четверг, 30 июня 2011 г.
Solis Women's Health Opens New Facility, Texas
Brad Hummel, Chief Executive Officer, said "This is our first dedicated screening-only center. By taking advantage of our integrated digital imaging network, Weatherford area patients will be afforded convenient access to the Solis team of specialized radiologists while remaining close to home. In the event additional diagnostic procedures are required, patients will have available the continuum of care provided in our comprehensive breast care centers located in the nearby Metroplex."
Hummel continued, "Early disease detection is the key to effective breast care. By providing accessible state of the art technology and highly trained physician interpretation, we eliminate obstacles to women obtaining annual mammograms and establish a new standard of care in the communities we serve."
About Solis Women's Health
Solis Women's Health is a specialized healthcare provider focused exclusively on the screening and diagnosis of breast cancer. Headquartered in Austin, TX, Solis operates eight north central Texas facilities; the Solis-Bertrand Breast Center in Greensboro, North Carolina; Solis-BenOra Imaging in Phoenix, Arizona; and has several sites under development in markets across the United States. Solis provides a complete range of breast health services including screening mammography, diagnostic mammography, computer-aided detection, breast ultrasound, bone densitometry and stereotactic and ultrasound-guided biopsy, breast specific gamma imaging and breast MRI. More information is available at SolisHealth.
среда, 29 июня 2011 г.
Molecular change during brain tumor progression evident in breast cancer
according to a study conducted at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute. The shift appears to be part of a
process that enables tumors to develop the new blood vessels they need to grow rapidly, migrate and invade other tissue.
Although the switch is evident even in an early stage of breast cancer when cells are proliferating but not infiltrating
normal tissue, it becomes more pronounced as the cancer progresses to the invasive stage. Therefore, the genes involved and
the proteins they produce may become markers that physicians can use to determine disease progression and patient prognosis.
They also may become targets for new therapies.
The switch affects proteins called laminins, which are components of the "basement membrane" of blood vessels, a thin
mesh-like structure beneath the cells of the blood vessel surface (epithelium). Although the surface cells and the basement
membrane are distinct entities, they affect each other through biochemical interactions. In fact, the cells actually
influence the composition of the basement membrane, and the membrane, in addition to serving as a scaffold for cell
attachment, regulates cell behavior, proliferation and migration.
The laminin molecule is composed of three chains -- designated alpha (Ј), beta (Ј]) and gamma (Ј^) -- that are linked
together in various combinations to form 15 known isoforms or types of laminin. Each isoform has distinct characteristics and
functions. Isoforms are known to change in normal tissues at various stages of development but they also have been found to
shift in the presence of several invasive cancers. This shift coincides with blood vessel changes that encourage tumor growth
and metastasis.
Over the past several years, Cedars-Sinai researchers published several articles related to their findings that the beta
chain of laminins changed as brain tumors called glioblastoma multiforme progressed. Specifically, laminin-9 (Ј4Ј]2Ј^1)
switched to laminin-8 (Ј4Ј]1Ј^1). Not only did the change occur, but as a brain tumor's grade advanced, the expression of
laminin-8 increased significantly.
Now, in their study of breast cancer, the researchers documented for the first time that laminin-9 switched to laminin-8, and
laminin-11 (Ј5Ј]2Ј^1) switched to laminin-10 (Ј5Ј]1Ј^1) as non-invasive ductal carcinoma in situ progressed to the invasive
ductal carcinoma (IDC), the type of breast cancer that accounts for about 80 percent of cases. The shift in these laminins
and the presence of another isoform (laminin-2) also were seen in breast cancer cells that had metastasized to the brain.
"Although the exact mechanism causing these shifts has not yet been defined, the overexpression of laminin-2, laminin-8 and
laminin-10 strongly relates to the development of breast cancer-induced neovascularization and tumor progression," said Keith
L. Black, M.D., director of the Maxine Dunitz Neurosurgical Institute and one of the paper's authors. "Determining the
relative expression of Ј]1 to Ј]2 chains may be useful in diagnosing the stage and progression of breast cancer, predicting
additional tumor growth and metastasis, and determining patient prognosis."
An aggressive tumor would quickly outgrow its source of nutrients and oxygen if not for the interaction between the blood
vessel cells and the basement membrane to ensure a constantly renewing supply of small vessels, said Black, who directs the
medical center's Division of Neurosurgery and the Comprehensive Brain Tumor Program. But in one of their laboratory studies
of brain tumor tissue, the researchers were able to reduce tumor cells' ability to invade neighboring tissue by blocking the
expression of the laminin-8 gene.
"Like malignant brain tumors, primary and metastatic breast tumors depend on angiogenesis, the tumor-driven creation of new
blood vessels. Now we have found that similar molecular changes happen in highly vascular and invasive tumors such as breast
and brain cancers," said Julia Y. Ljubimova, M.D., Ph.D., research scientist and senior author of the article.
"Anti-angiogenic therapy that seeks to impede the development of the tumor's vascular network is one of the relatively new
and promising approaches in the treatment of solid tumors. The molecular mechanisms that contribute to tumor proliferation
may prove to be targets for therapeutic intervention."
"The importance of the present paper is that this is the first demonstration of specific laminin isoform changes in
pre-cancerous (ductal carcinoma in situ) and invasive ductal carcinoma as well as its metastases, in comparison with normal
breast tissues," said Shikha Bose, M.D., an expert breast pathologist who participated in the study. "ѓТ1 chain of laminin-2,
-8 and -10 is detected in newly formed tumor vessels and might be important predictors for patient outcome."
One of only four hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai
Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 17 consecutive
years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area
residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of
programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the
top 10 non-university hospitals in the nation for its research activities and was recently fully accredited by the
Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available
at cedars-sinai.
Contact: Sandy Van
sandyprpacific
1-800-880-2397
Cedars-Sinai Medical Center
csmc
вторник, 28 июня 2011 г.
'Networks' Of Interactive Genes May Predict If Leukemia Is Aggressive Or Slow-Growing
One of the problems in deciding on the right therapy for chronic lymphocytic leukemia (CLL) is that it is difficult to know which type a patient has. One form progresses slowly, with few symptoms for years. The other form is more aggressive and dangerous. While tests exist and are commonly used to help predict which form a patient may have, their usefulness is limited.
Han-Yu Chuang, a Ph.D. candidate in bioinformatics and systems biology program in the department of bioengineering in the UC San Diego Jacobs School of Engineering, senior author Thomas Kipps, M.D., Ph.D., professor of medicine and deputy director for research at the Moores UCSD Cancer Center, and their colleagues analyzed the activity and patterns of gene expression in cancer cells from 126 patients with aggressive or slow-growing CLL. The researchers, using complex algorithms, matched these gene activity profiles with a huge database of 50,000 known protein complexes and signaling pathways among nearly 10,000 genes/proteins, searching for "subnetworks" of aggregate gene expression patterns that separated groups of patients. They found 30 such gene subnetworks that, they say, were better in predicting whether a disease is aggressive or slow-growing than current techniques based on gene expression alone.
They presented their results Monday, December 8, 2008 at the annual meeting of the American Society of Hematology in San Francisco.
"We wanted to integrate the gene expression from the disease and a large network of human protein interactions to reconstruct the pathways involved in disease progression," Chuang explained. "By introducing the relevant pathway information, we can do a better job in prognosis." Chuang, co-author Trey Ideker, Ph.D., professor of bioengineering at UCSD, and their co-workers have previously shown the potential of this method in predicting breast cancer metastasis risk.
"When you are analyzing just the gene expression, you are analyzing it in isolation," Chuang explained. "Genes act in concert and are functionally linked together. We have suggested that it makes more sense to analyze the genes' expression in a more mechanistic view, based on information about genes acting together in a particular pathway. We are looking for new markers - no longer individual genes - but a set of co-functional, interconnected genes," she said. "We would like to be able to model treatment-free survival."
The current work is "proof of principle," Chuang said. Clinical trials will be needed to validate whether specific subnetworks of genes can actually predict disease CLL progression in patients. She thinks that the subnetworks can be used to provide "small scale biological models of disease progression," enabling researchers to better understand the process.
Eventually, she said, a diagnostic chip might be designed to test blood samples for such genetic subnetworks that indicate the likely course of disease. The involved biological pathways could be drug targets as well.
The American Cancer Society estimates that, in 2008, there will be about 15,110 new cases of CLL in the United States, with about 4,390 deaths from the disease.
Laura Rassenti, Ph.D., UCSD, was also a co-author on the study.
