breast cancer

Test Approved to Determine if Breast Tumor may be Sensitive to Herceptin

Posted by Sharon Green on June 20, 2011 - 9:03am

The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment.

The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in tumor tissue. The HER2 gene is located on chromosome 17 in human cells. An excessive amount of the protein produced by the gene is found in some types of cancer cells, including breast cancer cells.

The Inform Dual ISH test allows lab personnel to count the number of copies of HER2 genes on chromosome 17 in a small sample of the breast tumor. The sample is stained with chemicals that cause copies of HER2 genes and chromosome 17 to change color. Copies of the HER2 gene appear black and copies of chromosome 17 appear red. These color changes can be seen under a standard microscope.

This feature allows lab personnel to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes. The Inform Dual ISH, however, allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time.

The FDA based its approval of the Inform Dual ISH on a U.S. study involving tumor samples from 510 patients with breast cancer. This study showed that the test was effective in confirming that a patient’s tumor sample contained more than the normal number of copies of the HER2 gene in 96 percent of the HER2 positive tumor samples. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy. About 20 percent of women diagnosed with breast cancer are HER2-positive.

Beware of Limitations for Breast Thermograpy

Posted by Sharon Green on June 2, 2011 - 6:14pm

Today, June 2, 2011, the U.S. Food and Drug Administration (FDA) warned women not to substitute breast thermography for mammography to screen for breast cancer. Some health care providers are promoting breast thermography on their websites and claiming that thermography is superior to mammography as a screening method for breast cancer, because it does not require radiation exposure or breast compression.

The FDA is unaware of any valid scientific evidence showing that thermography, when used alone, is effective in screening for breast cancer. To date, the FDA has not approved a thermography device (also referred to as a telethermographic device) for use as a stand-alone to screen or diagnose breast cancer. However, the FDA has previously cleared thermography devices for use only as an adjunctive diagnostic tool for breast cancer screening and diagnosis. Therefore, thermography devices should not be used as a stand-alone method for breast cancer screening or diagnosis.

Additional information can be found at the LINK.

Step-by-step Decisions Lead to Smarter Treatment Choices

Posted by Rose Pastore on April 25, 2011 - 8:57am

Choosing a treatment option for breast cancer can be almost as confusing and frightening as the diagnosis itself. But it doesn’t have to be. A new study from the University of Michigan has found that women make smarter choices about treatments when they receive information and make decisions in small doses rather than all at once.

The researchers wanted to know if asking women to make a series of simpler choices instead of one complex decision would help them better understand the benefits of each treatment. In the study, researchers asked two groups of women to choose between different breast cancer treatment options. The first group got all the information and made all the choices at once. The second group received the same information, but it was divided into two separate choices: First they chose whether to take hormonal therapy, and if they said yes, then they decided whether or not to add chemotherapy.

The women who received the treatment options all at once were more likely to be confused by the information, and more of them chose chemotherapy regardless of whether it would give them a benefit of 1 percent or 5 percent. But the women who made their decisions separately were more likely to choose chemotherapy only if it would give them a larger benefit.

By presenting information piece-by-piece, doctors can help ensure that patients truly understand the benefits before they choose an aggressive treatment like chemotherapy, said Brian Zikmund-Fisher, study author and assistant professor at the University of Michigan School of Public Health. To read the full study, click here.

Hot Flashes Associated with Lower Risk of Breast Cancer

Posted by Sharon Green on March 30, 2011 - 8:13am

Women who have experienced hot flashes and other symptoms of menopause may have a 50 percent lower risk of developing the most common forms of breast cancer than postmenopausal women who have never had such symptoms, according to a recent study by researchers at Fred Hutchinson Cancer Research Center.

The results of the first study to examine the relationship between menopausal symptoms and breast cancer risk are available online ahead of the February print issue of Cancer Epidemiology Biomarkers and Prevention.

The protective effect appeared to increase along with the number and severity of hot flashes—also known as hot flushes, according to senior author Christopher I. Li, M.D., Ph.D., a breast cancer epidemiologist in the Hutchinson Center’s Public Health Sciences Division. “In particular we found that women who experienced more intense hot flushes – the kind that woke them up at night – had a particularly low risk of breast cancer,” he said. Li and colleagues suspected a link between menopause misery and decreased breast cancer risk because hormones such as estrogen and progesterone play an important role in the development of most breast cancers, and reductions in these hormones caused by gradual cessation of ovarian function can impact the frequency and severity of menopausal symptoms.

