The oncologist · 2026
Effectiveness of sacituzumab govitecan in metastatic triple-negative breast cancer: a real-world retrospective cohort study from Central Europe.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Pieniążek Małgorzata, Polakiewicz-Gilowska Anna, Żubrowska Justyna, Rušinová Lenka, Študentová Hana, Konieczna Aleksandra, Młodzińska Agnieszka, Winsko-Szczęsnowicz Karolina, Lisik-Habib Maja, Pękala Anika, Krejčí Daniel, Šustr Jan, Kolářová Iveta, Danielewicz Iwona, Szymanik-Resko Magdalena, Soumarová Renata, Ciszewski Tomasz, Holánek Miloš, Czartoryska-Arłukowicz Bogumiła, Łacko Aleksandra, Smok-Kalwat Jolanta, Jarząb Michał, Pacholczak-Madej Renata, Malejčíková Miroslava, Bielčiková Zuzana, Püsküllüoğlu Mirosława
Аннотация
BACKGROUND: Sacituzumab govitecan (SG), an antibody-drug conjugate targeting TROP-2, demonstrated superior efficacy over standard chemotherapy in heavily pretreated metastatic triple-negative breast cancer (mTNBC) in the ASCENT trial. However, real-world data remain limited. This study evaluated the effectiveness and safety of SG in an unselected multinational cohort of patients with mTNBC.
METHODS: This retrospective analysis included 303 women who initiated SG treatment between August 2021 and April 2025 across 18 oncology centers in Poland, the Czech Republic and Slovakia, within the Central European Breast Cancer Collaboration (CEBCC-102). Primary endpoints were median progression-free survival (mPFS) and overall survival (mOS). Secondary objectives included response pattern, safety and identification of factors influencing outcomes. Adverse events (AEs) were graded using Common Terminology Criteria for AE, version 5.0, and treatment response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
RESULTS: The median follow-up was 8.8 months (IQR 4.5-14.4). The mPFS was 4.4 months, and mOS was 11.3 months. The overall response rate was 30.7%. The most frequent AEs were hematologic: neutropenia (69.0%) and anemia (39.6%). In multivariate Cox analyses, poor ECOG performance status and liver metastases were independently associated with worse outcomes. Diarrhea and hypersensitivity reactions showed favorable prognostic associations.
CONCLUSIONS: In this largest real-world cohort, the clinical benefit of SG observed in the ASCENT trial was confirmed under routine practice conditions. Poor performance status and liver metastases predicted inferior outcomes, while certain treatment-related AEs warrant further investigation.
METHODS: This retrospective analysis included 303 women who initiated SG treatment between August 2021 and April 2025 across 18 oncology centers in Poland, the Czech Republic and Slovakia, within the Central European Breast Cancer Collaboration (CEBCC-102). Primary endpoints were median progression-free survival (mPFS) and overall survival (mOS). Secondary objectives included response pattern, safety and identification of factors influencing outcomes. Adverse events (AEs) were graded using Common Terminology Criteria for AE, version 5.0, and treatment response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
RESULTS: The median follow-up was 8.8 months (IQR 4.5-14.4). The mPFS was 4.4 months, and mOS was 11.3 months. The overall response rate was 30.7%. The most frequent AEs were hematologic: neutropenia (69.0%) and anemia (39.6%). In multivariate Cox analyses, poor ECOG performance status and liver metastases were independently associated with worse outcomes. Diarrhea and hypersensitivity reactions showed favorable prognostic associations.
CONCLUSIONS: In this largest real-world cohort, the clinical benefit of SG observed in the ASCENT trial was confirmed under routine practice conditions. Poor performance status and liver metastases predicted inferior outcomes, while certain treatment-related AEs warrant further investigation.