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Mutations in the  ESR1  gene ( ESR1m ) are important mechanisms of resistance to endocrine therapy in estrogen receptor-positive advanced breast cancer and have been recognized as a prognostic and predictive biomarker as well as a potential therapeutic target. However, the prevalence of  ESR1m  in real-world patients has not been adequately described. Therefore, we sought to evaluate the prevalence of  ESR1m  in metastatic samples from Brazilian patients with estrogen receptor-positive (ER+) advanced breast cancer previously treated with endocrine therapy. The presence of  ESR1m  was evaluated in formalin-fixed paraffin-embedded (FFPE) breast cancer tissue using real-time quantitative polymerase chain reaction (RT-qPCR). Mutations in codons 380, 537, and 538 of the  ESR1  gene were analyzed. Out of 77 breast cancer samples, 11 (14.3%) showed mutations in the  ESR1  gene.  ESR1m  were detected in a variety of organs, and the D538G substitution was the most common mutation. In visceral metastasis,  ESR1m  were detected in 25% (8/32) of the samples, whereas in nonvisceral metastasis,  ESR1m  were detected in 6.7% (3/45) of the samples. The odds of a sample with visceral metastasis having an  ESR1  mutation is 4.66 times the odds of a sample of nonvisceral metastasis having an  ESR1  mutation (95% CI: 1.13–19.27;  p  value = 0.0333). Our study indicates that the prevalence of  ESR1m  in samples from Brazilian patients with metastatic ER+ breast cancer is similar to that described in patients included in clinical trials. We observed an association of  ESR1m  with visceral metastasis.

Association of ESR1 Mutations and Visceral Metastasis in Patients with Estrogen Receptor-Positive Advanced Breast Cancer from Brazil