Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.
Cancer. 2010 Jan 1;116(1):106-14. doi: 10.1002/cncr.24714.
Bendamustine hydrochloride is a novel alkylating agent. In this multicenter study, the authors evaluated the efficacy and toxicity of single-agent bendamustine in patients with rituximab-refractory, indolent B-cell lymphoma.
Eligible patients (N = 100, ages 31-84 years) received bendamustine at a dose of 120 mg/m(2) by intravenous infusion on Days 1 and 2 every 21 days for 6 to 8 cycles. Histologies included follicular (62%), small lymphocytic (21%), and marginal zone (16%) lymphomas. Patients had received a median of 2 previous regimens (range, 0-6 previous regimens), and 36%were refractory to their most recent chemotherapy regimen. Primary endpoints included overall response rate (ORR) and duration of response (DOR). Secondary endpoints were safety and progression-free survival (PFS).
An ORR of 75% (a 14% complete response rate, a 3% unconfirmed complete response rate, and a 58% partial response rate) was observed. The median DOR was 9.2 months, and median PFS was 9.3 months. Six deaths were considered to be possibly treatment related. Grade 3 or 4 (determined using National Cancer Institute Common Toxicity Criteria [version 3.0.19]. reversible hematologic toxicities included neutropenia (61%), thrombocytopenia (25%), and anemia (10%). The most frequent nonhematologic adverse events (any grade) included nausea (77%), infection (69%), fatigue (64%), diarrhea (42%), vomiting (40%), pyrexia (36%), constipation (31%), and anorexia (24%).
Single-agent bendamustine produced a high rate of objective responses with acceptable toxicity in patients with recurrent, rituximab-refractory indolent B-cell lymphoma.
盐酸苯达莫司汀是一种新型烷化剂。在这项多中心研究中，作者评估了单药苯达莫司汀治疗利妥昔单抗难治性惰性 B 细胞淋巴瘤患者的疗效和毒性。
符合条件的患者（N=100，年龄 31-84 岁）接受苯达莫司汀 120mg/m²，静脉输注，第 1 天和第 2 天，每 21 天为 1 个周期，共 6-8 个周期。组织学类型包括滤泡性（62%）、小淋巴细胞性（21%）和边缘区（16%）淋巴瘤。患者接受中位数为 2 种（范围 0-6 种）既往治疗方案，36%对最近的化疗方案耐药。主要终点包括总缓解率（ORR）和缓解持续时间（DOR）。次要终点为安全性和无进展生存期（PFS）。
观察到 75%的 ORR（14%的完全缓解率、3%的未确认完全缓解率和 58%的部分缓解率）。中位 DOR 为 9.2 个月，中位 PFS 为 9.3 个月。6 例死亡被认为可能与治疗相关。3 级或 4 级（根据国立癌症研究所通用毒性标准[版本 3.0.19]确定）的可逆血液学毒性包括中性粒细胞减少症（61%）、血小板减少症（25%）和贫血症（10%）。最常见的非血液学不良事件（任何级别）包括恶心（77%）、感染（69%）、疲劳（64%）、腹泻（42%）、呕吐（40%）、发热（36%）、便秘（31%）和厌食（24%）。
单药苯达莫司汀在复发、利妥昔单抗难治性惰性 B 细胞淋巴瘤患者中产生了高客观缓解率，且毒性可接受。
