Karimi Mohammad Amin, Norooziseyedhosseini Hanieh, Khademi Reza, Ghajary Alireza, Kargar Haniyeh, Abdollahi Seyyedeh Sana, Belbasi Mohaddeseh, Naziri Mahdyieh, Deravi Niloofar, Hajihosseini Sajjad, Mofidi Saharnaz
School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
BMC Pharmacol Toxicol. 2025 Feb 25;26(1):43. doi: 10.1186/s40360-024-00832-9.
Chronic lymphocytic leukemia (CLL) is a B-cell malignancy primarily diagnosed in older adults. For younger patients, treatment options often include regimens based on fludarabine, cyclophosphamide, and rituximab; however, at least 20% of patients exhibit resistance to these therapies. Ibrutinib, a covalent Bruton's tyrosine kinase (BTK) inhibitor, has demonstrated enhanced safety compared to conventional treatments. This meta-analysis examines the efficacy and safety of ibrutinib in managing relapsed/refractory CLL.
Relevant keywords were used to conduct a comprehensive search across online databases, including PubMed, Scopus, and Google Scholar. Data related to complete response (CR), overall response rate (ORR), and adverse events were extracted to evaluate the efficacy and safety of ibrutinib treatment. The results were presented in forest plots illustrating event rates and risk ratios with 95% confidence intervals (CI), while heterogeneity was assessed using I² statistics. Funnel plots were employed to examine potential publication bias visually.
Twenty-one studies were included in this meta-analysis. Ibrutinib as a single-agent treatment was associated with a 9% complete response (CR) rate (95% CI: 5-14%) and a 77% overall response rate (ORR) (95% CI: 70-83%). When combined with other agents, ibrutinib achieved a CR rate of 21% (95% CI: 9-41%) and an ORR of 84% (95% CI: 80-88%). Adverse events were not significantly correlated with treatment outcomes. Funnel plots indicated no significant publication bias.
Single-agent ibrutinib has proven to be an effective therapy for patients with relapsed/refractory CLL. However, combining ibrutinib with other agents has demonstrated enhanced treatment efficacy. Further studies are needed to evaluate the safety profile of this therapeutic regimen thoroughly.
慢性淋巴细胞白血病（CLL）是一种主要在老年人中诊断出的B细胞恶性肿瘤。对于年轻患者，治疗方案通常包括基于氟达拉滨、环磷酰胺和利妥昔单抗的方案；然而，至少20%的患者对这些疗法表现出耐药性。依鲁替尼是一种共价布鲁顿酪氨酸激酶（BTK）抑制剂，与传统治疗相比已显示出更高的安全性。这项荟萃分析研究了依鲁替尼在治疗复发/难治性CLL中的疗效和安全性。
使用相关关键词在包括PubMed、Scopus和谷歌学术在内的在线数据库中进行全面搜索。提取与完全缓解（CR）、总缓解率（ORR）和不良事件相关的数据，以评估依鲁替尼治疗的疗效和安全性。结果以森林图呈现，显示事件发生率和风险比以及95%置信区间（CI），同时使用I²统计量评估异质性。采用漏斗图直观检查潜在的发表偏倚。
本荟萃分析纳入了21项研究。依鲁替尼单药治疗的完全缓解（CR）率为9%（95%CI：5 - 14%），总缓解率（ORR）为77%（95%CI：70 - 83%）。与其他药物联合使用时，依鲁替尼的CR率为21%（95%CI：9 - 41%），ORR为84%（95%CI：80 - 88%）。不良事件与治疗结果无显著相关性。漏斗图显示无显著发表偏倚。
已证明依鲁替尼单药治疗对复发/难治性CLL患者是一种有效的疗法。然而，依鲁替尼与其他药物联合使用已显示出更高的治疗疗效。需要进一步研究以全面评估这种治疗方案的安全性。
