Efficacy and safety of sacituzumab govitecan in HR+/HER2– advanced breast cancer: A comprehensive systematic review and meta-analysis.

Abstract

e13085 Background: Breast cancer is the most commonly diagnosed cancer in women, with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) being the predominant subtype. Sacituzumab govitecan, a novel antibody-drug conjugate, has emerged as a promising treatment for metastatic HR+/HER2– breast cancer. The aim of this systematic review and meta-analysis was to evaluate its efficacy and safety. Methods: Adhering to PRISMA guidelines, a comprehensive search was conducted in PubMed, Scopus, and Cochrane databases up to December 2023. We included clinical trials and observational studies evaluating sacituzumab govitecan in patients with HR +/HER2–advanced breast cancer. The primary outcome was progression-free survival (PFS), while the secondary outcomes included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and adverse event profiles. Various statistical models were used for the analysis. Results: Nine studies met the inclusion criteria, and three were suitable for meta-analysis. The pooled analysis showed a Hazard Ratio (HR) of 0.57 for PFS, indicating a significant reduction in disease progression, and an HR of 0.68 for OS, suggesting improved survival. The treatment also significantly increased the likelihood of tumor response and clinical benefit but was associated with a higher occurrence of adverse events. Conclusions: Sacituzumab govitecan demonstrated significant efficacy in treating HR+/HER2– advanced breast cancer, reducing disease progression and mortality. However, its use is associated with a high rate of adverse events. These findings highlight the potential of Sacituzumab govitecan as a valuable addition to breast cancer treatment regimens, warranting further investigation and long-term studies.