NICE issued its final appraisal determination advising against NHS funding for Tyverb® (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 Lapatinib (in combination with Xeloda® [capecitebine]) offers a new treatment option for women whose disease has returned despite treatment with standard chemotherapies and Herceptin® (trastuzumab).2 There are very few treatment options available for these women and lapatinib offers a chance of additional time without their disease progressing.3 Lapatinib is the only licensed ErbB2 targeted treatment* for these patients.
GlaxoSmithKline (GSK) will consider appealing the decision. Simon Jose, General Manager, GSK UK commented; "We disagree with the NICE decision and believe Tyverb is a valuable and important treatment for eligible women. In recognition of the cost effectiveness challenges with drugs that treat patients with a short life expectancy, we offered the Tyverb Patient Access Programme to help ensure it was made available on the NHS. It is difficult to comment without the appearance of self interest. However, there is clearly more work to be done by all parties when flexible access programmes from industry and the recent changes by NICE for patients with a short life expectancy still fail to give them access to valuable medicines."
GSK proposed the patient access programme in the UK when NICE indicated early on in its review that it did not consider lapatinib to be cost effective in treating this patient population. In an effort to achieve a positive outcome for patients and greater value to the NHS, GSK bears the cost of lapatinib, for all eligible patients under the scheme, for up to the first 12 weeks of treatment. The NHS would commence payment only for the patients who continue to receive clinical benefit beyond 12 weeks. GSK will continue to honour the patient access programme for NHS trusts in the UK.
During the lapatinib assessment NICE proposed new advice for the assessment of treatments in small patient populations with a short life expectancy.4 Lapatinib is licensed for a particular type of breast cancer that affects around 2000 women a year.1Therefore lapatinib qualified for review under the new advice.
GSK submitted a sub-group analysis that met the overall survival criterion of this new NICE advice. However NICE concluded that whilst the data analysis could be useful in guiding future research, as it stands it would not change their conclusions. NICE's decision reflects the difficulty in demonstrating significant survival benefits in patients at this advanced stage of disease.1 Furthermore, trials are often halted early for ethical reasons to allow patients to cross over to the
active arm because of the effectiveness demonstrated by the medicine under study, as in the case of lapatinib.5
In its final appraisal determination NICE acknowledges that lapatinib is a clinically effective option, noting that lapatinib plus capecitabine demonstrated improved time to progression (TTP) and progression free survival (PFS) - significantly delaying the progression of the cancer and controlling the disease.1
GSK's NICE submission demonstrated that lapatinib, in conjunction with the patient access programme, could actually save the NHS money in patients who would have received trastuzumab (Herceptin®) containing regimens. NICE acknowledged this is the majority (>50%) of eligible patients, however NICE concluded that trastuzumab is not likely to be cost effective in this setting and therefore lapatinib plus capecitabine would not be cost effective.
Safety Information
Lapatinib plus capecitabine is generally well tolerated. The most common adverse events associated with lapatinib plus capecitabine were diarrhoea, rash, nausea, vomiting, fatigue and hand-foot syndrome.2,3 Diarrhoea and rash were more common with the combination whilst the incidence of hand-foot syndrome was similar between the two treatment groups.2 A decrease in left ventricular ejection fraction (LVEF) was reported by 2.5% of patients receiving lapatinib plus capecitabine vs. 1% of patients on capecitabine alone.2 Hepatobiliary events (mainly raised liver enzymes and/or bilirubin levels) have been reported commonly in association with lapatinib plus capecitabine therapy.2 Lapatinib has also been associated with reports of pulmonary toxicity.2
About Tyverb
- Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.2
- Healthcare professionals should refer to the Tyverb Summary of Characteristics (SPC) for full prescribing information, including warnings and precautions.2
- * Tyverb received a conditional marketing authorisation in Europe, June 2008.2
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit gsk
Tyverb® is a registered trademark of the GlaxoSmithKline group of companies. Herceptin® and Xeloda® are registered trademarks of F. Hoffmann-La Roche
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GlaxoSmithKline
View drug information on Herceptin; Xeloda.
