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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, December 23, 2022
In the phase III EMERALD trial, treatment with elacestrant demonstrated a significantly prolonged duration of progression-free survival and a manageable safety profile versus standard-of-care endocrine therapy in patients with estrogen receptor–positive, HER2-negative metastatic breast cancer who experienced disease progression with endocrine and CDK4/6 inhibitor therapy. The updated results, which were presented by Aditya Bardia, MD, MPH, of the Massachusetts General Hospital Cancer Center, Boston, and colleagues during the 2022 San Antonio Breast Cancer Symposium (SABCS; Abstract GS3-01), also revealed a significantly longer duration of progression-free survival with this selective estrogen receptor degrader that was positively associated with the duration of prior CDK4/6 inhibition.
A total of 478 patients who were previously administered one to two lines of endocrine therapy, a CDK4/6 inhibitor, and a maximum of one line of chemotherapy were randomly assigned in a 1:1 ratio to receive elacestrant or standard-of-care endocrine therapy with investigators’ choice of an aromatase inhibitor or fulvestrant. As of September 2022, the overall survival data were not yet mature. In all patients and in those with ESR1-mutated disease, the updated progression-free survival results seemed to significantly favor elacestrant. The duration of prior CDK4/6 inhibitor therapy was found to be positively associated with progression-free survival.
The updated safety data appeared to be consistent with previous reports. The investigators noted that most of the adverse events, including nausea, were grade 1 or 2. A total of 3.4% of patients treated with elacestrant and 0.9% of those who received a standard-of-care agent discontinued therapy because of an adverse event. An antiemetic was administered to 8.0%, 3.7%, and 10.3% of patients treated with elacestrant, fulvestrant, and an aromatase inhibitor, respectively. No hematologic safety signals were reported, and no patients experienced sinus bradycardia.
Disclosure: For full disclosures of the study authors, visit sabcs.org.
2022 San Antonio Breast Cancer Symposium
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