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ASCO Guideline: Sacituzumab Govitecan in Refractory Metastatic Breast Cancer 

The use of sacituzumab govitecan (SG) in patients with human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor–negative is recommended in an updated guideline from the American Society of Clinical Oncology. “Patients with hormone receptor–positive HER2-negative metastatic breast cancer who are refractory to endocrine therapy and have received at least two prior lines of chemotherapy for metastatic disease may be offered SG,” ASCO advises in a strong recommendation based on moderate-quality evidence of benefits outweighing harms.

Supporting the update are the results of the international, randomized, phase 3 TROPICS-02 trial that compared SG against 4 other chemotherapy treatments of physicians’ choice (TPC) (single-agent eribulin, vinorelbine, capecitabine, or gemcitabine). Among 543 patients with endocrine-resistant hormone receptor–positive and HER2-negative locally recurrent inoperable or metastatic breast cancer who had received 2 to 4 prior chemotherapy regimens for metastatic disease, the primary endpoint of progression-free survival was met after a median follow-up of 10.2 months with a 34% reduction in risk of progression or death (hazard ratio [HR], 0.66; 95% CI, 0.53 to 0.83; P = .0003).

“At the planned second interim analysis after a median follow-up of 12.5 months, SG had a statistically significant improvement in overall survival compared with TPC (HR, 0.79; 95% CI, 0.65 to 0.96; P = .020),” ASCO writes. “The median overall survival was 14.4 versus 11.2 months in patients treated with SG and TPC, respectively. Appraisal of the trial report using the GRADE instrument was performed as per ASCO’s methodology and found a moderate certainty of the evidence.”

Source: Journal of Clinical Oncology