“Since menopausal symptoms occur as hormone levels fluctuate and drop, we hypothesized that women who experienced symptoms such as hot flushes and night sweats – particularly frequent and severe symptoms – might have a lower risk of breast cancer due to decreased estrogen levels,” he said.

Indeed, the researchers found a 40 percent to 60 percent reduction in the risk of invasive ductal and invasive lobular carcinoma – the two most common types of breast cancer – among women who experienced hot flushes and other symptoms. The association between such symptoms and decreased cancer risk did not change even after the researchers accounted for other factors known to boost breast cancer risk, such as obesity and use of hormone replacement therapy.

For the study, which was funded by the National Cancer Institute, Li and colleagues interviewed 1,437 postmenopausal Seattle-area women, 988 of whom had been previously diagnosed with breast cancer and 449 of whom had not, who served as a comparison group. The women were surveyed about perimenopausal and menopausal symptoms ranging from hot flushes, night sweats and insomnia to vaginal dryness, irregular or heavy menstrual bleeding, depression and anxiety.

“While menopausal symptoms can certainly have a negative impact on quality of life, our study suggests that there may be a silver lining if the reduction in breast cancer risk is confirmed in future studies,” Li said. “If these findings are confirmed, they have the potential to improve our understanding of the causes of breast cancer and improve approaches to preventing this disease.”

Breast Cancer Therapy Contributes to Hip Fracture Risk

Posted by Sharon Green on February 23, 2011 - 7:10am

$hip_fracture2$ Painful Hip Fractures Strike Breast Cancer Survivors

A hip fracture is not common in a 54-year-old woman, unless she is a 54-year-old breast cancer survivor, according to a new Northwestern Medicine study. Researchers found that a combination of early menopause due to breast cancer treatment and common drugs used to treat breast cancer, could be weakening the bones of breast cancer survivors once they hit middle age, leading to hip fractures.

Results of the study are published in the February 2011 issue of Clinical Cancer Research.

Hip fractures are rare in people under 70. Yet, Northwestern Medicine physician Beatrice Edwards, M.D., found that several breast cancer survivors in their early 50s were coming to her for treatment of hip fractures. Edwards is director of the Bone Health and Osteoporosis program and associate professor of medicine and of orthopaedic surgery at Northwestern University Feinberg School of Medicine.

Researchers studied six of these women over one year and assessed the type of breast cancer they had, the treatment they underwent and a hip fracture’s effect on quality of life, said Edwards, lead author of the study.

“One year after the fracture the women still reported difficulty with climbing stairs, shopping and heavy housekeeping,” Edwards said. “Their health care costs may increase and their fractures contribute to losing some independence.”

Edwards was surprised to find that the majority of the women did not have osteoporosis, but did have lower than normal bone mineral density (osteopenia). This suggests that rapid change in bone architecture from chemotherapy, early menopause and adjuvant therapy may not be evident on bone mineral density test, Edwards said.

The women had early-stage breast cancer and received treatment including lumpectomy, radiation therapy and chemotherapy with cytoxan and adriamycin one to four years before the fracture occurred. They were all perimenopausal at the time of the fracture.

Four of the six women had breast cancer that grew in response to estrogen and received aromatase inhibitors (AIs) as part of their cancer therapy to block their bodies from making estrogen. Recent studies have linked AIs with possible bone loss in women. Edwards’ team also reviewed reports from the FDA’s adverse event reporting system and other databases and found that AIs were the most common drug class associated with hip fractures.

“Although the majority of women with breast cancer can expect to be fully cured from the disease, the prevention of cancer treatment-induced bone loss is important to consider in cancer survival,” Edwards said. “More research needs to be done before treatment guidelines are changed, but greater awareness of the adverse effects of certain breast cancer drugs is needed.”

Edwards said the next step is for researchers to conduct a clinical trial and give bone density screenings to women before they enter breast cancer chemotherapy. High-risk patients would be flagged and given preventive bone loss therapy and monitored for premature hip fractures.

“The pain and suffering and hospital stays and higher health costs associated with these hip fractures might be prevented through early intervention,” Edwards said.

