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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Tuesday, June 6, 2023
Sara M. Tolaney, MD, MPH, of Dana-Farber Cancer Institute, Boston, and colleagues presented the final overall survival analysis of the phase III TROPiCS-02 study at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 1003). The TROP-2–directed antibody-drug conjugate sacituzumab govitecan-hziy demonstrated a statistically significant overall survival benefit compared with treatment of physician’s choice in patients with pretreated, endocrine therapy–resistant, hormone receptor–positive, HER2-negative metastatic breast cancer at the second planned interim overall survival analysis. This current update reported the results of an exploratory analysis with a longer median follow-up.
“This improvement was independent of HER2-low status,” the investigators noted. “This analysis reinforces sacituzumab govitecan as an effective and safe treatment for this patient population with limited treatment options.”
A total of 543 eligible patients with hormone receptor–positive, HER2-negative metastatic breast cancer who had received prior taxane, endocrine therapy, a CDK4/6 inhibitor, and two to four prior lines of chemotherapy were randomly assigned to receive either sacituzumab govitecan or treatment of physician’s choice until disease progression or unacceptable toxicity. With an extended follow-up of 12.8 months, sacituzumab govitecan continued to demonstrate improved overall survival compared with treatment of physician’s choice (median, 14.5 vs. 11.2 months; hazard ratio [HR] = 0.79). The overall survival rates at 12, 18, and 24 months were higher with sacituzumab govitecan—60.9% vs. 47.1%, 39.2% vs. 31.7%, and 25.6% vs. 21.1%, respectively. An exploratory analysis based on HER2 immunohistochemistry (IHC) also showed improved overall survival in patients with HER2 IHC 0 (median, 13.6 vs. 10.8 months, HR = 0.86) and HER2-low (median, 15.4 vs. 11.5 months, HR = 0.74) status.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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