The Clinical Outcomes and Safety of Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative and HR+/HER2− Breast Cancer: A Multicenter Observational Study from Turkey
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Intervention and Treatment Protocol
2.3. Outcome Measures
2.4. Statistical Analysis
2.5. Ethics Statement
3. Results
3.1. Baseline Characteristics
3.2. Clinical Outcomes
3.3. Safety and Adverse Events
4. Discussion
4.1. Real-World Outcomes Compared to Clinical Trials
4.2. Safety and Tolerability Profile
4.3. Limitations
4.4. Clinical Implications
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | Value |
---|---|
Age (median, range) | 48 (29–78) |
De novo metastasis | 18 (26.5%) |
Molecular classification | |
mTNBC | 35 (51.5%) |
mHRPBC | 33 (48.5%) |
Her2 status | |
Her2 0 | 52 (76.4%) |
Her2 + 1 | 10 (14.7%) |
Her2 + 2 (FISH negative) | 6 (8.8%) |
ECOG PS | |
0 | 48 (70.6%) |
1 | 20 (29.4%) |
Metastatic sites | |
Liver | 35 (51.5%) |
Lung | 39 (57.4%) |
Brain | 29 (42.6%) |
Bone | 39 (57.4%) |
Lymph node | 58 (85.3%) |
Prior immunotherapy | 22 (32.4%) |
Dose reduction due to toxicity | 20 (29.4%) |
Treatment discontinuation due to toxicity | 2 (2.9%) |
Prior chemotherapy agents | |
Taxane | 64 (94.1%) |
Anthracycline | 54 (79.4%) |
Carboplatin | 48 (70.6%) |
Capecitabine | 53 (77.9%) |
Local treatment | 60 (88.2%) |
Prior lines of therapy in metastatic set | |
≤3 lines | 29 (42.6%) |
>3 lines | 38 (55.9%) |
Number of SG cycles (median, range) | 7 (3–37) |
G-CSF use with SG | 60 (88.2%) |
Variable | mPFS (Months) | 95% CI | p-Value | HR (95% CI) | Multivariate p-Value |
---|---|---|---|---|---|
Molecular subgroup | 0.78 | 0.348 | |||
mHRPBC | 5.76 | (4.28–7.24) | Ref. | ||
mTNBC | 6.5 | (4.45–8.54) | 0.73 (0.384–1.401) | ||
De novo metastases | 0.63 | ||||
Absent | 6.13 | (4.71–7.88) | |||
Present | 5.13 | (1.97–8.28) | |||
ECOG PS | 0.004 | 0.050 | |||
ECOG PS-0 | 7.26 | (5.32–9.21) | Ref. | ||
ECOG PS-1 | 3.76 | (2.26–5.27) | 1.96 (0.999–3.875) | ||
Liver metastases | 0.002 | 0.047 | |||
Absent | NR | (4.83–7.43) | Ref. | ||
Present | 4.43 | (2.74–6.12) | 2.04 (1.008–4.151) | ||
Lung metastases | 0.088 | ||||
Absent | 8.0 | (6.19–9.80) | |||
Present | 3.9 | (2.30–7.76) | |||
Brain metastases | 0.253 | ||||
Absent | 6.50 | (5.44–7.55) | |||
Present | 5.03 | (2.74–6.12) | |||
Bone metastases | 0.004 | 0.095 | |||
Absent | NR | NA | Ref. | ||
Present | 5.03 | (3.18–6.88) | 1.87 (0.89–3.91) | ||
Lymph node metastases | 0.086 | ||||
Absent | 5.33 | (4.31–6.35) | |||
Present | 6.50 | (4.07–8.92) | |||
Prior ICIs | 0.886 | ||||
Absent | 6.10 | (4.89–7.30) | |||
Present | 6.30 | (2.31–10.28) | |||
Prior chemotherapy | 0.352 | ||||
Taxane | 6.13 | (4.86–7.40) | |||
Antracycline | 6.13 | (4.79–7.47) | |||
Carboplatin | 6.23 | (4.62–7.84) | |||
Capecitabine | 6.13 | (4.94–7.32) | |||
Local treatment | 0.929 | ||||
Absent | 3.40 | (0.10–11.71) | |||
Present | 6.13 | (4.90–7.36) | |||
No. of chemotherapy lines | 0.796 | ||||
≤3 lines chemotherapy | 5.33 | (2.89–7.76) | |||
>3 lines chemotherapy | 6.23 | (5.32–7.14) | |||
Dose reduction due to toxicity | 0.270 | ||||
Absent | 6.23 | (5.33–7.13) | |||
Present | 3.13 | (0.13–6.13) | |||
G-CSF use with SG | 0.097 | ||||
Absent | NR | NA | |||
Present | NR | NA | |||
At diagnosis Ki-67 | 0.897 | ||||
≤20 | 6.13 | (4.55–7.71) | |||
>20 | 5.76 | (4.27–7.25) | 0.897 | ||
Metastatic setting Ki-67 | 1 | ||||
≤20 | 6.13 | (3.46–8.80) | |||
>20 | 6.23 | (4.67–7.79) | 1 |
Variable | mOS (Months) | 95% CI | p-Value | HR (95% CI) | Multivariate p-Value |
