| LYMPHLAND |
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| BREAST CANCER FEBRUARY 2008 |
| Public release date: 29-Feb-2008
Contact: NCI Press Officers ncipressofficers@mail.nih.gov 301-496-6641 NIH/National Cancer Institute New study of targeted therapies for breast cancer -- model for global clinical trials Two targeted medications designed to treat an aggressive form of breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents -- a clinical trial that investigators hope will provide a new model for global cancer research. This trial, dubbed ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study), will be one of the first global initiatives in which two large, academic breast cancer research networks covering different parts of the world have jointly developed a study in which all care and data collection are standardized, regardless of where patients are treated. The networks are The Breast Cancer Intergroup of North America (TBCI), based in the United States, and the Breast International Group (BIG) in Brussels, Belgium. TBCI consists of six National Cancer Institute (NCI)-funded clinical trials cooperative groups. NCI is part of the National Institutes of Health. ALTTO is designed to answer the most pressing questions regarding use of two widely used cancer agents: whether one agent is more effective, which agent is safer for patients, and what benefit will be derived by taking the drugs separately, in tandem order, or together" The trial is a randomized, Phase III study, which is considered a gold standard method for proving drug effectiveness. The two agents tested in ALTTO are drugs designed to treat HER2-positive tumors, which is a particularly aggressive form of cancer that affects approximately 20 percent to 25 percent of breast cancer patients. Both agents, trastuzumab (Herceptin) and lapatinib (Tykerb), have already been approved by the U.S. Food and Drug Administration for use for treatment of HER2-positive breast cancer. ALTTO will provide the first head-to-head comparison of trastuzumab and lapatinib in the earliest, most treatable stages of cancer. It will also be one of the first large-scale studies to evaluate lapatinib’s effectiveness in treating early breast cancer. HER2-positive breast cancer is caused by an excess of HER2 genes or by over-production of its protein, the HER2 cell surface receptor. Trastuzumab consists of large antibodies that once injected into patients, latch on to the portion of the HER2 protein that sits on the outer surface of the cancer cell whereas lapatinib acts by entering a cancer cell and binding to the part of the HER2 protein that lies beneath the surface of the cell. The trial is unusual in that it has two different designs depending on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. The study thus will compare four different regimens of targeted therapy administered over a 52-week period. Patients will be randomized to receive either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two treatments in combination. “There have been major improvements in the management of patients with early breast cancer in the last few years, so this new study builds on this knowledge and sets an example of the new era: good science, good worldwide collaboration,” said Edith Perez, M.D., an oncologist in the North Central Cancer Treatment Group (NCCTG) at Mayo Clinic in Jacksonville, Fla., who will lead the study for TBCI. “It may be that using two treatments that work in different ways against HER2-positive breast cancer offers a complementary strategy that is more powerful than either drug alone.” ALTTO will be one of the first trials of its scope in which translational research -- taking science from bench to bedside -- plays a critical role, investigators say. In ALTTO, biological material will be collected from thousands of patients in order to determine a tumor profile that responds best to the drugs -- information that could lead to individualized patient care and, possibly, to development of next generation agents. “The difference between this study and many that came before it is that the collection of biological materials occurs as the trial is being conducted, not as an afterthought. While there are exceptions, not many companies or organizations have been willing to invest in that kind of research before,” said Martine J. Piccart, M.D., Ph.D., professor of oncology at the Université Libre de Bruxelles, Belgium, and lead investigator for BIG, which she founded in 1996. “Now we have the chance to optimize therapy with powerful drugs in order to provide the best treatment possible for each of our patients.” Perez and Piccart led the development team of the ALTTO trial and will act as the study’s co-principal investigators. On behalf of BIG and TBCI, these two lead investigators have been working toward collaborative clinical studies for a number of years. The ALTTO study, they say, represents a new paradigm that blends the high standards of both systems in order to test the latest breast cancer treatments as efficiently as possible in thousands of women worldwide. "The NCI greatly appreciates the work that Mayo Clinic, TBCI and BIG are doing to help advance our understanding of the complex mechanisms that underlie different types of breast cancer,” said Jo Anne Zujewski, M.D., a senior investigator in the clinical investigations branch at NCI. “We hope that this model of international collaboration is one which we can build upon in the future." Lapatinib, in combination with the chemotherapy drug capecitabine, was approved by the U.S. Food and Drug Administration in March 2007 for the treatment of advanced or metastatic HER2-positive breast cancer in patients who had received prior therapy with three agents -- an anthracycline, a taxane and Herceptin. GlaxoSmithKline is providing the study drug, as well as additional financial support for the ALTTO trial. All drugs carry potential side effects, and more information of side effects for lapatinib and trastuzumab can be found in the Q&A at http://www.cancer.gov/newscenter/pressreleases/ALTTOQandA. NCI and GSK also provided comment and input on the design of the study. NCCTG will act as the treatment base for ALTTO in North America. BIG is a network of 41 non-U.S. research groups from around the world. Its Brussels-based BrEAST Data Center is providing centralized data management for the global study (including the United States). The other members of TBCI include the Eastern Cooperative Oncology Group (ECOG), the Cancer and Leukemia Group B (CALGB), the Southwest Oncology Group (SWOG), the American College of Surgeons Oncology Group (ACOSOG), and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). To date, more than 300 centers around the world have enrolled patients into ALTTO. Full enrollment is expected to involve about 500 centers in the United States and more than 800 centers in Europe and the rest of the world. A complete listing of ALTTO participating sites can be found by searching for ALTTO at http://clinicaltrials.gov. ### A Science Writer’s seminar on International Breast Cancer Trials and ALTTO will take place on Friday, February 29, 2008 in New York City. To register for the seminar, please call (301) 496-6641 or go to www.videocast.nih.gov to view a Webcast of the event. For Broadcasters: Video soundbites from the lead investigators are available through Pathfire’s Digital Media Gateway (DMG) or on the Web at www.TheNewsMarket.com. On the DMG main page, look for the Mayo Clinic branded page in the left navbar, or click on the VNF Master Locator and search for mayoclinic0078. If you have questions or problems in locating the story, contact Pathfire Customer Support at 888-345-0489 or support@pathfire.com. If you do not have access to Pathfire’s DMG, and would like access to Mayo Clinic’s video resources by satellite or other means, please call 507-538-0492 or e-mail: groenke.joyce@mayo.edu. For a Q&A on this trial, please go to http://www.cancer.gov/newscenter/pressreleases/ALTTOQandA. For Spanish translations of the press release and Q&A, please go to http://cancer.gov/espanol/noticias/ALTTOSpanishRelease. For more info on BIG, please go to http://www.breastinternationalgroup.org. For more info on Mayo, please go to http://clinicaltrials.mayo.edu or contact the Mayo Clinic Cancer Center Clinical Trials Referral Office at 507-538-7623. For more information about cancer, visit http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4 CANCER. ******************************************************************************************* Law.com Jury Awards $12 Million in Breast Cancer Case Friday February 29, 3:02 am ET Shannon P. Duffy, The Legal Intelligencer A Philadelphia jury on Wednesday awarded $12 million to a woman with terminal breast cancer in her suit against two doctors for allegedly failing to diagnose the disease before it had progressed to an incurable stage. ADVERTISEMENT Plaintiffs attorney Donna Lee Jones of Saltz Mongeluzzi Barrett & Bendesky said one of the doctors had settled confidentially prior to trial, and that the jury concluded that the settling doctor was 35 percent responsible for the failure to diagnose. As a result, Jones said, plaintiff Angela Sutherlin stands to recover 65 percent of the verdict, or $7.8 million, from the nonsettling doctor, Arthur D. Magilner, and the Fox Chase Cancer Center. The case is Sutherlin v. Magilner. The verdict was handed up by a unanimous 12-member jury after a weeklong trial before Philadelphia Common Pleas Judge Nitza I. Quinones Alejandro. According to court papers, Sutherlin had a screening mammography in June 2003 in a Fox Chase mobile unit. The suit alleged that, due to Sutherlin's history of breast problems, including a bloody discharge from her nipple that required a prior biopsy, she was not a proper candidate for a "screening" test in the mobile unit and instead should have undergone a "diagnostic" test. Magilner testified in his deposition that Sutherlin's questionnaire, which was completed by Fox Chase technicians, made no mention of Sutherlin's surgical history, nor the fact that she had undergone breast reduction surgery in 2000. The suit alleged that Magilner's report erroneously described a "dilated