BREAST CANCER

FDA Approves Drug for Early Breast Cancer-(Yahoo News-30/10/2004)

The Food and Drug Administration agreed Friday to allow a drug currently used against advanced breast cancer to be prescribed to prevent the disease from recurring in women who have been treated for early forms of the disease. The agency approved the new use for letrozole, which can now be prescribed for postmenopausal women who have finished five years of treatment with tamoxifen. The manufacturer, Novartis Pharmaceuticals, sells the drug under the name Femara. The daily tablet costs about $210 a month, the company said.

The drug offers new therapy to about 100,000 each year who complete tamoxifen treatment for breast cancer, said Dr. Diane Young, a Novartis vice president. A clinical study of the drug showed it cut the risk of recurrence by half. More than 5,000 women in North America and Europe participated in the study. They had the most common form of breast cancer and had completed the recommended five years of tamoxifen treatment. The women were given either letrozole or a dummy pill. After nearly 2 1/2 years, 132 of those taking the placebo had a cancer recurrence compared to 75 of those on letrozole. The study was stopped so women getting the placebo could be switched to letrozole. The hormone estrogen fuels the growth of many breast cancers and can encourage a dormant cancer to begin growing again.

Tamoxifen, which blocks estrogen from connecting to cells, is recommended after early breast cancer is treated with surgery and chemotherapy. After five years or so the body can become resistant, and until now, no follow-up treatment has been available. Letrozole also blocks the effects of estrogen. Hot flashes and arthritis were the most common side effects reported in the study.

High-Dose Chemo for Breast Cancer a Mixed Bag-(HealthDayNews-02/07/2003)

Two new studies seem to have reached vastly different conclusions on how to best treat aggressive, recurring breast cancer. The first report, out of Northwestern University's Feinberg School of Medicine in Chicago, concludes that adding high-dose chemotherapy with bone-marrow transplantation to traditional chemotherapy offers little benefit to women suffering from breast cancer. Not only that, but several women on the high-dose regimen died of leukemia or other disorders. The second study, out of the Netherlands, found exactly the opposite: high-dose chemotherapy and bone-marrow transplantation did improve relapse-free survival for certain patients. Both findings appear in the July 3 issue of the New England Journal of Medicine. A debate has long simmered over whether high-dose chemotherapy might improve the odds for women with aggressive, recurring breast cancer. Because the high-dose treatment destroys marrow, the procedure is accompanied by bone-marrow transplantation. Both studies looked at women who had positive lymph nodes and who had undergone surgery to remove the primary tumor.

The Northwestern researchers randomly assigned 540 women to receive either six cycles of standard chemotherapy or standard chemotherapy followed by high-dose chemotherapy with bone-marrow transplantation. The women were enrolled between 1991 and 1998 and were followed for a median of just over six years. After assessing 511 women, the authors found the six-year overall survival rate was 62 percent in the group that received standard chemotherapy alone and 58 percent in the group that received high-dose chemotherapy, a difference not considered statistically significant. Also at six years, 48 percent of the patients in the standard group were free of recurrence versus 55 percent in the high-dose group -- again, not a significant difference. But, 18 of the women getting the high-dose chemotherapy died.

The Dutch study looked at 885 women. All patients had five courses of a standard chemotherapy, followed by radiotherapy and tamoxifen, while one group also received high-dose chemotherapy with bone-marrow transplantation. The five-year, relapse-free survival rates were 59 percent in the conventional group and 65 percent in the high-dose group. Among women with at least 10 positive lymph nodes, the recurrence-free survival rates were 51 percent in the conventional group and 61 percent in the high-dose group.

Just as the studies reach different conclusions, experts too are divided on their significance. "When I look at the overall evidence [from these and other studies], I don't think high-dose chemotherapy is an accepted standard regimen," says Dr. Jeffrey Abrams, associate chief of the clinical investigations branch at the National Cancer Institute. "It may still be an area of investigation" for the future, he adds, "but with that said, I don't think it should be part of standard treatment."

However, Dr. George Somlo, associate director of high-dose chemotherapy in the division of medical oncology and therapeutics research at City of Hope National Medical Center, understandably has a different perspective. "The study from the Netherlands is the one I would consider more meaningful," he says. "The Dutch study to me is a better study in terms of design and credibility. Clearly they found that in those with 10 or more lymph nodes -- high-risk characteristics -- there was a definite advantage, in my mind."

"Both studies show no difference in overall survival between those that got high dose and those got conventional chemotherapy, so the only thing they show is that there may be a decrease in relapse rates in those who got the high dose," says Dr. Avi Barbasch, an associate clinical professor of medical oncology at the Mount Sinai School of Medicine in New York City. "It took a little bit longer for the disease to come back."

Another question is whether high-dose chemotherapy with bone-marrow transplantation has been supplanted by other therapies in the years since these studies were begun. "For people who have 10 or more nodes, I think the treatment today would be quite different," Barbasch says. Growth factors stimulate the body to make white blood cells. "One of the things that's getting a lot more play is doing it more frequently, dosing weekly or every two weeks with growth-factor support in between so the patient can withstand more intensive treatment," he adds. "People were hoping that given how toxic the [high-dose chemotherapy] treatment was that we would see a rather major effect, and the effect that we're seeing is not different than the types of improvements that we've seen by the simple addition of a new drug like Taxol to standard regimens, or a recent study that gave the standard treatment every two weeks instead of every three weeks," Abrams says. "Improvements are in the range of 5 to 10 percent, but those kinds of improvements haven't necessitated these high doses, which are extremely expensive and have severe side effects."

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Five Years of Tamoxifen Best for Most Women-(ET-26/06/2003)

A new study confirms that taking tamoxifen for five years better protects most breast cancer patients from a recurrence of the disease than a shorter regimen. Although the drug has been used for 25 years to treat women with breast cancer, there has been some dispute over just how long to continue treatment. Researchers in Italy compared a two-year regimen with a five-year regimen in women with early-stage breast cancer. They reported their results in the Journal of Clinical Oncology (Vol. 21, No. 12: 2276-2281). The researchers studied 1,901 women between the ages of 50 and 70 who had undergone surgery for early stage invasive breast cancer (some had also had radiation therapy). All began taking tamoxifen soon after their initial treatment to try to prevent recurrence. After two years, about half the women stopped taking tamoxifen; the rest continued taking the drug for three more years, for a total of five years.

The researchers followed the women for more than four years after the first group stopped tamoxifen treatment. Overall, they found little difference between the two groups when they looked at how many women had died and how many women had a recurrence of their disease. But when they examined only women with estrogen-receptor positive tumors, they found a significant difference. More than 28% of these women who took tamoxifen for just two years had a recurrence of their cancer (166 women), compared to 23.5% among the five-year tamoxifen group (131 women).

Tamoxifen works by blocking the effect of estrogen, which promotes the growth of ER-positive tumors. Women in the five-year group experienced more blood clots than women in the two-year group, but the researchers determined that the cancer protection they received from the tamoxifen outweighed this risk. The researchers say one way to address the problem of blood clots is to give women at high risk for clots newer drugs like anastrozole, which are effective but have lower incidence of this side effect. The debate over how long to continue tamoxifen use has centered on the fact that it has potentially harmful side effects. Previous research has shown it can increase the risk of blood clots in the legs and lungs, as well as cancers of the uterus. Because of this, doctors have looked to see if they could lower this risk while maintaining the same level of protection against breast cancer recurrence.

"Previous studies have shown the five-year mark to be about optimal, and this study confirms it," says Rick Alteri, MD, a medical editor for the American Cancer Society. The fact that the results were better in women with estrogen-receptor positive tumors was not a surprise, he adds, and is in line with current practice in the United States. "Most doctors have breast cancer specimens tested for estrogen receptor status, and only prescribe tamoxifen if it is positive. This study also validates the wisdom of this approach."

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Hormone Pills May Spur Breast Cancer-(AP-25/06/2003)

More negative fallout from a landmark government study suggests breast cancer linked to estrogen-progestin pills may be fast-growing and hard to detect, clarifying risks for millions of women still using hormone treatment. "Hopefully, it will convince women to reconsider," said Dr. Susan Hendrix of Wayne State University in Detroit, a co-author of the new analysis. "We've got to find a better way to help women with their menopausal symptoms." Some previous studies suggested breast tumors might be less aggressive in hormone users; other studies indicated the opposite. Previous research also suggested that hormones might make breast tissue more dense, hindering the detection of tumors.

Seeking more definitive answers, the researchers took a closer look at data from the government's landmark Women's Health Initiative study, which was halted last summer after it was found that estrogen-progestin pills raise the risk of heart attack, strokes and breast cancer. While last summer's findings led many women to stop taking hormones, Hendrix said an estimated 3 million women still use them, primarily to relieve hot flashes and other symptoms of menopause. The latest findings appear in the Journal of the American Medical Association. The analysis involved 16,608 women ages 50 to 79 who used either combined hormone treatment or dummy pills for an average of five years. As of January, breast cancer had developed in 245 women who used the combined hormone treatment and in 185 women who had taken dummy pills. Hormone users' tumors were larger at diagnosis, 1.7 centimeters on average versus 1.5 centimeters in placebo women. Tumors had begun to spread in 25.4 percent of hormone users, compared with 16 percent of placebo women.

The researchers said this appears to mean that in women on estrogen-progestin, the tumors both grow faster - that is, they are more aggressive - and escape detection longer. Overall, women on both hormones faced a 24 percent increased risk of breast cancer - equal to eight extra cases of cancer per year for every 10,000 women taking the pills. The increased risk did not appear in the first two years of treatment. But Hendrix said the tumors may have been present early on but were not detected until later because of hormone-induced breast density. The new analysis did not examine breast density. But researchers think progestin may be the culprit because it can cause breast cells - both normal and abnormal - to proliferate, an effect that may be accentuated when the hormone is combined with estrogen.

