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Background <p>Patients with metastatic triple-negative breast cancer (mTNBC) and brain metastases (BM) have poor prognosis and limited treatment options. In the ASCENT trial, sacituzumab govitecan (SG) showed modest progression-free survival (PFS) benefit but no overall survival (OS) advantage in a subgroup with stable BM. To address the limited evidence, we evaluated SGs effectiveness and safety in a real-world cohort.</p> Materials and methods <p>This retrospective multicenter study included patients with mTNBC and radiologically confirmed BM treated with ≥2 L SG at 13 centers in the Czech Republic, Poland and Slovakia. Clinical data included baseline features, BM characteristics, CNS-directed therapies, treatment response and safety. PFS and OS were assessed using Kaplan-Meier estimates; univariable Cox models evaluated the impact of BM burden on survival.</p> Results <p>29 women were included. Median number and size of BM were 3 and 16.5 mm, respectively. Prior neurosurgery was performed in 4 patients (14.3%) and radiotherapy in 28 (89.3%). Most had received ≥2 prior systemic therapies. After a median follow-up of 6.05 months, median OS was 8.9 months and PFS 3.09 months. Overall response rate was 30.8%, with CNS progression in 23.1%. Neither BM number nor size significantly affected survival. SG required dose delays in 51.7% and reductions in 37.9%; 7.7% discontinued due to toxicity. No unexpected safety signals were observed.</p> Conclusions <p>SG showed activity and manageable safety in real-world mTNBC with BM, with PFS and OS comparable or superior to the ASCENT BM subgroup. Outcomes were unaffected by BM burden, indicating SG efficacy irrespective of its extent.</p>

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Real-world outcomes of sacituzumab govitecan in patients with pretreated triple-negative breast cancer and brain metastases: data from CEBCC-102 study

  • 期刊论文

  • 发表日期：

    2026年1月14日

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  • Justyna Żubrowska,
  • Małgorzata Pieniążek,
  • Anna Polakiewicz-Gilowska,
  • Iveta Kolářová,
  • Miroslava Malejčíková,
  • Lenka Rušinová,
  • Miloš Holánek,
  • Renáta Soumarová,
  • Karolina Winsko-Szczęsnowicz,
  • Aleksandra Konieczna,
  • Agnieszka Młodzińska,
  • Daniel Krejčí,
  • Iwona Danielewicz,
  • Magdalena Szymanik-Resko,
  • Tomasz Ciszewski,
  • Maja Lisik-Habib,
  • Anika Pękala,
  • Hana Študentová,
  • Jan Šustr,
  • Agnieszka Rudzińska,
  • Marcin Kubeczko,
  • Bogumiła Czartoryska-Arłukowicz,
  • Jolanta Smok-Kalwat,
  • Aleksandra Łacko,
  • Michał Jarząb,
  • Renata Pacholczak-Madej,
  • Zuzana Bielčiková,
  • Mirosława Püsküllüoğlu

摘要

Background

Patients with metastatic triple-negative breast cancer (mTNBC) and brain metastases (BM) have poor prognosis and limited treatment options. In the ASCENT trial, sacituzumab govitecan (SG) showed modest progression-free survival (PFS) benefit but no overall survival (OS) advantage in a subgroup with stable BM. To address the limited evidence, we evaluated SGs effectiveness and safety in a real-world cohort.

Materials and methods

This retrospective multicenter study included patients with mTNBC and radiologically confirmed BM treated with ≥2 L SG at 13 centers in the Czech Republic, Poland and Slovakia. Clinical data included baseline features, BM characteristics, CNS-directed therapies, treatment response and safety. PFS and OS were assessed using Kaplan-Meier estimates; univariable Cox models evaluated the impact of BM burden on survival.

Results

29 women were included. Median number and size of BM were 3 and 16.5 mm, respectively. Prior neurosurgery was performed in 4 patients (14.3%) and radiotherapy in 28 (89.3%). Most had received ≥2 prior systemic therapies. After a median follow-up of 6.05 months, median OS was 8.9 months and PFS 3.09 months. Overall response rate was 30.8%, with CNS progression in 23.1%. Neither BM number nor size significantly affected survival. SG required dose delays in 51.7% and reductions in 37.9%; 7.7% discontinued due to toxicity. No unexpected safety signals were observed.

Conclusions

SG showed activity and manageable safety in real-world mTNBC with BM, with PFS and OS comparable or superior to the ASCENT BM subgroup. Outcomes were unaffected by BM burden, indicating SG efficacy irrespective of its extent.