duct" that was "unchanged" and suggested a follow-up test in one year. But Jones argued in court papers that a comparison of Sutherlin's 2001 and 2003 mammograms showed that the report from the first test made no mention of a dilated duct. "In short, Dr. Magilner missed a clear opportunity to note the change in the left ductal prominence, which is where Angela Sutherlin ultimately developed a palpable lump and breast cancer was found," Jones wrote in her pretrial memo. The suit alleged that when Sutherlin had another mammogram in March 2004 at the Albert Einstein Medical Center, another doctor, Susan Summerton, interpreted the films and noted "several small nodular densities," but found that they "remain stable compared to prior studies." But the suit alleged that no nodular densities had been noted in the prior report, and that Summerton therefore should not have labeled the finding as benign. In court papers, Jones argued that "like Dr. Magilner the previous year, Dr. Summerton missed the opportunity to timely diagnose Angela Sutherlin's breast cancer at a time when it was still Stage I and curable with a complete, simple mastectomy." Jones said Summerton and Albert Einstein Medical Center had settled prior to trial. At trial, Barry Singer, the plaintiff's expert oncologist, testified that Sutherlin's cancer was the type that went from Stage I directly to Stage IV. According to court papers, Sutherlin's surgery was unsuccessful, because the cancer had metastasized to her bones and organs. Jones told the jury that Sutherlin is currently receiving only palliative care, but that the high-dose narcotics cannot control her excruciating pain. Magilner was defended at trial by attorneys Dean F. Murtagh and Chilton G. Goebel III of German Gallagher & Murtagh. In an interview, Murtagh said he was disappointed by the verdict and that he believed his client had a strong defense. In her pretrial memo, Jones had demanded $2 million to settle the suit -- the combined limit for the two doctors' insurance policies -- and warned that "if a jury verdict is rendered, it will well exceed these policy limits, and expose the carriers for Dr. Magilner and Dr. Summerton to claims of bad faith." In an interview, Jones said that Magilner and Fox Chase had offered $125,000 to settle the case and never increased that offer during the trial. Go to Law.com for legal information and services on the web ------------------------------------------------------------------------------------ Breast cancer gene carriers need dual screening By Anthony J. Brown, MD Tue Feb 26, 9:05 PM ET NEW YORK (Reuters Health) - Among women with BRCA1 gene mutations, which are known to increase the risk of breast cancer, annual screening with both mammography and MRI is associated with better survival when compared with screening with either method alone, new research indicates. ADVERTISEMENT The trade-offs, however, are a high rate of false-positive results, which lead to unnecessary biopsies. The findings were based on data from 22 studies that included 8,139 women who carried the BRCA1 gene. In addition, the researchers developed a prediction model based on data from the Surveillance Epidemiology and End Results (SEER) Program (1975-1980) and the Breast Cancer Surveillance Consortium. The results indicated that annual combined screening with mammography plus MRI increased the average life expectancy by 1.38 years compared with follow-up only without screening tests (clinical surveillance). The false-positive rate was 84.0 percent. "For women who carry BRCA1 gene mutations, adding annual MRI to annual mammography has a clear benefit in terms of projected life expectancy and breast cancer mortality reduction," lead author Dr. Janie M. Lee told Reuters Health. "Whether the trade-offs related to MRI screening are acceptable to women at increased risk of developing breast cancer is still being investigated." In the general population, the lifetime risk of breast cancer for women is 13 percent. In BRCA1 mutation carriers, by contrast, this risk can be as high as 80 percent. Strategies to reduce this high risk have included preventative mastectomy, removal of the ovaries (to lower levels of estrogen which can encourage breast cancer growth), preventive chemotherapy, and more frequent office visits, according to the report in the journal Radiology. Younger women, especially those of childbearing age, are often reluctant to undergo preventative mastectomy, the investigators point out. Preventative chemotherapy might be a suitable choice, but unfortunately no studies to date have shown it to reduce breast cancer mortality. That leaves increased surveillance. According to the report, mammography is not nearly as sensitive at detecting breast cancers in BRCA1 mutation carriers as it is in the general population. Previous research has shown that MRI can achieve higher sensitivity than mammography, but whether this translates into reduced breast cancer mortality is unclear. Due to the long length of follow-up and the large number of patients required, the authors note that it is unlikely that any trial will ever investigate whether MRI screening can reduce breast cancer mortality. This prompted Lee, from Massachusetts General Hospital in Boston, and colleagues to conduct the current decision analysis. The average life expectancy was 71.15 years, the report indicates, and with clinical surveillance alone, the average diameter of breast cancers at diagnosis was 2.6 centimeters. Using annual screening with mammography, MRI, or both, the average tumor diameter at diagnosis fell to 1.9, 1.3, and 1.1 centimeters, respectively. Compared with clinical surveillance, all three imaging-based screening strategies increased life expectancy and reduced mortality from breast cancer. Again, the most pronounced benefit was with mammography plus MRI. In addition to the high false-positive rate seen with mammography plus MRI screening, nearly one in three women underwent one or more biopsies for what turned out to be benign disease. The false-positive rates and negative biopsy results with the other screening strategies were also increased, but not as high as that seen with the combined approach. More research is required to find the optimal sequence and frequency for screening tests for breast cancer, and to "minimize the potentially negative effects on women's health-related quality of life when screening with increased intensity is pursued," Lee noted. She added that her team is "currently working to extend our model of breast cancer natural history and screening in BRCA1 gene mutation carriers to women who carry BRCA2 mutations, and women whose lifetime risk of breast cancer exceeds 20 percent -- these women are defined by the American Cancer Society as being at 'high-risk' of developing breast cancer." SOURCE: Radiology, March 2008. ----------------------------------------------------------------------------------------- Cost of Breast Cancer Can Include Paycheck Tue Feb 26, 5:01 PM ET TUESDAY, Feb. 26 (HealthDay News) -- In the first year after being diagnosed with breast cancer, working women lose an average of 27 percent of their income, a new study finds. ADVERTISEMENT Researchers from Laval University in Quebec interviewed 829 women at one, six and 12 months after their breast cancer diagnosis. The women were asked a number of work-related questions, such as their working status before their diagnosis, the amount of time absent from work due to the disease, and types of compensation received during their work absences. The women were also asked about their perceptions of their financial status, and whether it had changed for the worse at one year after breast cancer diagnosis. Of the 800 women who completed all three interviews, 459 had paying jobs at the time of their diagnosis and 403 of those women had work absences or reduced work hours after their diagnosis. On average, these women lost 27 percent of the wages they would normally have earned if they hadn't been ill, even after all forms of compensation were taken into account. Ten percent of the women lost more than two-thirds of their income. The study found wide variation in the percentage of lost wages. Those most likely to suffer a large loss of income were: less educated; lived farther from the hospital where they had their cancer treatment; had more serious disease; required chemotherapy; or were self-employed, worked part time, or recently hired at their job. "These findings should sensitize clinicians to the real extent to which wage losses resulting from breast cancer can substantially and negatively affect the financial situation of working women and their families," the study authors wrote. The study was published in the Feb. 26 online issue of the Journal of the National Cancer Institute. More information The American Cancer Society offers tips for coping with breast cancer. -------------------------------------------------------------------------------------------------- Hormone therapy skews breast cancer diagnosis By Andrew Stern Mon Feb 25, 5:37 PM ET CHICAGO (Reuters) - Women on hormone replacement therapy have only a slightly higher risk of developing breast cancer, but there are much greater chances they will experience the worry of abnormal mammograms or may undergo an avoidable breast biopsy, researchers said on Monday. ADVERTISEMENT Mammograms and biopsy exams were also found to be less reliable at detecting breast cancer among women taking hormones, which counteract symptoms of menopause such as hot flashes and vaginal dryness. Originally, the 2002 Women's Health Initiative study involving 16,608 women aged 50 to 79 found breast cancer incidence among women taking the hormones estrogen and progestin projected to an additional one in 1,000 cases compared to women taking an inert placebo. "What this data does is emphasize that yes, the breast cancer risk is still there, but more importantly, instead of that low number of one in 1,000 getting breast cancer, one in 10 women are told they had an abnormal mammogram they'll have to deal with, and probably even more importantly, one in 25 women will have an otherwise avoidable breast biopsy," Dr. Rowan Chlebowski at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center