Wyeth Pharmaceuticals, maker of the Prempro pills used in the study, said hormones remain an appropriate therapy when used at the lowest possible dose for the shortest possible time. The latest analysis is by far the most conclusive, said Dr. Peter Gann, an associate professor of preventive medicine at Northwestern University who was not involved in the study. It "further worsens the news for long-term hormone replacement therapy. It suggests the excess breast cancer risk is not trivial," Gann said. Last summer's Women's Health Initiative findings shattered long-held beliefs that hormones are good for women's hearts. Last month, another analysis of data from the study found that instead of sharpening the mind, hormones may double the risk of Alzheimer's and other forms of dementia.

A second, smaller study in the journal also confirmed a link between combined hormone treatments and breast cancer and suggested estrogen-only treatment may be safer. The study involved 975 Seattle-area women ages 65 to 79. The greatest breast cancer risk was in women who used estrogen-progestin for at least five years, even if they took the progestin component only some days a month. Those who used estrogen alone, even for 25 years or longer, showed no appreciable increased risk, according to the study, led by Dr. Christopher Li of Fred Hutchinson Cancer Research Center in Seattle. Estrogen alone is recommended only for women with hysterectomies because it can cause uterine cancer unless balanced by progestin. The researchers said more definitive answers will come from the continuing estrogen-only part of the Women's Health Initiative study.

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Diabetes Tied to Increased Risk of Breast Cancer-(Reuters Health-27/06/2003)

Women with diabetes may have a slightly elevated risk of developing breast cancer, new study findings suggest. "We found there is a small but statistically significant association," said study author Dr. Karin B. Michels, an associate professor of epidemiology at Harvard Medical School in Boston. The results, drawn from the ongoing Nurses' Health Study, showed that women with type 2 diabetes were 17 percent more likely to develop breast cancer than those without diabetes. Type 2 diabetes, the most common form of the disease, usually develops in adulthood though it is on the rise in children, who are increasingly becoming overweight. In their analysis, Michels and colleagues accounted for various factors that may have influenced the results, such as heavy alcohol consumption, obesity and a family history of breast cancer. The research involved 116,488 female nurses who were ages 30 to 55 when the study began in 1976. They were followed for the next two decades, during which time there were 6,120 cases of type 2 diabetes and 5,605 cases of breast cancer. Of those who developed breast cancer, 202 had diabetes. The link between diabetes and breast cancer was apparent in postmenopausal but not premenopausal women, according to findings reported in the June issue of the journal Diabetes Care. Michels said the explanation for the association between the two diseases is not clear. "How all of this works mechanistically we're not entirely sure," she told Reuters Health. Some investigators have speculated that elevated levels of insulin in the blood of diabetics (news - web sites) may somehow promote breast cancer, the study authors note in the report. Insulin is a hormone produced by the pancreas that allows glucose, or blood sugar, to enter cells to be converted into energy. This process is impaired during insulin resistance, when the body becomes less sensitive to the effects of insulin, prompting the pancreas to pump out more insulin to try to compensate. Efforts to prevent diabetes by encouraging people to exercise regularly, control their weight and eat a healthful diet may have a new, added benefit for women, according to Michels. "Maybe we can prevent some breast cancers as well," she said.

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Breast cancer risk nearly halved by frequent miso soup intake Wed Jun 18, 6:36 AM ET Add Health - AFP to My Yahoo! TOKYO (AFP) - The risk of developing breast cancer (news - web sites) was nearly halved among Japanese women who had miso soup at least three times a day compared with those who had one or less bowl of the traditional soya-based dish per day. A team of Japanese researchers concluded that "frequent miso soup and isoflavone consumption was associated with a reduced risk of breast cancer," in the study published Wednesday in the US-based Journal of the National Cancer Institute (news - web sites). Miso is pureed steamed soybeans, mixed with salt and other fermenting agents. The research team, headed by Shoichiro Tsugane of Japan's National Cancer Center, tracked 21,852 Japanese women, aged 40 to 59 years old, across Japan over 10 years from 1990 and studied their consumption of soyabean products, such as miso soup and tofu. On average, 0.098 percent of those who had one or less bowl of miso soup developed breast cancer every year, while the incidence was reduced to 0.057 percent among those who had at least three bowls per day, the study found. "Consumption of miso soup and isoflavones ... was inversely associated with the risk of breast cancer," said Seiichiro Yamamoto, a researcher at the Japanese institute and leading author of the study. Laboratory studies have already shown that isoflavones, a group of compounds that the soyabean contains in abundance, inhibit breast cancer. Until now, however, various epidemiological studies had shown inconsistent associations between the breast cancer risk and consumption of soyabean and isoflavones, Yamamoto said. The study could not show statistically significant evidence that other soyabean products are associated with reduced breast cancer risk, Yamamoto said. "The tendency for lowered breast cancer risk (associated with other soyabean products) was observed but we need to do further studies to confirm it," he said. Researchers also believe frequent miso soup consumption may reduce the risk of prostate cancer (news - web sites) among men, Yamamoto said. But Yamamoto cautioned that miso is no miracle food, as it contains a lot of salt, which can cause stomach cancer and high blood pressure, among other diseases. He added, though, a balanced diet containing a lot of soyabeans "is healthy overall" and was believed to reduce the risk of developing cancer. "Very generally speaking there is a perception that the traditional Japanese diet is healthy. We will study what part of it had what kind of effect on people. Some were good, some were bad," Yamamoto said.

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New MRI Able to Pinpoint Smaller Tumors Wed Jun 18, 8:46 PM ET Add Health - AP to My Yahoo! By JEFF DONN, Associated Press Writer BOSTON - An enhanced type of MRI can detect much smaller tumors than ever before - some tinier than a pea - in an advance that could open a new age in diagnosing cancer without surgery, researchers say. The experimental technique examines the lymph nodes for signs of spreading cancer. Doctors already routinely use MRIs to check the lymph nodes to see whether cancer that originated somewhere else in the body - say, in the breast or the prostate gland - is spreading. But the enhanced technique proved superior to conventional MRIs when tested with cancer that had spread from the prostate. And the leader of the research, Dr. Mukesh Harisinghani, said his team has also had preliminary success using the approach to detect the spread of breast, testicular, bladder and kidney cancer. In the prostate study, the technique found 63 cancerous lymph nodes in 33 patients. Conventional magnetic resonance imaging, or MRI, would have missed 71 percent of the nodes, and the spreading cancer would have gone undetected in nine patients. "Even if it only works this well for prostate cancer (news - web sites), it's a significant advance," said Dr. Jeffrey Brown, a radiologist at Washington University in St. Louis. Earlier detection of spreading prostate cancer would allow more aggressive treatment sooner, help doctors track the response, and spare some patients unnecessary removal of the prostate gland or lymph nodes. About 200,000 prostate cancer cases are diagnosed each year, and 32,000 people die from it. The Food and Drug Administration (news - web sites) is considering whether to approve the new technique. It is unclear when the FDA might decide. Dr. Samuel Wickline, who studies imaging at Washington University, said this method and others like it will eventually "allow us to diagnose things that you can't even see with any imaging" now in use. The study, funded partly by the National Cancer Institute (news - web sites), was carried out by Massachusetts General Hospital in Boston and University Medical Center in Nijmegen, the Netherlands. The findings appear in Thursday's New England Journal of Medicine (news - web sites). The method relies on minuscule magnetic particles, known as nanoparticles, to enhance an MRI. Acting like a television's contrast dial, the injected particles collect in the immune system's lymph nodes and create a clearer separation between dark and light areas in the image. Imaging systems have never reliably shown tumors this small before anywhere in the body. Up to now, the smallest tumors detectable by MRI have been about four-tenths of an inch - the size of a fingernail. Conventional MRI uses a magnetic field, which allows doctors to see enough only to gauge the size of lymph nodes. Nodes bigger than four-tenths of an inch are generally considered cancerous; however, they are not always cancerous, while some smaller nodes are. The new technique shows detail within the nodes that reveals cancer's presence. The researchers gave patients an imaging agent known as lymphotropic superparamagnetic nanoparticles, which are specks of iron oxide less than a billionth of an inch across. Normally, the liver sucks up imaging agents before they reach the lymph nodes, but these particles are so small, they seep into the lymph system. The technique appeared to work in cancerous lymph nodes from two-tenths to four-tenths of an inch, which would normally go unnoticed with regular MRI. It detected 96 percent of cancerous nodes that size, compared with a detection rate of 29 percent for regular MRI, and it found 41 percent of cancerous nodes smaller than two-tenths of an inch, which are invisible to conventional MRI. When spreading cancer has already reached the lymph nodes, doctors typically order radiation or hormonal treatments. The researchers did not report any major side effects from the imaging agent. "I would anticipate that it's going to get approved, and I would anticipate that it's going to be a big seller," said Dr. Otis Brawley, a cancer specialist at Emory University in Atlanta. Selenium May Guard Against Breast Cancer 2 hours, 19 minutes ago Add Health - HealthDay to My Yahoo! (HealthDay is the new name for HealthScoutNews.) TUESDAY, June 17 (HealthDayNews) -- Selenium may help guard against breast cancer (news - web sites) in people who are genetically predisposed to the disease. That's what University of Illinois at Chicago researchers report in the June 15 issue of Cancer Research. Selenium is a trace element found in foods such as liver, kidneys and certain kinds of nuts. "For over 20 years, animal studies have shown that tiny amounts of selenium in the diet can suppress cancer in several types of organs. The animal data is very strong, but human data is just emerging," study co-author Alan Diamond, professor and head of human nutrition, says in a news release. It's unclear just how selenium might help prevent cancer. "We believe there are certain proteins in mammalian cells that contain selenium that can mediate the protective effects, but proving that is difficult," Diamond says. In this study, he and fellow researcher Jun Hu examined the role played in breast cancer by a selenium-containing protein called glutathione peroxidase, which is selenium-dependent and acts as an antioxidant. They did this by looking at a particular selenium-containing gene that encodes for selenium-containing proteins. Using tissue samples, they compared the genes from 517 people who were cancer-free with the genes of 79 breast cancer patients. They found there's a difference in the frequency of different versions of the genes of the cancer patients, compared with those without cancer. They also found those differences have a functional consequence. That suggests a person with a certain version of the gene may require more selenium in their diet to get the cancer-prevention benefits. By identifying what version of the gene a person has, doctors may someday be able to prescribe an appropriate amount of selenium to provide protection against cancer.

