Real-world evidence of sacituzumab govitecan in metastatic triple-negative breast cancer: an updated multicenter analysis.

BACKGROUND

The Trop-2-directed antibody-drug conjugate sacituzumab govitecan (SG) has shown significant benefit in metastatic triple-negative breast cancer (mTNBC) in clinical trials. However, evidence about its effectiveness and safety in real-world heterogeneous patient populations is limited. This multicenter study, including the largest European and second-largest worldwide real-world cohort of SG-treated patients with mTNBC, offers valuable insights for its use in routine clinical practice.

MATERIALS AND

METHODS

This analysis included 256 women with mTNBC treated with SG across 17 Italian oncology centers, consisting of 217 retrospectively identified patients and 39 prospectively enrolled patients. Treatment activity and safety were assessed according to RECIST v1.1 and Common Terminology Criteria for Adverse Events del National Cancer Institute (NCI-CTCAE) v5.0 criteria.

RESULTS

Median patient age was 54 years (range 26-80), and 70.7% had TNBC at initial diagnosis. The median interval from metastatic diagnosis to SG initiation was 16 months (range 0-115), with a median of two prior treatment lines (range 0-7). Frequent metastatic sites were lymph nodes (60.9%), bone (43.0%), lung (42.6%), liver (33.2%), and brain (26.2%). Overall, 37.5% achieved complete or partial response, 27.7% had stable disease, and 31.2% experienced progression. At a median follow-up of 17.4 months, 202 patients had progressed, and 139 had died. Median real-world progression-free survival was 6.4 months [95% confidence interval (CI) 5.3-7.3] and median real-world overall survival was 13.6 months (95% CI 11.5-15.5). The most common treatment-related adverse events were alopecia (69.1%), neutropenia (57.0%), nausea (49.6%), anemia (46.9%), and diarrhea (36.7%). Grade 3-4 neutropenia occurred in 18.0% and 5.9%, respectively. Dose reductions were required in 36.5%, and 2.7% discontinued treatment.

CONCLUSIONS

SG demonstrated durable clinical benefit and manageable toxicity in patients with mTNBC, highlighting the importance of optimized adverse-event management. The size and heterogeneity of the study population, including the largest reported cohort of patients with central nervous system metastases, support the robustness of these findings.