said in a telephone interview. "Both of those less reliably found cancer," he added. Previous research has shown hormone replacement therapy increases breast tissue density, which can make detection of cancerous tumors more difficult, although the current study did not examine this factor. Since the original findings of increased cancer risk, doctors generally have urged women opting for hormone therapy to use it at the lowest effective dose for the shortest possible time. Roughly 25 million U.S. prescriptions for hormone therapy are written yearly, Chlebowski said. The pharmaceutical company Wyeth said in a statement the study's findings did not change what is already known about the breast cancer risk from hormone replacement therapy. DOCTOR'S ADVICE "These findings represent a concern for post-menopausal women who are considering hormone therapy," Chlebowski said in a statement. "They should take the results of this study into consideration and consult with their physicians before undergoing even short-term hormone therapy." In the study published in the Archives of Internal Medicine, 35 percent of women taking hormones had mammograms with abnormal results compared to 23 percent of women taking a placebo. An abnormal test can create emotional as well as financial hardships, the study noted. Ten percent of women taking hormones had breast biopsies ordered by their doctors, compared to 6 percent of women taking a placebo. During the 5-1/2 years of the study, there were 199 breast cancers found in the hormone group and 150 in the placebo group. Women taking hormones had more advanced cancers yet biopsies ordered by their doctors had a lower rate of diagnosis -- 15 percent in the hormone group versus 20 percent in the placebo group. "(A year) after discontinuation (of the therapy) ... the adverse effects on mammogram and breast biopsy performance were seen even in younger women in the fifth decade of life, so the finding may impact women just entering menopause as well," Chlebowski said. (Editing by Eric Walsh)http://news.yahoo.com/s/nm/20080225/ts_nm/cancer_breast_hormones_dc_2 ---------------------------------------------------------------------------------------- Thursday February 28, 03:02 PM Plastic a big worry for cancer researchers Plastic which surrounds us in our daily lives may contribute to New Zealand's high rate of cancer, particularly breast cancer, says a visiting medical expert. Dr Karin Michels, an associate professor in the Department of Epidemiology at Harvard University in Massachusetts, will not eat food wrapped or stored in plastic, nor will she use a plastic shower curtain. ADVERTISEMENT Dr Michels, who is visiting New Zealand as guest of the Breast Cancer Research Trust as part of her research into the causes of breast cancer in women, said she and her research colleagues were "really concerned" about plastics and plasticisers used in every day life in many countries. "The plastic bottles we drink from, especially these hard plastic bottles which are reusable, the Tupperware, the baby bottles where we heat up the milk and shower curtains -- all release substances that screw up our hormone system." She said heating lunch in a plastic container in a microwave released substances into the food which entered the body. "You eat these substances that screw up your hormonal system and that has been associated with an increased risk of breast cancer in animals." The substances could also be breathed in when they were released from shower curtains during a hot shower. She said studies had yet to be done on humans because humans could not be fed carcinogenic substances. "But you can feed it to rats and if you give it to rats, they develop breast cancer." Dr Michels said heating plastic caused substances, including the carcinogenic substance, bisthenol A, to be released in greater quantities than eating food stored or wrapped in unheated plastic. "You are exposed to these kind of substances almost everywhere. If you wrap your food in plastic wrap it gets into the food. "It is particularly bad for babies because the baby's small, and you heat up the milk in a plastic body and all that stuff gets into the formula. "The baby gets all these chemicals and who knows what it does to the baby? We don't really know but it is something we are extremely concerned about." Bisthenol A was the substance that most concerned the medical research industry. She said the substances still came out of the plastic even when it was not heated. "It is a very scary thought." Dr Michels said the increasing use of plastic, such as plastic jars in supermarkets was not a good practice. "Good old glass is probably better." She said the potential risk from plastic had only been discovered recently but was hard to study because plastic was so widely used. New Zealand had one of the highest rates of breast cancer in the world. Dr Michels said breast cancer was the most common form of cancer in the world and one in seven women got breast cancer. "That's very scary. We know it is lifestyle but we don't seem to be able to eliminate it or reduce it." In New Zealand it killed more than 600 women a year Dr Michels said many woman gained weight after menopause and that also contributed substantially to their risk of breast cancer. Part of her research into breast cancer was to look at the relationship between diet and the disease. She said while the research had yet to identify the risk factors in breast cancer from food, alcohol had been identified as a risk. "Alcohol consumption like a glass of wine a day already increases your risk of breast cancer by 20 percent." That risk could be countered with a daily folate or B vitamin pill. A low-fat diet and regular exercise for young girls may also lower the cancer risk factor. She said diet before puberty could also affect the risk rate for breast cancer although the research in that area was still very preliminary and more was needed. A high birth weight also increased the risk factor for breast cancer, but the risk factors from the time of conception to puberty or early adulthood had not been considered. "That is something we have totally missed out on before for many years, almost decades, that we have done epidemiologic research which is the research that identifies risk factors for breast cancer." Dr Michels said the rise in the rate of breast cancer must be attributed to lifestyle and environment because women who moved from a country with a low rate of breast cancer to a country with a high rate, adopted the cancer rate of their new country. "It must be lifestyle. It is not genetic," she said. --------------------------------------------------------------------------------- Press Release Source: Interactive Supercomputing Northeastern University and Mass General Hospital Increase the Accuracy, While Reducing the Diagnosis Time, for Breast Cancer Detection Tuesday February 26, 9:00 am ET Research teams solve the computational hurdle using Star-P WALTHAM, Mass., Feb. 26 /PRNewswire/ -- Researchers at the Northeastern University Computer Architecture Research Lab (NUCAR) and the National Science Foundation's (NSF) Center for Subsurface Sensing and Imaging Systems (CenSSIS) are teaming with Massachusetts General Hospital (MGH) on a promising new breast cancer detection technology that improves breast cancer screening accuracy. The team is applying new supercomputing technology to a 30-year-old imaging modality called tomosynthesis, which until now has been relegated to research labs due to its massive and expensive computational requirements. ADVERTISEMENT Called Digital Breast Tomosynthesis (DBT), the system creates a 3D image of the breast using a series of x-ray projections collected during a 20- second, 40-degree sweep. It makes cancer lesions easier to detect among dense breast tissue by creating a stack of 1mm spaced high-resolution slices that can be displayed individually, or assembled into a 3D view that can be rendered for more careful examination. DBT also reduces the amount of breast compression required by traditional mammography, which can deter women from getting an annual screening. NUCAR scientists addressed this computational hurdle by creating a DBT reconstruction application on their desktop PCs using MATLAB®, and then running the code on an affordable Linux parallel cluster using Star-P software from Interactive Supercomputing, Inc. (ISC). Reconstructing DBT used to take many hours. With this new Star-P approach, imaging reconstruction can be completed in just a few minutes. The complicated parallel programming task has been dramatically simplified using Star-P, slashing development time from many months to days. General Electric is developing a commercial DBT device that should be generally available in 2009. The Northeastern team has been supported by a NSF Small Business Technology Transfer (STTR) project with ISC, the NSF's CenSSIS, and by Mass General Hospital, which is known worldwide for offering the most advanced breast screening and treatment services available. "The support from Northeastern has radically shifted this paradigm," said Richard Moore, program director for Breast Imaging Research and CenSSIS at MGH. "With this kind of performance, we can realistically rely on 3D methods that were out of the question previously. It's not just the speed, it's the exploratory freedom." "We've been able to take a technology that had an enormous computational barrier and turn it into a commercially viable product by making its underlying parallel computing platform fast, easy and affordable," said Professor David Kaeli, director of NUCAR and thrust leader in CenSSIS. "The multi-dimensional imaging technique involves the processing of up to 15 high resolution x-ray images. This kind of application typically requires a very long time to carry out repetitive operations on large image matrices. Parallelizing these large datasets on affordable hardware can now achieve the performance required for real-world implementations." The parallelization effort was performed by Dana Schaa, a graduate student working with Professor Kaeli. Kaeli said Star-P was a good solution for this challenge because it enabled his team of researchers to easily code