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Miso Soup, Soy Compound Lowers Breast Cancer Risk Tue Jun 17, 6:07 PM ET Add Health - Reuters to My Yahoo! By Alison McCook NEW YORK (Reuters Health) - Japanese women who are frequent eaters of miso soup, a soy-filled staple of Japanese cuisine, and soy ingredients called isoflavones appear to be less likely to develop breast cancer (news - web sites), researchers reported Tuesday. Women in Asian countries have only a fraction of the risk of breast cancer seen in Western countries, and the current findings add to a growing body of evidence that suggests isoflavone intake might help explain why. In Japan, for instance, women typically consume approximately 700 times more isoflavones than U.S. whites. Still, more studies are needed to determine whether the soy ingredient does, in fact, reduce breast cancer risk, study author Dr. Seiichiro Yamamoto of the National Cancer Center Research Institute in Tokyo told Reuters Health. "The evidence level of isoflavone/soy and breast cancer is elevated from 'possible' to 'probable' by our study," Yamamoto said. "But it is still not convincing." However, eating a little extra soy couldn't hurt, the researcher added. "Because no harmful evidence about soy intake is reported and Asian people eat a lot of soy, it is not bad to recommend to eat soy and isoflavone in Western countries," Yamamoto said. Many researchers have investigated the link between eating soy and developing breast cancer, but previous studies have shown mixed results, with some suggesting that soy and isoflavones offer no benefits in protecting women against breast cancer, according to the Journal of the National Cancer Institute (news - web sites) report. In the new study, the researchers asked more than 21,000 middle-aged women living in Japan how much soy and soy-containing products they ate, then followed them for 10 years and noted who developed breast cancer. During the study period, 179 women developed breast cancer, the authors write. Women who reported eating miso soup and foods that contain isoflavones were less likely to be diagnosed with the disease than others. Those women who consumed the most isoflavones typically drank at least two to three cups of miso soup daily and also ate soy-containing foods such as soybeans and tofu almost every day. These soy-containing foods alone, however, did not influence breast cancer risk in the same way as miso soup or total isoflavone amount. Interestingly, women who ate the least amount of isoflavones still consumed around 250 times more of a type of isoflavone called genistein than U.S. white women. And the highest rate of breast cancer -- seen in women who ate the least amount of isoflavones -- was still lower than that seen in similarly aged women living in Western countries, the authors report. Yamamoto and colleagues suggest that conflicting reports of the influence of isoflavones on breast cancer risk may have resulted from errors in measuring how much of the compound women ate, or from comparisons involving non-Asian women, who may show only small differences in the amount of isoflavones consumed by breast cancer patients and those who are cancer-free.

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Vitamin D May Aid Breast Cancer Treatment Fri Jun 6,11:47 PM ET Add Health - HealthDay to My Yahoo! By Colette Bouchez HealthScoutNews Reporter FRIDAY, June 6 (HealthScoutNews) -- Vitamin D could hold a clue to more effective breast cancer (news - web sites) treatment. That's the suggestion put forward by a group of Dartmouth researchers in a report in the June issue of the Journal of Clinical Cancer Research. The study, which involved the treatment of breast cancer tumors in mice, adds to a growing body of evidence that a derivative of vitamin D known as EB1089 may yield some powerful anti-cancer properties, particularly when combined with radiation therapy. "When compared to other cancer treatments, the vitamin D analog is much less toxic and, at least preliminarily, it appears to aid radiation therapy in impacting the growth of tumor cells," says lead author Sujatha Sundaram, a research assistant professor at Dartmouth Medical School. An analog is a synthetic, laboratory-made derivative of a parent compound -- in this case vitamin D -- that is genetically engineered by adding or removing certain chemical elements. In the instance of EB1089, it was necessary to modify vitamin D because "at the dose you need to give to have an effect on cancer, it could cause some side effects," Sundaram says. Those side effects would include an overload of calcium, a condition known as hypercalcaemia. The analog used in the study, Sundaram says, has little or no toxic reaction, even in high doses. Adding the vitamin D to the treatment regimen is thought to enhance the ability of the radiation to bring about apoptosis -- or cell death. It also reduces the proliferation, or growth of cancer cells, in the tumor itself, Sundaram explains. "These are all things that radiation therapy can accomplish on its own. But the EB1089 appears to make the treatment more effective, possibly reaching pockets of cells that might otherwise be missed, or in encouraging apoptosis in cells that for one reason or another might be stubborn or resistant to the effects of the radiation," Sundaram says. While the finding in this particular study is unique, previous research on vitamin D found it was effective against both prostate and breast tumors. Currently, a large European trial is testing EB1089 on human cancer patients. For radiation oncologist Dr. Victor Ayzenberg, the study results and the compound offer hope. "It's a very good study, with important information. It would be great if we can use it with patients," says Ayzenberg, a clinical professor of medicine at the Mount Sinai School of Medicine in New York City. It's a simple idea, he adds, but it clearly has merit. The new study was small, involving just eight mice, each implanted with human breast cancer cells. When tumors reached approximately 200 millimeters in size, half the mice received an infusion pump with a continuous flow of EB1089 for eight days. The other mice received a pump containing a harmless solvent solution. After a few days rest, both groups of mice received three "fractions" -- or doses -- of radiation therapy over the course of three days. The tumors were then monitored for 25 to 30 days, checking for both size and spread. The result: The mice treated with EB1089 had a far faster rate of tumor regression, with tumors shrinking to a much smaller size. In the final analysis, the tumors in the mice receiving EB1089 plus radiation were approximately 50 percent smaller than those receiving radiation alone. In addition, Sundaram says, there was less cancer cell proliferation -- or cell growth -- in the mice treated with the vitamin D analog. This, she says, indicates that EB1089 not only helped encourage apoptosis of the tumor cells, it also blocked new tumor cell growth. As encouraging as the findings are, Sundaram stresses cancer patients should not assume that vitamin D supplements will have the same effect. And she warns that overloading on supplements could be dangerous.

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Detecting Breast Cancer: An Image Problem 30 minutes ago Add Health - HealthDay to My Yahoo! By Colette Bouchez HealthDay Reporter (HealthDay is the new name for HealthScoutNews.) MONDAY, June 16 (HealthDayNews) -- In the high-stakes world of breast cancer (news - web sites), the traditional mammogram often finds itself pitted against the newer, more technologically savvy magnetic resonance imaging (MRI) as the best way to identify malignant tumors. Now, a study in the June 15 issue of Cancer shows a woman's risk of the disease could be an important factor in determining whether she benefits from an MRI. "Our research shows that the benefits of MR screening in low-risk women are small, while the disadvantages of such a screening in this group are high," says study co-author Dr. David Dershaw, director of breast imaging at Memorial Sloan-Kettering Cancer Center in New York City. Conversely, says Dershaw, for women at high risk for breast cancer, an MRI screening can be an important tool. "The goal here is to know, going into the screening, who is at high risk and who is not, so you know who will benefit from an MR and who will not," Dershaw says. Because an MRI can be ultra-sensitive in picking up what looks like breast abnormalities, a false-positive finding can be common in women at low risk for cancer. This, he says, often leads to an unnecessary biopsy. And since biopsies result in scar tissue that can compromise future imaging, the unnecessary treatment is detrimental on two fronts. New York University oncologist Dr. Julia Smith agrees. "As more tests become functionally based, the more scar tissue you have, the more difficult it can be to sort out what is going on," she says. Moreover, says Smith, the psychological and emotional trauma of a false-positive diagnosis can be great. "You don't want to be unnecessarily putting women through something this dramatic unless it's going to have a positive impact on their health and their health care," says Smith, a clinical assistant professor at New York University's School of Medicine. The new study is a retrospective look at the medical records of 367 women at high risk for breast cancer. None of the women reported any symptoms, and each had a normal mammogram result. These same women subsequently underwent their first MRI screening. It was during the MRIs that breast abnormalities were discovered. Ultimately, a diagnosis of "probably benign" was given to 89 of the 367 women who had the MRI -- equal to about 24 percent. After a second follow-up MRI (on average within 11 months), 20 women had biopsies. Of those 20 women, malignancies were found in 9, constituting 45 percent of the women who underwent biopsy and 10 percent of the original 89 diagnosed with "probably benign" lesions. The bottom line: "The study showed that women at high risk for breast cancer would benefit from an MR, but women at low or normal risk would not," Dershaw says. Further, he says that knowing a woman's risk profile before MRI screening is the best way to determine how accurate that diagnosis will be. Smith says it's this kind of information that ultimately will give every woman the opportunity to get the most accurate screening result possible, regardless of her risk status. "This study was the first step towards establishing a more personalized screening criteria, one from which all women ultimately will benefit," says Smith.

