Efficacy and safety of sacituzumab govitecan in hormone receptor–positive metastatic breast cancer: A systematic review and meta-analysis

Background Sacituzumab govitecan (SG) has shown clinical activity in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2− MBC), although evidence remains limited and heterogeneous. We performed a systematic review and meta-analysis to evaluate its efficacy and safety. Methods Studies assessing SG in HR+/HER2− MBC were systematically identified. Outcomes included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Random-effects models were used for pooled analyses. Results Twelve studies including 2431 patients (5 clinical trials, 7 real-world studies) were analyzed. The pooled ORR was 23% (95% CI, 17%–31%) and DCR was 68% (95% CI, 52%–80%). Median PFS and OS were 5.35 months (95% CI, 3.96–7.22) and 12.66 months (95% CI, 10.68–15.01), respectively. No significant differences in ORR were observed according to prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure, number of prior treatment lines, or study design. Grade ≥3 neutropenia, febrile neutropenia, and diarrhea occurred in 46%, 5%, and 8% of patients, respectively. Conclusions SG demonstrates clinically meaningful antitumor activity in heavily pretreated patients with HR+/HER2− MBC. No statistically significant differences in ORR were detected according to prior CDK4/6 inhibitor exposure, number of prior treatment lines, or study design; however, these findings should be interpreted cautiously given the limited number of studies and substantial heterogeneity. Within a continuously evolving treatment landscape, further prospective studies are warranted to better define the optimal positioning of SG.