The Moores UCSD Cancer Center is one of the nation's 41 National Cancer Institute-designated Comprehensive Cancer Centers, combining research, clinical care and community outreach to advance the prevention, treatment and cure of cancer. For more information, visit cancer.ucsd/.
Source: Steve Benowitz
University of California - San Diego
понедельник, 27 июня 2011 г.
Perceived Discrimination Affects Screening Rates
"We have yet to achieve bias-free health care. This has serious public health implications as we know that higher levels of screening lead to lower levels of mortality. Clinicians need to be aware that they may be sending signals, even unintentionally, that lead minorities to believe they are being discriminated against," said LaVera M. Crawley, M.D., M.P.H., an assistant professor at the Stanford University Center for Biomedical Ethics.
Exactly what those signals are will need to be determined in future studies, Crawley says, but the relationship between perceived discrimination and failing to get regular screenings is strong.
Crawley and colleagues analyzed data from the California Health Interview Survey, which examined cancer screening trends among African-American, American-Indian/Alaskan-Native, Asian and Latino adults. The data set included 11,245 respondents.
"Respondents answered yes or no to 'was there ever a time that you would have gotten better medical care if you had belonged to a different ethnic group?' However, we were not able to ask why they felt discriminated against," Crawley said.
If minority women perceived racial discrimination, they were 34 percent less likely to be screened for colorectal cancer and 48 percent less likely to be screened for breast cancer, compared with women of any racial group who did not perceive discrimination, researchers found.
The results were slightly different among minority men. Overall, men who perceived racial discrimination were no less likely to be screened for colorectal cancer than those who did not perceive discrimination.
However, if they had a regular source of health care, they were 70 percent less likely to receive colorectal screening if they perceived racial discrimination.
"This contradicts the general assumption in public health that having a usual source of care is a cure all," Crawley said. "If men felt discriminated against by their regular health care provider, they did not receive screening. So there is something else factoring in."
Crawley says the specific factor would need to be explored in further research, but it may be that there are specific racial stereotypes that apply to men that would not apply to women. "For example, African American men may be stereotyped as being more violent, which would affect how doctors respond to them and thus create a potential for discrimination," said Crawley.
According to Crawley, the consequences for delayed screening are dramatic. If detected early, five-year survival rates for colorectal and breast cancer are approximately 90 percent. However, if caught in later stages, the survival rate for colorectal cancer is 10 percent and 23 percent for breast cancer.
"The longer someone delays screening the worse the outcome. Perception of discrimination may be driving the differences we see in outcomes among minorities," said Crawley.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 28,000 basic, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and 80 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication and its sixth major journal, Cancer Prevention Research, is dedicated exclusively to cancer prevention, from preclinical research to clinical trials. The AACR also publishes CR, a magazine for cancer survivors and their families, patient advocates, physicians and scientists. CR provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship and advocacy.
American Association for Cancer Research
воскресенье, 26 июня 2011 г.
Medifocus Inc. Reports Improved Clinical Efficacy For Its Phase II, Randomized Clinical Study For The Treatment Of Early Stage Breast Cancer Tumors
The primary treatment modality for the treatment of early stage breast cancer is surgery. For early stage breast cancer, if the tumor is detected early enough, and the tumor is small enough, then a breast conservation surgery (BCS) known as lumpectomy could be offered. One of the biggest concerns for lumpectomy is positive tumor margins, which normally will require either re-excision or second incision to remove the remaining cancer cells. In addition, clinical studies indicate that if the surgery is performed and the margin is positive with cancer cells, then there is an estimated 500% increase in the chance for recurrence of the breast cancer compared to when the margins are negative. The reported clinical trial results demonstrated that when Medifocus's focused heat therapy alone was delivered prior to surgery, 0 of 34 (0%) of the tumors removed had positive margins whereas in the surgical arm without receiving the focused heat treatment, 4 of 41 or almost 10% had positive margins.
This study, along with the positive clinical efficacy results of another randomized study for the treatment of large breast cancer tumors that Medifocus reported last week, demonstrates that Medifocus's focused heat technology can potentially treat the majority of all localized and invasive breast cancer tumors detected. The study reported last week, demonstrated that when the Medifocus's focused heat was added to the standard of care (SOC) neo-adjuvant chemotherapy in the treatment of large breast cancer tumors, tumor shrinkage was increased by an additional 50% over that induced by (SOC) chemotherapy alone.
The treatment goal of the Medifocus study on early stage breast cancer, is to demonstrate that focused heat treatment delivered prior to surgery can improve surgical outcomes and decrease the need for re-excisions or a second incision which can improve cosmesis and may reduce recurrent rates of the breast cancer.
About Medifocus
Medifocus owns a patented microwave focusing technology (the Adaptive Phased Array ("APA") technology), which can precisely target and control microwave energy to cause heating in cancerous tumors anywhere in the body reliably and repeatedly. The ability to target tumors with a precision controlled dose of heat can be used to destroy tumors at higher temperatures, to treat tumors in combination with chemotherapy and/or radiation at moderate temperatures for increased effectiveness and reduced toxicity and to trigger the targeted release of therapeutic drugs and genes at tumor sites at lower temperatures. While the core technology has been licensed from the Massachusetts Institute of Technology, Medifocus has further refined the precision of the microwave focusing and control ability and developed a commercial system dedicated exclusively for the treatment of Breast Cancer.
Forward Looking Statements and Information
This News Release contains forward-looking statements which may not be based on historical fact. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
Source: Medifocus Inc
суббота, 25 июня 2011 г.
Breast-Cancer Risk Linked to Exposure to Traffic Emissions at Menarche, First Birth
cancer in women who are lifetime nonsmokers, a study by epidemiologists and geographers at the University at Buffalo has
found.
Their study was conducted among women who lived in Erie and Niagara counties of New York State between 1996 and 2001. They
found that higher exposure around the time of first menstruation to polycyclic aromatic hydrocarbons (PAHs), potential
carcinogens found in traffic emissions, was associated with increased risk of premenopausal breast cancer.
However, for postmenopausal women, higher exposure to PAHs at the time of the first birth was associated with increased risk.
Neither association was found in women with a history of smoking.
Results of the study were presented earlier this month at the annual meeting of the American Association for Cancer Research
held in Anaheim, Calif. Jing Nie, Ph.D., a postdoctoral fellow in epidemiology in UB's School of Public Health and Health
Professions is first author on the study.
"There is growing evidence that there may be times in a woman's life when exposures to potential carcinogens may be critical
for breast-cancer initiation and development," said Nie. "Our study findings support the hypothesis that exposures in early
life contribute to breast-cancer risk."
The study was based on data from the Western New York Exposures and Breast Cancer (WEB) study. All participants were women
between the ages of 35 and 79 who lived in Erie or Niagara counties at the time of data collection. Women with primary,
histologically confirmed breast cancer served as cases. Controls were randomly selected and matched to cases on age, race and
county of residence.
Researchers in the WEB study conducted in-depth personal interviews with study participants to collect data on potential
breast-cancer risk factors and a history of where they had lived at different times in their lives. Researchers were
interested particularly in information related to four time periods: menarche (first menstrual period), first birth, 20 years
prior to the interview and 10 years prior.
Several information sources provided data on traffic volumes on roads in question for the years from 1960 to 2002 and
tail-pipe emissions, including measurements from tunnels and tests on individual vehicles. A geographic model was used to
reconstruct historic traffic PAHs, using measurements of benzo[a]pyrene, a known potent mutagen and carcinogen, as a
surrogate for total PAH exposure. Cruise emissions, cold engine emissions and intersection emissions were used to estimate
total traffic PAH emissions.
In addition, meteorological information was used in a geographic dispersion model to determine PAH exposure at each
participant's residence.
While the researchers found increased risk for exposure at menarche and first birth for premenopausal and postmenopausal
participants, respectively, who were lifetime nonsmokers, there was no association of traffic emissions with breast cancer
for the other time periods.
Nie said these findings related to PAHs need to be interpreted with caution, because they could be explained by other
compounds in vehicle exhaust or by other exposures related to the traffic emissions.
"While these results are subject to the limitations of epidemiologic observational studies, they are provocative in providing
evidence both of the importance of early exposures and of the potential importance of an environmental agent in risk of
breast cancer," said Nie. "Further examination of PAH exposure in early life is clearly warranted."
The UB researchers currently are examining whether genetic polymorphisms involving PAH metabolism may modify the risk, if
lifeline cumulative exposure may be associated with the risk and if this study may be replicated in another geographic
settings.
Jo Freudenheim, Ph.D., UB professor of social and preventive medicine, heads the WEB study.