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Elderly Do Well After Breast-Sparing Cancer Surgery Thu Jun 12, 5:32 PM ET Add Health - Reuters to My Yahoo! NEW YORK (Reuters Health) - Older breast cancer (news - web sites) patients who undergo surgery that spares the breast may enjoy a better quality of life than those who have a mastectomy, a new study suggests. According to the study authors, older age has not been considered a deterrent to breast-sparing surgery, but research suggests older women are less likely to receive this more conservative treatment. They say their findings suggest doctors should offer older women the breast-sparing approach as a "reasonable alternative" to mastectomy more often than they traditionally have. For the study, Dr. J. C. J. M de Haes, of the Academic Medical Hospital in Amsterdam, the Netherlands, studied survival, treatment preference and quality of life among patients having either a mastectomy or removal of the tumor only. Women in the latter group were also treated with the drug tamoxifen. All patients were at least 70 years old. The authors found that although there was no difference in survival between the two groups, those who got breast-sparing surgery had fewer arm problems and tended to have a more positive body image. And more of these patients thought the treatment they received was preferable to the alternative -- 72 percent, versus 62 percent in the mastectomy group. The findings are published in the European Journal of Cancer. "The results of this study," the authors conclude, "suggest that surgeons should propose (tumor removal) and tamoxifen to older breast cancer patients as a reasonable alternative to mastectomy in a more systematic manner than is currently the case."

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Cancer May Spread Earlier Than Thought 2 hours, 2 minutes ago Add Health - HealthDay to My Yahoo! By Amanda Gardner HealthDay Reporter (HealthDay is the new name for HealthScoutNews.) MONDAY, June 9 (HealthDayNews) -- Individual breast cancer (news - web sites) cells may escape from the original tumor and travel to other parts of the body at an earlier stage than originally thought. This finding from German researchers, which appears in this week's issue of the Proceedings of the National Academy of Sciences (news - web sites), could change the way health experts think about approaches to cancer. "It's definitely a new paradigm," says Christos Patriotis, an associate member of the Fox Chase Cancer Center's department of medical oncology in Philadelphia. "There's always been a suspicion among scientists that advanced metastatic disease is not necessarily the same disease as the primary disease." The classic paradigm for cancer metastasis holds that cells in the primary tumor undergo a long series of genetic changes before leaving that tumor and heading off to other parts of the body. "So far, we have thought that probably the most advanced cell within the primary tumor will leave the primary site and found a metastasis," says study author Dr. Christoph Klein. The new research, which focused on breast cancer but could apply to other types of cancer, raises the possibility that there are actually two different routes by which the disease can spread: the classic one and this entirely new way. The idea could affect how doctors find metastatic cancer, which is cancer that has spread from one part of the body to another. "Many people are using primary tissue from the original breast tumor and exploring it, looking for indicators of spread. And what this [the new research] says is the changes you find in that breast tissue cancer may, in fact, not be the full changes that you get when there's metastatic disease," says Dr. Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York City. "The genetic changes that scientists have been looking for may not occur until late in the game, so don't be surprised when your preliminary looks at genetic instability don't yield impressive results. It is really interesting and it's not what anybody expected," Hudis adds. The new concept also has implications for treatment. "In most of the cases where there is a very clear in situ disease [one that has not spread], then the strategy is to have minimum surgery and treatment, as little as necessary," Patriotis says. "You treat the primary disease and ignore any other disease that has already escaped because you believe there is no such disease." But in breast cancer and also prostate cancer (news - web sites), there have been cases where the initial cancer is seemingly "cured," yet a secondary tumor develops years later. "We see cases where we treat the primary disease, we think that we are clean and out, then three to four years down the line we get relapses with metastatic disease," Patriotis explains. Ideally, the study authors say, treatment should take into account any differences between primary tumors and cells that have dispersed. "We think if you want to perform adjuvant therapy you have to know the characteristics of the target cells," Klein says. "Clinicians are administering drugs to patients to kill these [metastasized] cells but they don't know anything about them. That was why we decided to investigate these cells." Klein and his colleagues at the Institut fur Immunologie, Ludwig-Maximilians Universitat in Munich, took bone marrow from breast cancer patients and analyzed individual cells that had migrated to the marrow from the primary tumor. The sample group included both patients whose cancer had spread or metastasized and those whose cancer was still localized. "We were quite surprised about the genetic findings," Klein says. "It seems that the cells leave the primary tumor very, very early. We found [the dispersed cells] had even less changes than the primary tumor, meaning they leave at an early stage of genetic development, even before the primary tumor has accumulated certain changes." The majority of these wandering cells won't develop into a tumor, but there's always that potential. "That's why time is against us," Patriotis says. "The longer you live and the longer you have those cells around, the higher the risk that cells will accumulate the necessary mutations and really take off to become tumors." Which is why it's vital to find them as quickly as possible. The results of this study may lead to new clinical practices, such as sampling bone marrow even when a patient has localized disease. "Their [the study authors'] point is that looking for genetic indicators of metastatic potential might not help us much right now because genetic changes might occur late in game," Hudis says. "We have to look differently." There may also be a drive to find new signs of single metastatic cells in patients with early-stage cancer, Patriotis adds. Researchers would then need to see if the drugs that are used on primary tumors will also be effective on these errant cells. "Companies that develop new therapies should try to validate whether or not their compounds can work on these cells," Klein says. "They cannot rely on the data of the primary tumor." Investigations are already under way to see if the same process is at work in other cancers, such as prostate cancer, Klein says.

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UK Breast Cancer Cases at Record Levels Mon Jun 2,11:16 AM ET Add Health - Reuters to My Yahoo! LONDON (Reuters Health) - The number of British women diagnosed with breast cancer (news - web sites) each year has reached its highest level ever, topping 40,000 for the first time, according to new figures released on Monday by a leading charity. Cancer Research UK said the number of cases would keep increasing for some time, but screening and improved treatments meant more women are being successfully treated than ever before. Currently, three out of four women diagnosed with the disease survive for five years or more, and annual death rates have dropped 21 percent over the past 10 years to around 13,000 in 2001. "Tamoxifen has been in use for 20 years and the screening program has been up and running for the last 15. These two advances alone account for significant improvements in survival," said Professor Jack Cuzick, head of Cancer Research UK's epidemiology, mathematics and statistics department at the Wolfson Institute for Preventive Medicine in London. He said the reasons for the increasing number of cases were harder to understand, but were related to levels of the female hormone estrogen. "We know that obesity in post menopausal women is a risk factor and that it can raise the levels of estrogen. We also know that levels of obesity have been rising steadily in the past decade and this may be contributing to the upward trend." Genes also play a role, as do late menopause and the early onset of periods, which can also increase exposure to the hormone, he said. The charity's clinical director Professor Robert Souhami said research was beginning to uncover the factors that affect risk. "In the meantime, early detection remains very important in preventing deaths from breast cancer and it is essential that women are aware of this and attend for screening when they are invited."

