Experimental drug prolongs survival in treatment-resistant breast cancer, study finds

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An experimental drug called eribulin prolongs survival by an average of about 2.5 months in women whose breast cancer has proved resistant to other forms of chemotherapy, researchers reported Sunday.

Eribulin is the first drug shown to be effective in such women, Dr. Christopher Twelves of St. James Hospital in Leeds, England, told a Chicago meeting of the American Society of Clinical Oncology. Researchers had anticipated the new results because the U.S. Food and Drug Administration sad last week that it would give the drug expedited review, a decision presumably based on the new findings. The drug’s manufacturer, Eisai Oncology of Japan, had applied to the FDA for approval three years ago, but the agency told the company to go back and produce more clinical data.

The drug is a derivative of a toxin made by the black Pacific sea sponge. It blocks the replication of cancer cells, causing them to self-destruct.

Twelves and his colleagues studied 762 women who had failed at least two courses of chemotherapy for breast cancer, and as many as five. The women were randomized so that two-thirds received infusions of the drug and the rest received the best treatment their physician thought appropriate. The study was thus not blinded.

Twelves reported that the median survival for those receiving eribulin was 13.12 months, compared with a median of 10.65 months for those receiving other treatments. The most common side effects were fatigue, low white cell counts, hair loss and numbness or tingling in the extremities.

In a smaller trial of only 40 patients with advanced bladder cancer, Dr. David I. Quinn of USC’s Norris Cancer Center reported that 42% had significant tumor shrinkage.

-- Thomas H. Maugh II