Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. Median overall survival increased by 3.2 months in the sacituzumab govitecan group compared to chemotherapy.

2. One fatal treatment-related adverse event was reported in the sacituzumab group.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

In phase 3 of the TROPiCS-02 trial, sacituzumab govitecan demonstrated significant survival benefit versus chemotherapy among patients with hormone-receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. However, protocol-specified analysis of overall survival and endpoints was unexplored. This randomized controlled trial aimed to assess the safety and efficacy of sacituzumab govitecan versus chemotherapy in patients with HR+ and HER2- metastatic breast cancer. The primary outcome for this study was progression-free survival, while key secondary outcomes included overall survival and treatment-related adverse events. According to study results, sacituzumab govitecan demonstrated improved overall survival compared to chemotherapy alone. However, it was limited by the lack of long-term data, thus affecting its validity.

In-depth [randomized-controlled trial]:

Between May 30, 2019, and Apr 5, 2021, 776 patients were screened for eligibility across 91 centers in North America and Europe. Included were patients with HR+ and HER2– metastatic breast cancer who had exhausted previous treatment options. Altogether, 543 patients (272 in sacituzumab govitecan and 271 in chemotherapy) were assigned to either sacituzumab govitecan or chemotherapy. Patients in the sacituzumab group reported a significantly greater survival compared to chemotherapy (median 14.4 months, 95% confidence interval [CI] 13.0-15.7 vs. 11.2 months, 95% CI 10.1-12.7, hazard ratio [HR] 0.79, 95% CI 0.65-0.96, p=0.020). The majority of adverse events were mild-to-moderate in nature; however, one fatal adverse event (septic shock secondary to neutropenic colitis) occurred in the intervention group. Overall, findings from this study suggest that sacituzumab govitecan presents a promising treatment for patients with HR+ and HER2– metastatic breast cancer.

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