Efficacy and Safety of Sacituzumab Govitecan for Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs).

Objectives

Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, has demonstrated clinical activity in HER2-negative breast cancer. Our meta-analysis aimed to evaluate the efficacy and safety of SG compared with standard chemotherapy in patients with breast cancer.

Methods

We conducted a comprehensive literature search across multiple databases for RCTs comparing SG with standard treatment in patients with breast cancer. The primary outcomes were progression-free survival (PFS) and overall survival (OS). Secondary outcomes included objective response rate (ORR), clinical benefit rate (CBR), disease control measures, and treatment-related adverse events. Hazard ratios (HRs), mean differences (MDs), and risk ratios (RRs) with 95% CIs were pooled using a random-effects model.

Results

Six RCTs encompassing 2481 patients were included. SG significantly improved PFS (HR=0.59), OS (HR=0.63), and ORR (RR=1.64) compared with chemotherapy. CBR was also significantly higher with SG (RR=1.89), and the rate of progressive disease was significantly lower (RR=0.62). Overall treatment-related adverse events were similar in both groups (RR=1.05). Neutropenia and diarrhea were significantly more frequent in the SG group.

Conclusions

Our meta-analysis shows that sacituzumab govitecan significantly improves PFS, OS, and ORR compared with standard chemotherapy in patients with HER2-negative breast cancer. Although associated with higher rates of neutropenia and diarrhea, its overall safety profile remains manageable. These results reinforce the role of SG as an effective treatment option for both metastatic TNBC and HR+/HER2- breast cancer and support its continued evaluation in earlier treatment settings and combination strategies, including immunotherapy.