A report released on Thursday by a panel of U.S. and Canadian experts disputes a long-held view among scientists that smoking does not increase the risk of breast cancer in women, the New York Times reports. The panel, which was funded by the Public Health Agency of Canada, included 10 breast cancer and public health experts from Canada and the U.S. The report summarizes the panelists' review of newer studies that have been released in the past six or seven years, an analysis method that panelists said helped to distinguish differences between women who had never been exposed to smoke and those who had, either by smoking themselves or through secondhand smoke.
In its report, the panel said that evidence from new studies suggests that smoking increases the risk of breast cancer and that young women and girls face special risks from exposure to smoke. The panel noted that even secondhand smoke exposure during adolescence could increase the risk of breast cancer occurring later in life, the Times reports. The report cited several newer studies that suggest women who start smoking when they are young increase their risk of breast cancer by 20% and that many years of heavy smoking could increase the risk by up to 30%. The panelists did not attempt to quantify how many excess breast cancers are caused by exposure to smoke. Although the report found strong support that secondhand smoke added to premenopausal breast cancer, there was insufficient evidence to conclude that it increased the risk of postmenopausal breast cancer, the Times reports.
The report is "a sharp dissent" from the common belief among scientists that there is too little consistent evidence to determine whether smoke has a causal role in breast cancer, the Times reports. For example, a 2004 report by the International Agency for Research on Cancer found little or no link between breast cancer and active smokers, and the U.S. Office of the Surgeon General in 2006 said there was insufficient evidence that secondhand smoke causes breast cancer. If the panelists are correct, "they may be offering women a new piece of valuable information with practical advice about how to protect themselves from a common cancer that many fear," according to the Times.
Several experts who were not involved with the panel said any proof that smoking can cause breast cancer is elusive. Michael Thun, a former vice president of epidemiology and surveillance research for the American Cancer Society, said that although it is "definitely plausible" that smoking can cause breast cancer, he "think[s] the jury is still way out." He said, "The issue is, what's the level of the evidence? That's where the disagreement exists" (Rabin, New York Times, 4/24).
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.
© 2009 The Advisory Board Company. All rights reserved.
суббота, 30 апреля 2011 г.
пятница, 29 апреля 2011 г.
Breast Cancer Campaign: Breast Cancer Research Funding To Establish Effectiveness Of Radiotherapy
Scientists are closer to discovering why some people respond to breast cancer radiotherapy better than others, according to Breast Cancer Campaign.
Dr Laura Smith, at the Leeds Institute of Molecular Medicine, University of Leeds, has been awarded a pilot grant by Breast Cancer Campaign, to study why some types of breast cancers are difficult to destroy with radiotherapy.
The grant forms part of ВЈ2 million awarded to 20 projects in the UK and Ireland.
Previous research has shown that breast cancer cells which are difficult to destroy with radiotherapy contained reduced amounts of molecules called GRP78, PSMD9 and DARS.
Dr Smith and her team aim to find out what role these molecules play in preventing radiotherapy from working in breast cancer.
Dr Smith said, "We are grateful for this funding from Breast Cancer Campaign which we hope will lead to a way to predict how successful treatment will be in people with different types of breast cancer."
Arlene Wilkie, Director of Research and Policy, Breast Cancer Campaign said, "This research could lead to a simple test to establish the effectiveness of radiotherapy prior to treatment. Radiotherapy is not suitable for everyone with breast cancer and this would ensure that only those who will benefit from the treatment will receive it."