Additional researchers were Jan Beyea, Ph.D., from Consulting in the Public Interest of Lambertville, N.J., who developed the
geographic dispersion model; Matthew Bonner, Ph.D., of the National Cancer Institute (NCI); Daikwon Han, Ph.D., Dominica
Vito, and Maurizio Trevisan, M.D., from the Department of Social and Preventive Medicine, UB School of Public Health and
Health Professions; and Peter Rogerson, Ph.D., of the Department of Geography, UB College of Arts and Sciences, along with
John Vena, Ph.D., now at the University of South Carolina, and Paola Muti, M.D., now at Italy's National Cancer Institute in
Genoa.
The research was supported in part by grants from the U.S. Army Breast Cancer Research Program and NCI.
The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the
State University of New York.
Contact: Lois Baker
ljbakerbuffalo
716-645-5000 x1417
University at Buffalo
buffalo
пятница, 24 июня 2011 г.
News And Feature Story Ideas For Breast Cancer Awareness Month (October)
The Chicago Breast Cancer Task Force will hold a press conference at Rush University Medical Center at 10 a.m. on October 17 to announce the group's recommendations to address breast cancer disparities and improve breast cancer care for all women. The citywide task force was created in response to a report issued in October 2006 about the alarming disparities in breast cancer mortality rates between African-American women and white women in Chicago.
Rush Researchers Study Groundbreaking Drug Avastin
Avastin, a humanized monoclonal antibody designed to interfere with the blood supply to a tumor, has been shown in clinical trials to provide significant benefit for advanced breast cancer patients. The next step is studying the drug in the adjuvant setting to determine if it can prevent tumors from reoccurring. "This is a drug that sabotages new blood vessel formation. The tumor can't grow bigger than the size of a sesame seed without an oxygen supply," said Dr. Melody Cobleigh, medical director of the Coleman Foundation Comprehensive Breast Center at Rush. Rush has been involved in the study of Avastin from the very beginning, participating in both the Phase I and Phase II studies of the drug.
Testing New Approaches to Treat Breast Cancer
Oncologist Dr. Ruta Rao is studying the use of Tarceva, a targeted drug therapy against the epidermal growth factor, for breast cancer patients whose genetic makeup puts them in a subset of patients typically very difficult to treat. Tarceva is currently approved for metastatic lung cancer and metastatic pancreatic cancer. Researcher Xiulong Xu, PhD is studying a drug used to suppress an enzyme associated with increased tumor growth and examining its potential to prevent and treat breast cancer.
New Electronic Brachytherapy Treatment System for Breast Cancer
Rush is the first medical center in the Midwest to treat breast cancer patients using a miniature X-ray source that can deliver localized and targeted radiation treatment in any clinical setting, rather than in heavily-shielded environments. The Xoft Axxent Electronic Brachytherapy System delivers therapy in 10-15 minutes, two times a day, for five days straight. "This system reduces radiation treatment from seven weeks down to five days," said surgeon Dr. Kambiz Dowlat. "With the shorter treatment time, more patients may choose breast sparing surgery over the alternative of a full mastectomy."
Breast Cancer in Perspective: Amazing Advances Greatly Reduce Mortality
In the last 20 years, with most of the progress in the last 10 years, a number of advances have led to a reduced mortality in breast cancer. According to the American Cancer Society the death rate for women under the age of 50 has been decreasing approximately 3.3% every year since 1990 and the death rate is decreasing 2% every year for women over the age of 50. New and innovative types of treatment, preventive measures, and diagnostic techniques have been developed such as Tamoxifen for the prevention of breast cancer in high-risk women, Herceptin for the treatment of tumors that express Her2/ErbB2 and aromatase inhibitors for the treatment of postmenopausal estrogen receptor-positive breast cancer. "The vast majority of patients with operable breast cancer are cured today," said Dr. Melody Cobleigh
"Venture" Initiative Funds Research at the Earliest Stages
Breakthrough ideas grow during the earliest stage of research, which is the most difficult stage to fund through grants. The Segal Foundation Research Initiative in Women's Cancers is providing the "seed" funding for seven young researchers at Rush to help them take their ideas from vision to reality. Based on the idea of "venture philanthropy," the Segal Foundation's initiative represents a new way of thinking about traditional giving. Applying venture capital principals to the philanthropic process focuses on results and provides the most gratifying return on investment. The initiative has inspired other organizations to take a similar approach. The Brian Piccolo Cancer Research Fund, with support from the Gavers Community Cancer Foundation, will provide seed monies this year to three talented researchers studying new approaches to breast cancer diagnosis and treatment. Likewise, the Rush Associates Board, an auxiliary group of mid-career professionals, will support young Rush researchers seeking to test promising ideas in a variety of clinical disciplines that are not yet ready for funding by established foundations or governmental agencies.
Awareness is Up but Fewer Women Getting Mammograms
After rising steadily during the 1990s, mammography screening rates leveled off after 2000 and began to decline about 2003, according to a recent study from the National Cancer Institute. The report says only 66% of eligible women are being screened; three million fewer women than five years ago. "Early detection saves lives and increases treatment options," says Dr. Peter Jokich, director of the Rush Breast Imaging Center. "Approximately 75 percent of women who develop breast cancer have no significant risk factors. Therefore, every woman over the age of 40 should undergo a screening for breast cancer with mammography every year."
Future Advances, Clinical Trials Stalled by Low Patient Participation
Before a new treatment becomes available, researchers must recruit hundreds or thousands of patients to participate in clinical research trials. But finding these patients is increasingly difficult. "Only 2% of cancer patients participate in clinical trials," said Dr. Melody Cobleigh. "There is a need for greater participation, especially in randomized Phase III trials." Even a modest increase of 2 to 3 percentage points would make a major impact, meaning the difference between completing a study in two years instead of three years.
Will You Get Breast Cancer? Genetic Testing for High Risk Patients
The Rush Inherited Susceptibility to Cancer Program (RISC) counsels people on their personal and family risks for developing cancer, and provides information on prevention and early detection. Cancer-causing mutations in the BRCA1 and BRCA2 genes account for approximately 5%-10% of all breast cancer cases. "We don't recommend widespread testing for these mutations, however women with a strong family history of breast cancer should undergo counseling to determine if a genetic test is appropriate," said Dr. Lydia Usha, director of the RISC program.
Holistic Cancer Treatment Focuses on the Emotional, Psychological and Spiritual Effects of Cancer
The Cancer Integrative Medicine Program at Rush is designed to relieve stress, pain and fatigue, as well as help patients take an active role in enhancing their health. The program offers integrative and behavioral medicine methods of treatment including acupuncture, biofeedback, guided imagery, medical hypnosis, yoga, massage, nutritional counseling, and herbal counseling. "Stress is a huge issue for people with cancer," said Janine Gauthier, PhD, director of clinical services for the program. "When patients get relief from stress, they gain a sense of control and may tolerate their medical treatments better."
rush
View drug information on Avastin; Herceptin; Tarceva.
четверг, 23 июня 2011 г.
Hormone Replacement Therapy: Real Concerns And False Alarms
Despite "weak or statistically insignificant" data, scientific and media reports have emphasized the dangers of HRT, while downplaying its beneficial effects especially on menopausal symptoms, according to the article by Avrum Z. Bluming, M.D., and Carol Tavris, Ph.D. "Physicians and the public must be cautious about accepting 'findings by press release' in determining whether or not to prescribe or take HRT," according to Drs. Bluming and Tavris. Dr. Bluming is a Board-Certified Medical Oncologist, a Master of the American College of Physicians and a Clinical Professor of Medicine at the University of Southern California. Dr. Tavris is a social psychologist and writer.
Discrepancies Between Reports of HRT Dangers and Supporting Data
Doctors Bluming and Tavris cite the Harvard Nurses' Health Study, published in 1995, which employed retrospective substratification to exaggerate the association between HRT and breast cancer development. Statisticians have cautioned that spurious associations can result from this practice also called "data mining" in which researchers sift through their databases, looking for factors that might affect health outcomes. "The problem is that in a data set of many thousands of people, some relationship that is unearthed retrospectively will turn out to be statistically significant...just by chance."
The authors also criticize the Women's Health Initiative (WHI), published initially in 2002, which reported "relative risk" rather than "absolute risk" associations. This format can make "statistically modest or borderline results...look more impressive than they actually are." The authors note that the 26 percent relative risk of breast cancer in the initial WHI is similar to that reported for unlikely risk factors like eating grapefruit, working on a nightshift, or working as a flight attendant.
