,10

1:Div. of Hematol.,Yokohama City Seibu Hosp., St. Marianna Univ., Japan、2:Div. Hematol. and Oncol., St. Marianna Univ., Japan、3:Dept. Int. Med. and Clin. Immunol., Yokohama City Univ., Japan、4:Dept. Oncol., Kanagawa Cancer Center, Japan、5:Dept. Hematol., Yokohama City Univ. Medical Center, Japan、6:Dept. Hematol., Kitasato Univ., Japan、7:Dept. Hematol., Shonan Kamakura General Hosp., Japan、8:Dept. Hematol., Yokohama City Minato Red Cross Hosp., Japan、9:Dept. Hematol. Oncol., Tokai Univ., Japan、10:Kanagawa Clinical Oncology Study Group, Japan

 

PURPOSE:The aim of this multicenter phase 2 study was to evaluate the safety and efficacy of bendamustine(B) plus rituximab(R) combination therapy in Japanese patients with relapsed or refractory follicular lymphoma(FL). METHODS: Eligibility for this study defined as follows (1) histologically confirmed CD20 positive FL, (2) relapsed or refractory FL after R containing regimen, (3) age 20-79, (4) adequate organ function with ECOG performance status of < 3, and (5)written informed consent. BR regimen consisted of 120mg/m2 of B on two consecutive days in day1-3 and 375mg/m2 of R on day1. The course was repeated every 4 weeks for 6 cycles. The primary end point was the overall response rate(ORR) after 3 and 6 cycle of BR.Secondary end points included complete response rate (CRR) and toxicity.ORR and CRR were assessed by IWG criteria. Toxicity was graded according to CTCAEv4.0.RESULTS: A total of 35 patients were enrolled at 8 institutions.Twenty-six patients who received at least 1 cycle were evaluated in this interim analysis.Twenty patients have completed the protocol therapy with 5 median cycles. Most common grade 3 or 4 adverse events were neutropenia (65%) and thrombocytopenia (12%).Twenty-one patients who received at least 3 cycles were evaluated the efficacy. ORR and CRR was 95% and 57%, 100% and 80% after 3 and 6 cycles respectively. CONCLUSION: 120mg/m2of B plus R regimen may be feasible and effective for patients with relapsed or refractory FL in this interim analysis.

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