algorithms using their familiar desktop environment, automatically transforming the application to run on parallel clusters. Star-P eliminates the need to re-program the applications in complex languages such as C, FORTRAN or MPI (message passing interface) to run on the cluster -- which otherwise requires arcane programming knowledge and months to complete. About Interactive Supercomputing Interactive Supercomputing (ISC) launched in 2004 to commercialize Star-P, an interactive parallel computing platform. With automatic parallelization and interactive execution of existing desktop simulation applications, Star-P merges two previously distinct environments - desktop computers and high performance servers - into one. Based in Waltham, Mass., the privately held company markets Star-P for a range of biomedical, financial, and government laboratory research applications. Star-P is a registered trademark of Interactive Supercomputing Inc. All other trademarks mentioned herein are the property of their respective owners. Contacts: Ilya Mirman Michelle Dillon Interactive Supercomputing Beaupre & Co. Public Relations 781-419-5088 603-559-5835 mdillon@beaupre.com --------------------------------------------------------------------------------------------- FDA clears Avastin for breast cancer By MATTHEW PERRONE, AP Business Writer Fri Feb 22, 6:30 PM ET WASHINGTON - A Genentech drug received federal approval on Friday to treat breast cancer, a surprise decision that could represent a shift in standards for assessing the effectiveness of cancer medicines. ADVERTISEMENT Going against the recommendation of its advisory panel, the Food and Drug Administration judged the effectiveness of Avastin based on measurements of tumor growth, not patient survival. The ruling prompted a mixed reaction from both doctors and advocates for breast-cancer patients. Some bemoaned the lowering of medical standards, but others applauded the federal government's endorsement of a drug that is already prescribed "off-label" to an estimated 9,500 patients and for whom insurance coverage is limited. Avastin, which is already approved in the U.S. for treating lung and colon cancer, was Genentech's best-selling product last year with revenue of $2.3 billion. Through a partnership with Genentech, Swiss drug maker Roche markets the drug in Europe, where it had previously been approved as a breast-cancer treatment. Shares of Genentech Inc. rose $5.76, or 8 percent, Friday to $77.36 in after hours trading. FDA approval for drugs targeted at cancer patients who have never been treated before is usually contingent upon data showing a drug extended, or improved the quality of, patients' lives. Avastin showed neither in a study submitted by Genentech, though the drug did slow tumor growth. Wall Street analysts believe FDA's Avastin decision opens the door for more cancer drugs to be approved for their tumor-shrinking capabilities — a trend that worries some health experts. "If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint," said Dr. Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University. In December, a panel of outside FDA advisers voted 5 to 4 against Genentech's application, indicating the drug's benefits did not outweigh toxic side effects. Nevertheless, U.S. doctors continued prescribing it "off-label," or without a federal endorsement. Some insurers are reluctant to pay for Avastin's use among breast-cancer patients, which can cost $100,000 for a year's supply. Dr. Joseph Sparano of Montefiore Medical Center in New York said he prescribes Avastin because it has shown better results at slowing breast cancer growth than any other drug on the market. The Y-ME National Breast Cancer Organization said the approval gives patients an important new option. "The benefits we're looking at here matter because they give patients hope," said Margaret C. Kirk, the group's chief executive. "Without disease progression they may survive to see a discovery that can help them." they may survive to see a discovery that can help them." But the president of the National Breast Cancer Coalition said the decision marked a lowering of standards for FDA. She argued that the drug's effectiveness should not have outweighed safety risks, pointing to six deaths attributed to the drug in the study submitted to FDA. "All they had was progression-free survival in one trial, no increase in quality of life and patient deaths in the Avastin group," said Fran Visco. "We're very confused why FDA made this decision." First approved in the U.S. to treat colon cancer in 2004, Avastin was the first drug to fight cancer by blocking nutrients from reaching tumors. ------------------------------------------------------------------------------------------ Catholics asked to stop Komen donations By JON GAMBRELL, Associated Press Writer Tue Feb 26, 11:24 PM ET LITTLE ROCK, Ark. - The Diocese of Little Rock is urging its members not to donate to a breast cancer foundation known for its fundraising races across the globe because the group supports Planned Parenthood. ADVERTISEMENT The diocese says the Susan G. Komen for the Cure foundation, which has invested about $1 billion in cancer outreach and research, gives money to Planned Parenthood to hold breast exams and offer education to women in its clinics. "Donors cannot control how an organization designates its funds," a diocese statement reads. "Therefore, money donated for a specific service ... directly frees up funds to support other areas of an organization's agenda." Marianne Linane, director of the diocese's "respect life" office, said those other agendas includes abortions and contraceptive services. The Catholic church's policy is that abortion is wrong in every instance. Linane said the Little Rock diocese, which oversees all churches in Arkansas, used the same statement sent out by the church's St. Louis diocese last year. However, the end of the Little Rock letter included addresses of Arkansas hospitals parishioners could donate to that would eliminate "the administrative funds for a middle broker." Monsignor J. Gaston Hebert sent the statement to parishes and Catholic schools this month and planned to send out a follow-up letter, Linane said. Hebert did not return a call for comment Tuesday. Little Rock follows other dioceses in raising concerns with the foundation. In 2005, the Roman Catholic Diocese of Charleston abandoned its support of the foundation, while in 2006 the newspaper of the Catholic Diocese of Phoenix took issue over Komen's Planned Parenthood funding. Rebecca Gibson, a spokeswoman for the Komen foundation, said the group invested $69.6 million in more than 1,600 community-based education and screening programs during 2007. Planned Parenthood received less than 1 percent of that money, she said. "It's insignificant in relation to all of the funding we do," Gibson said. "I think it's just really unfortunate undue attention is being shed on organizations that are providing vital services in those communities." The diocese's decision comes as northwest Arkansas prepares for its running of the Race for the Cure on April 19. Officials estimated Little Rock's running last year brought out more than 43,000 participants and raised more than $1.65 million. ___ On the Net: Susan G. Komen for the Cure: http://www.komen.org/ Diocese of Little Rock: http://www.dolr.org ------------------------------------------------------------------------------------------- HRT Can Lead to Abnormal Mammograms, Biopsies By Amanda Gardner HealthDay Reporter Mon Feb 25, 5:03 PM ET MONDAY, Feb. 25 (HealthDay News) -- Women who take combined hormone therapy for about five years have a higher risk of abnormal mammograms and breast biopsies. ADVERTISEMENT This, in turn, may decrease the effectiveness of these methods of detecting breast cancer, according to a new study published in the Feb. 25 issue of Archives of Internal Medicine. "Women need to be aware of the risks, and it's not just risk of increased breast cancer. It's a risk of possibly having abnormal mammograms and really being tortured by them," said Dr. Kristin Byrne, chief of breast imaging at Lenox Hill Hospital in New York City, who was not involved with the study. "It's a whole slew of things they need to be aware of before making a decision to go on hormone therapy." Study lead author Dr. Rowan Chlebowski, a medical oncologist with the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, said that for women with severe menopausal symptoms, the new findings "won't be an issue." "It [hormone-replacement therapy] is safer than we thought maybe a year and a half ago," he said. "Certainly, no one is going to brush off a breast biopsy. But for women trying to decide whether to start on hormone therapy or who want to see if their symptoms get better, they have to think about whether they would mind having a call back" for a mammogram. The landmark Women's Health Initiative (WHI) study found that combined estrogen plus progestin hormone replacement therapy (HRT) increased the risk of breast cancer. One recent study indicated that the risk was greater for lobular breast cancer than ductal carcinoma malignancy. Since 2003, there has been a decline in breast cancer incidence that coincided with a decline in HRT use for menopausal symptoms. Nevertheless, Chlebowski pointed out, "a lot of people are still using hormone therapy." For the new study, the authors looked at 16,608 women who participated in the WHI from 1993 to 1998. The women were randomly assigned to receive combined hormone replacement therapy (estrogen plus progesterone) or a placebo. Mammograms and breast exams were conducted annually and biopsies performed, if indicated. More than one in 10 women had otherwise avoidable mammogram abnormalities (an increase of 11 percent), while one out of 25 women had otherwise avoidable breast biopsies (an increase of 4 percent), after taking the hormone therapy for five years. Ten percent of women in the HRT group had to have a biopsy, compared to 6.1 percent in the placebo group. Yet the biopsies only detected 14.8 percent of cancers in the HRT group, compared with 19.6 percent in the placebo group. "Your breasts become denser [with HRT], and we all know that mammography