The core issue, according to Drs. Bluming and Tavris, is the difference between information and knowledge. "What we're trying to do is make a plea for knowledge, not just information, especially loosely based associations that are generated by epidemiologic studies. That isn't science. Post-hoc findings that make little or no scientific sense may give us clues for future investigation, but they shouldn't be accepted as proof of cause and effect."
Jumble of 'Positive, Negative and Meaningless' Findings
Press releases linking HRT to breast cancer failed to report that the initial WHI report of a 26 percent relative risk did not reach the level of statistical significance. Nevertheless, several editorials by prominent authorities highlighted the increase in risk as "statistically significant" a false claim repeated in news stories.
Subsequent analyses gave varying results: smaller but significant risk, larger but nonsignificant risk, or no significant difference in risk. "It is difficult to resist the conclusion that the WHI investigators have been doing everything they could to wring the bleakest possible interpretation from their recalcitrant data," Drs. Bluming and Tavris write.
Although concerns about breast cancer and other health risks are valid, "HRT is not the clear and present danger that the WHI and much of the media have made it out to be," Drs. Bluming and Tavris conclude. They contend that the weight of available evidence supports the use of HRT by women who are having menopausal symptoms, beginning at the start of menopause and continuing for as many years as necessary.
About The Cancer Journal
The Cancer Journal: The Journal of Principles & Practice of Oncology provides an integrated view of modern oncology across all disciplines. The Journal publishes original research and reviews, and also serves to update the content published in the textbook Cancer: Principles & Practice of Oncology
About Lippincott Williams & Wilkins
Lippincott Williams & Wilkins (LWW) is a leading international publisher for healthcare professionals and students with nearly 300 periodicals and 1,500 books in more than 100 disciplines publishing under the LWW brand, as well as content-based sites and online corporate and customer services. LWW is part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.
Wolters Kluwer Health is a division of Wolters Kluwer, a leading global information services and publishing company. The company provides products and services for professionals in the health, tax, accounting, corporate, financial services, legal, and regulatory sectors. Wolters Kluwer had 2008 annual revenues of €3.4 billion ($4.9 billion), employs approximately 20,000 people worldwide, and maintains operations in over 35 countries across Europe, North America, Asia Pacific, and Latin America. Wolters Kluwer is headquartered in Amsterdam, the Netherlands. Its shares are quoted on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices.
Source: Wolters Kluwer Health
среда, 22 июня 2011 г.
Kansas Breast And Cervical Cancer Screening Program For Low-Income, Uninsured Women Runs Out Of Funding
The screening program depleted its funds in March. However, program officials reserved a limited amount of funding to provide diagnostic tests until the new fiscal year begins on July 1 to women who display symptoms of breast or cervical cancer. Women who inquire about the program will be placed on a waiting list and will be screened when funding becomes available. Kansas women ages 40 to 64 who are uninsured and meet income guidelines are eligible for the program. According to Neff, about 5,800 of the at least 27,000 women in Kansas who qualify to receive no-cost screenings have done so since July 1, 2007.
Neff said she requested slightly more than $2.3 million in federal funds for FY 2009 (Shideler, Wichita Eagle, 5/5).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
вторник, 21 июня 2011 г.
Industry-funded Breast Cancer Trials More Likely To Yield Positive Results
Published online Monday (Feb. 26) in Cancer, the journal of the American Cancer Society, the study explores the impact of pharmaceutical-company involvement on breast cancer clinical trial design and outcome. Drug-industry investment in research now exceeds the operating budget of the National Institutes of Health and previous studies have examined the impact on other areas of clinical medicine, but not breast cancer.
"Our study shines a flashlight on the issue of the rising role and potential impact of the pharmaceutical industry on breast cancer research and highlights important questions that need to be addressed through further research," said Dr. Jeffrey Peppercorn, assistant professor of medicine in UNC School of Medicine's division of hematology and oncology and a member of the UNC Lineberger Comprehensive Cancer Center.
"The significance of our study is not to say that the drug industry does anything wrong they are excellent at developing new therapies, and there are many recent examples in breast cancer research. But if more and more research is funded by drug companies, then the limited amount of funding coming from other sources may need to be directed to address other questions," Peppercorn said.
The researchers reviewed all breast cancer clinical trials published in 10 English-language medical journals in the years 1993, 1998 and 2003. They focused their formal statistical analysis on the 2003 trials because the identification of industry funded or non-industry funded research was likely more accurate due to more stringent disclosure guidelines than earlier periods.
Trials with industry involvement were more likely than non-industry studies to use a single-arm study design, without a comparison group. This isn't surprising, Peppercorn notes, because these studies are a key step in drug development.
In 2003, 57 percent of studies reported pharmaceutical involvement. Of these, 66 percent were single-arm studies. Only 33 percent of non-industry studies used single-arm design.
The industry studies were also more likely to yield positive results; 84 percent of industry-supported studies showed positive results, compared with 54 percent of non-industry studies.
"It's been seen again and again in various branches of clinical medicine that studies that involve pharmaceutical industry sponsorship are more likely to have positive outcomes," Peppercorn said. "It's not fair to say at this point that it's necessarily related to biased interpretation of results." For instance, another explanation could be that industry makes smarter or safer choices about what drugs are brought to trial.
However, as industry funding becomes an increasingly dominant source of research funding, clinical questions that aren't directly related to drug development may be neglected, Peppercorn said. Such questions include the optimal duration for giving a medication or whether certain groups of patients benefit from a medication more than others, he said.
Study co-authors are Emily Blood, Dr. Eric Winer and Dr. Ann Partridge, all of the Dana Farber Cancer Institute, where Dr. Peppercorn received his training and initiated the study.
University of North Carolina at Chapel Hill School of Medicine
101 Manning Dr., 6002 East Wing
Chapel Hill, NC 27514
United States
med.unc
понедельник, 20 июня 2011 г.
Lapatinib Could Be Beneficial In Treating Patients With Aggressive Inflammatory Breast Cancer
In inflammatory breast cancer, the protein epidermal growth factor receptor 2 (HER2) implicated in the signaling pathways leading to cell growth is manifested much more than in other less aggressive cancers. This disease makes up one to six percent of all invasive breast tumors in Western Europe and the USA and five to ten percent in North Africa and Arabian countries. The clinical symptoms are: rapid onset of swelling, redness of the breast skin, fluid under the skin of more than two thirds of the breast resulting in a bumpy appearance, painfulness, hardening and warming of the breast.
Lapatinib hinders tumor growth because it is an oral inhibitor of HER2. Options are limited for patients with resistance to conventional anthracycline or taxane and trastuzumab treatment. The study included 126 patients receiving a daily dose of lapatinib (1,500 mg). Every four weeks, skin disease was evaluated and cancer evolution (local and secondary) was assessed using standard criteria.
Findings showed that none of the patients had an absolute response to the treatment but 39 percent (49 patients) had a partial response with a 50 percent healing in extent of skin disease from baseline. The average progression-free survival was of fifteen weeks, with an average duration of response of twenty one weeks. Six months later, 22 percent of patients were still progression-free. The probability of response to lapatinib was not altered by prior treatment with trastuzumab. The general average of survival was accounted for four groups of patients:
• 33 patients who responded to lapatinib and had previous treatment with trastuzumab. Median survival: 18.4 months.
• 15 patients who responded to lapatinib and had no previous treatment with trastuzumab. Median survival: 14.0 months.
• 61 patients unresponsive to lapatinib and previous treatment with trastuzumab. Median survival: 8.4 months.
• 16 patients unresponsive to lapatinib with no previous trastuzumab treatment. Median survival: 8.2 months.
Undesirable events were frequent since 92 percent of patients experienced at least one. Although the majority was not considered linked to lapatinib, 32 percent of patients suffered serious adverse events: eight of them experienced shortness of breath, and six of them had fluid around the lungs. There were five deaths from adverse events that were possibly treatment related.
The researchers point out: "Patients who responded to treatment with lapatinib had a longer median overall survival than did those patients who did not respond, irrespective of previous exposure to trastuzumab. Patients exposed to previous trastuzumab treatment who experienced a response to lapatinib had the longest median overall survival. This finding confirms the clinical benefit of targeted therapy in these patients."
They write in conclusion: "Lapatinib monotherapy is potentially clinically effective in heavily pretreated patients with inflammatory breast cancer with HER2+ tumours. The objective response rate noted...coupled with the median duration of response and median overall survival supports a role for lapatinib in these patients."
thelancet
Written by Stephanie Brunner (B.A.)
воскресенье, 19 июня 2011 г.