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The Use of Taxotere(R) in Treating Breast Cancer Highlighted at American Society of Clinical Oncology Annual Meeting Monday June 2, 9:15 am ET CHICAGO, IL --(MARKET WIRE)--Jun 2, 2003 -- TaxotereŽ (docetaxel) Injection Concentrate, an active chemotherapy agent, shows positive results in various treatment regimens in early and advanced breast cancer according to numerous phase II and III clinical studies presented at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO). Among the studies involving TaxotereŽ at this year's ASCO, several focused on the use of TaxotereŽ to treat women with early stage breast cancer before (neoadjuvant) or after (adjuvant) surgery, as well as women with advanced disease. Improvement in Disease-Free Survival with Adjuvant TC Abstract #59, Poster Discussion Sunday, June 1, 8:00 AM (CT), S106 Three-year results of a prospective, randomized trial of adjuvant therapy among patients with stage I-III operable, invasive breast cancer showed a 21 percent reduction in the risk of recurrence in patients given TaxotereŽ and cyclophosphamide (TC) versus those given doxorubicin and cyclophosphamide (AC). At a median follow-up of 43 months, TC was also better tolerated than the standard AC adjuvant regimen. "Since many patients are unable to receive anthracycline-based chemotherapy, it is important that we try to establish the efficacy and tolerability of non-anthracycline-based adjuvant regimens for the treatment of breast cancer, especially in early stage disease. This study is exciting because it suggests that the non-anthracycline-based regimen of TaxotereŽ and cyclophosphamide is at least equivalent and possibly superior to AC, a standard adjuvant regimen," said study author Stephen Jones, MD, Chair, Breast Committee, US Oncology Research, Houston, TX. "While longer follow-up is needed, we are encouraged nonetheless by the results we have seen." The trial included 1,016 patients who were randomized to receive either four courses of the standard dose of AC, 60/600-mg/m2, or four courses of TC, 75/600-mgs/m2, each given every three weeks preceding adjuvant radiation therapy and tamoxifen if indicated. Benefits in First-Line Treatment of Metastatic Breast Cancer Abstract #71, Poster Discussion Monday, June 2, 8:00 AM (CT), S106 Researchers from the Magee-Women's Hospital and the University of Pittsburgh Cancer Institute also reported phase II study results that showed the combination of TaxotereŽ, carboplatin and traztuzumab (herceptin) (TCH) is an extremely effective first-line treatment for Her 2 Neu (+) metastatic breast cancer (MBC). Forty previously untreated patients with MBC participated in this study. TCH was administered on day one every three weeks for up to nine cycles. Evaluation of responses was done after three and six cycles. The overall response rate was 82 percent and the overall one-year survival was 93 percent. Thirty-seven percent of patients had a complete response (CR) and 45 percent showed partial response (PR). Fourteen percent of patients had stable disease (SD) after chemotherapy, and three patients maintained their SD for more than six months. Seventeen patients with a CR, PR or SD are still being followed. In four patients, there was no evidence of progression for greater than 30 months. "Previous studies suggest a synergy between TaxotereŽ, carboplatin and traztuzumab. The findings of this study confirm that the TCH combination resulted in a response rate among the highest yet achieved for Her 2 Neu positive metastatic breast cancer. These findings are extremely encouraging, and we hope will lead to a new, effective treatment option for advanced breast cancer patients," said study author Adam Brufsky, MD, PhD, assistant professor of medicine and director of the Magee Breast Program of the University of Pittsburgh Medical Center Cancer Centers. "The high response rate seen in this patient population may have positive implications for the use of TCH as adjuvant non-anthracycline containing chemotherapy for early-stage Her 2 Neu positive breast cancer as well." Abstract #90, Poster Discussion Monday, June 2, 8:00 AM (CT), S106 Additionally, researchers from North Central Cancer Treatment Group presented favorable phase II study results that showed the combination of TaxotereŽ and carboplatin is an active regimen that provides comparable efficacy to other combination regimens used in the treatment of MBC with low levels of serious neurotoxicity. Fifty-three patients with MBC were enrolled in the study. TaxotereŽ and carboplatin was administered on day one every three weeks. Median number of treatment cycles completed was six. The overall response rate was 60 percent and the one-year survival rate was 64 percent. The median time to progression was 9.8 months with median survival not yet reached (33 of 53 patients are still alive as of April 2003). Six patients are still receiving treatment on this study protocol. Notably, ninety-six percent of patients did not experience serious neurotoxicity (grade 3/4) during treatment. "The results of this study show that TaxotereŽ plus carboplatin is a very active regimen as a first-line therapy for metastatic breast cancer with low levels of neurotoxicity," said Edith A. Perez, MD, Professor of Medicine, Mayo Medical School, and Director, Breast Cancer Program and the Cancer Clinical Study Unit, Mayo Clinic in Jacksonville, Florida. "The combination warrants further investigation in metastatic breast cancer as well as in the neoadjuvant setting." Survival Benefits and High Response Rates Seen With Taxotere in Neoadjuvant Setting Abstract #143, Poster Saturday, May 31, 9:00 AM (CT), S Hall A2 Updated response and survival data from a multi-center study examining the use of TaxotereŽ in the neoadjuvant setting showed a high pathological complete response (pCR) rate of 10 percent (breast + axilla). In this phase II study, patients with stage III breast cancer were treated with four cycles of TaxotereŽ followed by surgery and adjuvant doxorubicin and cyclophosphamide. Patients were evaluated for both clinical response (tumor reduction) and pathological response (microscopic analysis of breast tissue). A pathological complete response indicates that the tumor is no longer present in the breast or the adjacent lymph nodes. At a median follow-up of five years, the disease free survival among the 42 patients eligible for response was 79 percent and overall survival was 81 percent. About TaxotereŽ TaxotereŽ, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. TaxotereŽ promotes their assembly and blocks their disassembly, thereby preventing cancer cells from dividing and resulting in cancer cell death. TaxotereŽ is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. The most common severe side effects associated with TaxotereŽ include low blood cell count, fatigue, fluid retention and mouth sores. The most common non-severe side effects included hair loss, neurosensory, cutaneous, nail changes, nausea and diarrhea. These side effects are generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. TaxotereŽ is not appropriate therapy for patients with significant liver impairment or a low white blood cell count. Patients 65 years of age or older may experience some side effects more frequently. For more information about TaxotereŽ, visit www.taxotere.com or see full prescribing information including boxed WARNINGS. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit www.aventisoncology.com. About Aventis Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of Euro 17.6 billion (US $16.6 billion), invested Euro 3.1 billion (US $3 billion) in research and development, and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the U.S., please visit: www.aventis-us.com Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at www.aventis-us.com. Also available at this U.S. Web site are copies of this release or any recent release. Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission

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Early Puberty Linked to Breast Cancer 21 minutes ago Add Health - HealthScoutNews to My Yahoo! By Ed Edelson HealthScoutNews Reporter WEDNESDAY, June 4 (HealthScoutNews) -- Early puberty makes some women more likely to develop breast cancer (news - web sites) later in life, says a study that provides new clues in the ongoing hunt for genes involved in the disease. Those as yet unknown genes seem to make women more sensitive to the ill effect of hormones at one important time of life, puberty, explains study author Ann S. Hamilton, an assistant professor of preventive medicine at University of Southern California Keck School of Medicine. Female hormones are known to be involved in the risk of breast cancer, Hamilton says, and research has focused on the effects of lifetime exposure. The new study results indicate the hunt should also include genes that affect "this critical time period, genes that make hormones more important at that time." Hamilton and another Keck faculty member, Dr. Thomas M. Mack, made that finding with 1,811 pairs of female twins, one or both of whom had breast cancer. Some were identical twins with the same set of genes, some were fraternal twins whose genes differed slightly. They were questioned about a number of factors that could affect breast cancer risk -- number of children, age when the first child was born, age of menopause, and age of puberty. Among the 209 pairs of identical twins who both had breast cancer, the one who began puberty earlier was more than five times as likely to get breast cancer first. Indicators of puberty were first menstruation, when menstruation became regular, and breast development. The effect was strongest for the women who began menstruating before age 12, says a report in the June 5 issue of the New England Journal of Medicine (news - web sites). What's true for these twins is probably true for some other women, Hamilton says. "Women with this particular genetic susceptibility are affected at the time of puberty," she says. "And the gene-environment interaction is strongest when puberty occurs earlier." A couple of genes, designated BRCA1 and BRCA2, are known to increase the risk of breast cancer, Hamilton says, but there are a number of reasons to believe they are not responsible for the puberty effect. Hamilton and Mack have begun to study possible genetic factors in the twins, a study that promises to be a long one, she says. The study is "very provocative, something that should be followed up," says Patricia Hartge, deputy director of the epidemiology and biostatistics program at the National Cancer Institute (news - web sites), who wrote an accompanying editorial. There is room for a shade of doubt, because the number of women in the study was relatively small, Hartge says, but she believes "the puberty finding will hold up." It was an ingenious idea to study twins, Hartge says. "They understood that if you have identical twins and they both develop breast cancer, they probably have some of the genes we are looking for." Now comes the hard part, Hartge says: finding the genes. "We don't know what those genes are," she says. "In the next stage of research, we want them to be identified."

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Predicting Breast Cancer on a Molecular Level Tue Jun 3,11:48 PM ET Add Health - HealthScoutNews to My Yahoo! TUESDAY, June 3 (HealthScoutNews) -- The Mayo Clinic will lead a national study to search for molecular predictors of breast cancer (news - web sites). The scientists intend to research biomarkers that may help identify women with benign breast disease who are at risk for developing breast cancer. Women who have a breast biopsy with benign findings are defined as having benign breast disease. "We know that some women with benign breast disease have an increased risk of eventually developing breast cancer and that the cancer can occur in either breast," principal investigator Dr. Lynn Hartmann says in a news release. "What we lack are good research studies that identify these women so they can receive the necessary screening and risk-reduction strategies," Hartmann says. Each year, more than 200,000 women in the United States are diagnosed with benign breast disease. But few tests can pinpoint which women have a greater risk of developing breast cancer. This study will examine benign tissue specimens taken from 700 women who had breast biopsies at the Mayo Clinic between 1967 and 1991 and later developed breast cancer. Their tissue samples will be compared to benign tissue samples taken over the same time period from 700 other women who didn't develop breast cancer. The researchers will compare molecular tissue markers in the tissue samples from the two groups of women.

