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Multicenter Study
. 2025 Sep 1;48(9):450-457.
doi: 10.1097/COC.0000000000001201. Epub 2025 May 19.

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

Federica Martorana  1   2 , Maria V Sanò  1 , Alessandra Fabi  3 , Ida Paris  3 , Vita Leonardi  4 , Gabriella Bini  5 , Oriana Maiorana  6 , Paolo Vigneri  1   2 , Vittorio Gebbia  7   8 , Giuseppina Scandurra  9   8 , Francesco Giotta  10 , Annabella Curaba  7   8 , Maria R Valerio  11
Affiliations
Multicenter Study

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

Federica Martorana et al. Am J Clin Oncol. .

Abstract

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.

Keywords: effectiveness; metastatic; real-world evidence; sacituzumab govitecan; safety; triple-negative breast cancer.

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Conflict of interest statement

F.M. received travel grants and lecture fees from Gilead. P.V. and V.G. received lecture fees from Gilead. The remaining authors declare no conflicts of interest.

References

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    1. Jeon Y, Jo U, Hong J, et al. Trophoblast cell-surface antigen 2 (TROP2) expression in triple-negative breast cancer. BMC Cancer. 2022;22:1014–1022.
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