isn't as sensitive for the detection of breast cancer in women with dense breasts," Byrne explained. The increase in abnormal mammograms persisted for at least 12 months even after discontinuing hormone therapy, the study found. For the medical community, Chlebowski said, this finding "focuses attention that diagnosis is hindered. We have additional imaging modalities, and maybe we should evaluate them to see if we can get rid of this hindrance or delay in diagnosis. It hasn't been a factor for attention before, but it probably should be." Chlebowski has consulted for several pharmaceutical companies. A prepared statement from Wyeth Pharmaceuticals, which makes the hormonal product Prempro, said: "This study looks at data first reported in 2002 which showed an increase in the number of repeat mammograms and breast biopsies related to the use of estrogen combined with progestin. Current labeling for all hormone therapy products provides information about breast cancer risks, abnormal mammograms and guidance regarding yearly breast examinations by a healthcare professional. "While use of estrogen combined with progestin increased the need for repeat mammograms in this study, nearly one in four women in the placebo group also needed repeat mammograms due to abnormalities. The findings in this report do not change what we already know about the benefits and risks of hormone therapy," the statement said. More information For more on the Women's Health Initiative, visit the U.S. National Heart, Lung, and Blood Institute. ---------------------------------------------------------------------------------------- Cut-Off Cancer Patient to Get $9M By THOMAS WATKINS,Associated Press Writer AP - Sunday, February 24LOS ANGELES - A woman who had her medical coverage canceled as she was undergoing treatment for breast cancer has been awarded more than $9 million in a case against one of California's largest health insurers. ADVERTISEMENT Patsy Bates, 52, a hairdresser from Lakewood, had been left with more than $129,000 in unpaid medical bills when Health Net Inc. canceled her policy in 2004. On Friday, arbitration judge Sam Cianchetti ordered Health Net to repay that amount while providing $8.4 million in punitive damages and $750,000 for emotional distress. "It's hard to imagine a situation more trying than the one Bates has had to endure," Cianchetti wrote in the decision. "The rug was pulled out from underneath, and that occurred at a time when she is diagnosed with breast cancer, one of the leading causes of death for women." Bates, a mother of two, said she screamed when she heard about the damage award. "I am elated," she said. Bates' attorney William Shernoff said he wanted other insurers to take notice of the award. "We are going to put a stop to this practice," he said. Health Net said it was implementing a freeze on policy cancelations that would last until the company sets up a third-party review panel to scrutinize cases. "Obviously we regret the way that this has turned out, but we are intent on fixing the processes to maintain the public trust," spokesman David Olson said. The award came a day after the Los Angeles city attorney sued Health Net, claiming it illegally canceled the coverage of about 1,600 patients. City Attorney Rocky Delgadillo also said the company illegally ran an incentive program in which it paid bonuses to an administrator for meeting targets of policy cancelations. Health Net acknowledged that such a program existed in 2002 and 2003 but was subsequently scrapped. "It's hard to imagine a policy more reprehensible than tying bonuses to encourage the recision of health insurance that helps keep the public well and alive," Cianchetti wrote in the Bates decision. Bates had been insured with another company but was persuaded to switch over to a Health Net policy after an agent suggested she could save money. She said she had undergone surgery to remove a tumor and had received her first two chemotherapy treatments when doctors stopped treating her because her bills were going unpaid. "I was devastated. I didn't know what was going to happen," Bates said. "It's boggling that someone can do that to you." Bates went on to complete her cancer treatment through a state-funded program. Health Net also said it would review its practices and the way its brokers and agents are trained. -------------------------------------------------------------------------------- Saturday February 23, 11:49 AM Diet tied to breast cancer risk A new study suggests that women who eat diets rich in meat and dairy may have a decreased risk of breast cancer, while those who bulk up on fibre, fruits and vegetables show a lower risk of ovarian cancer. The findings, published in the International Journal of Cancer, add to questions surrounding the role of diet in women's risk of the cancers. ADVERTISEMENT High alcohol intake has been consistently linked to breast cancer risk, but when it comes to other facets of the diet, studies have yielded conflicting results, according to the researchers on the current work, led by Dr Valeria Edefonti of the University of Milan. Some studies, for example, have found that women who eat a lot of red and processed meat are more likely to develop breast cancer than other women; but other studies have found no such link. Saturated fat, found mainly in animal products, has been tied to higher breast cancer risk in some studies, but not in others. While many of these studies have looked at single nutrients or food groups, another way to address the question is to look at dietary patterns - the combination of nutrients and foods that a person tends to favour. For their study, Edefonti and her colleagues assessed dietary patterns among 3,600 women with either breast or ovarian cancer, and 3,413 healthy women of the same age. Using detailed dietary questionnaires, the researchers identified four common dietary patterns in the study group: an "animal product" pattern, which was heavy in meat and saturated fat, but also zinc, calcium and certain other nutrients; a "vitamins and fibre" pattern, which besides fibre was rich in vitamin C, beta-carotene and other nutrients found in fruits and vegetables; an "unsaturated fat" pattern that contained high amounts of vegetable and fish oils, as well as vitamin E; and a "starch-rich" pattern high in simple carbohydrates, vegetable protein and sodium. Overall, the study found, women who followed a pattern rich in vitamins and fibber had a 23 percent lower risk of ovarian cancer than women who consumed the lowest amounts of those foods and nutrients. On the other hand, the animal-product pattern was linked to a similar reduction in breast cancer risk. Women who followed the unsaturated-fat pattern had a slightly reduced risk of breast cancer, while the starch-rich diet was tied to elevated risks of both cancers. It's not yet clear what to make of the findings, in part because they show associations between dietary patterns and cancer risk - and not that the foods directly affect cancer development. In terms of general health, experts usually recommend limiting red meat and saturated fat, while eating more fruits, vegetables, whole grains and sources of "good" unsaturated fat - like fish, nuts and olive oil. SOURCE: International Journal of Cancer, February 2008. --------------------------------------------------------------------------------------- Press Release Source: Diane Connolly-Zaniboni Breast Cancer Research Fund 3,000 ''Cure Breast Cancer'' License Plates Now on the Road in Massachusetts Wednesday February 20, 12:52 pm ET BOSTON--(BUSINESS WIRE)--It was October 31, 2006 when the “Cure Breast Cancer” license plate first became available in the Commonwealth. Since then, over 3,000 people have signed up for this license plate, raising more than $100,000 for research to find a cure for breast cancer. This amount will only get exponentially larger thanks to the efforts of Deb McNeill, Janice Connolly-Laubenstein and others who have spear-headed the plate initiative. ADVERTISEMENT The special license plate, designed by McNeill, costs an additional $40 above the regular registration Registry fee. Of that $40, $12 goes to the Registry of Motor Vehicles for production with the remaining $28 deposited in the Diane Connolly-Zaniboni Breast Cancer Research Fund at Tufts New England Medical Center in Boston. The plate is renewed every two years, at which point $40 goes directly into to the breast cancer research fund. Deb McNeill, a breast cancer survivor herself, is thrilled that the dream of a breast cancer license plate has finally come true. “Each plate sold represents a personal, unique story,” said McNeill. “It represents a community of supporters who have stepped up and made a statement to help the fight against breast cancer. These individuals and the stories they share is what makes all of our hard work worthwhile.” McNeill is not alone in her belief that this plate has helped support both breast cancer survivors and the loved ones of those impacted by this disease. As supporters register for their “Cure Breast Cancer” plates, they offer their stories and the personal connections to the cause. Plate 280 writes: “I lost my 47-year-old sister Judy on May 24th of this year to breast cancer. I miss her very much… She was my only sister. I feel in my heart that getting a plate is something I can do for the cure of breast cancer.” Plate 436 writes: “My mother was diagnosed with breast cancer in April of 1996, one month before my wedding. She went on to have 5 years cancer free. Her cancer returned in July of 2001, when my sister and I were both 6 months pregnant. She lived until June of 2003, fighting for every day to spend with her grand babies. I miss her terribly…” Plate 1409 writes: “As a daughter of a breast cancer survivor and having lost two close friends to this disease, I am honored to display this plate on my car.” The breast cancer license plate honors so many people who have lost their battle with breast cancer, including the late Diane Connolly-Zaniboni. The license plate with a pink ribbon and the word “Cure” serves as a symbol of hope, strength and support to those currently suffering from the disease. To get your plate go to your local Registry