Study proves Eribulin extends lives of breast cancer patients

STUDY SHOWS TREATMENT WITH ERIBULIN EXTENDS LIVES OF HEAVILY PRE-TREATED BREAST CANCER PATIENTS COMPARED WITH TREATMENTS OF PHYSICIAN’S CHOICE (EMBRACE study)

Extending the lives of women who have had extensive treatment for breast cancer that has spread is not a lost cause, conclude authors of a study published Online First in The Lancet. The study shows that monotherapy with the drug eribulin extends the lives of breast cancer patients by a median 2.5 months compared with the treatment of the physician’s choice (median survival 13.1 vs 10.6 months). The Article is by Dr Javier Cortes, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain, and Professor Chris Twelves, University of Leeds and St James’ University Hospital, Leeds, UK, and colleagues.

New treatment options are urgently required for patients who either do not respond, or become resistant, to agents such as anthracyclines, the taxanes and in many cases capecitabine. There is then no proven, effective treatment for such women ; indeed, until now there have been few, if any, data to guide oncologists in selecting subsequent therapy and the benefits have been unclear. Eribulin is a new chemotherapy drug, originally derived from a marine sponge that binds microtubules in a way different to existing chemotherapy drugs. These microtubules form the cytoskeleton or “scaffold” that allows cell division, and binding by eribulin leads to cell death.

In the absence of a single standard of care for women with heavily pre-treated breast cancer, the EMBRACE trial randomly allocated 762 women in a 2:1 ratio either to eribulin (508) or treatment of the physician’s choice (TPC; 254); TPC was defined as any single-agent chemotherapy, hormonal or biological treatment approved for the treatment of cancer administered according to local practice; radiotherapy; or symptomatic treatment alone. Median overall survival was significantly improved in women assigned to eribulin (13? months) compared with TPC (10? months). The most common adverse events in both groups were asthenia or fatigue (54% of 503 patients on eribulin and 40% patients on TPC at all grades) and depletion of white blood cells (neutropenia) (52% of patients receiving eribulin and 30% of those on TPC at all grades). Peripheral neuropathy (numbness or pain) was the most common adverse event leading to discontinuation from eribulin, occurring in 24 (5%) of 503 patients.

The authors say: “This global phase 3 study establishes a potential new standard treatment for women with heavily pretreated metastatic breast cancer, for whom there was previously no chemotherapy treatment with proven survival benefit.”

They conclude: “The benefit that eribulin has shown as a single agent in this setting suggests that this drug could become a new standard of care; further evaluation earlier in the natural history of breast cancer is warranted. These results show that cytotoxic agents directed at a well defined target remain worthy of evaluation. They also challenge existing assumptions in trial design, and suggest that extension of overall survival is a realistic and achievable aim during assessment of new treatments in women with heavily pretreated metastatic breast cancer.”

In a linked Comment, Dr Nancy U. Lin, and Dr Harold J. Burstein, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA, say: “EMBRACE provides much needed, high-level evidence for chemotherapy use in patients with heavily pretreated breast cancer. And that evidence suggests that the methods to treat advanced breast cancer are growing, the treatment challenge in refractory disease is a little bit less daunting, and the treatment results are a little bit better than they were before.”

Dr Javier Cortes, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain. Contact via Maria Reales, Press Office. T) +34 629 44 17 50 E) mreales@vhio.net

Professor Chris Twelves, University of Leeds and St James’ University Hospital, Leeds, UK. T) + 44 (0)113 2067469 E) c.j.twelves@leeds.ac.uk

Dr Harold J. Burstein, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. T) +1 617 470 4227 E) hburstein@partners.org

 

 

Posted: March 2011

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