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Aromatase Inhibitors Effective in Preventing Breast Cancer Reoccurrence E-mail
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Two separate meta-analyses of clinical trials from around the world that tested tamoxifen against aromatase inhibitor drugs in postmenopausal women with early breast cancer have each reached the same conclusion: aromatase inhibitors are more effective in preventing breast cancer from coming back. Patients using aromatase inhibitors had more than a 3 percent lower cancer recurrence 6-8 years after diagnosis, compared to women using tamoxifen alone.

One of these studies also found a significant survival benefit (1.6 percent) for users of aromatase inhibitors, but researchers say not enough time has passed since treatment to judge with confidence whether one drug is superior to another in saving lives. The joint analyses are being presented at the Cancer Therapy & Research Center-American Association for Cancer Research (CTRC-AACR) 31st annual San Antonio Breast Cancer Symposium. “Tamoxifen is a good drug, but it looks like aromatase inhibitors may be somewhat better,” says James Ingle, M.D., a professor of oncology at Mayo Clinic, who is presenting the results on behalf of the Aromatase Inhibitors Overview Group (AIOG).

“The importance of these findings can be seen from the fact that 80,000 to 90,000 women in the United States alone are using endocrine therapy this year,” he says. “While a three percent difference in cancer recurrence may not seem like much, it can mean that several thousand women could be spared from a breast cancer recurrence.”

This international group includes leaders of all the major clinical trials that tested aromatase inhibitors against use of tamoxifen. AIOG is a subset of the Early Breast Cancer Trials Collaborative Group (EBCTCG), a global organization of researchers that studies all randomized evidence of therapies used to treat breast cancer to find insights not apparent from examining individual trials – a technique known as a meta-analysis. The AIOG collaboration is led by Professor Mitch Dowsett of the Royal Marsden Hospital, London, UK.

Tamoxifen and aromatase inhibitors are widely used to prevent recurrence of, or to treat, tumors that are estrogen-receptor positive (ER+), which comprise 70 to 80 percent of all breast cancers.

While individual studies of tamoxifen and aromatase inhibitor drugs (including anastrozole, exemestane and letrozole) have found benefit for aromatase inhibitors, it was critically important that data from all of these studies be pooled and examined, Professor Dowsett says. “This kind of analysis provides knowledge on such end points as survival and allows us to have confidence that the improvement in preventing the return of breast cancer applies to all subgroups of patients but that those at greatest risk of recurrence have most to gain. That is not possible even with a large individual trial,” he says. “The global community has come together to do this.”

The researchers divided the major studies into two different cohorts, or groupings. Cohort 1 consists of clinical trials in which patients were randomized to treatment with either tamoxifen or aromatase inhibitors for five years. Two trials were examined (ATAC and BIG 1-98) that included 9,856 patients. Cohort 2 included studies in which breast cancer patients received tamoxifen for two to three years and then were randomized to complete their five years of adjuvant endocrine therapy with tamoxifen or to receive an aromatase inhibitor for the remainder of their five years of therapy. These studies (ABCSG 8, ARNO 95, IES/BIG 2-97, ITA) enrolled 9,015 patients.

The AIOG researchers found that in cohort 1, five years after beginning treatment, women using aromatase inhibitors had a 2.9 percent lower recurrence rate than those women who received tamoxifen; that decrease in recurrence rate increased to 3.9 percent at eight years after diagnosis. There were no statistically significant gains in survival between the two groups, Dr. Ingle says. “We need to follow these patients longer, for 10 to 15 years, to be sure of the effect on survival,” he says.

In cohort 2, six years after the randomization, there was a 3.5 percent reduced risk of breast cancer recurrence in women who switched to aromatase inhibitors, compared to women who continued using tamoxifen. There was also a 1.6 percent reduced risk that patients using aromatase inhibitors would die from their disease – a statistically significant difference, Dr. Ingle says.

Professor Dowsett added, “These data should give clinicians and their patients greater confidence in understanding the relative effectiveness of these treatments in early breast cancer, but it is important to note that each drug is associated with its own set of side effects, and these also need to be considered in treatment decisions.”