of Motor Vehicles or order online at: http://www.mass.gov/rmv/express/cureBreastCancer.htm Contact: For Diane Connolly-Zaniboni Breast Cancer Research Fund Deb McNeill, 781-820-0199 debmcneill@comcast.net -------------------------------------------------------------------------------- Source: Diane Connolly-Zaniboni Breast Cancer Research Fund ------------------------------------------------------------------------------------------------- Press Release Source: Hologic, Inc. Three Year Analysis of Treatment Efficacy, Cosmesis, and Toxicity Support use of the Hologic Mammosite Radiation Therapy System Monday February 25, 4:00 pm ET American Society of Breast Surgeons Study Represents Largest Patient Population to Date BEDFORD, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Hologic, Inc. (Nasdaq: HOLX - News) a diversified medical technologies company specializing in imaging systems, diagnostics, and interventional devices dedicated to serving the healthcare needs of women, today announced the publication of a study evaluating the Hologic MammoSite® Radiation Therapy System (RTS), one-, two- and three-years after treatment. The study by Frank A. Vicini, M.D., and others, published in the February 15, 2008, issue of Cancer(1), the peer- reviewed professional journal of the American Cancer Society, reports on treatment efficacy, cosmetic results and toxicities of patients enrolled in the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial. ADVERTISEMENT The American Society of Breast Surgeons MammoSite Registry(2) includes a total of 1,440 patients with early stage breast cancer, who were undergoing breast-conserving therapy and were treated with MammoSite RTS between May 2002 and July 2004. Of the total, 87 percent of the patients had invasive breast cancer and 13 percent had been diagnosed with ductal carcinoma in situ (DCIS). The authors presented a subset analysis of the first 400 cases enrolled in the study with a median follow-up of 37.5 months. The three-year actuarial rate of local or regional recurrence was less than 2 percent in this group. The percentage of breasts with good and/or excellent cosmetic results was 93 percent at 36 months. The authors also reported a three-year actuarial local control rate of 100 percent in the first 48 patients enrolled with DCIS. An analysis of the overall registry population with a median follow-up of 30.1 months, showed a two-year actuarial rate of local or regional recurrence of 1.0 percent; good and/or excellent cosmetic results of 94 percent at 24 months and a 10.6 percent rate of symptomatic seromas. The authors note that the MammoSite Radiation Therapy System is "logistically simpler, technically more reproducible, and patient 'friendly'" than other interstitial brachytherapy devices. The authors go on to say that "These results demonstrate that treatment efficacy, cosmesis, and toxicities 2-years and 3-years after treatment with APBI [Accelerated Partial Breast Irradiation] using the MammoSite device in this registry trial are similar to those reported with other forms of APBI with similar follow-up." "The American Society of Breast Surgeons Registry represents the largest patient population treated with the MammoSite Radiation Therapy System," said Ellen Sheets, M.D., Chief Medical Officer for Hologic. "We are very encouraged by these results and believe they support the clinical benefits of this unique technology." The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (the surgical removal of a breast tumor). MammoSite RTS delivers radiation from inside the lumpectomy cavity over a course of five days. The device targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Since its introduction in 2002, more than 38,000 breast cancer patients have received partial breast irradiation utilizing the MammoSite RTS. A copy of the study may be downloaded by going to the web site below: http://www3.interscience.wiley.com/cgi- bin/abstract/117880284/ABSTRACT?CRETRY=1&SRETRY=0 About Hologic, Inc. Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, and mini C-arm for extremity imaging. For more information visit www.hologic.com. Forward Looking Disclaimer This News Release contains forward-looking information that involves risks and uncertainties, including statements about the effect of the use of Hologic's MammoSite Radiation Therapy System on breast cancer patients. There can be no assurance that the effects demonstrated in the study described herein will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of Hologic's MammoSite Radiation Therapy System on patients with breast cancer can only be determined on a case-by-case basis depending on the particular circumstances of the patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in Hologic's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission. 1 Frank Vicini, M.D., Peter D. Beitsch, M.D., F.A.C.S., Coral A. Quiet, M.D., Angela J. Keleher, Delia Garcia, M.D., Howard C. Snider Jr, Mark A. Gittleman, M.D., Victor J. Zannis, M.D., Henry M. Kuerer ,M.D., Ph.D., Maureen Lyden, Three-year analysis of treatment efficacy, cosmesis, and toxicity by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation (APBI), Cancer, 2008;112(4),758 766 2 The MammoSite Breast Brachytherapy Trial was supported in part by a grant from Cytyc (Hologic). Co-authors Victor J. Zannis and Maureen Lyden received support from Cytyc (Hologic). Contact: Frances Doria Jim Culley Director, Investor Director, Strategic Relations Projects Hologic, Inc. Hologic, Inc. Tel: 781.999.7377 Tel: 781.999.7583 Source: Hologic, Inc. --------------------------------------------------------------------------------------- Study debunks personality link to breast cancer Tue Jan 29, 2008 4:11pm ET Email This Article | Print This Article | Reprints [-] Text [+] By Will Dunham WASHINGTON (Reuters) - The idea that a woman's personality traits can make her more prone to get breast cancer appears to be nothing more than a myth, according to a Dutch study that tested the notion. Women who were unemotional, depressed or anxious were no more or less likely to get breast cancer than any other women, the study found. Nor were women who were optimistic, angry or understanding, or had any combination of personality traits. The Dutch researchers measured 11 personality traits in 9,705 Dutch women in a survey in 1989 and 1990, then tracked them through 2003 to see who got breast cancer. Reuters Pictures "The present results indicate that women should not worry about a possible impact of personality factors as a risk factor for breast cancer," Eveline Bleiker of the Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital in Amsterdam, who led the study, said by e-mail. "Moreover, women with breast cancer should not worry that their character might have contributed to the development of their disease," Bleiker added. Bleiker noted that some researchers in the 1980s advanced the idea of a "cancer-prone" personality with such traits as stoicism and difficulty in expressing emotions. "The earlier studies had a number of methodological flaws," Bleiker said, adding that more recent, large studies have not found the existence of a "cancer-prone" personality. "In summary, there is currently no convincing evidence that such a personality profile exists," Bleiker said. Continued... --------------------------------------------------------------------------------------- Surgeons' Characteristics Influence Breast Cancer Care Gender, race, schooling influence likelihood of giving radiation, study says TUESDAY, Jan. 29 (HealthDay News) -- Individual surgeon characteristics, such as gender and medical training, may influence whether a women receives radiation after breast conservation cancer surgery, a U.S. study suggests. Many breast cancer patients don't receive radiation therapy after breast conservation therapy, even though it's been shown to reduce breast cancer recurrence and is considered a standard of quality care, according to background information in the study. Previous research has shown that certain patient characteristics, such as race and distance from a radiation therapy facility, influence the likelihood of receiving radiation after breast cancer surgery. But the effect of doctor characteristics has been unclear. In this study, published in the Jan. 29 online issue of the Journal of the National Cancer Institute, researchers at the Herbert Irving Comprehensive Cancer Center at Columbia University in New York City analyzed data on about 30,000 women, 65 and older, who were diagnosed with breast cancer between 1991 and 2002 and received breast-conservation surgery. The researchers also looked at the 4,453 surgeons who operated on the women. About 75 percent of the women in the study received radiation after surgery and, each year from 1991 to 2002, there was an increase in the percentage of women who received radiation. But older women, black women, unmarried women and those living outside urban areas were less likely to receive radiation. After they adjusted for patient and tumor characteristics, the study authors concluded that women who received radiation were more likely to have a surgeon who was female, had an M.D. degree (compared to a D.O. degree), or was trained in the United States. "Our study is one of the first to demonstrate associations between certain surgeon characteristics and quality of breast cancer care. If confirmed, more research is needed on whether they reflect surgeon behavior, patient response, or physician-patient interactions," the researchers wrote. --JANUARY---------------------------------------------------------------------------------------- Breast cancer drugs increase heart risk slightly » printer friendly version NEW YORK (Reuters Health) - Aromatase inhibitors, a class of drugs used to ward off the recurrence of breast cancer after surgery, increase the risk of cardiovascular disorders slightly more than does treatment with tamoxifen, a new study shows. Aromatase inhibitors are superior to tamoxifen in some circumstances, the researchers point out in the medical journal Cancer, but previous reports have suggested a trend toward increased cardiac events in association with their use. To look into this, Dr. Federica Cuppone from Regina Elena National Cancer Institute, Rome, and colleagues analyzed data from seven studies involving a total of nearly 20,000 postmenopausal women with early breast cancer. ADVERTISEMENT After follow-up periods ranging from about 2 years to 5 years, there was a small 31 percent relative increase |
