Phase II Study Evaluates Neoadjuvant Eribulin vs Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Locally Advanced HER2-Negative Breast Cancer
In a randomized phase II trial (NSABP FB9) reported in Breast Cancer Research and Treatment, Abraham and colleagues found no improvement in pathologic complete response rate with neoadjuvant eribulin (Halavan) vs weekly paclitaxel followed by doxorubicin/cyclophosphamide in women with locally advanced HER2-negative breast cancer.
Study Details
In the study, 49 patients were randomly assigned 2:1 between January 2013 and August 2013 to receive weekly paclitaxel at 80 mg/m2 for 12 weeks (n = 19) or eribulin at 1.4 mg/m2 on days 1 and 8 of four 21-day cycles (n = 30) followed by standard doxorubicin/cyclophosphamide every 21 days for four cycles.
Median age was 50 years in the eribulin group and 48 years in the paclitaxel group. Triple-negative disease was present in 9 (30%) of 30 patients in the eribulin group and 8 (42%) of 19 in the paclitaxel group.
Response Rates
Pathologic complete response in breast and axillary lymph nodes was observed in 5 (17%) of 30 patients in the eribulin group (including 2 of 9 with triple-negative disease and 3 of 21 with hormone receptor–positive disease) vs 5 ( 26 %) of 19 patients in the paclitaxel group (including 3 of 8 with triple-negative disease and 2 of 11 with hormone receptor-positive disease); the response rate in nodes with or without residual invasive disease in the breast was 30% vs 42%. Magnetic resonance imaging response rates on central review were 40% in the eribulin group (1 complete response, 11 partial responses) and 58% in the paclitaxel group (1 complete response and 10 partial responses).
Breast-conserving surgery was performed in 28% vs 33% of patients.
Adverse Events
Treatment-related grade 3 or 4 adverse events consisted of grade 3 diarrhea in one patient (5%) during paclitaxel treatment and grade 3 neutropenia in four patients (13%), grade 4 neutropenia in one patient (3%), and grade 3 febrile neutropenia in one patient (3%) during eribulin treatment.
The investigators concluded: “[S]ubstitution of [eribulin] for [weekly paclitaxel] as administered in this study did not suggest increased [pathologic complete response] in HER2-negative [locally advanced breast cancer]. Further study of [eribulin] with this dose schedule in the neoadjuvant setting does not appear to be warranted.”
Samuel A. Jacobs, MD, of The University of Pittsburgh Cancer Institute and NSABP Foundation, Inc, Pittsburgh, is the corresponding author for the Breast Cancer Research and Treatment article.
The study was supported by Eisai Inc.
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