The researchers will continue mining the data in the future and specific projects are in the planning stages by the AIOG investigators. Dr. Ingle says, “The meta-analysis process provides the potential for learning more about cancer treatments than can be learned from individual clinical trials. The more we know, the better doctors can treat their patients.”

The study was funded by Cancer Research UK and the Medical Research Council in the United Kingdom.

About Breast Cancer

Breast cancer is a malignant (cancerous) tumor that starts from cells of the breast. The disease occurs mostly in women, but men can get breast cancer too. In the U.S., it affects one in eight women. There are many types of breast cancer, though some of them are very rare. Sometimes a breast tumor can be a combination of these types and to have a mixture of invasive and in situ cancer.  The most common types of breast cancer are: 
  • Ductal carcinoma in situ (DCIS): This is the most common type of non-invasive breast cancer (85 - 90% of all cases). DCIS means that the cancer is only in the ducts. It has not spread through the walls of the ducts into the tissue of the breast. Nearly all women with cancer at this stage can be cured. Often the best way to find DCIS early is with a mammogram.
  • Lobular carcinoma in situ (LCIS): This condition which occurs in approximately 8% of all cases, begins in the milk-making glands but does not go through the wall of the lobules. Although not a true cancer, having LCIS increases a woman's risk of getting cancer later. For this reason, it's important that women with LCIS to follow the screening guidelines for breast cancer.
Less common are: 
  • Inflammatory breast cancer (IBC): This uncommon type of invasive breast cancer accounts for about 1% to 3% of all breast cancers. Usually there is no single lump or tumor. Instead, inflammatory breast cancer (IBC) makes the skin of the breast look red and feel warm. It also gives the skin a thick, pitted appearance that looks a lot like an orange peel. Doctors now know that these changes are not caused by inflammation or infection, but by cancer cells blocking lymph vessels in the skin. The breast may become larger, firmer, tender, or itchy. IBC is often mistaken for an infection in its early stages. Because there is no defined lump, it may not appear on a mammogram, which may make it even harder to catch it early. It usually has a higher chance of spreading and a worse outlook than invasive ductal or lobular cancer.
  • Paget's disease of the nipple. Paget's disease of the nipple or breast is a rare type of breast cancer, which can occur in women and men. It shows up in and around the nipple, and usually signals the presence of breast cancer beneath the skin. Most cases are found in menopausal women, but can also appear in women that are as young as 20.  Early stages symptoms include redness, scaly and flaky, and  mild irritation of  nipple skin. Advanced stages may include: tingling in nipple skin, very sensitive skin on the nipple, burning or painful nipple skin, ooze or bloody discharge from the nipple (not milk), itchiness that doesn't respond to creams, nipple retraction (pulls into the breast), scaly rash on areola skin, and/or breast lump beneath the affected skin.
Symptoms of breast cancer may include: 
  • a lump or a thickening in the breast or in the armpit. Note Most breast lumps are benign (be-nine); that is, they are not cancer. Benign breast tumors are abnormal growths, but they do not spread outside of the breast and they are not life threatening. But some benign breast lumps can increase a woman's risk of getting breast cancer. Most lumps turn out to be caused by fibrocystic (fi-bro-sis-tik) changes. Cysts are fluid-filled sacs. Fibrosis is the formation of scar-like tissue. Such changes can cause breast swelling and pain. The breasts may feel lumpy, and sometimes there is a clear or slightly cloudy nipple discharge.
  • a change of size or shape of the mature breast
  • fluid (not milk) leaking from the nipple
  • a change of size or shape of the nipple
  • a change of color or texture of the nipple or the areola, or of the skin of the breast itself (dimples, puckers, rash)
  • a discharge from the breast

About the 2008 San Antonio Breast Cancer Symposium (SABCS)

The 2008 San Antonio Breast Cancer Symposium (SABCS) is the first Symposium presented by the CTRC, AACR, and the Baylor College of Medicine. The driving force behind the new collaboration is the shared mission of the organizations to advance progress against breast cancer. By combining their respective strengths, the 2008 San Antonio Breast Cancer Symposium will encompass the full spectrum of breast cancer research and facilitate the rapid transition of new knowledge into improved care for breast cancer patients.

 
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