Efficacy of bendamustine hydrochloride in patients with rituximab-refractory indolent B-cell non-Hodgkin's lymphoma：results from a phaseⅢmulticenter study
10.3969/j.issn.1000-8179.2015.20.978
- VernacularTitle: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
- Author:
Teng SONG
;
Huilai ZHANG
;
Huaqing WANG
;
Jingmin LI
;
Xiaoyan KE
;
Junning CAO
;
Huiqiang HUANG
;
Weijing ZHANG
;
Jun ZHU
;
Yun FAN
;
Jifeng FENG
- Publication Type:Journal Article
- Keywords:
bendamustine hydrochloride;
rituximab-refractory;
non-Hodgkin's lymphoma;
efficacy;
safety
- From:
Chinese Journal of Clinical Oncology
2015;(20):1025-1030
- CountryChina
- Language:Chinese
-
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 2010 and 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 of 56 (rang-ing from 28 to 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), and 4 (4.3%) had progression disease (PD). The ORR and DCR were 72%and 95.7%, respectively. After a median follow-up of 26.6 months (ranging from 2 to 48.4 months), 59 patients (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 op-tions for second-line treatment of these patients. The most common adverse event is hematologic toxicity.
