Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): A phase 3 open-label randomised study
The Lancet - Early Online Publication, 03/04/2011
Cortes J et al. – The authors aimed to compare overall survival of heavily pretreated patients receiving eribulin versus currently available treatments. Eribulin showed a significant and clinically meaningful improvement in overall survival compared with TPC in women with heavily pretreated metastatic breast cancer. This finding challenges the notion that improved overall survival is an unrealistic expectation during evaluation of new anticancer therapies in the refractory setting
Methods- In this phase 3 open-label study, women with locally recurrent or metastatic breast cancer randomly allocated (2:1) to eribulin mesilate (1·4 mg/m2 administered intravenously during 2—5 min on days 1 and 8 of a 21-day cycle) or treatment of physician's choice (TPC)
- Patients had received between two and five previous chemotherapy regimens (two or more for advanced disease), including an anthracycline and a taxane, unless contraindicated
- Randomisation stratified by geographical region, previous capecitabine treatment, and human epidermal growth factor receptor 2 status
- Patients and investigators were not masked to treatment allocation
- Primary endpoint OS in intention-to-treat population
- 762 women randomly allocated to treatment groups (508 eribulin, 254 TPC)
- OSsignificantly improved in women assigned to eribulin (median 13·1 months, 95% CI 11·8—14·3) compared with TPC (10·6 months, 9·3—12·5; HR 0·81, 95% CI 0·66—0·99; p=0·041)
- Most common adverse events in both groups asthenia or fatigue (270 [54%] of 503 patients on eribulin and 98 [40%] of 247 patients on TPC at all grades) and neutropenia (260 [52%] patients receiving eribulin and 73 [30%] of those on TPC at all grades)
- Peripheral neuropathy was most common adverse event leading to discontinuation from eribulin, occurring in 24 (5%) of 503 patients
