The efficacy and safety of belzutifan inhibitor in patients with advanced or metastatic clear cell renal cell carcinoma: a meta-analysis.

IF 2.8 3区医学 Q2 PHARMACOLOGY & PHARMACY

BMC Pharmacology & Toxicology Pub Date : 2024-12-20 DOI:10.1186/s40360-024-00828-5

Ge Song, Song Xue, Yingming Zhu, Chunling Wu, Xiaowei Ji

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引用次数: 0

Abstract

Background: The belzutifan is a hypoxia inducible factor-2 alpha (HIF-2α) inhibitor for the treatment of advanced or metastatic clear cell renal cell carcinoma (mccRCC) and has exhibited good safety and efficacy in clinical trials. We conducted a meta-analysis of relevant studies to further clarify the efficacy and safety of belzutifan for the treatment of mccRCC.

Methods: Multiple databases and abstracts from major scientific meetings were systematically reviewed for eligible articles published before June 1, 2024. The following outcomes were analyzed: objective response rate (ORR), disease control rate (DCR), median duration of response (mDOR), median progression-free survival (mPFS), median overall survival (mOS), and treatment-related adverse events (TRAes). 426 records were reviewed, and data were extracted by at least two individuals.

Results: Seven studies involving 715 patients were included in this meta-analysis. The pooled ORR was 34% (95% confidence interval [CI]: 23-46%), the DCR was 79% (95% CI: 66-90%), the mDOR was 21.8 months (95% CI: 14.82-28.78), and the mPFS time was 8.8 months (95% CI: 6.15-11.44). The pooled incidence of grade 3-5 TRAes was 46%, and the most common TRAe was anemia. Further subgroup analysis revealed that, compared with belzutifan monotherapy, the combination of belzutifan with tyrosine kinase inhibitors (TKIs) as second- or later-line therapy was associated with a statistically significant increase in the ORR. Toxicity was also greater with combined inhibition therapy.

Conclusions: Our meta-analysis revealed moderate antitumor activity and a manageable safety profile of the inhibitor belzutifan in patients with mccRCC.

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贝尔祖替芬抑制剂治疗晚期或转移性透明细胞肾细胞癌的疗效和安全性：一项荟萃分析。

背景：belzutifan是一种缺氧诱导因子-2α (HIF-2α)抑制剂，用于治疗晚期或转移性透明细胞肾细胞癌（mccRCC），在临床试验中显示出良好的安全性和有效性。我们对相关研究进行了荟萃分析，以进一步明确贝祖替芬治疗mccRCC的有效性和安全性。方法：系统检索2024年6月1日之前发表的符合条件的文章，检索多个数据库和主要科学会议的摘要。分析以下结果：客观缓解率（ORR）、疾病控制率（DCR）、中位缓解持续时间（mDOR）、中位无进展生存期（mPFS）、中位总生存期（mOS）和治疗相关不良事件（TRAes）。审查了426份记录，并由至少两个人提取了数据。结果：本荟萃分析纳入了7项研究，涉及715例患者。合并ORR为34%(95%可信区间[CI]: 23-46%)， DCR为79% (95% CI: 66-90%)， mor为21.8个月（95% CI: 14.82-28.78）， mPFS时间为8.8个月（95% CI: 6.15-11.44）。3-5级TRAe的总发生率为46%，最常见的TRAe是贫血。进一步的亚组分析显示，与贝祖替芬单药治疗相比，贝祖替芬联合酪氨酸激酶抑制剂（TKIs）作为二线或二线治疗与ORR的统计学显著增加相关。联合抑制治疗的毒性也更大。结论：我们的荟萃分析显示，抑制剂贝尔祖替芬在mccRCC患者中的抗肿瘤活性中等，安全性可控。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY

CiteScore

4.80

自引率

0.00%

发文量

审稿时长

12 weeks

期刊介绍： BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.