首个trop -2靶向抗体-药物结合物（sacituzumab govitecan）治疗转移性乳腺癌的荟萃分析和系统评价

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-07-07 DOI:10.1007/s00228-025-03876-w

Jue Wang, Shengyou Lin, Jialin Zhang, Jingyang Su

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引用次数: 0

摘要

为了评估sacituzumab govitecan治疗转移性乳腺癌（MBC）的有效性和安全性，我们进行了一项比较sacituzumab govitecan与化疗的随机对照试验的荟萃分析。方法：系统检索多个数据库的相关研究。主要结局包括无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）和不良事件（ae）。数据分析采用RevMan 5.3软件。结果：经过严格筛选和质量评估，纳入3项研究。与化疗相比，sacituzumab govitecan可显著延长PFS [HR 0.57；95% ci 0.43, 0.77；P = 0.0002]， OS改善[HR 0.64；95% ci 0.48, 0.85；P = 0.002]， ORR升高[RR 2.84；95% ci 1.27, 6.37；p = 0.01]。然而，sacituzumab govitecan与更高的ae发生率相关(P)。结论：在本研究中，与化疗方案相比，sacituzumab govitecan可改善MBC患者的PFS和OS。需要进一步的研究来验证其广泛的适用性和长期的治疗稳定性。

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A meta-analysis and systematic review of the first Trop-2-targeting antibody-drug conjugate (sacituzumab govitecan) in treating metastatic breast cancer.

Objectives: To assess the effectiveness and safety of sacituzumab govitecan in metastatic breast cancer (MBC), we performed a meta-analysis of randomized controlled trials comparing sacituzumab govitecan with chemotherapy.

Methods: We systematically searched multiple databases for relevant studies. Primary outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events (AEs). Data were analyzed using RevMan 5.3 software.

Results: Three studies were included after rigorous screening and quality assessment. Compared with chemotherapy, sacituzumab govitecan significantly prolonged PFS [HR 0.57; 95% CI 0.43, 0.77; P = 0.0002], improved OS [HR 0.64; 95% CI 0.48, 0.85; P = 0.002], and increased ORR [RR 2.84; 95% CI 1.27, 6.37; P = 0.01]. However, sacituzumab govitecan was associated with higher incidence of AEs (P < 0.00001).

Conclusion: In this study, sacituzumab govitecan demonstrated improved PFS and OS compared to chemotherapy regimens in patients with MBC. Further research is required to validate its broad applicability and long-term treatment stability.

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.