ABCSG-12: Zoledronic
acid shows long-term benefit in survivorship for premenopausal ER-positive
breast cancer
Researchers have proven the continuing effectiveness
of treating patients with estrogen receptor-positive premenopausal
breast cancer with adjuvant zoledronic acid in addition to adjuvant
endocrine treatment including ovarian function suppression.
Data from the Austrian Breast & Colorectal Cancer Study Group
(ABCSG-12), reported at the 2011 CTRC-AACR San Antonio Breast Cancer
Symposium, held Dec. 6-10, 2011, confirmed and extended data reported
at 48 months and 62 months of follow-up. Now at 84 months of follow-up,
patients are experiencing drastically fewer recurrences of breast
cancer and improved rates of survivorship without toxic side effects.
"We have confirmed what this trial showed initially, which
was both exciting and surprising," said Michael Gnant, M.D.,
professor of surgery and president of the ABCSG at the Medical University
of Vienna. "The continued success of this treatment means we
can intervene early and still observe persistence of the benefit
of treatment."
In the four-arm trial, researchers randomly assigned 1,803 premenopausal
patients with early-stage, estrogen receptor (ER)-positive breast
cancer to receive tamoxifen or anastrazole or each of these two
treatments with zoledronic acid for three years. In the initial
report, presented in 2008, Gnant and his colleagues reported significantly
improved disease-free survival.
The most recent long-term data, at 84 months after treatment, revealed
a 28 percent reduced risk for recurrence and a 36 percent reduction
in risk for death among patients treated with zoledronic acid. Also,
no patients experienced osteonecrosis of the jaw or renal failure
― thus, Gnant said, proving the safety of the treatment seven years
later.
Researchers also found that patients aged older than 40 years with
presumed complete ovarian blockade had a 34 percent reduced risk
for recurrence and a 44 percent reduced risk for death. They found
no significant survival benefits among patients aged younger than
40 years.
Gnant and his team said these data, considered with previously
demonstrated bone-protective effects of zoledronic acid, suggest
that adding zoledronic acid to adjuvant endocrine therapy including
ovarian function suppression should be considered for premenopausal
women with ER-positive early breast cancer.
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