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Zoledronic Acid (Zometa) to Prevent Breast Cancer Recurrence

Zoledronic acid (Zometa, Novartis) is an intravenous drug that can reduceZometa,-cancer-RX-picture or delay bone complications from bone metastases in patients with breast, prostate, and lung cancer as well as multiple myeloma. In this important study, it was tested as an adjuvant therapy (i.e. drugs that modify the effect of other drugs) after surgery in combination with several hormone therapies used for breast cancer. Dr. Michael Gnant from the Medical University of Vienna is interviewed about an Austrian clinical trial assessing the use of zoledronic acid (Zolmeta, Novartis) to reduce breast cancer recurrence rates in premenopausal women when combined with anastrozole (Arimidex, AstraZeneca).

In this major study involving over 1800 women with breast cancer, the addition of zoledronic acid (Zometa ) to adjuvant endocrine therapy anastrozole (Arimidex) improved disease-free survival in premenopausal patients with estrogen-responsive early breast cancer. Details of the study, with Dr Gnant as the lead author, are published in the February 12, 2009 issue of the New England Journal of Medicine (vol 360; pages 679-91).

Here’s more information from about predicting recurrence of breast cancer:

Two new tests take advantage of a technology known as gene expression profiling, which allows for several genes in a tumor specimen to be studied at the same time. This type of analysis provides information on the expression (activity) of genes that activate and suppress the development of cancer cells. Researchers have found that the genetic profile of a tumor is related to its behavior; that is, the activity of specific genes can indicate whether the tumor will recur or metastasize. The test is currently valid only for early-stage, ER-positive breast cancers.

One test, Oncotype DX®, evaluates the activity of 21 genes (16 cancer genes and 5 control genes) in a tissue specimen and the activity is calculated as a Recurrence Score® of 0 to 100 points. ER, PR, and HER2 are included in these 21 genes. A low score indicates low risk and a high score indicates high risk of recurrence within 10 years after diagnosis. The Oncotype DX assay has been recommended by both ASCO and the NCCN to predict the risk of recurrence for women with newly diagnosed ER-positive breast cancer that had not spread to the lymph nodes (node-negative). It is performed in paraffin blocks of the tumor, readily available in all hospitals.

The other test, MammaPrint®, is an assay of 70 genes that research has found to be related to distant recurrence of breast cancer. With this test, a tissue specimen from the breast cancer is analyzed for the activity of these 70 genes, and the results indicate either a high or low risk of the cancer recurring within 10 years after diagnosis. Several studies have demonstrated that MammaPrint is a reliable predictor of disease-free survival, and in 2007, the US Food and Drug Administration cleared the test for use in the United States (not a requirement for use). This assay requires fresh tumor tissue or tissue that is frozen shortly after it has been removed from the body.

Oncotype DX® assay had been recommended by both ASCO and NCCN (which publishes treatment guidelines for all types of cancer) as a way to predict the risk of recurrence for women with newly diagnosed ER-positive, node-negative breast cancer. The ASCO statement also notes that the test can be used to identify patients who may be successfully treated with hormone therapy and therefore may safely avoid adjuvant chemotherapy.

The benefit of both MammaPrint and Oncotype DX is that treatment can be tailored—or customized —to the specific risk and needs of each individual woman. In determining the optimum treatment plan, the oncologist will consider the likelihood of recurrence (as identified by either test) as well as traditional factors, such as the size or grade of the tumor. In general, women with a low risk of recurrence can avoid the side effects of chemotherapy and be treated safely with hormone therapy alone. Women with a high risk of recurrence can be treated with adjuvant chemotherapy to help reduce that risk and can be monitored closely to help ensure early intervention if cancer does recur.

Medicare and private health insurance policies generally cover such testing for ER-positive, node-negative breast cancer, but you may want to check with your individual provider.

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