演題詳細

ポスター / Poster

ポスター 23 (Poster 23) :低悪性度B細胞リンパ腫:ベンダムスチン

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日程
2013年10月11日(金)
時間
16:50 - 17:50
会場
ポスター会場 / Poster (ロイトン札幌 3F ロイトンホールABCD)
座長・司会
瀧本 理修 (Rishu Takimoto):1
1:札幌医科大学医学部附属病院 腫瘍・血液内科
 
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Post-marketing surveillance study in all patients treated with bendamustine (TREAKISYM)

演題番号 : PS-1-168

太田 雅貴 (Masataka Ohta):1、蓑原 茂 (Shigeru Minohara):2、永井 美和子 (Miwako Nagai):2、大根 有司 (Yuji Ohne):2

1:Research & Development Div., SymBio Pharmaceuticals Ltd., Japan、2:Pharmacovigilance Dept., Research & Development Div., SymBio Pharmaceuticals Ltd., Japan

 

Objectives: TREAKISYM was approved for the treatment of patients with relapsed or refractory, indolent B cell non-Hodgkin's lymphoma (i-NHL) and mantle cell lymphoma (MCL). This post-marketing surveillance study was conducted to evaluate the safety and efficacy of TREAKISYM in all patients who were registered in advance and then treated with the drug.
Results: A total of 583 patients were enrolled between December 10, 2010, and February 21, 2011. Patients had the following characteristics: median age, 67.0 (range, 24-90); male gender, 58.1%; the median number of prior regimens, 2; and major histological types: i-NHL, 71.4% and MCL, 28.0%. The initial dose was 120 (43.9%) or 90 (43.2%) mg/sqm, and the median number of cycles was 4 (range, 1-6). The overall incidence of adverse drug reactions (ADRs) was 96.7%, the majority of which was represented by myelosuppression. The incidence of serious ADRs was 38.4%, with myelosuppression and infections as predominant ADRs. The following priority items for survey were assessed: severe infections including opportunistic infection (10.6%); tumor lysis syndrome (1.4%); serious skin lesions (0.2%); and anaphylactoid reaction (0.5%). The efficacy of the drug was evaluated in 497 patients, and overall and complete response rates were 69.4% and 40.8%, respectively.
Conclusions: The safety profile of the drug was nearly equivalent to that in the phase I and II trials, while the efficacy outcomes thereof were slightly inferior to those in the phase II trial probably due to differences in patient population characteristics.

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