Sacituzumab govitecan in heavily pretreated metastatic triple-negative breast cancer: a secondary analysis of the CEBCC-102 real-world cohort

Abstract

Abstract Background Real-world evidence on sacituzumab govitecan (SG) in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC) remains limited. This study assessed SG outcomes in a multicentre Central European cohort. Methods This retrospective study included patients from CEBCC-102 project treated in Poland, the Czech Republic and Slovakia. The analysis was restricted to patients who received SG in the third or later line of systemic therapy for metastatic disease. Eligibility required either at least three prior chemotherapy lines for metastatic disease or prior (neo)adjuvant chemotherapy followed by at least two chemotherapy lines for metastatic disease. For subgroup analyses, prior (neo)adjuvant chemotherapy was counted as one prior chemotherapy line. Baseline characteristics, prior therapies, response, progression-free survival (PFS) and overall survival (OS) were analysed descriptively; survival outcomes were estimated using the Kaplan–Meier method. Results Among 107 patients, 67 had a total of three prior chemotherapy lines and 40 had at least four, including prior (neo)adjuvant chemotherapy where applicable. Median follow-up estimated using the reverse Kaplan–Meier method was 19.6 months (95% CI, 17.3–27.5 months). Median PFS was 4.1 months, with a 6-month PFS rate of 37.3% (95% CI, 27.8–46.8%). No significant difference in PFS was observed according to the total number of prior chemotherapy lines (three vs. ≥ 4: 4.1 vs. 3.7 months; p = 0.58). Median OS was 10.6 months, with a 12-month OS rate of 42.7% (95% CI, 32.5–52.5%), without significant differences according to the total number of prior chemotherapy lines (three vs. ≥ 4: 10.5 vs. 11.7 months; p = 0.65). SG was generally well tolerated, with no unexpected toxicities or grade 5 adverse events. Conclusions In this secondary analysis SG showed activity in heavily pretreated patients with mTNBC. No significant survival differences were observed according to the total number of prior chemotherapy lines; however, this finding may reflect survivorship and selection biases and should not be interpreted as evidence of equivalent efficacy irrespective of prior treatment exposure. SG may retain clinical value beyond earlier metastatic treatment lines in clinically fit patients.