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The study tested it in 762 women whose cancer had either recurred after initial treatment or had spread beyond the breast. All were getting worse despite having tried an average of four previous drugs.
Two-thirds were given eribulin, and the others received whatever treatment their doctors wanted to try, since there is no standard of care in this situation.
Median survival was just over 13 months for those on eribulin versus less than 11 months for the others, said study leader Dr. Christopher Twelves, of St. James's Institute of Oncology in Leeds, England.
About half of women on eribulin had typical chemotherapy side effects -- fatigue, low white blood cell counts, loss of hair, numbness and tingling in different parts of the body. About one-fourth of women in each group had serious side effects related to their treatments.
The study was sponsored by Japan-based Eisai Inc., which last week received a promise of quick review from the FDA. A company spokesman said no price has yet been set for the drug.
"There aren't many drugs that show a survival advantage in this setting," and the amount of benefit seen in this study gives eribulin "a reasonable chance" of being approved, said Dr. Eric Winer, breast cancer chief at the Dana-Farber Cancer Institute in Boston.
More than 1 million women worldwide are diagnosed with breast cancer each year. In the United States last year, there were an estimated 194,280 new cases and 40,610 deaths from the disease.
The studies were reported at the annual meeting of the American Society of Clinical Oncology.
Cancer meeting: http://www.asco.org/
National Cancer Institute: http://www.cancer.gov/
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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