Bendamustine plus rituximab for previously untreated patients with indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma: a multicenter Phase II clinical trial in Japan
Bendamustine plus rituximab for previously untreated patients with indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma: a multicenter Phase II clinical trial in Japan
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DOI：
10.1007/s12185-016-2146-4
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发表时间：
2017-04-01
影响因子：
2.1
通讯作者：
Tobinai, Kensei
中科院分区：
文献类型：
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作者：
Ogura, Michinori;Ishizawa, Kenichi;Tobinai, Kensei
在日本，在既往未经治疗的高肿瘤负荷惰性B细胞非霍奇金淋巴瘤（B-NHL）患者和既往未经治疗的套细胞淋巴瘤（MCL）老年患者中进行了苯达莫司汀+利妥昔单抗（BR）方案的II期、多中心临床试验。苯达莫司汀90 mg/m2/天，第1天和第2天，以及利妥昔单抗375 mg/m2，第1天静脉给药，最多6个周期。主要终点是根据国际研讨会缓解标准（1999）评估的完全缓解（CR）率。69例患者（59例惰性B-NHL和10例MCL）接受了治疗。交付周期的中位数为6个（范围1-6）。惰性B-NHL和MCL的CR率分别为67.8% [95%置信区间（CI）54.4-79.4%]和70.0%（95% CI 34.8-93.3%）。估计30个月时无进展生存率在惰性B-NHL中为72.1%（95% CI 58.5-82.0%），在MCL中为67.5%（95% CI 29.1-88.2%）。主要3/4级毒性为血液学毒性，包括淋巴细胞减少症（97%）、CD 4淋巴细胞减少症（91%）、中性粒细胞减少症（86%）和白细胞减少症（83%）。BR方案显示出高疗效，其预期的CR率和持久的反应以及研究人群可接受的安全性特征证明了这一点。
A Phase II, multicenter clinical trial of bendamustine plus rituximab (BR) regimen was conducted in previously untreated patients with high-tumor-burden indolent B-cell non-Hodgkin lymphoma (B-NHL) and previously untreated elderly patients with mantle cell lymphoma (MCL) in Japan. Bendamustine 90 mg/m(2)/day on days 1 and 2, as well as rituximab 375 mg/m(2) on day 1 were administered intravenously up to six cycles. The primary endpoint was the complete response (CR) rate as assessed by the International Workshop Response Criteria (1999). Sixty-nine patients (59 with indolent B-NHL and 10 with MCL) were treated. The median number of delivered cycles was six (range 1-6). The CR rates were 67.8% [95% confidence interval (CI) 54.4-79.4%] and 70.0% (95% CI 34.8-93.3%) for indolent B-NHL and MCL, respectively. Estimated progression-free survival at 30 months was 72.1% (95% CI 58.5-82.0%) in indolent B-NHL and was 67.5% (95% CI 29.1-88.2%) in MCL. Major grade 3/4 toxicities were hematologic and included lymphopenia (97%), CD4 lymphopenia (91%), neutropenia (86%), and leukopenia (83%). No treatment-related death was found. The BR regimen showed high efficacy as evidenced by the expected CR rate and durable response, as well as an acceptable safety profile for the study populations.