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

OBJECTIVE: 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.