To Escape Death By Hormonal Therapy Breast Cancer Cells Recycle
About 70 percent of breast cancer cells have receptors for the hormone estrogen, which acts as a nutrient and stimulates their growth. Patients typically get an antiestrogen such as tamoxifen for five years to try to starve them to death, says Dr. Patricia V. Schoenlein, cancer researcher in the Medical College of Georgia Schools of Medicine and Graduate Studies.
"About 50 to 60 percent of these women really benefit from hormonal therapy," says Dr. Schoenlein. Why others don't has been asked for at least two decades.
One reason may be breast cancer cells switch into a survival mode that normal cells also use when faced with starvation, according to research published in the September issue of Molecular Cancer Therapeutics. Dr. Schoenlein also is reporting on the research during the 2nd World Conference on Magic Bullets (Ehrlich II) Oct. 3-5 in NГјrenberg, Germany.
It's called macroautophagy - autophagy means "self eating" - and within a week, breast cancer cells can reorganize component parts, degrade non-essentials and live in this state until antiestrogen therapy is stopped or the cells mutate and resume proliferation in the presence of tamoxifen. "It's like taking your foot off of the gas pedal of your car," says Dr. Schoenlein, corresponding author on the study. "The cancer cell is in idle, unable to grow or replicate. But the cell is smart enough to use component parts generated by macroautophagy for the most necessary things required for survival." She notes that macroautophagy can't be maintained indefinitely; cells can actually self-digest. "This is a time-buying strategy."
Chemotherapeutic drugs are more direct killers but also kill healthy cells and can be tolerated by patients only for relatively short periods. Antiestrogen therapy is more specific, targeting breast cancer cells that express estrogen receptors.
In the laboratory, 20-25 percent of breast cancer cells died when Dr. Schoenlein and colleagues gave antiestrogen continuously over time - similar to how patients get it. More typically, the cells expressed increasing levels of macroautophagy and survived. "They don't grow, but they survive the therapy. They will grow if you take away the therapy." Adding a macroautophagy inhibitor promoted robust cell death.
"We believe targeting the autophagosome function will significantly improve the efficacy of hormonal treatment for estrogen-positive breast cancer," says the researcher. She recently received a three-year, $1.1 million National Cancer Institute grant to pursue that strategy.
She'll now look for ways to block macroautophagy in an animal model, including using chloroquine, a drug used to treat malaria. "We know patients can take it with few side effects," she says. If it works in animals, the drug, in combination with an antiestrogen, could move relatively quickly into human testing.
During autophagy, the internal pH for the recycling center of the reorganized cell gets acidic and chloroquine increases pH. "If you add this particular inhibitor of the recycling center, you alter the pH and block its ability to do what it is supposed to do," says Dr. Schoenlein.
A University of Pennsylvania team led by Dr. Craig Thompson reported in 2007 in The Journal of Clinical Investigation that chloroquine increased death of suicide-resistant lymphoma cells being treated with chemotherapy. Dr. Schoenlein will give chloroquine along with an antiestrogen and measure cell death.
"Most cancers probably use autophagy as a survival mechanism. You can either block the autophagosome with your therapy or you can make the cell eat itself to the point of no return and the cell self-destructs. You have to push it either way," she says. Although there are no known compounds in clinical use to induce self-destruction by autophagy, there is some evidence arsenic trioxide, a compound used in China to treat some aggressive cancers, prompts cancer cells to die from self digestion, she says. That and other compounds will no doubt be studied further, she says.
Dr. Schoenlein believes breast cancer survival during macroautophagy requires high activity of the tumor suppressor protein Rb and low levels of the lipid ceramide. Ceramide is vital but causes cell death at high levels. MCG researcher Erhard Bieberich and colleague Dr. Brian G. Condie at the University of Georgia showed in 2003 that high levels of ceramide kill cells that are unnecessary to the developing brain. The new studies will further explore the roles of Rb and ceramide in breast cancer survival during macroautophagy and determine if chloroquine can change their balance.
MCG news categories related to this story:
Cancer
School of Medicine
School of Graduate Studies
Source: Toni Baker
Medical College of Georgia
суббота, 18 июня 2011 г.
More Complete View Of Breast Cancer Gene Mutations In US Population: New Findings
Each year, approximately 200,000 women in the United States are diagnosed with breast cancer. The majority of breast cancer cases are caused by genetic changes that occur during a woman's lifetime and not by genetic mutations inherited from her parents. However, researchers estimate that inherited mutations play a role in anywhere from 5 to 27 percent of all breast cancer cases. In the mid 1990s, researchers found that mutations in the BRCA1 and BRCA2 genes are a major cause of the hereditary form of the disease. Women inheriting these mutations have a 40 to 85 percent lifetime risk of developing breast cancer, as well as an increased risk of ovarian cancer.
To date, most of the studies on BRCA1 and BRCA2 mutations have focused on families known to be at high risk for breast cancer and on women who develop breast cancer at a relatively young age. The new study, published today in the journal Cancer Research, looked at the prevalence and predictors of BRCA1 and BRCA2 mutations in under-studied groups of women, such as African Americans and older women.
"Studies of any notable size have focused almost exclusively on white women and young women. This research clearly was needed to improve our means of assessing the likelihood of carrying BRCA1 and BRCA2 mutations in a wider spectrum of women," said one of the study's lead investigators, Elaine Ostrander, Ph.D., chief of the Cancer Genetics Branch in the National Human Genome Research Institute's Division of Intramural Research. Dr. Ostrander was previously head of the genetics program at the Fred Hutchinson Cancer Research Center, which is the institution that led the study.
The researchers examined the prevalence and predictors of BRCA1 and BRCA2 mutations in 1,628 women with breast cancer and 674 similar women without breast cancer, all of whom were participants in the National Institute of Child Health and Human Development's (NICHD's) Women's Contraceptive And Reproductive Experiences (CARE) study. The women involved in the study were white and African American women, ages 35 to 64, who lived in the Atlanta, Detroit, Los Angeles, Philadelphia and Seattle metropolitan areas.
"The advantages of this study include its large sample size, inclusion of under-studied groups of women and the fact that the results are population based," said one of the study's co-authors, Robert Spirtas, Dr.P.H, former chief of NICHD's Contraception and Reproductive Health Branch and now retired.
Researchers found that 2.4 percent of the breast cancer patients had BRCA1 mutations and 2.3 percent had BRCA2 mutations. BRCA1 mutations were more common among white breast cancer patients (2.9 percent) than among African American patients (1.4 percent). Breast cancer patients of Jewish ancestry were also significantly more likely to have BRCA1 mutations than non-Jewish patients - 10.2 percent compared to 2.0 percent. For BRCA2, African American patients were slightly more likely to have mutations, 2.6 percent, than were white patients, 2.1 percent.
Based on their findings, the researchers went on to calculate the prevalence of BRCA1 and BRCA2 mutations in the general U.S. population. Among white and African American women ages 35 to 64, the prevalence of BRCA1 mutations is 0.06 percent and the prevalence of BRCA2 mutations is 0.4 percent, the researchers estimated.
"These findings from our large, population-based study are compatible with earlier estimates made by extrapolating from smaller studies. However, we found a slightly lower frequency of BRCA1 mutations and a higher frequency of BRCA2 mutations," said the study's other lead investigator, Kathleen Malone, Ph.D., Member of the Public Health Sciences Division at the Fred Hutchinson Cancer Center. "We think the difference lies in the fact that earlier studies were confined mainly to whites, and that African American women carry BRCA2 mutations more often than white women."
The researchers also identified key predictors of whether a woman with breast cancer is likely to carry a BRCA1 or BRCA2 mutation. Such information is important because it can help to improve means of assessing which women may benefit the most from genetic testing, increased breast cancer screening and other measures aimed at early detection, treatment or prevention. The most significant predictors for BRCA1 mutations were: Jewish ancestry, a family history of ovarian cancer and a family history of breast cancer occurring before age 45.
For BRCA2 mutations, researchers uncovered fewer predictors, and they had more modest effects. Among the breast cancer patients studied, the only significant predictors of a BRCA2 mutation were early age of onset (before age 45) in the patient herself or early onset of breast cancer in mother, sisters, grandmothers or aunts.
"These findings underscore why women need to learn as much as they can about their family health history and then share that information with their health-care professionals. However, it must be emphasized that the presence or absence of a predictive factor does not automatically equate with a high or low likelihood of carrying a breast cancer gene mutation," said NIH Director Elias A. Zerhouni, M.D. "The majority of women with breast cancer - even those with a family history of the disease - do not carry mutations in these genes. These predictors need to be considered in the context of each woman's complete family health history."
