Efficacy and safety of bendamustine-rituximab combination therapy for newly diagnosed indolent B-cell non-Hodgkin's lymphoma and elderly mantle cell lymphoma: a multi-center prospective phase II clinical trial in China
10.3760/cma.j.issn.0253-2727.2023.07.004
- VernacularTitle:国产苯达莫司汀联合利妥昔单抗一线治疗惰性B细胞淋巴瘤及老年套细胞淋巴瘤的疗效及安全性——多中心、前瞻性、Ⅱ期临床研究
- Author:
Hui WANG
1
;
Qiang HE
;
Dan LIU
;
Xiuzhi DENG
;
Ji MA
;
Linna XIE
;
Zhongliang SUN
;
Cong LIU
;
Rongrong ZHAO
;
Ke LU
;
Xiaoxia CHU
;
Na GAO
;
Haichen WEI
;
Yanhua SUN
;
Yuping ZHONG
;
Lijie XING
;
Haiyan ZHANG
;
Hao ZHANG
;
Wenwei XU
;
Zengjun LI
Author Information
1. 山东省肿瘤医院，山东第一医科大学附属肿瘤医院淋巴血液科，济南 250000
- Keywords:
Bendamustine;
Rituximab;
B cell indolent non-Hodgkin's lymphoma;
Mantle cell lymphoma;
Treatment
- From:
Chinese Journal of Hematology
2023;44(7):550-554
- CountryChina
- Language:Chinese
-
Abstract:
Objectives:This study aimed to assess the efficacy and safety of bendamustine in combination with rituximab (BR regimen) for the treatment of newly diagnosed indolent B-cell non-Hodgkin's lymphoma (B-iNHL) and elderly mantle cell lymphoma (eMCL) .Methods:From December 1, 2020 to September 10, 2022, a multi-center prospective study was conducted across ten Grade A tertiary hospitals in Shandong Province, China. The BR regimen was administered to evaluate its efficacy and safety in newly diagnosed B-iNHL and eMCL patients, and all completed at least four cycles of induction therapy.Results:The 72 enrolled patients with B-iNHL or MCL were aged 24-74 years, with a median age of 55 years. Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 were observed in 76.4% of patients, while 23.6% had scores of 2. Disease distribution included follicular lymphoma (FL) (51.4% ), marginal zone lymphoma (MZL) (33.3% ), eMCL (11.1% ), and the unknown subtype (4.2% ). According to the Ann Arbor staging system, 16.7% and 65.3% of patients were diagnosed with stage Ⅲ and stage Ⅳ lymphomas, respectively. Following four cycles of BR induction therapy, the overall response rate was 98.6%, with a complete response (CR) rate of 83.3% and a partial response (PR) rate of 15.3%. Only one eMCL patient experienced disease progression during treatment, and only one FL patient experienced a relapse. Even when evaluated using CT alone, the CR rate was 63.9%, considering the differences between PET/CT and CT assessments. The median follow-up duration was 11 months (range: 4-22), with a PFS rate of 96.8% and an OS rate of 100.0%. The main hematologic adverse reactions included grade 3-4 leukopenia (27.8%, with febrile neutropenia observed in 8.3% of patients), grade 3-4 lymphopenia (23.6% ), grade 3-4 anemia (5.6% ), and grade 3-4 thrombocytopenia (4.2% ). The main non-hematologic adverse reactions such as fatigue, nausea/vomiting, rash, and infections occurred in less than 20.0% of patients.Conclusion:Within the scope of this clinical trial conducted in China, the BR regimen demonstrated efficacy and safety in treating newly diagnosed B-iNHL and eMCL patients.
