Eribulin is also being evaluated for use earlier in patients with breast cancer, in both the metastatic and adjuvant settings, in three studies described at the San Antonio meeting.
In a phase II study of eribulin as first-line treatment for locally recurrent or metastatic HER2-negative breast cancer in 48 patients, response rates were 27% overall, 29% for the estrogen receptor–positive subset, and 30% for the triple-negative subset; disease control rates were 75%, 83%, and 60%, respectively.1 Overall, 30 patients (62%) experienced a grade 3/4 treatment-related or treatment-emergent adverse event, most commonly alopecia, neutropenia, and fatigue. The most common grade 3/4 toxicity was neutropenia, which occurred in 50% of patients.
In a phase II trial of 40 HER2-positive patients with locally recurrent or metastatic disease, eribulin given concurrently with trastuzumab produced responses in 55% of patients, and the disease control rate was 92%.2 Duration of response in the 22 responders was 204 days. For all treated patients, median progression-free survival was 9.2 months.
In the adjuvant setting, investigators are testing the benefit of adding eribulin following dose-dense doxorubicin and cyclophosphamide.3 Fifty-five patients were enrolled, but the investigators determined that the regimen conferred an unacceptable risk for neutropenia. The study was amended to include a cohort who will follow a regimented growth factor protocol, to improve the feasibility of the treatment. ■
1. Vahdat L, Schwartzberg L, Gluck S, et al: Results of a phase 2, multicenter, single-arm study of eribulin lmesylate as first-line therapy for locally recurrent or metastatic HER2-negative breast cancer. 2012 San Antonio Breast Cancer Symposium. Abstract P1-12-02. Presented December 11, 2012.
2. Vahdat L, Schwartzberg L, Wilks S, et al: Eribulin mesylate + trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer: Results from a phase 2, multicenter, single-arm study. 2012 San Antonio Breast Cancer Symposium. Abstract P5-20-04. Presented December 13, 2012.
3. Cadoo K, Fornier M, Lake DE, et al: Adjuvant treatment of early-stage breast cancer with eribulin mesylate following dose-dense doxorubicin and cyclophosphamide: Preliminary results from a phase 2, single-arm feasibility study. 2012 San Antonio Breast Cancer Symposium. Abstract P1-13-11. Presented December 11, 2012.
While a global phase III trial failed to meet its primary endpoint in showing an overall or progression-free survival benefit for eribulin (Halavan) in metastatic breast cancer, a trend toward greater efficacy than capecitabine (Xeloda) was observed, researchers reported at the 2012 San Antonio...
Lisa Carey, MD, Preyer Distinguished Professor in Breast Cancer Research at the University of North Carolina, Chapel Hill, said the study should not be interpreted as negative for eribulin.
“Most of the patients in this study were being treated second-line. EMBRACE was a totally different...