| From Medscape Hematology-Oncology
Talking With Your Patients About Cancer What Patients Need to Know About Hot Flashes Posted 02/27/2008 Charles L. Loprinzi, MD Author Information Editor's Note: Hot flashes are an inevitable part of life for most women as their ovaries stop producing estrogen, their menstrual periods diminish, and they become menopausal. In women with breast cancer, hot flashes may be more severe and frequent than in women without breast cancer, largely due to the various treatments used for treating the breast cancer. For the most part, however, the efficacy of treatments for hot flashes in patients with breast cancer is similar to that in women without breast cancer. Although estrogen-based therapy has been standard treatment and perhaps still the most effective therapy for hot flashes, most physicians are reluctant to give estrogen to women with breast cancer. Ongoing study of nonhormonal treatments has shown the benefit of several treatment approaches, including some newer antidepressants and an antiseizure drug; alternative therapies have undergone considerable study, but efficacy claims are largely unsubstantiated by reliable clinical trials. For a woman with breast cancer, discussion about hot flashes and their management typically takes place with her oncologist. According to Charles L. Loprinzi, MD, Professor of Oncology at the Mayo Clinic College of Medicine in Rochester, Minnesota, an expert on this topic, oncologists have a responsibility to talk to their breast cancer patients about treatment options for hot flashes. In a recent interview with Mary Beth Nierengarten, MA, on behalf of Medscape, Dr. Loprinzi addressed some of the common concerns of patients with breast cancer in regard to hot flashes and currently available treatments. Ms. Nierengarten: Most women experience hot flashes as a normal symptom of menopause. Are hot flashes different in women with breast cancer? Dr. Loprinzi: Hot flashes are a major problem for many women as they go through the menopausal period. The reason women experience hot flashes is because the ovaries cease the production of estrogen, which eventually leads to the cessation of menstrual periods. This is normally a relatively slow process that begins around the age of 50 years and occurs over a few years, but it can vary from age 45 to 60. In many women with breast cancer, hot flashes can be even more of a problem than for those without breast cancer because some of the treatments used to treat breast cancer can cause an abrupt or premature menopause. Chemotherapy or ovarian suppression treatments (either removing the ovaries or suppressing their function through medical means) can cause this menopause. For example, a 35-year-old woman who has had her ovaries removed usually will have a lot of trouble with hot flashes. Administration of the antiestrogen agent tamoxifen or an aromatase inhibitor can also lead to hot flashes. In postmenopausal women who start tamoxifen, hot flashes are more common among those who had substantial difficulty with hot flashes at the time of menopause or who had been taking estrogen replacement therapy. Premenopausal women tend to have less trouble with hot flashes while receiving tamoxifen and their hot flashes are often temporary. Ms. Nierengarten: Why are hot flashes more of a problem in women who undergo an abrupt ending of their menses? Dr. Loprinzi: During a natural menopause, hormone concentrations in the blood usually decrease somewhat gradually over the course of months to a few years. An abrupt cessation of hormone concentrations in the blood seems to lead to more severe symptoms. What occurs in men is similar. Men usually do not experience hot flashes because they typically do not have abrupt decreases in testosterone blood concentrations; rather, they very gradually decrease over time. However, when testosterone concentrations are abruptly lowered, as occurs when men are treated for prostate cancer, hot flashes may be a substantial problem. Ms. Nierengarten: How are hot flashes measured in your studies? Dr. Loprinzi: In all of our studies, patients keep track of their hot flashes for a week, using a daily diary to record how many hot flashes they have every day. We also ask them to grade the severity of the hot flashes on a scale of 1-4, with 1 being mild, 2 moderate, 3 severe, and 4 very severe. Then we can either determine the frequency by just counting the number of hot flashes per day, or develop a hot flash score using both the frequency and the severity rating. For example, a person who records 10 hot flashes a day and labels their severity as 3 will have a score of 30. If you look at the results of these studies graphically, you almost always see that the decrease in hot flash frequency from baseline is the same as the decrease in the hot flash score. This tells me that the hot flash frequency and severity generally go hand in hand. Ms. Nierengarten: For how long a period do hot flashes typically last? Dr. Loprinzi: On average, hot flashes last for 3-4 years. However, 15% of women will have them for 10-15 years or longer. On the other hand, some women will not experience hot flashes at all. Ms. Nierengarten: As a medical oncologist, how did you develop an interest in studying hot flashes? Isn't this an issue usually evaluated by gynecologists or endocrinologists? Dr. Loprinzi: Hot flashes are a substantial problem in patients with a history of breast cancer. Two decades ago, when we first started studying hot flashes in these patients, physicians were wary of using estrogen therapy in this population and therefore denied them what was the most effective therapy for hot flashes. At that time, there was less concern about the use of estrogen in women who did not have a history of breast cancer, and there was not much effort to find nonestrogenic means of treating hot flashes. Thus, my colleagues and I started to look at nonestrogenic therapies for hot flashes for our patients with breast cancer. Ms. Nierengarten: What are some of the nonestrogenic therapies used to treat hot flashes in women with breast cancer? Dr. Loprinzi: One of the nonestrogenic therapies that we have studied, although still a hormonal therapy, is progesterone.[1-4] Before discussing the results of studies with progesterone and other agents, it is worth noting that there is about a 25% reduction of hot flashes among those who receive a placebo when data after 4 weeks of treatment are compared with those from the baseline week. Megestrol acetate was the first progesterone that we studied, administered orally at low doses. About an 85% reduction of hot flashes was demonstrated with this drug. In another study, a single intramuscular injection of medroxyprogesterone acetate reduced hot flashes by 80% to 85% for at least 6 weeks. This is a progesterone agent that has a relatively long half-life. Despite these drugs being very effective for decreasing hot flashes, many physicians are afraid to prescribe any hormones for a person with breast cancer. Although there is some rationale for why progesterone alone might cause breast cancer-related problems, there is also a rationale for why it might be safe to administer progesterone hormones without concurrent estrogen. One reason is that we've used these drugs over the years to treat breast cancer. Ms. Nierengarten: Do you recommend hormonal therapies for hot flashes in your patients with breast cancer? Dr. Loprinzi: After discussing the potential risks and benefits, I am often willing to provide hormonal therapies as an option for patients with breast cancer. If a woman does not have breast cancer or has hormone receptor-negative breast cancer, then short-term use of hormonal therapy is a reasonable option. In that situation, I like to administer a single intramuscular injection of medroxyprogesterone acetate because it can last for a relatively long time. If a woman is hormone receptor-positive, I talk to her about the pros and cons of hormonal therapy and let her know about other options. Again, I am willing to prescribe hormonal therapy for a patient if she understands the issues. Ms. Nierengarten: Do some women with breast cancer still want hormonal therapy for hot flashes, particularly given the results of the Women's Health Initiative trial[5] that showed an increased risk for breast cancer in women who received hormonal replacement therapy? Dr. Loprinzi: Yes, some women still want to receive hormonal therapy for hot flashes. The Women's Health Initiative trial showed an increased risk for breast cancer in women (none of whom had a history of breast cancer) who received combined estrogen/progestin therapy, but in another arm of the study that included women who did not have their uteruses and who received estrogen alone, the incidence of breast cancer was neutral or even showed a trend toward a decreased risk for breast cancer. On the basis of this study, therefore, there has been concern about the use of combined estrogen/progestin therapy because that is what seems to increase the risk for breast cancer. The women in our progesterone trials did not receive estrogen but progesterone alone. Whether progesterone alone increases breast cancer risk is unknown. Because we really don't know, I tell my patients: "It might have some detrimental effect in terms of breast cancer risk; it might have some beneficial effect; or it might have a neutral effect." Whatever the effect, I think it is small. Ms. Nierengarten: This is still a big question for many women. Dr. Loprinzi: Let me change your word from "big" to "humongous." I would say this is true for physicians as well. However, I think it is a reasonable option to administer progesterone alone. Women certainly don't have to use it, but it works nicely against hot flashes, accepting that there is a potential risk. Ms. Nierengarten: What other types of treatments are available for women who do not want to take hormonal therapy? Dr. Loprinzi: Several newer antidepressants appear to reduce hot flashes. Venlafaxine and paroxetine appear to be the most effective agents, on the basis of results of the currently published studies.