---|---|---|---|---|---|
Molecular subgroup | 0.380 | 0.046 | |||
mHRPBC | 11.30 | (9.16–25.4) | Ref. | ||
mTNBC | 11.93 | (5.22–18.64) | 0.46 (0.22–0.98) | ||
De novo metastases | 0.716 | ||||
Absent | 12.50 | (10.78–14.21) | |||
Present | 14.73 | (4.23–25.23) | |||
ECOG-PS | 0.178 | ||||
ECOG-0 | 14.73 | (10.52–18.94) | |||
ECOG-1 | 13.33 | (2.56–24.10) | |||
Liver metastases | 0.001 | 0.022 | |||
Absent | 17.73 | NA | Ref. | ||
Present | 5.96 | (2.79–9.14) | 3.15 (1.184–8.383) | ||
Lung metastases | 0.076 | ||||
Absent | 17.30 | (11.29–23.31) | |||
Present | 7.13 | (3.65–14.78) | |||
Brain metastases | 0.025 | 0.429 | |||
Absent | 17.30 | (11.12–23.47) | Ref. | ||
Present | 7.13 | (1.07–13.18) | 1.39 (0.609–3.205) | ||
Bone metastases | 0.008 | 0.073 | |||
Absent | NR | NA | Ref. | ||
Present | 11.93 | (4.98–18.88) | 2.28 (0.927–5.624) | ||
Lymph node metastases | 0.884 | ||||
Absent | 21.40 | NA | |||
Present | 12.50 | (10.72–14.27) | |||
Prior ICIs | 0.963 | ||||
Absent | 14.73 | (4.89–24.57) | |||
Present | 12.50 | (10.31–14.68) | |||
Prior chemotherapy | 0.293 | ||||
Taxane | - | - | |||
Antracycline | 13.33 | (4.56–22.10) | |||
Carboplatin | 12.30 | (4.71–19.88) | |||
Capecitabine | 12.50 | (9.95–15.04) | |||
Local treatment | 0.673 | ||||
Absent | 6.36 | (0.10–16.03) | |||
Present | 12.50 | (10.75–14.24) | |||
No. of chemotherapy lines | 0.745 | ||||
≤3 lines chemotherapy | 14.73 | (4.99–24.47) | |||
>3 lines chemotherapy | 12.30 | (5.81–18.79) | |||
Dose reduction due to toxicity | 1.00 | ||||
Absent | 12.50 | (10.70–14.29) | |||
Present | NR | NA | |||
G-CSF use with SG | 0.724 | ||||
Absent | 12.30 | (0.10–24.75) | |||
Present | 13.33 | (6.96–19.69) | |||
At diagnosis Ki-67 | 0.460 | ||||
≤20% | 14.73 | (4.85–22.63) | |||
>20% | 12.30 | (6.02–18.57) | |||
Metastatic setting Ki-67 | 0.184 | ||||
≤20% | 14.73 | (2.81–30.21) | |||
>20% | 12.50 | (10.82–14.17) |
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Muğlu, H.; Helvacı, K.; Köylü, B.; Yücel, M.H.; Celayir, Ö.M.; Demirci, U.; Uluç, B.O.; Başaran, G.; Korkmaz, T.; Selçukbiricik, F.; et al. The Clinical Outcomes and Safety of Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative and HR+/HER2− Breast Cancer: A Multicenter Observational Study from Turkey. Cancers 2025, 17, 1592. https://doi.org/10.3390/cancers17091592
Muğlu H, Helvacı K, Köylü B, Yücel MH, Celayir ÖM, Demirci U, Uluç BO, Başaran G, Korkmaz T, Selçukbiricik F, et al. The Clinical Outcomes and Safety of Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative and HR+/HER2− Breast Cancer: A Multicenter Observational Study from Turkey. Cancers. 2025; 17(9):1592. https://doi.org/10.3390/cancers17091592
Chicago/Turabian StyleMuğlu, Harun, Kaan Helvacı, Bahadır Köylü, Mehmet Haluk Yücel, Özde Melisa Celayir, Umut Demirci, Başak Oyan Uluç, Gül Başaran, Taner Korkmaz, Fatih Selçukbiricik, and et al. 2025. "The Clinical Outcomes and Safety of Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative and HR+/HER2− Breast Cancer: A Multicenter Observational Study from Turkey" Cancers 17, no. 9: 1592. https://doi.org/10.3390/cancers17091592
APA StyleMuğlu, H., Helvacı, K., Köylü, B., Yücel, M. H., Celayir, Ö. M., Demirci, U., Uluç, B. O., Başaran, G., Korkmaz, T., Selçukbiricik, F., Ölmez, Ö. F., & Bilici, A. (2025). The Clinical Outcomes and Safety of Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative and HR+/HER2− Breast Cancer: A Multicenter Observational Study from Turkey. Cancers, 17(9), 1592. https://doi.org/10.3390/cancers17091592