A Multicenter Real-Life Evaluation of Safety and Effectiveness of the Antibody-Drug Conjugate Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer.

Objectives: Randomized trials showed that the third-generation antibody-drug conjugate, sacituzumab govitecan (SG), is active against metastatic triple-negative breast cancer (mTNBC). Real-world data are relatively limited. This retrospective study reports the efficacy and safety of SG in a series of women with mTNBC in clinical practice.

Methods: Eighty-four patients with widely pretreated, de novo, or metachronous mTNBC were treated with SG at the recommended dose of 10 mg/kg on days 1 and 8 every 3 weeks over a 3-hour intravenous infusion at 6 medical oncology units.

Results: No complete response was observed. Overall, 29 patients (34%; 95% CI: 24.4%-44.7%) achieved a partial response with a median duration of 6 months (range: 5 to 14 mo). Twenty patients 24 (29%; 95% CI: 18.9%-38.2%) had stabilization of disease with a median duration of 7 months (4 to 13 mo), while 31 (37%; 95% CI: 26.6%-47.2%) progressed. The median progression-free survival was 5 months (range: 1 to 14 mo) and the median overall survival as 10 months (range: 1 to 18 mo). Twelve patients (22%) had metastatic deposits in CNS and had received radiotherapy.

Conclusions: The real-life data reported in this paper confirm the randomized trial results regarding efficacy and tolerability. The authors stressed the importance of the early identification of severe side effects in managing these patients.