In a Japanese noninferiority phase III trial (EMERALD) reported in the Journal of Clinical Oncology, Yamashita et al found that the addition of eribulin to trastuzumab/pertuzumab (HP) was noninferior in progression-free survival vs the addition of a taxane to HP in the first-line treatment of patients with HER2-positive, locally advanced or metastatic breast cancer.
Study Details
In the multicenter, open-label, noninferiority trial, 446 patients were randomly assigned between August 2017 and June 2021 to receive HP with either eribulin (n = 224) or a taxane (n = 222; docetaxel = 186, paclitaxel = 36). Treatment consisted of HP on day 1 of 21-day cycles with eribulin at 1.4 mg/m2 once daily on days 1 and 8 or taxane treatment with docetaxel at 75 mg/m2 on day 1 or paclitaxel at 80 mg/m2 once daily on days 1, 8, and 15. The primary endpoint was progression-free survival with a noninferiority hazard ratio (HR) margin of 1.33 for the eribulin group vs the taxane group.
Key Findings
Median follow-up was 35.7 months (range = 0.3–66.5 months). Median progression-free survival was 14.0 months (95% confidence interval [CI] = 11.7–16.2 months) in the eribulin group vs 12.9 months (95% CI = 10.8–15.6 months) in the taxane group (HR = 0.95, 95% CI = 0.76–1.19), confirming noninferiority of the HP plus eribulin regimen.
Median overall survival was not reached in the eribulin group vs 65.3 months in the taxane group (HR = 1.09, 95% CI = 0.76–1.58). Objective response rate was 76.8% vs 75.2%.
Treatment-related grade ≥ 3 adverse events occurred in 58.9% of the eribulin group vs 59.2% of the taxane group. The most common adverse events included neutropenia (33.9%), peripheral sensory neuropathy (9.8%), and febrile neutropenia (4.5%) in the eribulin group and neutropenia (20.6%), febrile neutropenia (8.7%), diarrhea (6.9%), and edema (6.9%) in the taxane group.
The investigators concluded: “The results suggested that eribulin [plus] HP is an option for first-line treatment of locally advanced/metastatic HER2-[positive breast cancer].”
Toshinari Yamashita, MD, PhD, of the Department of Breast Surgery and Oncology, Kanagawa Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Japan Breast Cancer Research Group and Eisai Co, Ltd. For full disclosures of the study authors, visit ascopubs.org.