суббота, 2 июля 2011 г.
пятница, 1 июля 2011 г.
Los Angeles Times Examines Association Between Breast Cancer Risk, Obesity
The Los Angeles Times on Monday examined the association between obesity and the risk of developing breast cancer. According to the Times, a high body mass index for women of childbearing age appears to lower the risk of developing breast cancer; however, the risk increases for girls who have a high BMI before puberty or for postmenopausal women who have a high BMI. A study published last week in the Nov. 27 issue of the Archives of Internal Medicine found that the association between fat and a lower risk of developing breast cancer was stronger earlier in a woman's life, the Times reports. The results of the study "square with the current understanding of how breast cancer develops," according to the Times. Studies have found that women who have a lower lifetime exposure to estrogen have a lower risk of developing breast cancer. In premenopausal women, fatty tissue produces low levels of estrogen that "feeds back on the ovaries and dampens their cyclical release of estrogen," thus subtracting from the total amount of estrogen to which they are exposed, the Times reports. Postmenopausal women have low levels of estrogen, "thus, any extra estrogen from fat is contributing to their total load, not subtracting," according to the Times. "It's like taking a little birth control pill," Anne McTiernan, director of the Prevention Center at the Fred Hutchinson Cancer Research Center, said, adding, "Obese and overweight women are not ovulating normally." In addition, obese and overweight premenopausal women are not producing progesterone -- a hormone associated with a higher risk of developing breast cancer -- in the same way that women of regular weight are, McTiernan said. According to the Times, health experts say the association of developing breast cancer and obesity should not prompt premenopausal women to gain weight. Amtul Carmichael, a breast cancer researcher at Russells Hall Hospital in Dudley, England, said, "[O]bese premenopausal women will become obese postmenopausal women," adding, "Obese women are two to three times more likely to die from breast cancer, and that's common to both pre- and postmenopausal women." In addition, treatments such as chemotherapy might be less effective for obese women because chemotherapy is based on weight, but physicians might give obese women slightly lower doses to avoid toxicity, Carmichael said (Beckman, Los Angeles Times, 12/4).
"Reprinted with 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 . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with 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 . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 30 июня 2011 г.
Solis Women's Health Opens New Facility, Texas
Solis Women's Health announced that it has opened its eight DFW area facility in Weatherford, Texas. The center, located near the campus of Weatherford Regional Medical Center, is the community's only diagnostic facility to offer full field digital mammography.
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.
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
A molecular change that takes place during the progression of malignant brain tumors also occurs 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
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
Rather than testing for individual marker genes or proteins, researchers at the University of California, San Diego (UC San Diego) and the Moores UCSD Cancer Center have evidence that groups, or networks, of interactive genes may be more reliable in determining the likelihood that a form of leukemia is fast-moving 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
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
Minority men and women who perceived discrimination from their health care providers were less likely to be screened for colorectal or breast cancer, according to a report in the August issue of Cancer Epidemiology, Biomarkers and Prevention, a journal of the American Association for Cancer Research
"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
"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
Medifocus Inc. (TSXV:MFS) announced that positive clinical results when using the Company's proprietary focused heat treatment prior to surgery for the treatment of early stage breast cancer tumors, were presented during the Market Opening Ceremony of Medifocus at the Toronto Stock Exchange on March 25, 2009 and also at the 19th National Interdisciplinary Breast Center Conference held March 14-18, 2009 in Las Vegas, Nevada. The patient data were obtained from a multi-center, randomized clinical study to reduce cancer cells at the surgical margins, which potentially can reduce either re-excisions rates or second incision rates when Medifocus's focused heat, is delivered prior to surgery. This study was conducted in the USA under an Investigational Device Exemption (IDE) issued by the Food and Drug Administration (FDA). The data presented at the 2009 National Interdisciplinary Breast Center Conference represent the final analysis of the clinical data for the focused heat treatment for early-stage breast cancer. Dr. William C. Dooley, MD, at the University of Oklahoma, Health Sciences Center, was the Principal Investigator of the multi-institutional study that was conducted at 10 breast centers in the United States and the United Kingdom.
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
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
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