In addition to the Fred Hutchinson Cancer Center, NHGRI and NICHD, the team included researchers from the National Cancer Institute; Bay State Medical Center, Springfield, Mass.; the University of Pennsylvania, Philadelphia; University of Southern California, Los Angeles; and Wayne State University, Detroit.
About NIH
The National Cancer Institute, the National Institute of Child Health and Human Development, and the National Human Genome Research Institute are among the 27 institutes and centers that make up the National Institutes of Health (NIH) - The Nation's Medical Research Agency. NIH is a component of the U. S. Department of Health and Human Services (HHS). It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
How to Create a Family Health History
To help people in the task of creating their family health histories, HHS offers a free, computerized tool that organizes health information into a printout that can be can taken to health-care professionals. The tool, called "My Family Health Portrait," is available at https://familyhistory.hhs/.
Contact: Geoff Spencer
NIH/National Human Genome Research Institute
пятница, 17 июня 2011 г.
Study Finds Race Affects African American Survival Of Breast Cancer
The analysis published on line Oct. 23 by Cancer, a peer-reviewed journal of the American Cancer Society, indicates that race is associated with unfavorable tumor biology, which, along with other factors, likely contributes to the lower rate of breast cancer survival among African-Americans.
"These findings should prompt additional research on how we can improve outcomes for African-American patients by understanding and addressing tumor biology," says first author Wendy Woodward, M.D., Ph.D., assistant professor of radiation oncology at M. D. Anderson. "It's important to identify unique features in different populations and subgroups of all women with breast cancer so we can understand a woman's risk and factors that affect her care on an individual level."
African-American women are less likely than Caucasian women to have breast cancer but are more likely to die from it. Many factors have been implicated in this disparity, the researchers note, including access to health care and screening, differing treatments, socioeconomic status and racial bias.
By examining two series of clinical trials in which treatment was specified and rigorously followed for all patients, the research team minimized biases related to access to care and type of treatment, two variables that often confound analysis of the issue.
Between 1975 and 2000, 2,140 breast cancer patients were treated in two prospective series of clinical trials at M. D. Anderson involving use of the chemotherapy doxorubicin before and after a radical or modified radical mastectomy.
Of the total patients, 1,590 were Caucasian, 300 were Hispanic, and 250 were African-American, with racial categories based on self-reporting by the patients. In both trials, African-American women received at least as many cycles of chemotherapy as did Hispanics and Caucasians.
In the clinical trial for post-operative chemotherapy, the 10-year overall survival rate for African-Americans was 52 percent. For Hispanics and Caucasians it was 62 percent.
More African-American women came to the trial with later stage disease (24 percent compared with 18 percent of Hispanics and 16 percent of Caucasians) and tumors greater than 5 centimeters (22 percent compared with 13 percent each for Hispanic and Caucasians). African-Americans were more likely to have tumors that were estrogen-receptor negative, which are considered more difficult to treat (41 percent compared with 32 percent for Hispanics and 33 percent for Caucasians).
The trial of pre-operative chemotherapy showed similar results, with African-American 10-year survival rate of 40 percent, compared with 56 percent for Hispanics and 54 percent for Caucasians. As in the post-operative trial, higher percentages of African-Americans came to the trial with later-stage disease, larger tumors, and estrogen-receptor negative disease.
A multivariable analysis that took into account age, estrogen receptor-negative status, primary tumor size, and whether the disease had spread to the lymph nodes, showed that African-American race is an independent factor in reduced overall survival rate.
The researchers note they could not take into account factors that might have influenced the patients' care before they entered the clinical trials. And their analysis did not include socioeconomic factors because that information was not available for patients. However, they doubt socioeconomic factors could fully explain differences in survival rate because Hispanic and African-American women have similar socioeconomic status in M. D. Anderson's patient referral area.
"We interpret these data as suggesting that intrinsic biological differences in the disease and response to treatment among racial groups contributed to the poorer overall survival rates seen in the African-American cohorts," the researchers conclude.
"It's important to note that African-Americans, and people in all self-reported racial groups, are genetically and culturally diverse," Woodward says. "Not all African-American women will have worse survival prospects for breast cancer, but there are probably subsets of patients for whom we could be doing something better.
"The tools and technology are emerging that will allow us to understand how one person's tumors differ from another and how we can more effectively assign people to treatments," Woodward says.
The paper notes that explaining the association of African-American race with more aggressive breast cancer will be challenging, and suggests analysis of genetic variation and regulation of genes by environmental factors as two potential areas of research.
Co-authors with Woodward, all from M. D. Anderson, are: Eugene Huang, M.D., Marsha McNeese, M.D., George Perkins, M.D., Eric Strom, M.D., and senior author Thomas Buchholz, M.D., all of the Department of Radiation Oncology; Susan Tucker, M.D., Department of Biostatistics; Lavinia Middleton, M.D., Department of Pathology; and Karen Hahn, M.D., and Gabriel Hortobagyi, M.D., Department of Breast Medical Oncology.
Contact: Scott Merville
University of Texas M. D. Anderson Cancer Center
четверг, 16 июня 2011 г.
Eisai Announces Extension Of FDA Review Of Drug Application For Investigational Agent Eribulin Mesylate
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing and controls (CMC) section of the NDA as a major amendment to the NDA. The new action date will give the agency additional time to review the information submitted for this complex synthetic process.
In addition to the U.S. FDA priority review, eribulin is currently under active regulatory review in Japan, the European Union (EU), Switzerland and Singapore.
Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer, and their healthcare professionals.
About Eribulin
Eribulin mesylate (E7389) is an investigational agent being evaluated as a potential treatment for locally advanced or metastatic breast cancer. A non-taxane, microtubule dynamics inhibitor, eribulin is a synthetic analog of halichondrin B, which is derived from a natural product isolated from the marine sponge Halichondria okadai. Eribulin is the state of the art in modern synthetic chemistry, which has 826 of molecular weight, 62 steps of total synthetic route and 19 chiral carbons.
About Advanced or Metastatic Breast Cancer
Advanced or metastatic breast cancer occurs when a malignant tumor in the breast spreads from its original site to other parts of the body. Approximately 50 percent of women worldwide initially diagnosed with breast cancer are expected to develop recurrent or metastatic disease within 15 years of their first diagnosis. Only one in five women with metastatic breast cancer survives longer than five years. In the U.S., an estimated 155,000 women are currently living with metastatic breast cancer, and that number is projected to increase to 162,000 by 2011.
Source:
Eisai Inc.
среда, 15 июня 2011 г.
Researchers Identify Gene That Regulates Breast Cancer Metastasis
Deaths of most breast-cancer patients are the result of metastasis, a complex, multi-step, and poorly understood process. "Identifying the gene that suppresses the spread of tumor cells and the mechanisms by which this suppression occurs can lead to the discovery of new markers of metastasis and potential targets for cancer prevention and treatment," says Qihong Huang, M.D., Ph.D., assistant professor at The Wistar Institute and senior author of the study.
In this study, which appears in the October on-line issue of Nature Cell Biology, Huang and colleagues introduced a genetic screen targeting 40,000 mouse genes into mammary tumor cells that do not usually spread, and then transplanted those cells to the mammary fat pads in mice where they would be expected to remain. Through RNA interference (RNAi) technology, they then reduced the expression of a metastasis-suppressor gene in five mice, one of which developed lung metastases in seven weeks. RNA retrieved from the metastasized cells corresponded to KLF17.
To determine whether KLF17 played a similar role in human breast-cancer metastasis, the researchers knocked down KLF17 expression in a tagged human-breast-cancer cell line and then transplanted these cells along with a control group still expressing KLF17 into mammary fat pads of mice. Within eight to 10 weeks, lung metastases developed in the KLF17-deficient cells, whereas the control cell set did not metastasize, demonstrating that knockdown of KLF17 expression also promotes the spread of human breast-cancer cells.
The researchers also were interested specifically in genes whose expression were increased in KLF17 knockdown cells but decreased in KLF17 overexpressing cells or vice versa. In collaboration with Professor Louise C. Showe, Ph.D. at the Wistar Institute, they found the significant genes that met these criteria. Among them, the gene Id1 was found to be up-regulated in KLF17 knockdown cells and down-regulated in KLF17 overexpressing cells. Recent findings suggest that Id1 is deregulated in various types of cancers and is important in the development of embryonic stem cell like phenotypes in cancer cells.
To further investigate the interactions of KLF17 and Id1, the Huang lab scanned a DNA segment of mouse Id1 and found two potential KLF17 binding sites. To examine the effect of Id1 upregulation in tumor metastasis in vivo, the team generated tagged mouse and human cell lines expressing mouse or human Id1, respectively. Following transplantation back into the mice, lung metastasis developed from Id1-upregulated cells but not in controls, demonstrating that Id1 expression promotes tumor metastasis in vivo.
