Zometa - zoledronic acid significantly prevents recurrence in women with breast cancer after the menopause and gives significantly better results in survival, but not in younger women. Estrogen levels appears to play a decisive role. Thus, large phase III study. Article updated March 19, 2011
December 10, 2010: Source: Azure study and Medscape
Zoledronic acid - Zometa shows a significant positive impact on both recurrence and survival in postmenopausal women with breast cancer (more than 5 years after menopause), but no effect in premenopausal women. According to a subanalysis of the large phase III study (study Azure). Overall Azure taken the study showed that there was no effect on preventing a recurrence and survival of women with breast cancer and so this study also brought out. Novartis attracts their advice to all women with breast cancer Zometa prescribing. However, for women after menopause shows Zometa - zoledronic acid is an important role to play in preventing a recurrence and also on overall survival. Impact on bone resorption remains Zometa - bisphosphonate zoledronic acid as a good way of course. See studies known in the left column
Medscape wrote a big article on this study. For full story click here but here are some quotes from the article:
"...... In light of the new and contradictory Findings from AZURE, she said, "the routine use of zolendronic Acid to Prevent Breast Cancer Recurrence Is Not Indicated." The Has A drug use in osteoporosis and Other bone disorders, Which are approved indication list.
The finding of a significant effect in postmenopausal women in a subgroup analysis is "intriguing but not definitive," she said.
However, Several experts disagreed and said That They Were Already Would prescribing the drug and continued to do so.
Michael Gnant, MD, professor of surgery at the Medical University of Vienna, who led the positive Austrian trial, said after results Came Out Those That Would not it use zolendronic Acid in Patients who Were similar to the trial participants or That (premenopausal women who Were Treated with goserelin to induce artificial menopause). Now, on the basis of the positive subgroup Findings, he said he Would Also use zolendronic acid in postmenopausal women.
"Before I Would Say That Would I treat my wife, who is 42. Now Also i would treat my mother, who is 82," he said.
Rowan Chlebowski, MD, PhD, Medical Oncologist at the Harbor-University of California, Los Angeles, Told Medscape Medical News, huh That Would Also use zolendronic acid in postmenopausal women with breast cancer to reducing risk for Their Recurrence. "Many states cover or use zolendronic Acid to Prevent Bone Loss in the patient population, so I PRESCRIBE it for That," he said.
Last year, Dr. Chlebowski Reported That a large observational study showed That Women Who Were Taking oral bisphosphonates (Which did not include zolendronic Acid, Which is Administered intravenously) for osteoporosis had a significantly lower risk for breast cancer. Two Other observational studies have Reported similar findings. In all of theses studies, the Were postmenopausal women, Dr.. Chlebowski noted .......
..... Dr.. Gnant Explained That zolendronic acid is Administered by injection once everytime 6 months, and That a healthy individual Would clear the drug from the system in about 24 hours. But the drug persist changes in bone and the bone marrow environment, Dr. Gnant Told Medscape Medical News. There is good reason to believe That breast cancer cells Collect Within the bone marrow, forming a "StemCell sanctuary," Particularly in early disease. They Can Be dormant there, Sometimes for years, Before They escape and cause breast cancer Recurrence, he said. It Appears That zolendronic acid is now alte ring the bone marrow environment in Such a Way That the breast cancer cells are less Likely to escape and cause a Recurrence, he said.
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The AZURE study was designed after the positive results from the Austrian trial Came Out and zolendronic acid Began To Be Used In The Wider breast cancer population, Dr.. Coleman Explained. It was an academic study, an emphasized hey, Conducted in 3360 women from 174 centers worldwide (but mostly in the United Kingdom).
These women had stage II or III breast cancer. Nearly All Were Treated with adjuvant chemotherapy (93% anthracyclines, taxanes 23%), and some endocrine therapy Also Received. Half of Them Were randomized to receive zolendronic acid 4 mg intravenously over 3 to 4 weeks for 6 doses, 3 months and then everytime everytime for 8 doses and 6 months for 5 doses.
All of These details are differentiate from the Austrian trial, Dr.. Gnant noted, Where Were the women of all stage I, none Received chemotherapy, and zolendronic acid was once everytime Used 6 months.
Dr. Coleman Explained thats the more intensive schedule of administration was AZURE Used becauses at the time the trial was designed, it was thought That zolendronic acid had a direct anti-cancer effect.
The differences in dosing schedule Might Also be related to the fact That osteonecrosis of the jaw, a Known adverse effects of bisphosphonates, was not seen in the Austrian study, but was Reported in 17 patients (1.16%) in the AZURE trial.
The overall results from AZURE, after a median follow-up of 59 months, show no significant effect on acid zolendronic Either from disease-free or overall survival, although there was a positive trend for overall survival.
Significant Effect in Subgroup
However, in a preplanned subset analysis based on menopausal status, zolendronic acid did show a significant effect on overall survival in a subgroup of women (n = 1101) with well-established menopause (More Than 5 years postmenopausal), Reducing the risk for death by 29%. Were there 86 deaths in the zolendronic acid groups, compared with 120 in the Other group (hazard ratio, 0.71, P = .017 )......




