苯达莫司汀联合米托蒽醌治疗复发/难治性慢性淋巴细胞白血病（CLL）：德国 CLL 研究组（GCLLSG）多中心 II 期研究结果。

Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG).

机构信息

Haematology/Oncology Group Practice, Koblenz, Germany.

Department of Internal Medicine III HELIOS Klinikum, Bad Saarow, Germany.

出版信息

Br J Haematol. 2012 Jul;158(2):238-241. doi: 10.1111/j.1365-2141.2012.09132.x. Epub 2012 May 10.

DOI:10.1111/j.1365-2141.2012.09132.x

PMID:22571691

Abstract

The efficacy of bendamustine (50 mg/m², days 1-3) plus mitoxantrone (10 mg/m², day 1), every 28 days for up to four courses, was evaluated in a Phase II multicentre trial enrolling 59 patients with relapsed or refractory B-cell chronic lymphocytic leukaemia (CLL). Major toxicities were grade 3/4 leucopenia, thrombocytopenia and infections in 42%, 12% and 12% of patients, respectively. Complete and partial response was achieved in 5/59 and 25/29 patients, respectively (overall response rate, 51%). Median time to progression was 22 months (range 1-49 + ) and median survival 27 months (range 0-49 + ). The combination of bendamustine and mitoxantrone is an active regime in relapsed or refractory CLL.

摘要

在一项纳入 59 例复发或难治性 B 细胞慢性淋巴细胞白血病（CLL）患者的 II 期多中心试验中，评估了苯达莫司汀（50mg/m²，第 1-3 天）联合米托蒽醌（10mg/m²，第 1 天），每 28 天为一个疗程，最多四个疗程。主要毒性为 42%、12%和 12%的患者分别出现 3/4 级白细胞减少、血小板减少和感染。59 例患者中分别有 5 例（10%）和 25 例（42%）达到完全缓解和部分缓解（总缓解率为 51%）。中位无进展生存期为 22 个月（范围 1-49+），中位总生存期为 27 个月（范围 0-49+）。苯达莫司汀联合米托蒽醌是复发或难治性 CLL 的一种有效治疗方案。