Wang Jingfei, Cheng Hai-En, Sun Yanhua, Li Zhenfeng, Zang Yunke, Zhao Yuying, Yang Guimao, Liu Zhijun, Sun Yaqi, Sun Yanli
School of Medical Laboratory, Shandong Second Medical University, Weifang, China.
Department of Hematology, Weifang People's Hospital, Weifang, China.
Front Pharmacol. 2025 Apr 1;16:1559056. doi: 10.3389/fphar.2025.1559056. eCollection 2025.
Tirabrutinib is a potent, irreversible, and highly selective Bruton's tyrosine kinase (BTK) inhibitor that has demonstrated significant therapeutic activity in patients with relapsed or refractory B-cell lymphoma. However, the safety and efficacy of tirabrutinib monotherapy have not been systematically assessed. This meta-analysis aims to assess the safety and efficacy of tirabrutinib monotherapy in patients with B-cell lymphoma.
We conducted a comprehensive literature search in Embase, PubMed, Web of Science, and Cochrane Library databases to identify prospective clinical trials evaluating tirabrutinib monotherapy in B-cell lymphoma. Data on efficacy and safety were extracted and analyzed.
A total of seven studies were included in the meta-analysis. The clinical trials primarily involved patients with chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia (WM). The pooled overall response rate (ORR) was 72.5%, with complete response (CR) rate of 18.6%, stable disease (SD) rate of 13.8%, and partial response (PR) rate of 41.1%. The highest median progression-free survival (mPFS) was observed in patients with CLL, reaching 38.5 months. Neutropenia was the most common adverse event (AE), both all grades and grade ≥3. Additionally, a high incidence of skin-related AEs was reported.
Tirabrutinib monotherapy demonstrates a manageable safety profile and promising efficacy in patients with B-cell lymphoma. However, these findings need to be confirmed by larger and higher-quality randomized controlled trials in the future. Further research should also explore the long-term effects and potential benefits of combination therapies involving tirabrutinib.
Identifier CRD42024552721.
替雷利珠单抗是一种强效、不可逆且高度选择性的布鲁顿酪氨酸激酶（BTK）抑制剂，已在复发或难治性B细胞淋巴瘤患者中显示出显著的治疗活性。然而，替雷利珠单抗单药治疗的安全性和有效性尚未得到系统评估。本荟萃分析旨在评估替雷利珠单抗单药治疗B细胞淋巴瘤患者的安全性和有效性。
我们在Embase、PubMed、Web of Science和Cochrane图书馆数据库中进行了全面的文献检索，以确定评估替雷利珠单抗单药治疗B细胞淋巴瘤的前瞻性临床试验。提取并分析了疗效和安全性数据。
荟萃分析共纳入7项研究。这些临床试验主要涉及慢性淋巴细胞白血病（CLL）、原发性中枢神经系统淋巴瘤（PCNSL）、套细胞淋巴瘤（MCL）和华氏巨球蛋白血症（WM）患者。汇总的总缓解率（ORR）为72.5%，完全缓解（CR）率为18.6%，疾病稳定（SD）率为13.8%，部分缓解（PR）率为41.1%。CLL患者的中位无进展生存期（mPFS）最高，达到38.5个月。中性粒细胞减少是最常见的不良事件（AE），包括所有级别和≥3级。此外，还报告了皮肤相关AE的高发生率。
替雷利珠单抗单药治疗在B细胞淋巴瘤患者中显示出可控的安全性和有前景的疗效。然而，这些发现需要未来更大规模、更高质量的随机对照试验来证实。进一步的研究还应探索涉及替雷利珠单抗的联合治疗的长期效果和潜在益处。
标识符CRD42024552721。
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