In cases that have spread or returned despite radiotherapy and/or repeated courses of other cancer drugs.
The results are being presented tomorrow (Tuesday 8 June) by the trial’s lead investigator, Professor Christopher Twelves of the University of Leeds and St. James’s Institute of Oncology, U.K. , at the annual conference of the American Society of Clinical Oncology, the world’s leading professional organization of cancer specialists.
Researchers found that on average, women with breast cancer that had returned or metastasized and spread to other parts of the body, and who had already been heavily treated with conventional therapies, lived 25 percent longer if they were given the new agent, eribulin mesylate.
“Until now, there hasn’t really been a standard treatment for women with such advanced breast cancer. For those women who have already received all of the recognized treatments, these are promising results,” Professor Twelves said.
Eribulin mesylate is a type of agent known as a ‘microtubule dynamics inhibitor’ that affects cell division. It is a man-made copy of a natural product extracted from the marine sponge Halichondria okadai.
The drug has been submitted for regulatory approval in Japan, the US and the European Union but it is not yet available for routine clinical treatment.
The multicenter trial, called EMBRACE, compared eribulin to the “treatment of doctor’s choice”. All women enrolled in the study had locally recurrent or metastatic breast cancer and had already received on average four prior other chemotherapy drugs such as anthracyclines and taxanes.
Because no single chemotherapy regimen is standard for these women, doctors were free to choose which treatment to give in the study’s control arm, just as they would in real life.
Professor Twelves and colleagues compared the overall survival of 762 patients with metastatic breast cancer who were randomized to receive either eribulin (508 women) or their doctor’s choice of therapy (254 women), which was typically another chemotherapy agent.
Average survival for women was significantly longer for women who received eribulin compared to those who did not (13.1 months versus 10.7 months). The new agent was also generally well tolerated.
“These results may establish eribulin as a new, effective treatment for women with late-stage metastatic breast cancer,” Professor Twelves said.
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