- The results of a clinical trial led by researchers at VHIO have established eribulin as effective therapy in patients with advanced breast cancer previously treated with chemotherapy, as well as standard treatment in patients with triple-negative tumours.
- This study has led to the approval of eribulin in Europe for patients whose disease progresses after treatment of metastatic breast cancer.
Barcelona, 29 January 2015-. A Phase III clinical trial led by Javier Cortés, Principal Investigator of VHIO´s Breast Cancer & Melanoma Group, compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer. Findings showed that there were no significant differences between the use of the two agents and stablished eribulin to be an effective second-line single-agent chemotherapy. The clinical trial included more than 1000 patients with locally advanced or metastatic breast cancer previously treated with chemotherapy that included an anthracycline and a taxane agent.
While Study 301, a superiority trial carried out in collaboration with other research groups, did not meet its co-primary endpoint of improved overall survival or progression free survival, eribulin (Halaven®) demonstrates a numerical trend towards improved overall survival compared with capecitabine (Xeloda®). Adverse side-effects reported in the study were consistent with the known toxicity profiles of both treatments.
These results, recently reported in the Journal of Clinical Oncology (JCO), show eribulin to be an effective single-agent chemotherapy in patients with advanced breast cancer who had previously been treated with chemotherapy that no longer worked. “Considering that there are few treatment options to show improvement in both survival and in quality of life for women who have exhausted other therapies, these results are significant,” commented VHIO´s Javier Cortés. “Eribulin is the first and only single-agent chemotherapy that has been compared with capecitabine in this setting. We have demonstrated the efficacy and validity for expanding the therapeutic arsenal available for these cases. Thanks to this study, eribulin has been approved as a second-line therapy — whereas before, it was third-line. Furthermore, in the group of patients with the most difficult to treat of all breast cancers known as triple-negative tumours, eribulin improved outcomes over capecitabine and can now be considered as standard treatment for these patients”.
Although breast cancer survival has significantly risen over the last decade, when therapy ceases to be effective and cancer advances or metastasises, long-term survival remains a challenge for oncologists, especially in terms of ensuring quality of life. Up until now, capecitabine was considered the standard therapy when chemotherapy with anthracyclines and taxanes stopped working. This study has established the efficacy of Eribulin as a second-line treatment, which led to marketing authorisation by the European Commission for its earlier use in advanced breast cancer and its approval for this indication.
Eribulin expands current therapeutic arsenal
Women with locally advanced or metastatic breast cancer who were included in the study had previously been treated with chemotherapy (an anthracycline and a taxane). They were divided from the outset, depending on HER2 expression, and randomly assigned to treatment with eribulin (554 women) or capecitabine (548 women). The results showed that the median overall survival with eribulin was 15.9 months, compared to 14.5 months with capecitabine. General state of health and quality of life over time was similar in both treatment groups.
Eribulin is the first inhibitor of microtubule dynamics from the halichondrin family. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product obtained from the sea sponge Halichondriaokadai. It is believed to act through inhibition of the growth phase of microtubule dynamics, which prevents cell division. Eribulin is currently indicated to treat women with metastatic or locally advanced breast cancer with disease progression after at least one line of chemotherapy that includes an anthracycline and a taxane. It was initially approved in 2011, with the trade name of Halaven® (Eisai), and received marketing authorisation from the European Commission in July 2014 for its early use in advanced breast cancer. Thanks to this study, it has been approved as second-line therapy in these patients.
JCO article:
Additional information:
On metastatic breast cancer
Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease. Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body (lungs, bones, etc.).
On HER2+ breast cancer
HER2 stands for human epidermal growth factor receptor. It is a protein found in small amounts on some normal cells, including breast cells, stomach cells and bladder cells. It is one of the proteins involved in cell growth. Some cancers have cells with large amounts of this protein and they are called HER2 positive. These cancers can be treated with drugs that target the HER2 protein. If a cancer does not have large amounts of the HER2 protein it is called HER2 negative.
Triple negative breast cancers are cancers that don’t have receptors for estrogen, progesterone or Her2. Only around 15 out of every 100 breast cancers (15%) are triple negative.
The clinical trial was carried out with the support of the pharmaceutical company Eisai, who have provided the following information:
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
