KEY TAKEAWAYS
- The TROPiCS-02 phase III trial aimed to report the study’s final results on how long pts lived and other outcomes, according to Trop-2 expression and other factors.
- The primary endpoint was to determine the PFS. Secondary endpoints included OS, ORR, and patient-reported outcomes.
- The study found that sacituzumab govitecan improves survival in pretreated, endocrine-resistant HR+/HER2− metastatic breast cancer.
Sacituzumab govitecan extends time without cancer progression in patients(pts) with advanced breast cancer that has stopped responding to other treatments. Researchers aimed to report the study’s final results on how long pts lived and other outcomes, according to Trop-2 expression and other factors.
The study randomly assigned(1:1) pts with confirmed HR+ and HER2– locally recurrent inoperable or metastatic breast cancer who had received at least one previous endocrine therapy, a taxane, and a CDK4/6 inhibitor in any setting and two to four previous chemotherapy regimens for metastatic disease to receive sacituzumab govitecan or chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in 91 centers across North America (the USA and Canada) and Europe (Germany, Belgium, France, Italy, the Netherlands, Spain, and the UK). The primary endpoint was to determine progression-free survival (PFS) (previously reported and not included in this analysis). Secondary endpoints included overall survival(OS), objective response rate(ORR), and patient-reported outcomes. OS was assessed using stratified log-rank tests and Cox regression. Trop-2 expression was assessed in tumor tissue by immunohistochemistry. In the order of importance of the statistical tests, ORR and patient-reported outcomes were tested sequentially if OS was significant.
About 543 out of 776 screened pts were randomly assigned to two groups: 272 in the sacituzumab govitecan group and 271 in the chemotherapy group. Over a median follow-up of 12.5 months (IQR 6.4–18.8), 390 pts out of the 543 passed away. The study showed that sacituzumab govitecan significantly improved OS compared to chemotherapy (median 14.4 months [95% CI 13.0–15.7] vs 11.2 months [10.1–12.7]; HR 0.79, 95% CI 0.65–0.96; P=0.020). Sacituzumab govitecan also yielded a significantly higher ORR compared to chemotherapy (57 [21%] pts vs 38 [14%]; odds ratio 1·63 [95% CI 1·03–2·56]; P=0·035). It extended the time to deterioration of global health status and quality of life (median 4.3 months vs 3.0 months; HR 0.75 [0.61–0.92]; P=0.0059) and reduced fatigue (median 2.2 months vs 1.4 months; HR 0.73 [0.60–0.89]; P=0.0021). The safety profile of sacituzumab govitecan remained consistent with previous studies, including the TROPiCS-02 primary analysis and the ASCENT trial. One fatal adverse event (septic shock caused by neutropenic colitis) was determined to be related to sacituzumab govitecan treatment.
The study found that sacituzumab govitecan improves survival in pretreated,endocrine-resistant HR+/HER2− metastatic breast cancer.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01245-X/fulltext
Clinical Trial: https://clinicaltrials.gov/study/NCT03901339
Rugo HS, Bardia A, Marmé F, Cortés J, Schmid P, Loirat D, Trédan O, Ciruelos E, Dalenc F, Gómez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Aug 23:S0140-6736(23)01245-X. doi: 10.1016/S0140-6736(23)01245-X. Epub ahead of print. PMID: 37633306.
