Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma
Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma
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DOI：
10.1200/jco.2008.17.0001
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发表时间：
2008-09-20
影响因子：
45.3
通讯作者：
Cheson, Bruce D.
中科院分区：
文献类型：
--
作者：
Robinson, K. Sue;Williams, Michael E.;Cheson, Bruce D.
目的盐酸苯达莫司汀是一种具有临床活性的双功能机械氯胺衍生物，治疗非霍奇金淋巴瘤。这项研究评估了苯达莫司汀联合利妥昔单抗治疗67例复发、缓解性B细胞或套细胞淋巴瘤的疗效，这些患者对先前的利妥昔单抗没有耐药性。患者和方法患者在每28天周期的第2天和第3天静脉注射利妥昔单抗375 mg/m(2)，在每个28天周期的第2天和第3天静脉注射苯达莫司汀90 mg/m(2)，共4至6个周期。在第一个周期前1周和最后一个周期后4周再加用一剂利妥昔单抗。66名患者(中位年龄，60岁)接受了至少一剂两种药物的治疗。结果总有效率为92%(完全缓解41%，未证实完全缓解14%，部分缓解38%)。中位有效时间为21个月(95%可信区间为18~24个月)。中位无进展生存期为23个月(95%可信区间，20~26个月)。惰性或套层细胞组织学患者的结果相似。联合用药耐受性良好，主要毒性为骨髓抑制(3~4级中性粒细胞减少36%，3~4级血小板减少9%)。
PurposeBendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.Patients and MethodsPatients received rituximab 375 mg/m(2) intravenously on day 1 and bendamustine 90 mg/m(2) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.ResultsOverall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression- free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).ConclusionBendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.