Eribulin capecitabine metastatic breast cancer treatment has emerged as a promising combination therapy, according to data presented at the 2014 San Antonio Breast Cancer Symposium. A Phase 2 open label study found an overall response rate of 42.9% and a clinical benefit rate of 57.1% in women with metastatic breast cancer, with a safety profile consistent with previous findings.
What Is the Eribulin and Capecitabine Combination?
Eribulin and capecitabine are two chemotherapy agents that have been studied together as a treatment option for women with locally advanced or metastatic breast cancer. The combination addresses a longstanding challenge in oncology: finding a regimen that is both effective and well tolerated.
As Dr. Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology at the University of Leeds, noted, most chemotherapy combinations in metastatic breast cancer tend to produce unacceptable side effects despite being more active. This Phase 2 study suggests the eribulin capecitabine combination may offer a better balance.
Eribulin Capecitabine Metastatic Breast Cancer: Phase 2 Trial Results
The open label dose confirmation study reported a median progression free survival of 7.1 months (95% CI: 4.4, 9.8) for the eribulin capecitabine combination in women with metastatic breast cancer. These results were among five posters presented at SABCS 2014, collectively providing evidence on the efficacy, safety, and quality of life profile of eribulin across multiple breast cancer settings.
A second Phase 2 multicentre study explored the feasibility of eribulin plus capecitabine as an adjuvant therapy in women with early stage, estrogen receptor positive breast cancer, further expanding the potential applications of this combination.
Quality of Life Outcomes
Two additional studies examined quality of life for women treated with eribulin. The first assessed eribulin as a first line monotherapy for women with HER2 negative metastatic breast cancer, generating stable or improved scores on the EORTC QLQ-C30 quality of life scale.
The second study investigated eribulin in combination with trastuzumab, showing positive improvements in pain and in arm and breast symptoms — results that researchers say warrant further investigation.
Eribulin Benefit Across Breast Cancer Subtypes
Pooled data from the pivotal Phase 3 EMBRACE trial, Study 301, and a single arm Phase 2 study found that the benefit of eribulin was similar for women with invasive lobular carcinoma and invasive ductal carcinoma, with overall survival of 13.4 versus 13.6 months and a hazard ratio of 1.07.
Invasive lobular carcinoma is the second most common breast cancer subtype and is typically associated with lower response rates to preoperative chemotherapy. These results contrast with data from current standard chemotherapies, suggesting eribulin may offer a more consistent benefit across subtypes.
Regulatory Background
Eribulin received European Marketing Authorisation Approval in June 2014 for women with locally advanced or metastatic breast cancer who had progressed after at least one chemotherapeutic regimen. The approval was based on clinical evidence from the EMBRACE and Study 301 Phase 3 trials. Prior therapy must have included an anthracycline and a taxane unless patients were not suitable for those treatments.
Eribulin Capecitabine Metastatic Breast Cancer: What This Means for Patients
The growing body of evidence around eribulin capecitabine metastatic breast cancer treatment points to a combination that is both clinically active and manageable in terms of side effects. Community based clinical research is essential to generating this kind of evidence and expanding access to emerging therapies for patients across the country. Learn more about ongoing oncology research on our blog.
For the full source data, see the original release from Eisai EMEA.
Source: Eisai EMEA | Originally published December 9, 2014