Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study
Abstract Introduction Sacituzumab govitecan (SG) is approved for patients with previously treated metastatic or locally advanced triple-negative breast cancer (TNBC), as per the ASCENT trial results. Real-world studies (RWSs) cover more diverse patients than clinical trials, offering crucial data fo...
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| Format: | Article |
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Adis, Springer Healthcare
2024-09-01
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| Series: | Oncology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40487-024-00307-1 |
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| author | Miroslawa Püsküllüoğlu Małgorzata Pieniążek Manuela Las-Jankowska Joanna Streb Marek Ziobro Renata Pacholczak-Madej Paulina Kilian-Van Miegem Agnieszka Rudzińska Aleksandra Grela-Wojewoda Aleksandra Łacko Michał Jarząb Anna Polakiewicz-Gilowska |
| author_facet | Miroslawa Püsküllüoğlu Małgorzata Pieniążek Manuela Las-Jankowska Joanna Streb Marek Ziobro Renata Pacholczak-Madej Paulina Kilian-Van Miegem Agnieszka Rudzińska Aleksandra Grela-Wojewoda Aleksandra Łacko Michał Jarząb Anna Polakiewicz-Gilowska |
| author_sort | Miroslawa Püsküllüoğlu |
| collection | DOAJ |
| description | Abstract Introduction Sacituzumab govitecan (SG) is approved for patients with previously treated metastatic or locally advanced triple-negative breast cancer (TNBC), as per the ASCENT trial results. Real-world studies (RWSs) cover more diverse patients than clinical trials, offering crucial data for healthcare policies. This study aimed to investigate the safety and efficacy of SG in real-world Polish patients with previously treated metastatic TNBC. Methods In this ambispective multicenter cohort study, we collected demographic and clinical data. Premedication, adjustments in SG dosage, and treatment regimen adhered to the product's characteristics. Results We included 79 female patients. The median age at SG initiation was 53 years; 32% of patients were initially diagnosed with a non-TNBC subtype. The median number of previous palliative lines was 2. Seven patients presented with brain metastases. The median overall survival was 10.3 months, and the median progression-free survival (PFS) was 4.4 months. The overall response rate was 35%, with a median time to response of 2 months. SG was discontinued by 70% of patients, primarily due to disease progression (95%). Treatment delays due to adverse events (AEs) occurred in 67% and dose reductions in 25% of patients, with neutropenia being the most common. Grade ≥ 2 AEs included neutropenia (43%), anemia (10.1%), and diarrhea (4%). A longer interval between breast cancer diagnosis and SG initiation or between metastasis diagnosis and SG initiation correlated with improved PFS, likely reflecting the disease's biological aggressiveness rather than treatment efficacy. Conclusion In this RWS, SG demonstrated effectiveness and safety in patients with previously treated metastatic TNBC, consistent with ASCENT trial outcomes. Further research is needed to explore the efficacy of SG in different patient populations and healthcare systems. |
| format | Article |
| id | doaj-art-a291db8f8f3349639563673c8304027e |
| institution | Kabale University |
| issn | 2366-1070 2366-1089 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Oncology and Therapy |
| spelling | doaj-art-a291db8f8f3349639563673c8304027e2024-11-24T12:15:01ZengAdis, Springer HealthcareOncology and Therapy2366-10702366-10892024-09-0112478780110.1007/s40487-024-00307-1Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort StudyMiroslawa Püsküllüoğlu0Małgorzata Pieniążek1Manuela Las-Jankowska2Joanna Streb3Marek Ziobro4Renata Pacholczak-Madej5Paulina Kilian-Van Miegem6Agnieszka Rudzińska7Aleksandra Grela-Wojewoda8Aleksandra Łacko9Michał Jarząb10Anna Polakiewicz-Gilowska11Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Oncology, Wrocław Medical UniversitySurgical Oncology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Oncology Centre, Nicolaus Copernicus University in TorunDepartment of Oncology, Jagiellonian University Medical CollegeDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Anatomy, Jagiellonian University Medical CollegeChemotherapy Outpatient Clinic, Oncology Center Prof. F. Łukaszczyk in BydgoszczDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Oncology, Wrocław Medical UniversityBreast Cancer Unit, Maria Skłodowska-Curie National Research Institute of OncologyBreast Cancer Unit, Maria Skłodowska-Curie National Research Institute of OncologyAbstract Introduction Sacituzumab govitecan (SG) is approved for patients with previously treated metastatic or locally advanced triple-negative breast cancer (TNBC), as per the ASCENT trial results. Real-world studies (RWSs) cover more diverse patients than clinical trials, offering crucial data for healthcare policies. This study aimed to investigate the safety and efficacy of SG in real-world Polish patients with previously treated metastatic TNBC. Methods In this ambispective multicenter cohort study, we collected demographic and clinical data. Premedication, adjustments in SG dosage, and treatment regimen adhered to the product's characteristics. Results We included 79 female patients. The median age at SG initiation was 53 years; 32% of patients were initially diagnosed with a non-TNBC subtype. The median number of previous palliative lines was 2. Seven patients presented with brain metastases. The median overall survival was 10.3 months, and the median progression-free survival (PFS) was 4.4 months. The overall response rate was 35%, with a median time to response of 2 months. SG was discontinued by 70% of patients, primarily due to disease progression (95%). Treatment delays due to adverse events (AEs) occurred in 67% and dose reductions in 25% of patients, with neutropenia being the most common. Grade ≥ 2 AEs included neutropenia (43%), anemia (10.1%), and diarrhea (4%). A longer interval between breast cancer diagnosis and SG initiation or between metastasis diagnosis and SG initiation correlated with improved PFS, likely reflecting the disease's biological aggressiveness rather than treatment efficacy. Conclusion In this RWS, SG demonstrated effectiveness and safety in patients with previously treated metastatic TNBC, consistent with ASCENT trial outcomes. Further research is needed to explore the efficacy of SG in different patient populations and healthcare systems.https://doi.org/10.1007/s40487-024-00307-1Triple-negative breast cancerMetastasesSacituzumab govitecanReal-world studyPoland |
| spellingShingle | Miroslawa Püsküllüoğlu Małgorzata Pieniążek Manuela Las-Jankowska Joanna Streb Marek Ziobro Renata Pacholczak-Madej Paulina Kilian-Van Miegem Agnieszka Rudzińska Aleksandra Grela-Wojewoda Aleksandra Łacko Michał Jarząb Anna Polakiewicz-Gilowska Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study Oncology and Therapy Triple-negative breast cancer Metastases Sacituzumab govitecan Real-world study Poland |
| title | Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study |
| title_full | Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study |
| title_fullStr | Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study |
| title_full_unstemmed | Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study |
| title_short | Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study |
| title_sort | sacituzumab govitecan for second and subsequent line palliative treatment of patients with triple negative breast cancer a polish real world multicenter cohort study |
| topic | Triple-negative breast cancer Metastases Sacituzumab govitecan Real-world study Poland |
| url | https://doi.org/10.1007/s40487-024-00307-1 |
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