Bendamustine monotherapy for Chinese patient treatment with relapsed or refractory B cell non-Hodgkin lymphoma: a phase Ⅱ, prospective, multicenter, single-arm study
10.3760/cma.j.issn.0253-2727.2022.11.009
- VernacularTitle:苯达莫司汀单药治疗复发/难治B细胞非霍奇金淋巴瘤：一项前瞻、多中心、单臂、Ⅱ期临床研究
- Author:
Yan GAO
1
;
Yu YANG
;
Hong CEN
;
Hong LIU
;
Jinxiang FU
;
Shunqing WANG
;
Ru FENG
;
Ding YU
;
Xinyou ZHANG
;
Zhuowen CHEN
;
Yufu LI
;
Huiqiang HUANG
Author Information
1. 中山大学肿瘤防治中心肿瘤内科，广州 510060
- Keywords:
Bendamustine;
Lymphoma, B-cell;
Treatment outcome;
Safety
- From:
Chinese Journal of Hematology
2022;43(11):934-939
- CountryChina
- Language:Chinese
-
Abstract:
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.
