CDK4/6 Inhibitor Duration Linked With PFS in Patients with Metastatic Breast Cancer on Elacestrant

By Cancer Nursing Today Editors - Last Updated: November 7, 2023

Elacestrant significantly prolongs progression-free survival (PFS) with a low rate of adverse events (AEs) compared with standard of care in patients with metastatic breast cancer, including those with ESR1 mutations, according to a recent study.

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Aditya Bardia, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, and colleagues presented the phase III EMERALD trial findings presented at JADPRO Live 2023, the Annual APSHO Meeting.

Dr. Bardia and colleagues randomly assigned patients to receive elacestrant 400 mg once daily (n=239) or standard of care (n=239). All patients had estrogen receptor-positive/HER2-negative advanced breast cancer with Eastern Cooperative Oncology Group performance status of 0 or 1. The patients previously received 1-2 lines of endocrine therapy in combination with a CDK4/6 inhibitor, and at least 1 prior line of chemotherapy. The primary end points of the trial were PFS in all patients and PFS in patients with ESR1 mutations.

These updated findings showed that the longer a patient was on a CDK4/6 inhibitor, the longer their PFS on elacestrant compared with standard of care. All patients with at least 18 months of prior CDK4/6 treatment had a median PFS of 5.4 months in the elacestrant group versus 3.2 months in the standard of care group.

Furthermore, this was more pronounced in patients with detectable ESR1 mutations. Patients with ESR1 mutations who had at least 18 months of prior CDK4/6 treatment duration achieved a median PFS of 8.6 months with elacestrant compared, around 4 times the median PFS of 2.1 months with the standard of care.

Grade 1 and 2 nausea was common in both groups and there were no grade 4 treatment-related AEs (TRAEs) reported. However, 3.4% of patients receiving elacestrant and 0.9% receiving standard of care discontinued therapy because of a TRAE. The researchers did not observe bradycardia in either group.

Based on these findings, Dr. Bardia and colleagues concluded that elacestrant can become an important oral endocrine monotherapy agent in the second- or third-line as an alternative to combination therapies that are associated with challenging safety profiles.

Reference

Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Presented at JADPRO Live 2023, the Annual APSHO Meeting; November 9-12, 2023; Orlando, Florida.

Post Tags:JADPRO 2023 BC
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