盐酸苯达莫司汀治疗利妥昔单抗耐药的B 细胞惰性淋巴瘤多中心Ⅲ期临床研究

Efficacy of bendamustine hydrochloride in patients with rituximabrefractory indolent B- cell non- Hodgkin's lymphoma: results from a phaseⅢmulticenter study

  • 摘要: 目的:评价注射用盐酸苯达莫司汀单药治疗利妥昔单抗治疗失败的B 细胞惰性淋巴瘤的有效性和安全性。方法:2010年4 月至2013年4 月,全国8 个研究中心入组100 例利妥昔单抗治疗失败的B 细胞惰性淋巴瘤患者,接受苯达莫司汀单药治疗(120 mg/m2,d1、2,每21天1 个周期,最多8 个周期)。 主要终点指标为总反应率(ORR ),次要终点指标包括疾病控制率(DCR )、无进展生存(PFS)、总生存(OS)及安全性评估。结果:全组100 例患者,中位年龄为56(28~74)岁,共计化疗447 个周期,中位4(1~8)个周期。93例患者完成至少2 个周期治疗,可评价疗效。15例(16.1%)获得完全缓解(CR),52例(55.9%)获得部分缓解(PR),22例(23.7%)稳定(SD),4 例(4.3%)进展(PD),ORR 为72% ,DCR 为95.7% 。中位随访时间26.6(2~48.4)个月,59例(63.4%)出现疾病进展,中位PFS 为8.53个月(95%CI:6.518~10.542),1 年PFS 率(40.6 ± 5.3)% 。48例(48%)出现3/ 4 级不良事件,3/ 4 级白细胞减少、中性粒细胞减少、血小板减少发生率分别为26% 、24% 和11% 。结论:苯达莫司汀治疗利妥昔单抗耐药的B 细胞惰性淋巴瘤客观缓解率较高,骨髓抑制为最常见不良反应,系二线治疗惰性B 细胞淋巴瘤的新选择。

     

    Abstract: Objective: To evaluate the efficacy and toxicity of single- agent bendamustine in patients with indolent B- cell non-Hodgkin's lymphoma (NHL) refractory to rituximab.Methods:Between April 2010and April 2013, 100 patients with rituximab-refrac -tory indolent B- cell NHL from 8 institutions were enrolled. Bendamustine was administered at 120 mg/m2 on days 1 and 2 every 21 days for 6- 8 cycles. The primary endpoint was the overall response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results:One hundred patients with a median age of56(rang-ing from 28to 74) years were recruited in this clinical study. The total number of chemotherapy was 447 cycles, and the median number was 4 cycles. Ninety-three patients could be evaluated for efficacy. Fifteen patients ( 16.1%) had complete remission (CR), 52(55.9%) had partial remission (PR), 22(23.7%) had stable disease (SD), and4 (4.3%) had progression disease (PD). The ORR and DCR were 72% and 95.7%, respectively. After a median follow-up of26.6 months (ranging from 2 to 48.4 months), 59patients ( 63.4%) had PD. The median PFS was 8.53(95% CI:6.518- 10.542) months, and PFS rate for 1 year was (40.6 ± 5.3)%. Forty-eight patients (48%) had 3/4 grade adverse events, including leucopenia (26% ), neutropenia (24% ), and anemia (11 % ). Conclusion:Single- agent bendamustine produced a high rate of objective responses in patients with rituximab-refractory indolent B-cell NHL and could be one of the new options for second-line treatment of these patients. The most common adverse event is hematologic toxicity.

     

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