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Published on 12 February 2009

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Zometa reduces risk of breast cancer recurrence

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A newly published study in The New England Journal of Medicine shows that in premenopausal women with early breast cancer administering Zometa (zoledronic acid) along with post-surgery hormone therapy provided a reduction in risk of recurrence or death that was 36% beyond that achieved with hormone therapy alone.

The study, from the Austrian Breast & Colorectal Cancer Study Group (ABCSG), is the first large, randomised, phase III clinical trial to show that Zometa offers significant protection against the return of early breast cancer in premenopausal women. Prior laboratory research suggested that Zometa might have direct anticancer effects, including helping to protect against the return and spread of cancer before it reaches an advanced stage.

“The possible return of breast cancer is a major concern among women who’ve undergone surgery to remove their tumours. We anticipate that this publication in The New England Journal of Medicine will provide oncologists with evidence regarding an additional treatment regimen to further help reduce the risk of breast cancer recurrence, or even death, for premenopausal women with hormone-sensitive breast cancer,” said lead investigator Michael Gnant, of the Medical University of Vienna.

“It is encouraging to see a significant reduction in risk of recurrence in these patients from a therapy that was also well-tolerated,” said David Epstein, President and CEO of Novartis Oncology.

“The findings of this landmark trial substantiate the strong anticancer effect of Zometa beyond the well-established benefit of this treatment in preventing bone complications in advanced cancers.”

The ABCSG Trial 12 (ABCSG-12) included more than 1,800 premenopausal women with early-stage breast cancer who, following curative surgery and goserelin treatment to suppress the ovaries, were treated with hormone therapy with or without Zometa for three years. The results demonstrated that the addition of Zometa to hormone therapy (tamoxifen or anastrozole) significantly prolonged both disease-free survival and recurrence-free survival.

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