[6,7] In our study of venlafaxine, we achieved a 60% reduction in hot flashes using low to intermediate doses, that is, doses that are low compared with those used to treat depression. Similar results were observed with paroxetine, with about a 60% to 70% reduction in hot flashes. Sertraline and fluoxetine do not seem to work as well,[8] and the evidence is still out with regard to citalopram, although it looks promising. New data, published in January 2008, support the efficacy of another antidepressant, desvenlafaxine, in reducing hot flashes. These newer antidepressants do not decrease hot flashes as much as hormones do, but they are better than a placebo. Ms. Nierengarten: Do any of these drugs interfere with breast cancer treatment? Dr. Loprinzi: It is important to know that some of these drugs, such as paroxetine, do interfere with use of tamoxifen. For tamoxifen to be effective, it needs to be converted in the body by an enzyme, CYP2D6. Some drugs inhibit that enzyme, with paroxetine being one of the chief offenders. Sertraline and some of the other antidepressants may inhibit the enzyme to some degree, but all of the answers are not in on that drug. Venlafaxine does not appear to inhibit CYP2D6 to any significant degree. Thus, if a patient is on tamoxifen therapy, she should avoid paroxetine and other drugs that inhibit the CYP2D6 enzyme. Ms. Nierengarten: For how long do patients need to take these drugs? Dr. Loprinzi: The effects of antidepressants on hot flashes usually are apparent within the first 2-3 weeks. In one of our trials of venlafaxine,[6] patients taking venlafaxine at the lowest dose of 37.5 mg/day had a 40% reduction in hot flashes after 1 week. When we increased the dose to 75 mg/day, a 60% reduction in hot flashes was seen. Patients in the placebo group had only a 27% reduction. No one has actually looked at the best length of time to treat hot flashes. What happens in clinical practice is that after a while, if the hot flashes are controlled, patients will wean themselves off treatment or their physician will help them wean off treatment. That could be a few months, a year, or a few years later. That applies to all treatments. Ms. Nierengarten: What is your experience with patients starting and stopping drugs, such as venlafaxine? Dr. Loprinzi: With venlafaxine, it is important to start at a low dose because it can cause some toxicity -- nausea and vomiting being the most common. About 10% of women cannot tolerate venlafaxine; other women will have initial nausea that ends after about a week even though the drug is continued. When this drug is discontinued, it should be titrated down to the lowest dose. Some patients will have drug withdrawal reactions, even with slow downward titration. Ms. Nierengarten: Are some patients reluctant to take drugs labeled antidepressants? Dr. Loprinzi: Some women don't want to take an antidepressant just as they don't want to take an antiseizure medication. When we first started to use these drugs for the treatment of hot flashes, some said that the only reason they were effective was because they helped with depression. That is not true. The women in our trials did not have clinical depression. In addition, the effect of these agents on hot flashes is much more rapid than on depressive symptoms. Ms. Nierengarten: You mentioned antiseizure medication. Is this an option for the treatment of hot flashes in women with breast cancer? Dr. Loprinzi: Gabapentin, an antiseizure medication that is also used for pain management, is another drug that has efficacy against hot flashes. It is approved by the FDA [US Food and Drug Administration] for the treatment of postherpetic neuralgia and seems to be effective against other types of pain, such as diabetic neuropathy. Randomized controlled trials of gabapentin have shown a 50% to 60% reduction of hot flashes, which is similar to that achieved with antidepressants.[9,10] This drug is pretty well tolerated. Some patients report light-headedness and some swelling. As with the antidepressants, it is necessary to start at a low dose and titrate upward. Although therapy can be initiated at 300 mg/day, the most studied dose is 900 mg/day. Higher doses may be more effective for hot flashes, but this has not yet been established. For people who use gabapentin for pain, doses can be as high as 3000 mg/day. A question that remains to be answered is whether the newer form of gabapentin, pregabalin will also be effective against hot flashes. Studies are under way. Ms. Nierengarten: What about other types of drugs? Dr. Loprinzi: Clonidine, an older drug that historically was used to treat high blood pressure, is the first drug we tested for hot flashes.[11] Clonidine decreases hot flashes by about 40%, so it is generally less effective than the antidepressants or gabapentin. Clonidine works nicely in some women but not in others. That is actually true for all of these agents. Clonidine is not used all that often for a number of reasons: (1) it doesn't work as well as some of the newer drugs, and (2) it has been associated with more side effects, such as dry mouth, sleeping difficulty, and low blood pressure. Ms. Nierengarten: When discussing these treatment options with your patients, do you tell them that it may take trial and error to find the treatment that best suits them? Dr. Loprinzi: Yes, I do. Ms. Nierengarten: What about alternative therapies for the treatment of hot flashes? There is a lot of information in the mainstream media about vitamin E, black cohosh, and soy. This subject can be very confusing for patients. Dr. Loprinzi: One study[12] has examined the effects of vitamin E on hot flashes and has suggested some benefit in terms of a reduction of 1 hot flash per day. Thus, with vitamin E, a person might have the equivalent of the placebo effect, plus a little bit more. We initially thought that vitamin E was well tolerated, but newer information has suggested that it might increase mortality in patients with chronic diseases. Many other alternative therapies have been thought to be helpful and studied, but the claims of benefit have not been substantiated by good studies. In that category are soy products. We conducted one of the first studies on the effects of soy on hot flashes and it was convincingly negative.[13] Most of the other soy studies had the same conclusion. So, at this point in time, no soy product has been clearly demonstrated to be helpful. That does not mean that there might not be some soy product at some time that may be beneficial to some degree. Also in this category is black cohosh, despite the advertisements. The good placebo-controlled trials on black cohosh do not show a benefit in terms of preventing hot flashes.[14] Some published studies do claim a benefit associated with black cohosh, but they are not very good studies. Another alternative therapy thought to play a role in the prevention of hot flashes is acupuncture. There is one published placebo-controlled trial from our group at the Mayo Clinic that did not show a benefit.[15] Ms. Nierengarten: If a patient asks you about using these alternative therapies, what do you say to her? Dr. Loprinzi: One question that I am asked by many patients is whether there is any evidence that these therapies can be harmful. What about soy? The pendulum has swung back and forth. Fifteen years ago there was information suggesting that soy might prevent breast cancer, and that the reason why women in Asia did not develop breast cancer was because of the high level of soy in their diet. Later, other data suggested that soy, because it is estrogenic, increases breast cancer risk. I currently conclude that there is nothing convincing one way or the other. Data are lacking that would make me recommend pharmacologic doses of soy for hot flashes or for breast cancer prevention. On the other hand, if patients like to include soy in their diet, I suspect that that may be better than eating all animal fat, and I don't try to dissuade them. Ms. Nierengarten: Are there any other things that women can do to relieve hot flashes? Dr. Loprinzi: Among the things that women can do is to layer their clothing, use fans to keep the air moving to cool them down, not sleep with too many blankets, and keep their bedroom cooler at night. Other interventions that may be helpful are meditation and hypnosis. Preliminary data show that meditation-type breathing might be helpful, not at the time of a hot flash but once or twice a day on a scheduled basis. I emphasize that this might help prevent hot flashes. Studies are ongoing to try to substantiate this claim. Hypnosis also might be helpful; early data are becoming available, but more definitive data are needed. Ms. Nierengarten: Does having breast cancer change or affect the efficacy of these treatments for hot flashes? In other words, is there a difference in the efficacy of hot flash treatments based on breast cancer status? Dr. Loprinzi: In terms of the efficacy of treatment of hot flashes, it doesn't matter whether a woman has breast cancer. Also, for all practical purposes, it doesn't matter whether a woman is taking tamoxifen.[16] That is not general knowledge and it is not generally accepted, but there is information to support that statement. Ms. Nierengarten: What message would you like to give to other oncologists about talking to their breast cancer patients about hot flashes? Dr. Loprinzi: Hot flashes can be a substantial problem in many women, including patients with breast cancer. A number of therapies do work to reduce hot flashes, including estrogen and progesterone. Nonhormonal therapies, mostly the newer antidepressants and gabapentin, also reduce hot flashes, but not to the same degree as estrogen or progesterone. One agent cannot be guaranteed to work for everyone, and there are side effects associated with any of these treatments. Nonetheless, options are available for women who wish to have therapy for their hot flashes. Supported by an independent educational grant from Susan G. Komen for the Cure. |