Further characterization of KLF17 is an ongoing subject of study for Wistar researchers. "We are continuing to examine ways to activate KLF17 and the methods by which that process slows or prevents cancer metastasis," Huang says.
The lead author on the study is Wistar's Kiranmai Gumireddy, Ph.D. Study investigators also included Professor Louise C. Showe, Ph.D.; and Anping Li, from the Wistar Institute; Andres J. Klein-Szanto, M.D.; from Fox Chase Cancer Center; and Phyllis A. Gimotty, Ph.D., Dionyssios Katsaros, M.D., Ph.D.; George Coukos, M.D., Ph.D.; and Lin Zhang, M.D.; from the University of Pennsylvania.
The project was supported by the Breast Cancer Alliance, Pardee Foundation, V Foundation, Commonwealth Universal Research Foundation of the Pennsylvania Department of Health, the National Cancer Institute, and the Mary Kay Ash Charitable Foundation.
The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the country, Wistar has long held the prestigious Cancer Center designation from the National Cancer Institute. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. The Wistar Institute: Today's Discoveries Tomorrow's Cures.
Source: Wistar Institute
вторник, 14 июня 2011 г.
Everolimus May Help Thwart Trastuzumab Resistance In Breast Cancer Patients
The findings are from two trials presented at the joint 15th European Cancer Organization (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress.
Everolimus is an oral mTOR inhibitor that is approved for the treatment of patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapy.
The drug has also been shown to reverse trastuzumab resistance caused by PTN loss in preclinical studies and additionally has shown anti-tumor activity as a single agent in patients with metastatic breast cancer.
Dr. Sara Hurvitz, with the UCLA School of Medicine, and colleagues conducted a study to establish the feasible dose schedule for daily and weekly administration of everolimus combined with weekly trastuzumab and paclitaxel in patients with HER-2 overexpressing metastatic breast cancer whose disease had progressed during or after trastuzumab therapy.
Results in 33 patients showed that the combination was well tolerated and that the recommended starting dose for the phase II study is 10 mg daily.
Combination therapy involving everolimus, paclitaxel, and trastuzumab demonstrated "encouraging" efficacy in this heavily treated population of patients refractory to trastuzumab and taxanes. In particular, everolimus demonstrated activity in all patients who were evaluable for efficacy and assigned to the 5 mg everolimus treatment group.
The disease control rate was 85% (28 of 33 evaluable patients).
Biomarker results were similar to those observed during everolimus monotherapy in patients with metastatic renal cell cancer and suggest that the activity of everolimus is mediated in part through inhibition of VEGF-A-driven angiogenesis, Dr. Hurvitz said.
In a second study, similar results were obtained with the combination of everolimus (5 mg daily or 20 or 30 mg weekly) with vinorelbine and trastuzumab.
Dr. Fatima Cardoso, with the Jules Bordet Institute in Brussels, reported that the combination was feasible and tolerable in a similar heavily pretreated group of breast cancer patients and also showed promising clinical activity with a relevant long-term disease control. The disease control rate was 80% (37 of 46 evaluable patients).
In the study, there was no limit to the number of prior antineoplastic treatments.
Overall, 30 patients were assigned to a 5 mg daily dose of everolimus, and 20 patients received a 20 or 30 mg weekly dose.
Dr. Cardoso said that the addition of everolimus can bolster the therapeutic activity of vinorelbine and trastuzumab and reverse or postpone the onset of trastuzumab resistance.
Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
понедельник, 13 июня 2011 г.
Clinical Study of Sentinel Breast Scan
"We are pleased and excited to commence this study with Cornell, and we believe that the information obtained from the Sentinel system will prove it to be a highly effective adjunctive tool in the war against breast cancer" explained ISC Vice President, Matthew Campisi. "The Sentinel system provides a new physiological dimension to breast health information that is not available from any other fully non-invasive testing method."
Sentinel BreastScan is a painless, touchless, non-invasive procedure offered to women of any age. The technology is based on advanced digital infrared imaging that is combined with sophisticated software employing artificial intelligence techniques. Immediately following the 4-minute test, it provides the doctor with a fully-interpreted, objective report. It is the only system like it in the world.
Sentinel BreastScan is intended to be an adjunctive procedure and does not replace mammography or ultrasound, or stand alone as a single test that can determine overall breast health.
For more information contact Infrared Sciences Corporation., at 213 Hallock Road, Suite 5, Stony Brook, New York, 11790. TEL: 631 240-9106, FAX: 631 240-9108, infoinfraredsciences, or visit infraredsciences.
воскресенье, 12 июня 2011 г.
Follow-Up Study Confirms Link Between Migraines And Reduced Breast Cancer Risk
The study appears in the July 2009 issue of Cancer Epidemiology, Biomarkers and Prevention, a journal of the American Association for Cancer Research. It was led by Christopher I. Li, M.D., Ph.D., a breast-cancer epidemiologist and associate member of the Hutchinson Center's Public Health Sciences Division. Li led the first-of-its-kind study linking migraines with breast cancer risk reduction that was published in the same journal last November.
This time researchers found that the risk reduction remained statistically similar regardless of a woman's menopausal status, her age at migraine diagnosis, use of prescription migraine medications or whether she avoided known migraine "triggers" such as alcohol consumption, smoking and taking hormone replacements. These triggers are also well-established breast cancer risk factors.
Some key differences between this study and the initial one that discovered the link include:
The sample size was more than four times larger this time - more than 4,500 cases and controls versus about 1,000 each in the first study - and was more diverse geographically, drawing women from five metropolitan areas instead of only one. "From an epidemiological perspective, having a larger and more diverse study in its underlying population helps in replicating the finding," Li said.
The age range of women studied was wider this time, 34-64 years of age versus 55-74 years old. "We were able to look at whether this association was seen among both pre-menopausal and post menopausal women," Li said. "In breast cancer this is relevant because there are certain risk factors that are different between older and younger women. In this study we saw the same reduction in breast cancer risk associated with a migraine history regardless of age."
Researchers were able to ascertain whether women in the study had lifestyle behaviors that are known migraine triggers - alcohol consumption, smoking and taking hormone replacement therapy. Researchers posited that perhaps women who had migraines drank and smoked less and didn't take hormone replacements. "But in this study we looked at women who never drank, never smoked and who also didn't use hormones and found the same association within each of those groups, suggesting that the association between migraine and reduced breast cancer risk may be independent of those other factors and may stand alone as a protective factor," he said.
What remains unknown is how migraine confers its apparent protection against breast cancer. "We know that migraine is definitely related to hormones and that's why we started looking at this in the first place," Li said. "We have different ideas about what may be going on but it's unclear exactly what the biological mechanisms are."
In the meantime, research on migraines and breast cancer continues. Li and his colleagues are conducting a follow-up investigation among the women in the first study to determine the types, timing, intensity and severity of their migraines in hopes that the data may elicit additional clues.
And, the research group has submitted a third study for publication that found that the association between migraine and reduced breast cancer risk holds up independent of whether women with migraine took non-steroidal anti-inflammatory drugs such as aspirin and ibuprofen. Earlier studies linked these medications to reduced breast cancer risk as well.
Source:
Dean Forbes
Fred Hutchinson Cancer Research Center
суббота, 11 июня 2011 г.
Possible Negative Effect Of Disadvantaged Neighborhoods On Breast Cancer In Black Women
The initiative is funded with a $9.7 million grant from National Institutes of Health and is the first to use animal models to help determine what the biological factors might be behind the development of certain forms of breast cancer.
Gehlert is lead author of the paper discussing the findings, titled "Targeting Health Disparities: Linking Upstream Determinants to Downstream Interventions" published in the current issue of Health Affairs.
Joining Gehlert, who is the Helen Ross Professor in the School of Social Service Administration at the University, as an author in the paper is Olufunmilayo Olopade, the Walter L. Palmer Distinguished Service Professor in Medicine and Human Genetics at the University. As part of the work of the CIHDR, Olopade and other scholars studied early onset breast cases in Nigerian women, whose genetic heritage is similar to African-Americans because the ancestors of African Americans largely came from West Africa.
African-American, like Nigerian women, develop breast cancer earlier than white women, and it is often much deadlier. While white women usually develop the disease after menopause, it develops prior to menopause among women of African heritage.
Co-author Martha McClintock, the David Lee Shillinglaw Distinguished Service Professor in Psychology at the University, carried out the animal modeling by studying the development of spontaneous mammary tumors in socially isolated rats.
