Gao Y, Yang Y, Cen H, Liu H, Fu J X, Wang S Q, Feng R, Yu D, Zhang X Y, Chen Z W, Li Y F, Huang H Q
Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, and Collaborative Innovation Center of Cancer Medicine,Guangzhou 510060, China.
Department of Lymphoma and Head and Neck Cancer, Fujian Tumor Hospital, Affiliated Cancer Hospital of Fujian Medical University, Fuzhou 350014, China.
Zhonghua Xue Ye Xue Za Zhi. 2022 Nov 14;43(11):934-939. doi: 10.3760/cma.j.issn.0253-2727.2022.11.009.
To evaluate the efficacy and safety of bendamustine monotherapy in Chinese patients with relapsed/refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL) . This prospective, multicenter, open label, single-arm, phase Ⅱ study investigated bendamustine's efficacy and safety in Chinese patients with R/R B-NHL. A total of 78 patients with B-NHL in 11 hospitals in China from March 2012 to December 2016 were included, and their clinical characteristics, efficacy, and survival were analyzed. The median age of all patients was 58 (range, 24-76) years old, and 69 (88.4% ) patients had stage Ⅲ/Ⅳ disease. 61 (78.2% ) patients were refractory to previous treatments. Patients received a median of 4 (range, 1-10) cycles of bendamustine treatment. The overall response rate was 61.5 (95% 49.8-72.3) % , the median response duration was 8.3 (95% 5.5-14.0) months, and the complete remission (CR) rate was 5.1 (95% 1.4-12.6) % . In the full analysis set, median progression-free survival (PFS) and median OS were 8.7 (95% 6.7-13.2) months and 25.5 months (95% 14.2 months to not reached) , respectively, after a median follow-up of 33.6 (95% 17.4-38.8) months. Lymphopenia (74.4% ) , neutropenia (52.6% ) , and leukopenia (39.7% ) , thrombocytopenia (29.5% ) and anemia (15.4% ) were the most common grade 3-4 hematologic adverse events (AE) . The most frequent non-hematologic AEs included nausea (43.6% ) , vomiting (33.3% ) , and anorexia (29.5% ) . Univariate and multivariate analysis showed that <4 cycles of bendamustine treatment was a poor prognostic factor for PFS (=0.003) , and failure to accept fludarabine containing regimen was a poor prognostic factor for OS (=0.009) . Bendamustine monotherapy has good efficacy and safety in the treatment of patient with R/R B-NHL.
评估苯达莫司汀单药治疗中国复发/难治性（R/R）B细胞非霍奇金淋巴瘤（B-NHL）患者的疗效和安全性。这项前瞻性、多中心、开放标签、单臂Ⅱ期研究调查了苯达莫司汀治疗中国R/R B-NHL患者的疗效和安全性。纳入了2012年3月至2016年12月期间中国11家医院的78例B-NHL患者，并分析了他们的临床特征、疗效和生存情况。所有患者的中位年龄为58岁（范围24-76岁），69例（88.4%）患者为Ⅲ/Ⅳ期疾病。61例（78.2%）患者对先前治疗耐药。患者接受苯达莫司汀治疗的中位周期数为4个（范围1-10个）。总缓解率为61.5%（95% 49.8-72.3），中位缓解持续时间为8.3个月（95% 5.5-14.0），完全缓解（CR）率为5.1%（95% 1.4-12.6）。在全分析集中，中位无进展生存期（PFS）和中位总生存期（OS）分别为8.7个月（95% 6.7-13.2）和25.5个月（95% 14.2个月至未达到），中位随访时间为33.6个月（95% 17.4-38.8）。淋巴细胞减少（74.4%）、中性粒细胞减少（52.6%）、白细胞减少（39.7%）、血小板减少（29.5%）和贫血（15.4%）是最常见的3-4级血液学不良事件（AE）。最常见的非血液学AE包括恶心（43.6%）、呕吐（33.3%）和厌食（29.5%）。单因素和多因素分析显示，苯达莫司汀治疗周期<4个是PFS的不良预后因素（P=0.003），未接受含氟达拉滨方案治疗是OS的不良预后因素（P=0.009）。苯达莫司汀单药治疗R/R B-NHL患者具有良好的疗效和安全性。