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Femara(R) Demonstrated Early Survival Advantage Over Tamoxifen in Advanced Breast Cancer as Reported in Journal of Clinical Oncology Thursday May 29, 8:00 am ET Femara First and Only Aromatase Inhibitor to Show Significant Early Survival Advantage Over Tamoxifen EAST HANOVER, NJ--(MARKET WIRE)--May 29, 2003 -- The largest study ever to evaluate a hormonal therapy in advanced breast cancer demonstrated that FemaraŽ (letrozole tablets) showed superior time to disease progression, objective tumor response rate, and reported an early survival advantage, compared with tamoxifen in postmenopausal women with locally advanced or metastatic breast cancer. The study was published in the June 1, 2003, issue of the Journal of Clinical Oncology (JCO). The data are from a Phase III study evaluating Femara and tamoxifen as first-line treatments in patients with advanced breast cancer. They show that, compared with tamoxifen, Femara demonstrated higher one- and two-year survival rates. The study included a cross over to the alternate therapy if patients were deemed to be appropriate candidates for further treatment with hormonal therapy. Thus, an analysis was done to isolate the impact of first-line therapy. This showed patients treated on Femara survived 12 months longer than those treated with tamoxifen. Femara, a leading aromatase inhibitor, is a once-a-day oral, first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. "Demonstrating a survival advantage has been an important goal of breast cancer research for a long time," said Henning Mouridsen, M.D., Rigshospitalet Department of Oncology, Copenhagen, Denmark. "Now that we have evidence that Femara offers a significant early survival advantage over tamoxifen in the first-line setting, it may become the standard of care for patients in whom hormonal therapy is appropriate." Clinical Data The randomized, double blind study of 907 postmenopausal women was designed to compare Femara (453 patients) with tamoxifen (454 patients) as first-line therapy in women with locally advanced or metastatic breast cancer. Survival rates at one and two years show Femara offers a statistically significant survival advantage compared with tamoxifen (1 year P=0.004; 2 years P=0.02). The median overall survival for Femara was 35 months vs. 32 months for tamoxifen (P=0.514). At the discretion of the investigator, the study design allowed patients to cross over to the other therapy upon progression. Approximately 50% of all randomized patients remained on the same therapy throughout the study. At the end of the trial (median follow-up of 32 months), 48% of the patients receiving first-line Femara remained free of tumor progression, compared with 27% of the patients receiving first-line tamoxifen. In addition, the odds of responding to treatment were 78% greater with Femara (P=0.0002) than with tamoxifen, and the risk of progression was 28% less with Femara than with tamoxifen (P < 0.0001). Equally important, patients treated with Femara rather than tamoxifen experienced a significantly longer interval until they needed chemotherapy (median time-to-chemotherapy 16 vs. 9 months, P=0.005). The reported data also confirm earlier findings that use of Femara significantly delayed progression of the disease for a median of 9.4 months, compared with a median of 6.0 months for tamoxifen (P < 0.0001). Femara Helps Patients to Maintain Performance As breast cancer advances, it often affects a woman's ability to function and perform routine daily activities. In the reported trial, researchers measured women's daily performance by using the Karnofsky Performance Score, a standard clinical measurement tool based on a 100-point scale (100 being the top performance point). A change of 20 points or more on the KPS-scale is considered clinically relevant. The investigators found that significantly more women taking Femara were able to maintain their original level of performance for a longer period of time than those treated with tamoxifen. Femara Contraindications and Adverse Events Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Femara is generally well tolerated and adverse reaction rates in the first-line study in which Femara was compared with tamoxifen were similar with those seen in second-line studies. The most commonly reported adverse events for Femara vs. tamoxifen were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain (18% vs. 19%), nausea (17% vs. 17%), dyspnea or labored breathing (18% vs. 17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%), constipation (10% vs. 11%), chest pain (6% vs. 6%) and headache (8% vs. 6%). Femara may cause fetal harm when administered to pregnant women. There is no clinical experience to date on the use of Femara in combination with other anticancer agents. The incidence of peripheral thromboembolic events, cardiovascular events, and cerebrovascular events was 3-4% in each treatment arm. The foregoing release contains forward-looking statements that can be identified by terminology such as "demonstrated," "showed," "may become," "delayed," "superior," "higher," or similar expressions, or by discussions regarding potential new indications for Femara, or regarding the long-term impact of a patient's use of Femara. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Femara will be approved for any additional indications in any market. Neither can there be any guarantee regarding the long-term impact of a patient's use of Femara. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding commercialization of Femara could be affected by, among other things, additional analysis of Femara clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.

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Cancer Drug's Heart Risk Underestimated Mon May 19,11:48 PM ET Add Health - HealthScoutNews to My Yahoo! By Adam Marcus HealthScoutNews Reporter MONDAY, May 19 (HealthScoutNews) -- Doctors have known a common cancer drug causes heart failure in some patients, forcing them to stop treatment and in rare cases requiring an organ transplant, but a new study says that risk may be significantly greater than previously believed. The drug, doxorubicin, is used in the treatment of many cancers, from leukemia and breast tumors to lung and testicular cancers. The new research doesn't second-guess the therapy. However, experts say it should prompt cancer specialists to be especially vigilant about budding congestive heart failure, particularly in patients most vulnerable to the problem, such as children, the elderly and those who've had radiation therapy. "What this paper has demonstrated is that while we thought we had a pretty good idea of exactly what the risks are of doxorubicin, we have to be a little more cautious" in using it, says study co-author Dr. Michael Ewer, a heart expert at the University of Texas' M.D. Anderson Cancer Center. "If you have signs of decreasing function then you do need to stop the drug right away, but that's usually a little later than you wished you would have stopped it." A report on the findings appears in the June 1 issue of Cancer. The work was funded by Pharmacia, which makes a version of doxorubicin called Adriamycin. Ewer's group, led by Dr. Sandra Swain of the National Cancer Institute (news - web sites), reviewed three earlier studies of doxorubicin, also known as Rubex, and heart failure in patients with lung and breast cancer (news - web sites). Of the 630 subjects, 32 were diagnosed with congestive heart failure. The risk of the complication rose with the cumulative dose of the drug. Heart failure occurred in 1.7 percent of patients taking a low dose -- measured in milligrams per meters squared -- but it occurred in 26 percent of people on a moderate to high regimen. Nearly half of patients on the highest doses developed the condition. The overall rate of heart failure in people on doxorubicin was roughly 5 percent at a medium dose, higher than the rate reported in the most recent study to examine the effect. In addition to the greater prevalence of heart problems, Ewer's group noted two other areas of concern with the cancer drug. People over age 65 were about 20 percent more likely than younger patients to suffer the complication. And a heart output test doctors have been using to monitor heart function in people taking doxorubicin doesn't seem to be of much use. Some patients with no problems have abnormal test results, while others with failing pumps go undetected. "It's just an imperfect test," Ewer says

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Cancer Society Endorses Mammograms-(AP-15/05/2003)

Mammograms remain the most important tool in detecting breast cancer and women need not worry about performing breast self-exams, the American Cancer Society said. The Atlanta-based society updated its breast cancer guidelines for the first time since 1997. More research has confirmed the society's 1997 recommendation for women to receive mammograms annually from age 40. "A lot of women were reading a year or so ago that some people were not sure whether mammography had any benefit," said Debbie Saslow, the society's director of breast and gynecologic cancers. "The level of confidence in the benefit is higher than ever. Mammograms find 80 percent to 85 percent of cancers - we know they increase survival dramatically."

The largest change in the guidelines involves the breast self-exam, which previously was recommended once a month. But research has found the exams did not contribute to breast cancer survival rates. Where mammograms typically find cancers that have grown for two years, self-exams typically detect cancer that has been growing for six years, Saslow said. "We don't have evidence that doing it every month is having any survival benefit," she said. "For us it's not a huge change as a lot of people weren't doing breast self-exams anyway. To the public it probably is a big change." The recommendations say women in their 20s should be told about the benefits and limitations of the self-exam and that it is OK for women to choose to perform it occasionally or not to perform it at all. "Unfortunately by the time you can feel something, it's big enough where it's either had a chance to spread and grow or it's pretty benign and finding it wouldn't hurt if you didn't find it," Saslow said.

The society also said women ages 20 to 39 should receive a clinical breast exam every three years and annually for women age 40 or older. Older women who are healthy may find benefit in a mammogram but those with health problems need to consult their doctor to determine if the mammogram will be helpful, as "the survival benefit of a current mammogram may not be seen for several years," the society said. Women at increased risk - such as those with a family history of breast cancer - may wish to have mammographies at age 30 as well as breast ultrasound or breast MRI. But women who receive the breast MRI should receive it at a facility able to perform an MRI-guided biopsy in case something is detected that cannot be seen in a mammogram or by touch, Saslow said.

The society also warned that new, non-mammography screening technologies must equal or exceed the detection ability of mammography before they should be used as screening tools. "There's over a dozen out there, some have not been approved," Saslow said. "None of them are far enough along or have enough effectiveness for screening instead of mammography." Officials from the Susan G. Komen Breast Cancer Foundation said in a statement on their Web site they concurred with the society's updated guidelines and were "pleased to see updated recommendations specific to older women and women at increased risk."

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Gene Test Predicts Aggressive Breast Cancers-(Reuters Health-09/05/2003)

Using a test to gauge the activity of genes in a tumor, researchers were able to accurately predict which breast cancers were most likely to spread beyond the initial site and into the lymph nodes, according to a report. And in a test in a small group of women, the researchers were able to predict which patients with little or no lymph node involvement initially would have a recurrence within three years, according to the study published in the Lancet. Cancerous lymph nodes are a critical factor in determining a woman's long-term survival and also the type of care she will receive. If cancer reaches nearby lymph nodes, it's a signal the tumor is more aggressive, study co-author Dr. Mike West, a professor of statistics and decision sciences at Duke University said in an interview. If you can find patterns of genes that predict which patients will have lymph node involvement, that will help you make better treatment decisions, West said. And, you may also be able to avoid surgery to remove and scrutinize lymph nodes to look for cancer spread, he added. This surgery can come with unpleasant side effects for women, West explained.

For the new study, researchers chose to look at the effect of groupings of 50 to 100 genes that have similar characteristics -- dubbed metagenes -- rather than a single gene at a time. They pored over thousands of genes in tumor samples from 89 women. Of the 89, 19 had no lymph node involvement and 52 had three or fewer nodes affected by cancer. Eighteen women had more than ten cancerous lymph nodes. Ultimately, the researchers homed in on a collection of genes that were associated with immune response, study co-author Joseph Nevins, a professor of molecular genetics and microbiology at Duke, said in an interview with Reuters Health. "It's hard to know for sure what that means," Nevins said. "It could mean that the immune response is not very effective in these tumors or alternatively, it could mean that the immune response itself is contributing to the spread of the tumor."

By looking at patterns of genes, the researchers were able to predict whether a woman's cancer would spread to her lymph nodes about 90% of the time. The results need to be replicated, Nevins said. But if they are, doctors may have a new tool to figure out which patients need more aggressive therapies. This is especially important for women who might normally be categorized as low risk, West said. As many as one third of women who have cancer-free lymph nodes end up with a recurrence of their cancer, he pointed out. "In the case of a woman who appears to be low risk because her lymph nodes are negative, her genetic profile might say she's high risk," West said. "You might begin treating her more aggressively."

