Wu Jing-Jing, Wang Wen-Hua, Dong Meng, Ma Shan-Shan, Zhang Xu-Dong, Zhu Li-Nan, Niu Song-Tao, Ding Meng-Jie, Zhang Jie-Ming, Zhang Lei, Li Xin, Li Ling, Sun Zhen-Chang, Wang Xin-Hua, Fu Xiao-Rui, Li Zhao-Ming, Chang Yu, Nan Fei-Fei, Yan Jia-Qin, Yu Hui, Wu Xiao-Long, Zhou Zhi-Yuan, Zhang Ming-Zhi
Department of Oncology, the First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, 450052, China.
Invest New Drugs. 2022 Jun;40(3):650-659. doi: 10.1007/s10637-022-01219-5. Epub 2022 Feb 9.
Central nervous system lymphoma (CNSL) is an aggressive lymphoma. Orelabrutinib, an oral Bruton tyrosine kinase inhibitor, is a new treatment strategy for CNSL. This study aims to evaluate the efficacy and safety of orelabrutinib-based regimens in the treatment of patients with CNSL.
Twenty-three patients with CNSL were included in this retrospective study. All patients received the orelabrutinib-based regimen. Efficacy was evaluated based on investigators' assessment of overall response rate (ORR), complete response/unconfirmed complete response (CR/CRu), partial response (PR), stable disease (SD), progressive disease (PD), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). The safety of orelabrutinib-based regimens has also been evaluated.
A total of 17.39% of patients received orelabrutinib-based regimens for consolidation therapy, and 82.61% of patients for induction therapy (4 newly diagnosed CNSL, 15 relapsed/refractory CNSL). In the newly diagnosed CNSL group, the ORR was 100% (1 CR, 1 CRu, 2 PR). The 6-month DOR rate, 6-month PFS rate, and 6-month OS rate were 100%, 100%, and 100%, respectively. Of the 15 relapsed/refractory CNSL patients, five therapy regimens were applied (orelabrutinib, n = 3; orelabrutinib/immunotherapy, n = 3; orelabrutinib/chemotherapy, n = 2; orelabrutinib/immunochemotherapy, n = 6; orelabrutinib/radiotherapy, n = 1). The ORR was 60.00% (4 CR, 5 PR). The 6-month DOR rate, 6-month PFS rate, and 6-month OS rate were 92.30%, 67.70%, and 70.00%, respectively. Twenty-one patients reported adverse events (AEs), and 6 patients experienced grade ≥ 3 AEs.
Orelabrutinib-based regimens were efficacious and well-tolerated in patients with CNSL. These combined therapies offer a new potential therapeutic strategy for patients with CNSL.
中枢神经系统淋巴瘤（CNSL）是一种侵袭性淋巴瘤。奥雷巴替尼是一种口服布鲁顿酪氨酸激酶抑制剂，是治疗CNSL的一种新的治疗策略。本研究旨在评估基于奥雷巴替尼的治疗方案治疗CNSL患者的疗效和安全性。
本回顾性研究纳入了23例CNSL患者。所有患者均接受基于奥雷巴替尼的治疗方案。疗效根据研究者对总缓解率（ORR）、完全缓解/未确认完全缓解（CR/CRu）、部分缓解（PR）、疾病稳定（SD）、疾病进展（PD）、缓解持续时间（DOR）、无进展生存期（PFS）和总生存期（OS）的评估来进行评价。基于奥雷巴替尼的治疗方案的安全性也进行了评估。
共有17.39%的患者接受基于奥雷巴替尼的治疗方案进行巩固治疗，82.61%的患者接受诱导治疗（4例新诊断的CNSL，15例复发/难治性CNSL）。在新诊断的CNSL组中，ORR为100%（1例CR，1例CRu，2例PR）。6个月的DOR率、6个月的PFS率和6个月的OS率分别为100%、100%和100%。在15例复发/难治性CNSL患者中，应用了五种治疗方案（奥雷巴替尼，n = 3；奥雷巴替尼/免疫治疗，n = 3；奥雷巴替尼/化疗，n = 2；奥雷巴替尼/免疫化疗，n = 6；奥雷巴替尼/放疗，n = 1）。ORR为60.00%（4例CR，5例PR）。6个月的DOR率、6个月的PFS率和6个月的OS率分别为92.30%、67.70%和70.00%。21例患者报告了不良事件（AE），6例患者发生了≥3级AE。
基于奥雷巴替尼的治疗方案对CNSL患者有效且耐受性良好。这些联合治疗为CNSL患者提供了一种新的潜在治疗策略。