Researchers are studying 230 black women with newly diagnosed breast cancers living in predominantly black Chicago neighborhoods to learn about environmental factors, such asneighborhood features that might lead to social isolation.
"These women experience stress from dealing with situations they cannot control, from seeing crime in their neighborhood, from being afraid to go out, and not being able to form casual relationships with their neighbors that might make them feel safe," Gehlert said.
By studying multiple pathways to the development of the disease, leading from environmental challenges to gene regulation, the team will help inform policy makers about making decisions in how to create cost-effective interventions, McClintock said.
The team said that the women's vulnerability to stress and social isolation could be reduced if communities work with neighborhood and city leaders to reduce building vacancies and establish networks that would give women a greater feeling of control over their environments.
Other authors in the study are University researchers Dana Sohmer, Tina Sacks and Charles Mininger.
Source: William Harms
University of Chicago
пятница, 10 июня 2011 г.
Enrollment Restrictions For California Breast Cancer Screening Program Lead To Reduced Services
DPH also increased the minimum age for program participants from 40 to 50, mirroring recent U.S. Preventive Services Taskforce guidelines stating that most women should begin screenings at age 50, rather than 40. According to Sean Tuffnell, a public policy expert for the Susan Komen Foundation for the Cure, California is the only state that has adjusted its mammogram eligibility rules since the recommendations were issued.
Several clinics and mobile care units reported drops in patient volume since the program changes. For example, the Elizabeth Center for Cancer Detection in Los Angeles reported a 34% decrease in its patient load during the first three months of 2010. The clinic temporarily closed in April but now offers services three days per week. CEO Don Cook said the clinic faces permanent closure at the end of May.
Mobile Mammography Screening President Deborah Wright said she laid off all of her 40 mammography technicians and suspended service at her 11 mobile units after the program changes. The mobile clinics screened 1,600 patients in January, down from a monthly average of 6,250 patient screenings in 2009.
For fiscal year 2009-2010, Every Woman Counts received $61.3 million in funding, a nearly $10 million increase from the previous fiscal year. However, officials said the funding reflected a one-time budget boost from an unspent tax and did not cover cost increases.
State Sen. Jenny Oropeza (D) has introduced a bill (SB 836) that would reinstate funding for the program. The legislation is before the state Senate Appropriations Committee (Mohajer, AP/San Francisco Chronicle, 5/9).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
четверг, 9 июня 2011 г.
Breast Cancer Survival Rates Improved By Novel Drug Sequence, Say Researchers
Postmenopausal women with early-stage hormone-sensitive primary breast cancer are usually treated with tamoxifen for five years, once they are free of disease, to reduce the risk of their cancer recurring. This therapy was once viewed as the 'gold-standard' treatment and it has been shown to cut the risk of death by 34%.
Over recent years, increasing numbers of these women have been receiving treatment with tamoxifen followed by Aromatase Inhibitors such as exemestane.
The Intergroup Exemestane Study (IES), which involved women from 37 different countries, has been examining the benefits of taking tamoxifen for two to three years and then switching to exemestane for the remainder of the five-year period. This new research is the first to show that early benefits of the tamoxifen and exemestane treatment sequence are maintained after treatment has stopped. The study, which was led by researchers from Imperial College London and The Institute of Cancer Research, was funded by Cancer Research UK and Pfizer.
The majority of breast cancer cases are hormone-sensitive, meaning that the cancer cells respond to oestrogen and die when they are deprived of the hormone. Tamoxifen works by preventing oestrogen from acting on cancer cells, whereas exemestane is an Aromatase Inhibitor, which works by stopping the body's production of oestrogen.
The researchers believe that during treatment with tamoxifen, some cancer cells can become resistant to the effects of the drug. Exemestane is subsequently able to kill these resistant cells by withdrawing the oestrogen from circulation.
The researchers examined 2,352 postmenopausal women with early-stage breast cancer who switched to exemestane, compared with another group of 2,372 women who were treated with tamoxifen alone. The women were halfway through their five-year tamoxifen treatment when they joined the study and they were followed up for a median of 56 months after this point.
The study found that the women taking exemestane had a 15% lower risk of dying than those taking only tamoxifen. When women whose tumours were found not to be hormone sensitive were excluded (8% of the total), the improvement increased to 17%.
The results of the study also suggest that sequential use of tamoxifen and exemestane is safe and well tolerated.
Professor Charles Coombes, lead author of the paper from the Cancer Research UK Department of Cancer Medicine at Imperial College London, and based at Hammersmith Hospital, said: "This study shows that, in order to get best results, patients need to be treated with a sequence of anti-hormonal treatments. Just giving one or other drug, such as has been done in some other studies, has not been shown to give added benefit in terms of improved survival. The task now is to determine what other drugs should be given in sequence to prevent cancer cells that have become resistant to exemestane from growing."
Professor Judith Bliss, Director of The Cancer Research UK Clinical Trials and Statistics Unit at The Institute of Cancer Research said: "This trial is an excellent example of how international collaborations between researchers and clinicians can be quickly translated into a cost effective treatment strategy providing patient benefit. To the many postmenopausal breast cancer patients around the world this new research offers the hope of improved treatment options."
Current practice is to give patients treatment for a period of time after surgery and then stop. Following this, doctors wait for a recurrence of the cancer, at which point it is often impossible to cure the disease.
Professor Coombes added: "The other challenge is to find a way of monitoring breast cancer to find a blood test that can tell us when some cancer cells are once more growing. This will allow us to time the sequence of treatment more accurately. A test for early resistance would give us a chance of curing the disease whilst it is still at an early stage."
IMPERIAL COLLEGE UNIVERSITY OF LONDON
Exhibition Road
London
SW7 2AZ
ic.ac.uk
среда, 8 июня 2011 г.
New Guidance To Address Lack Of Support For Employees Affected By Cancer, UK
The research is accompanied by new practical guidance to help employers to manage the estimated 90,000 people of working age who receive a cancer diagnosis each year, and support them during their treatment and recuperation, as well as in their rehabilitation and return-to-work.
Key findings from today's report, produced jointly by the Chartered Institute of Personnel and Development (CIPD), Cancerbackup and the Working with Cancer group, include:
-- Two thirds of employers say they do not provide any training for managers to support employees with cancer
-- More than 40% of employers do not provide any support or information to employees with cancer, and a further 36% of respondents did not know if such information or support was provided
-- More than one in five employers (22%) are not aware that the Disability Discrimination Act now classes cancer as a disability
-- Nearly three-quarters (73%) of employers do not have a formal policy in place for managing employees affected by cancer.
More than half a million people in the UK under the age of 65 have been diagnosed with cancer and many will remain in work during treatment, or seek to return to work after treatment. With new treatments being developed all the time, this figure is likely to increase. The guidance launched today aims to provide employers, human resources and line managers with the tools to ensure that staff feel respected and informed throughout their cancer journey. The guidance includes:
-- First steps - meeting with the employee
-- Returning to work
-- Disability caused by cancer
-- Disability Discrimination act
-- A template cancer policy
The research, based on a survey of 219 employers, employing a total of over 800,000 people, and guidance for employers, was inspired by the Working with Cancer group, a group of leading human resources professionals, all of whom were diagnosed with cancer, who on returning to work were shocked at the lack of support for staff affected by cancer and decided to campaign to raise awareness amongst employers.
Barbara Wilson, spokesperson for the Working with Cancer group and Head of Resourcing and Development at Schroders, said:
"While I was being treated for cancer, I found I was surrounded by booklets to help me cope with the illness and the treatments, how to tell my children and so on. But there was nothing to help me deal with my employers, or to help them deal with me. The guidance we're unveiling today will help employers to understand how to manage employees working with cancer, to provide appropriate information and support to their colleagues, and to help the employee with cancer keep working or return successfully to work after treatment."
Ben Willmott, Employee Relations Adviser at the CIPD, said:
"Employers that fail to provide support and advice to those diagnosed with cancer run the risk of losing talented and experienced employees who would otherwise continue to make a contribution to the organisation. At the extreme, employers could also find that insufficient support and unsympathetic attitudes leave them open to claims under the DDA - a fact that our survey shows one in five employers are unaware of."
"Cancer can be both physically and emotionally extremely draining, which is why it is important that people feel supported by their employers," says Joanne Rule Cancerbackup, Chief Executive. "Cancerbackup's research into people's experience of work and cancer found that many people are not offered any information about their statutory rights by employers nor offered flexible working arrangements to fit around treatment and returning to work. As a result many people don't return to work, even though they want to."
Download Working with Cancer Survey Results (PDF 416.51 Kb)
cancerbackup.uk