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Survey Finds Room For Improvement In Prophylactic Mastectomy-(ET-04/05/2003)

Women who are considering a double mastectomy to prevent breast cancer may not be getting enough information and support when they make their decision, British researchers say. These women need to know more about their risks of developing the disease, the risks of surgery, and the physical and emotional challenges they will face after the procedure, professor Lesley Fallowfield, DPhil, and colleagues conclude in a new analysis. The work was published in the journal The Breast (2003, 12: 1-9). Prophylactic mastectomy removing the breasts before any cancer has developed is an option that a small number of women who have a very high risk of developing breast cancer may consider. These women typically have a genetic mutation that greatly increases their risk of developing the disease, and may have a strong family history of breast cancer. The American Cancer Society stated that "only very strong clinical and/or pathologic indications warrant doing this type of preventive operation."

Fallowfield and colleagues from the psychosocial oncology group of Cancer Research UK, surveyed 80 women in this high-risk group who were offered the option of preventive mastectomy. Sixty women had the surgery, while 20 declined. Women who had the surgery were surveyed before the operations, then six months and 18 months after; women who declined surgery were interviewed at the time they made their decision and 18 months later. The researchers asked the women about their anxiety about getting breast cancer, their expectations for the surgery, and their expectations for recovery. Overall, the women in both groups were satisfied with the decision they had made. "Certainly, to date, there was little evidence of post-decisional regret in the group of women in our study although other researchers reported that 5% of women did express regret following (prophylactic mastectomy)," Fallowfield writes.

This bears out results from previous studies, which have found that many women who opt for prophylactic mastectomy greatly reduced their anxiety about developing breast cancer. But many women in both groups said they had lacked certain information at the time they were making their decision. "The most important aspect of this study is the finding that the information and support needs of women at high genetic risk opting for surgery are qualitatively different from those of women with breast cancer," Fallowfield said. "People seem to assume that the issues -- and therefore information leaflets, etc. -- that have been designed for women with breast cancer are appropriate for this group. They are not." Women who opt for prophylactic mastectomy need more information about their actual risk of developing breast cancer and about the different surgical procedures that might be used. They also need to be better informed of the physical and emotional consequences of the surgery. Many women who had the mastectomy said they were unprepared for the level of pain and incapacitation they experienced after the procedure. Many did not realize they would need help with simple daily tasks, and had not made adequate arrangements for childcare and household help. The researchers found that even 18 months after surgery, half the women interviewed still had problems related to the surgery.Women who declined the surgery felt they had not had enough information about genetic testing and how women who did have the surgery felt about it afterwards.

Breast reconstruction was also an area of confusion for many of the women in the study. The women who had surgery, as well as those who didn't, would have liked to have seen pictures of breast reconstructions. The few women who did see pictures, however, were shown pictures of reconstructions performed after breast cancer surgery, rather than preventive surgery. Because the surgical techniques are different, the pictures were not representative of what the women would be facing. Women who did have breast reconstruction often expressed surprise at some of the side effects of the procedure (scarring, itching, appearance, and feel of the reconstructed breasts).

Women in both groups expressed a strong desire for a support group to help them through the decision about prophylactic mastectomy. Despite the support of friends and family, many women who opted for surgery still felt isolated and wanted to speak with others who had been through the same experience. Even women who declined surgery wanted to talk to women who had undergone the procedure to learn more about it. Some women also said they wanted better support from the medical community. Some felt that their doctors considered the prophylactic surgery less traumatic than surgery for breast cancer. A few of the women who decided against the surgery cited dissatisfaction with the support received from their doctor as one of the reasons for not having the procedure.

"Doctors probably underestimate the physical as well as emotional impact (of the procedure)," Fallowfield said. "Bilateral prophylactic mastectomy with immediate reconstruction is a major operative procedure." Fallowfield said her analysis shows that information on prophylactic mastectomy needs to be tailored specifically to women at high genetic risk for breast cancer, in order to address the specific questions and concerns in this group. Nevertheless, she notes in her report that many women who do opt for this surgery experience great relief and peace of mind afterward, because they no longer worry about developing breast cancer.

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Study Confirms Life-Saving Benefit of Mammograms-(Reuters Health-25/04/2003)

The largest study to date into the benefits of mammograms shows that the screening technique reduces deaths from breast cancer by around 28 percent in women between the ages of 40 and 69, researchers said. In a study of 210,000 Swedish women, international researchers found that those who had mammograms during the 20 years after a screening program began in 1978 were 44 percent less likely to die from breast cancer than women in the years before screening. Thanks to improvements in drugs for the disease, even women who did not go to the screening sessions were 16 percent less likely to die of breast cancer -- suggesting around 28 percent of the reduction was due to the mammography. "This produces very strong evidence that screening women for breast cancer, along with other improvements in breast cancer care, can almost halve the number of women who might otherwise die from the disease," said lead researcher Professor Stephen W. Duffy, from the charity Cancer Research UK.

In recent years, some doubt has been cast on the benefits of mammograph Duffy said the latest research was designed partly to address those concerns. "One thing that I would say is that we were deliberately conservative in our analysis," Duffy told reporters ahead of the article's publication in the medical journal The Lancet. "It suggests very strongly that the reservations expressed in the last couple of years about mammography are essentially unfounded." In making their calculations, the researchers took into account a range of factors that could have biased the results. Specifically, they factored in changes in breast cancer treatment, alterations in the incidence of breast cancer and the fact that women who chose to attend screening tend to be slightly healthier. They also accounted for possible mistakes in classifying women as having been exposed to screening, and the odds that their cause of death was wrongly classified.

"Screening works," Duffy said. "It reduces deaths from breast cancer. This is not an artifact of some bias, but a real effect of screening." The researchers also tried to address the question of how much benefit mammogram screening is to women younger than 50. They found a similar reduction in deaths among those between 40 and 49 years of age as in older women. "There is a good case for offering younger women the chance to be screened if they have any additional risk of getting breast cancer, such as a strong family history of the disease," said the researcher. Julietta Patnick, national coordinator for breast screening in Britain's National Health Service, said the study would help reassure the 1.5 million women who are invited for screening in England. "The breast screening program has always been based on sound evidence and it has research programs to examine the appropriateness of screening women under 50 and whether or not we need to alter the current screening interval," she said in a statement. In the U.S., many experts recommend that women in their 40s and older get a mammogram every one to two years. Those at higher-than-average risk are advised to talk to their doctors about whether they should start screening earlier.

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Study Ties Breast Cancer to Pesticide Exposure-(HealthScoutNews-23/04/2003)

A new study has found that women with breast cancer were more than five times as likely to have traces of the pesticide DDT in their blood than women without breast cancer. These women were more than nine times as likely to have a residue of the fungicide hexachlorobenzene (HCB), the Belgian study says. The findings, which appear in the May issue of Occupational and Environmental Medicine, do not prove conclusively that DDT or HCB actually cause breast cancer. It's also not clear if they add to the case implicating pesticides in human cancer. "I don't think that this research would shake the ground in the environmental research field," says Dwight E. Randle, director of the award and research grant program at the Susan G. Komen Breast Cancer Foundation in Dallas. "Other studies have gone back and forth. If you look at the research that's been done in this area as a whole, the bottom line is that we don't know yet."

The search for a definitive answer is fueled largely by a desire to explain why breast cancer has been on the rise during the last 100 years or so. "When we look at the increase in the incidence of breast cancer over the past century, it seems plausible that there's some environmental factor that's associated with this rise," says Dr. Carina Biggs, director of breast surgery at Maimonides Medical Center in New York City. "Whether that is an estrogenic pesticide or whether pesticides are only a small fraction of environmental influences is unclear."

DDT, or dichlorodiphenyltrichloroethane, was developed after World War II to eradicate insects that carried malaria, typhus, and other diseases as well as to protect crops. The U.S. Environmental Protection Agency (EPA) banned its use in 1972 after evidence suggested that it disrupted reproductive mechanisms in birds. The pesticide is also banned in Canada and Europe, according to the study authors, but is still used for mosquito control in developing countries. DDT can remain active in tissues for up to 50 years, say the study authors, and even today people ingest small quantities of the compound from dietary and other sources.

HCB was used during the same time period (1940s until the 1970s) on grain seeds such as wheat, according to the EPA. Although it is no longer used as a pesticide, it is formed inadvertently as a by-product in the production of other pesticides, chlorine, metal cans, and more. DDT, HCB and other "environmental endocrine disrupters" mimic the action of certain hormones, including estrogen, in the body.

Breast cancer, along with several other cancers, has a strong hormonal component, leading to suppositions that these compounds have contributed to the rise in breast cancer incidence. That supposition led the authors of this study to look at 159 women with newly diagnosed breast cancer at a hospital in Liege, Belgium. All women were tested for levels of DDT and HCB in their blood before undergoing any treatment, including surgery, radiation, or chemotherapy. The samples were compared with blood taken from a group of 250 healthy women who served as controls. The women with breast cancer were more than five times as likely to have detectable levels of DDT as the healthy women and more than nine times as likely to have detectable levels of HCB. Women who had estrogen-receptor-positive breast cancer did not have higher levels of DDT or HCB.

The findings are in keeping with what is already know about estrogen and breast cancer. "Women who have estrogen withdrawn from them at an early part of life have a dramatically lower risk of breast cancer," says Dr. Jay Brooks, director of hematology/oncology at the Ochsner Clinic Foundation in Baton Rouge, La. "What we're beginning to realize is that anything that increases estrogen or estrogen-like compounds probably does increase the risk of a woman developing breast cancer." Whether or not DDT and HCB can be included in that category is still a big unknown. "A lot of people are interested in giving a definitive answer to this question but that definitive series of studies hasn't been done yet," Randle says.

