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. 2024 Dec;12(4):787-801.
doi: 10.1007/s40487-024-00307-1. Epub 2024 Sep 27.

Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study

Miroslawa Püsküllüoğlu  1 , Małgorzata Pieniążek  2   3 , Manuela Las-Jankowska  4   5 , Joanna Streb  6 , Marek Ziobro  7 , Renata Pacholczak-Madej  8   9   10 , Paulina Kilian-Van Miegem  11 , Agnieszka Rudzińska  7 , Aleksandra Grela-Wojewoda  7 , Aleksandra Łacko  2   3 , Michał Jarząb  12 , Anna Polakiewicz-Gilowska  12
Affiliations

Sacituzumab Govitecan for Second and Subsequent Line Palliative Treatment of Patients with Triple-Negative Breast Cancer: A Polish Real-World Multicenter Cohort Study

Miroslawa Püsküllüoğlu et al. Oncol Ther. 2024 Dec.

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.

Keywords: Metastases; Poland; Real-world study; Sacituzumab govitecan; Triple-negative breast cancer.

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Conflict of interest statement

Declarations Conflict of Interest Miroslawa Püsküllüoğlu obtained travel grants and lecture honoraria from AstraZeneca, Roche, Novartis, Elli Lilly, Janssen, Gilead and Amgen; Małgorzata Pieniążek travel grants and lecture fees from Pfizer and Novartis; lecture fees from Gilead, advisory board from Novartis; Manuela Las-Jankowska, Joanna Streb and Paulina Kilian-Van Miegem report no conflicts of interest. Marek Ziobro reports travel grants and lecture honoraria from Pierre Fabre, Novartis, Ipsen; Renata Pacholczak-Madej travel grants from Accord, GSK, BMS, lecture fees from BMS; Agnieszka Rudzińska from Gilead, BMS, Sandoz; Aleksandra Grela-Wojewoda from Novartis, BMS, Pierre Fabre, Roche, Amgen, MSD, Gilead and Pfizer, Aleksandra Łacko from Astra Zeneca, Pfizer, Novartis, Eli Lilly, Roche, Gilead Science including advisory board member role; Michał Jarząb conference fees by Gilead, Roche, speaker’s honoraria by Novartis, Roche, Lilly, Pfizer, Teva, Exact Sciences, Mammotome, advisory boards by Novartis, Pfizer; and Anna Polakiewicz-Gilowska lecture honoraria and travel grants from AstraZeneca, Roche, Novartis, Elli Lilly, Swixx, Gilead and Pfizer. Ethical Approval All activities conducted in studies involving human participants adhered to the ethical guidelines set forth by the institutional ethical committee and were in accordance with the principles outlined in the 1964 Helsinki Declaration and its subsequent amendments or equivalent ethical standards. This study was approved by the Ethical Committees of the Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw Branch, Poland (reference number 21/2024, dated 22 Feb 2024) and Krakow Branch (reference number 2/2023 dated 18 April 2023). Informed consent, including standard institutional consent, was obtained from each patient before initiating SG treatment under the national reimbursement program. The Ethical Committee determined that informed consent for retrospective data collection was not required.

Figures

Fig. 1
Fig. 1
Progression-free survival (PFS) (a) and overall survival (OS) (b)
See this image and copyright information in PMC

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