首个靶向Trop-2的抗体药物偶联物（戈沙妥珠单抗）治疗转移性乳腺癌的荟萃分析与系统评价
A meta-analysis and systematic review of the first Trop-2-targeting antibody-drug conjugate (sacituzumab govitecan) in treating metastatic breast cancer.
作者信息
Wang Jue, Lin Shengyou, Zhang Jialin, Su Jingyang
机构信息
Department of Oncology, Hangzhou TCM Hospital of Zhejiang Chinese Medical University (Hangzhou Hospital of Traditional Chinese Medicine), Hangzhou, 310007, China.
Department of Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China.
出版信息
Eur J Clin Pharmacol. 2025 Jul 7. doi: 10.1007/s00228-025-03876-w.
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.
目的
为评估戈沙妥珠单抗治疗转移性乳腺癌（MBC）的有效性和安全性，我们对比较戈沙妥珠单抗与化疗的随机对照试验进行了荟萃分析。
方法
我们系统检索了多个数据库以查找相关研究。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）。使用RevMan 5.3软件进行数据分析。
结果
经过严格筛选和质量评估，纳入了三项研究。与化疗相比，戈沙妥珠单抗显著延长了PFS [风险比（HR）0.57；95%置信区间（CI）0.43，0.77；P = 0.0002]，改善了OS [HR 0.64；95% CI 0.48，0.85；P = 0.002]，并提高了ORR [相对危险度（RR）2.84；95% CI 1.27，6.37；P = 0.01]。然而，戈沙妥珠单抗与更高的AE发生率相关（P < 0.00001）。
结论
在本研究中，与MBC患者的化疗方案相比，戈沙妥珠单抗显示出改善的PFS和OS。需要进一步研究以验证其广泛适用性和长期治疗稳定性。
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