Phase III study did not show superiority of eribulin mesylate compared with capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes
Results show a trend towards improved overall survival and greater activity in certain subsets of patients
- Date : 11 Dec 2012
- Topic : Breast cancer
A phase III open-label, randomised, multicentre study of eribulin mesylate in women with previously treated metastatic breast cancer failed to meet its co-primary endpoints of improved progression-free survival and overall survival compared with capecitabine, according to data presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium, held 4-8 December 2012.
The study did not show a statistically significant benefit of eribulin over capecitabine in terms of overall survival, and it did not show a benefit in progression-free survival, so the main study objectives were not met, according to Dr Peter Kaufman, associate professor of medicine at the Geisel School of Medicine at Dartmouth and the Norris Cotton Cancer Center in Lebanon (USA).
This is the first study to demonstrate that eribulin is active in the first-, second- and third-line setting in metastatic breast cancer.
Eribulin is a non-taxane microtubule dynamics inhibitor. In a previous phase III trial, eribulin demonstrated a statistically significant improvement in overall survival versus current treatments and a manageable toxicity profile, in heavily pre-treated patients with metastatic breast cancer.
In 2010, the FDA approved eribulin for the treatment of patients with metastatic breast cancer who had previously received an anthracycline and a taxane and at least two cytotoxic chemotherapy treatment regimens for metastatic breast cancer. The FDA granted approval based on data showing a statistically significant improvement in overall survival compared with current treatments. Eribulin has been approved by the European Medicines Agency in March 2011 for the treatment of locally advanced or metastatic breast cancer which has continued to spread after at least two other treatments for advanced cancer. Previous treatment should include an anthracycline and a taxane unless these treatments were not suitable.
In the latest study, Dr Kaufman and colleagues examined whether eribulin would be effective as an earlier-line treatment in women with metastatic breast cancer. They randomly assigned 1,102 patients to eribulin or capecitabine. Patients had all received prior anthracycline- and taxane-based therapy and received the study drug as the first-, second- or third-line of therapy for metastatic disease.
The median overall survival for patients assigned to eribulin was 15.9 months compared with 14.5 months for patients assigned to capecitabine. Median progression-free survival was 4.1 months for eribulin and 4.2 months for capecitabine.
Exploratory analyses of patient subsets showed that the median overall survival in women with HER2-negative breast cancer was 15.9 months with eribulin compared with 13.5 months with capecitabine. In women with triple-negative breast cancer, which is a particularly aggressive subset, the median overall survival was 14.4 months with eribulin compared with 9.4 months with capecitabine.
Dr Kaufman and colleagues are still compiling data from the quality-of-life analysis, which according to the researchers, will help guide their next steps in further studying eribulin in this patient population.
Although the study primary endpoints were not met, this is still the first study demonstrating the activity of eribulin in earlier lines of treatment of metastatic breast cancer, according to Dr Kaufman. Eribulin is an active therapy in this setting, and it has potentially comparable activity to capecitabine.
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