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New Gene Linked to Breast Cancer-(Reuters-22/04/2003)

U.S. researchers said they had found a new gene linked with breast cancer that could lead to new treatments and help explain why black women are more likely to die from breast cancer than whites. The gene, called BP1, was found in 80 percent of the samples of tissue from breast cancer patients, the researchers report in the June issue of the journal Breast Cancer Research. "We are hoping our results will be especially helpful for African-American women," Dr. Patricia Berg of the George Washington University Medical Center, who led the study, said in a telephone interview. While just 57 percent of samples from white breast cancer patients tested positive for the gene, 89 percent from black women did, the researchers said. "Because BP1 is expressed abnormally in breast tumors, it could provide a useful target for therapy," Berg's team writes.

Berg noted that her team tested only 46 samples, but she said the percentages were consistent. Of the nine normal breast samples she has tested, only one has shown "expression," or activation, of the BP1 gene. She also only tested ductal cancer -- but ductal cancer makes up 80 percent of breast cancers. Berg said that like some other genes linked with cancer, BP1 was activated early in the development of an embryo and turned off later.

Gene activates other genes. It is known as a transcription factor. "This type of gene makes a protein that is like a policeman directing traffic and turns on and turns off other genes," she said. Her team will now try to find out what those other genes are. In earlier work, Berg had found that BP1 is active in leukemia, particularly a form called acute myeloid leukemia, or AML. In AML patients it was very active in children. A leukemia drug called all-trans-retinoic acid seemed to deactivate BP1 in lab dishes, Berg said -- showing there is potential for a drug targeting the gene. "What we want to do is discover whether this gene will be useful for the early detection and treatment of breast cancer," Berg said. "We found that the gene is active in all three grades of breast tumors, from the earliest to the most advanced. That means it is activated quite early in the process and potentially might be good for early detection."

She said she is working with a colleague to try to develop such a test. In a potential lucky piece of news, all the estrogen receptor-negative tumors tested positive for the BP1 gene, the researchers said. Breast cancers fall into two categories -- those that respond to anti-estrogen therapy and those that do not. So-called ER-positive tumors are easier to treat and respond to such popular drugs as tamoxifen. ER-negative tumors, which make up 40 percent of breast cancers, do not. BP1 might offer a new avenue for treating such tumors, Berg's team said. Black women in the United States are more likely to have ER-negative tumors, researchers have found, and are also more likely to die of breast cancer even when they get similar treatment to white women. More than 1.2 million women worldwide will develop breast cancer this year -- 200,000 in the United States. In the United States, 40,000 will die of breast cancer in 2003, according to the American Cancer Society.

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Study Finds Women Exercise Less After Breast Cancer Diagnosis-(ET-17/04/2003)

Women with breast cancer tend to exercise less after being diagnosed with the disease, a new study has found, even though physical activity is an important part of recovery. By getting less physical activity, the researchers said, women are putting themselves at risk for weight gain, which may increase the risk of cancer recurrence. Lead researcher Melinda Irwin, PhD, of Yale University, and colleagues from five other institutions studied 812 women recently diagnosed with breast cancer. They asked the women about the type of exercise they got in the year before diagnosis and in the year after diagnosis. The questions addressed 29 activities, including walking, jogging, aerobics and sports, as well as house cleaning and yard work.

The researchers found that on average, women got two fewer hours of physical activity per week after being diagnosed with breast cancer than before - a reduction of 11%. Although some decrease was expected because of the fatigue, nausea, and pain often associated with breast cancer treatment, Irwin said she was surprised by the extent. Women cut back on light activity like housework, as well as on more vigorous activities, such as sports. And even patients who only had surgery, or who had surgery and radiation but no chemotherapy, exercised less. Patients who were treated with surgery, radiation, and chemotherapy showed the greatest declines in physical activity. Overweight and obese women showed greater decreases in physical activity after diagnosis when compared to lean women. The finding is troubling, Irwin said, because heavier women are already at greater risk of recurrence and poor prognosis.

The study results point to a gap in the treatment of cancer patients, Irwin said. "When a woman is diagnosed with any cancer, part of the treatment process needs to be rehabilitation related to activity level, diet, weight control," Irwin said. Previous studies have shown that exercise can help lessen the fatigue associated with cancer treatment, and help patients improve their physical functioning. Being diagnosed with cancer can provide an opportunity to adopt healthier behaviors, Irwin noted. "If they're currently meeting the recommendations (for exercise and body weight), they need to maintain that. If they weren't doing any exercise, we need to give them a program that works for them." Irwin said her study provides evidence that some of the weight gain associated with breast cancer treatment could be related to decreases in physical activity, in addition to the effects of diet changes and drug side effects. The same group of patients participating in this study is still being followed to determine what effect the reduced exercise level may have on weight, hormone levels, and other factors. More research also is needed to determine whether increasing physical activity levels will actually improve the prognosis of breast cancer patients, the report concluded.

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Some Breast Cancer Drugs May Block Body's Defense Against Recurrence-(HealthScoutNews-17/04/2003)

The discovery of a new molecular pathway involved in the spread of breast cancer may have far-reaching public health implications for women, possibly influencing the way breast cancer is treated. That's the word from scientists at Emory University and The Winship Cancer Institute, where the latest research not only offers a new understanding of what makes certain breast cancers more aggressive, but also how some medications -- particularly those used to reduce cancer risks -- might ultimately contribute to its spread. "We defined a pathway that regulates invasion [of cancer cells] and what we see is that some of the traditional anti-cancer drugs knock out this pathway," says Paul Wade, an assistant professor of pathology and laboratory medicine at Emory University School of Medicine. Wade oversaw the research, which appears in Cell.

By examining laboratory cancer cell lines, the study focused on uncovering genetic differences between tumors that are "estrogen-sensitive" -- encouraged by estrogen to grow -- and those that are not. In the process, Wade and his group came upon a protein pathway known as MTA3, which, among other things, regulates a molecule identified as E-cadherin. This acts as a kind of biological "glue" that holds normal cells together, keeping them from rapidly dividing and forming tumors. In tumors that are estrogen-sensitive, Wade says it's clear the MTA3 pathway is active -- along with the "glue" molecule holding cells together. This may be one reason why these tumors appear less aggressive and less likely to spread, he adds. Conversely, they found that when a tumor was "estrogen receptor negative" -- meaning it did not require estrogen to grow -- the MT3A pathway was shut down and the E-cadherin protein didn't function at all. This, says Wade, may be one reason why estrogen-negative tumors appear more virulent. However, the inferences drawn from this study don't stop there. Wade believes the findings also have implications concerning popular anti-cancer drugs known as SERMs -- selective estrogen receptor modulators -- which include medications such as tamoxifen.

Frequently recommended following breast cancer treatment to reduce future risk of the disease, SERMs are thought to work by latching onto breast cells that would normally attract the tumor-promoting estrogen. When estrogen can't "log on," the thinking is the tumors won't grow. What Wade now proposes is that part of the way in which drugs such as tamoxifen do their job is by disabling the MT3A pathway -- in a sense, turning a estrogen-positive tumor into one that is estrogen-negative. In the process, SERMS may also disable the E-cadherin "glue-like" protein -- and that, in turn, may ultimately turn any future cancers more aggressive, Wade says. One of the inevitable consequences of long-term SERM therapy is that cancer cells do develop a resistance to the drugs. Wade believes it is at this point that the less desirable effects demonstrated by the new research may kick in. "We are not saying these are bad drugs -- it just means they can do more than one thing and one of the consequences of the therapy is a loss of the necessary pathway we defined," Wade says.

New York University breast cancer expert Dr. Julia Smith calls the research as important as it is fascinating. "I think that these are, in fact, the kinds of molecular issues that, as we come to understand, will truly change our ability to treat not only breast cancer, but probably all cancers," Smith says. However, she is less sure of Wade's conclusions regarding drugs such as tamoxifen. "Their statement that there could be potentially negative results from compounds that affect cell architecture -- that tamoxifen could have deleterious effects -- right now, this is a leap of faith that is not yet proven in this research," Smith says. She advises women who are taking tamoxifen not to worry, and not to stop the drug based on this one finding. Wade agrees more research is in order. However, he believes it will only reinforce the idea that calls for more judicious use of SERM drugs -- not only in the treatment of breast cancer, but also in the treatment of other diseases. They include osteoporosis, for which certain SERM medications are currently prescribed. "It's a new pathway, something that we think is important, and it's impacted by drugs that are used by an awful lot of women," says Wade. "So ultimately, it's going to be important for us to examine the consequences of treating women with these drugs in terms of what happens with the pathway that we've defined."

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Online Support Groups Help Women with Breast Cancer-(Reuters Health-18/04/2003)

Being diagnosed with cancer can be a traumatic experience, but new research finds that online support groups may offer the help people need to overcome depression, stress and cancer-related trauma. In a study of 72 breast cancer patients, researchers found that the 36 women who participated in a support group called Bosom Buddies experienced a 36 percent drop on depression scales, on average. At the start of the study, 19 women in the support group were depressed, but only nine were still depressed 12 weeks later. "That means 10 of the 19 were no longer depressed," Dr. Andrew J. Winzelberg, lead author of the study and a psychologist at Stanford University School of Medicine in California, told Reuters Health. "That's pretty good." Winzelberg and his colleagues also noted that the support group helped 14 percent of women beat post-traumatic stress syndrome related to their cancer diagnosis and curbed general stress levels in 19.5 percent of women, on average. The study was published in a recent issue of the journal Cancer.

Previous research has shown that women who participate in face-to-face breast cancer support groups achieve "significant reduction" in mental distress and pain and experience improvements in quality of life. About a third of the women in the study were participating in other breast cancer groups or receiving individual counseling at the start of the study. But little research has been done to test the effectiveness of Web-based social circles, which are widely used. The researchers noted that the message boards for the Bosom Buddies support group created a venue where women with breast cancer could reduce their social isolation