The title of the paper is “Cancer therapy associated bone loss: Implications for hip fractures in mid-life women with breast cancer.”

By Erin White, Northwestern Newscenter

3-D Mammography System Approved

Posted by Sharon Green on February 16, 2011 - 10:05am

The U.S. Food and Drug Administration (FDA) has approved the first 3-D mammography imaging system that may boost accuracy in breast cancer detection and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

Hormone Therapy and Breast Cancer Risk

Posted by Sharon Green on February 10, 2011 - 2:24pm

Starting Hormone Therapy at Menopause Increases Breast Cancer Risk

Women who start taking menopausal hormone therapy around the time of menopause have a higher risk of breast cancer than women who begin taking hormones a few years later. The finding, from the Million Women Study (MWS)—a large observational study in the United Kingdom—adds to a growing body of evidence that the use of combined hormone therapy (estrogen plus progestin) to treat menopausal symptoms increases the risk of breast cancer and deaths from the disease. The results appeared in the Journal of the National Cancer Institute on January 28.

The pattern of increased breast cancer risk “was seen across different types of hormonal therapy, among women [in the MWS] who used hormonal therapy for either short or long durations, and also in lean and in overweight and obese women,” Dr. Valerie Beral of Oxford University and her colleagues wrote. Their findings support results from the Women’s Health Initiative (WHI), a randomized clinical trial that, in 2002, first reported evidence linking combined hormone use to breast cancer.

“The new findings underscore the idea that there’s really no safe window of time for women to take combined hormone therapy,” said Dr. Leslie Ford of NCI’s Division of Cancer Prevention and the Institute’s WHI liaison. After the initial WHI results were announced, she noted, some people had argued that hormones may be safer when started at the time of menopause. “The new findings refute that argument,” she added.

WHI and MWS investigators have both reported that breast cancer incidence rates declined rapidly once women stopped taking combined hormone therapy. “It is important for women to know that if they stop using hormones, the risk of breast cancer very quickly returns to where it was before hormone therapy began,” Dr. Ford said.

There has been a discrepancy between the WHI and MSW results to date as to whether estrogen-only therapy raises breast cancer risk in postmenopausal women. WHI reports have found little risk associated with this treatment, whereas the MWS investigators have observed a statistically significant increased risk.

Additional follow-up from the WHI estrogen-only intervention trial should help clarify this issue in the coming years, noted Drs. Rowan T. Chlebowski of Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and Garnet L. Anderson of the Fred Hutchinson Cancer Research Center in an accompanying editorial.

Breast Implants May Increase Risk for Rare Cancer

Posted by Sharon Green on January 27, 2011 - 5:18pm

After an intensive review of known cases of a rare form of cancer in breast implant recipients, the Food and Drug Administration says women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.

FDA scientists reached that conclusion after examining scientific literature that focused on cases of ALCL in 34 women with breast implants, as well as information from agency reports, international regulatory agencies, scientific experts, and breast implant manufacturers.

But with an estimated five to 10 million breast implant recipients worldwide, agency experts say the known ALCL cases are too few to say conclusively that breast implants cause the disease. FDA believes there are about 60 of these ALCL cases worldwide, though that number is difficult to verify because not all of them were chronicled in scientific publications and some reports may have been duplicated.

In an effort to gather more information, FDA and the American Society of Plastic Surgeons are establishing a registry of ALCL patients who have breast implants. FDA scientists hope the registry yields enough information to better understand what the risks for developing ALCL are for women with breast implants.

The Institute for Women's Health Research at Northwestern University encourages women to participate in the registry that is being set up so that researchers will be able to confirm whether there is a statistically significant risk. More studies are needed and this registry will provide a tool that will be very valuable. To read the full FDA advisory, click HERE.

Alcohol and Breast Cancer

Posted by Sharon Green on December 30, 2010 - 1:24pm

While the role of alcohol consumption has been established as a risk factor for breast cancer, most of the research has focused the relationship on hormonally sensitive breast cancers. A new study published in the Journal of the National Cancer Institute takes a look at the risk of alcohol and breast cancer subtype. While the study reconfirmed a higher breast cancer risk from alcohol overall and a higher risk for hormone-receptor positive cancers, it found that the associated alcohol/breast cancer risk was observed in invasive lobular cancer but not for invasive ductal cancers.