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摘要
目的： 评估苯达莫司汀单药治疗中国复发/难治B细胞非霍奇金淋巴瘤（B-NHL）患者的有效性和安全性。 方法： 本研究为前瞻性、多中心、开放标签、单臂Ⅱ期临床研究。纳入2012年3月至2016年12月国内11所医院78例接受苯达莫司汀治疗的B-NHL患者，分析患者的临床特征、疗效及生存。 结果： 患者的中位年龄为58（24~76）岁，69例（88.4%）患者为Ⅲ/Ⅳ期，61例（78.2%）患者对末线治疗耐药。全组患者中位接受4（1~10）个周期苯达莫司汀治疗。全分析集中，客观缓解率为61.5（95% CI 49.8~72.3）%，完全缓解率为5.1（95%CI 1.4~12.6）%。中位随访33.6（95%CI 17.4~38.8）个月，中位缓解持续时间为8.3（95%CI 5.5~14.0）个月，中位无进展生存（PFS）期和中位总生存（OS）期分别为8.7（95%CI 6.7~13.2）个月和25.5个月（95%CI 14.2个月~未达到）。最常见的3~4级血液学不良反应为淋巴细胞减少（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%）。最常见的非血液学不良反应为恶心（43.6%）、呕吐（33.3%）和厌食（29.5%）。多因素分析显示，苯达莫司汀治疗<4个周期是影响PFS的预后不良因素（P＝0.003），既往未接受含氟达拉滨方案是影响OS的预后不良因素（P＝0.009）。 结论： 苯达莫司汀单药治疗复发难治B-NHL患者有良好的疗效和安全性。.; Objective: To evaluate the efficacy and safety of bendamustine monotherapy in Chinese patients with relapsed/refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL) . Methods: 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. Results: 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% CI 49.8-72.3) % , the median response duration was 8.3 (95% CI 5.5-14.0) months, and the complete remission (CR) rate was 5.1 (95% CI 1.4-12.6) % . In the full analysis set, median progression-free survival (PFS) and median OS were 8.7 (95% CI 6.7-13.2) months and 25.5 months (95% CI 14.2 months to not reached) , respectively, after a median follow-up of 33.6 (95% CI 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 (P=0.003) , and failure to accept fludarabine containing regimen was a poor prognostic factor for OS (P=0.009) . Conclusion: Bendamustine monotherapy has good efficacy and safety in the treatment of patient with R/R B-NHL.
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