Notes
Breast Cancer Campaign aims to beat breast cancer by funding innovative world-class research to understand how breast cancer develops, leading to improved diagnosis, treatment, prevention and cure Currently it supports 115 research projects, worth almost ВЈ16 million, in 44 centres of excellence across the UK and Ireland Breast cancer is the most common cancer in the UK and accounts for nearly one in three of all cancers in women In the UK, nearly 46,000 new cases of breast cancer are diagnosed each year - that's 125 a day Visit breastcancercampaign Read Chief Executive Pamela Goldberg's blog pamelagoldbergblog.blogspot/
The 2008 Research Assessment Exercise showed the University of Leeds to be the UK's eighth biggest research powerhouse. The University is one of the largest higher education institutions in the UK and a member of the Russell Group of research-intensive universities. The University's vision is to secure a place among the world's top 50 by 2015. leeds.ac.uk The Leeds Institute of Molecular Medicine (LIMM) is a research Institute of the University dedicated to defining the molecules involved in human diseases, and using this knowledge to develop novel therapies and new drugs. limm.leeds.ac.uk/
Source
Breast Cancer Campaign
Dr Laura Smith, at the Leeds Institute of Molecular Medicine, University of Leeds, has been awarded a pilot grant by Breast Cancer Campaign, to study why some types of breast cancers are difficult to destroy with radiotherapy.
The grant forms part of ВЈ2 million awarded to 20 projects in the UK and Ireland.
Previous research has shown that breast cancer cells which are difficult to destroy with radiotherapy contained reduced amounts of molecules called GRP78, PSMD9 and DARS.
Dr Smith and her team aim to find out what role these molecules play in preventing radiotherapy from working in breast cancer.
Dr Smith said, "We are grateful for this funding from Breast Cancer Campaign which we hope will lead to a way to predict how successful treatment will be in people with different types of breast cancer."
Arlene Wilkie, Director of Research and Policy, Breast Cancer Campaign said, "This research could lead to a simple test to establish the effectiveness of radiotherapy prior to treatment. Radiotherapy is not suitable for everyone with breast cancer and this would ensure that only those who will benefit from the treatment will receive it."
Notes
Breast Cancer Campaign aims to beat breast cancer by funding innovative world-class research to understand how breast cancer develops, leading to improved diagnosis, treatment, prevention and cure Currently it supports 115 research projects, worth almost ВЈ16 million, in 44 centres of excellence across the UK and Ireland Breast cancer is the most common cancer in the UK and accounts for nearly one in three of all cancers in women In the UK, nearly 46,000 new cases of breast cancer are diagnosed each year - that's 125 a day Visit breastcancercampaign Read Chief Executive Pamela Goldberg's blog pamelagoldbergblog.blogspot/
The 2008 Research Assessment Exercise showed the University of Leeds to be the UK's eighth biggest research powerhouse. The University is one of the largest higher education institutions in the UK and a member of the Russell Group of research-intensive universities. The University's vision is to secure a place among the world's top 50 by 2015. leeds.ac.uk The Leeds Institute of Molecular Medicine (LIMM) is a research Institute of the University dedicated to defining the molecules involved in human diseases, and using this knowledge to develop novel therapies and new drugs. limm.leeds.ac.uk/
Source
Breast Cancer Campaign
четверг, 28 апреля 2011 г.
Physical Therapists Walk To Raise Funds For Free Mammograms For Alexandria Women
The American Physical Therapy Association (APTA) will participate in the city of Alexandria's 16th Annual Walk to Fight Breast Cancer, October 24, 2009, at the AMC Hoffman Theatres on Swamp Fox Road beginning at 8 am. Since 2002, APTA has sponsored the event whose proceeds support free mammograms and other diagnostic screening procedures for Alexandria women who could not otherwise obtain this necessary medical care.
October is both National Physical Therapy Month and National Breast Cancer Awareness Month. During this time APTA sheds light on the role that physical therapists play in the treatment of women living with breast cancer and the side effects of cancer treatment.
"Early detection is key to decreasing the progression of this disease to more advanced stages and APTA is proud to support the city of Alexandria in its effort to help women obtain these critical screenings," said APTA CEO John Barnes.
When surgery is required, physical therapists help patients regain strength and range of motion in the shoulders and arms throughout the healing process. They also provide scar massage to help keep the tissue flexible and develop quality cancer-specific exercise programs for post-surgical patients and those dealing with fatigue caused by chemotherapy and radiation to keep them moving.
Physical therapists are also instrumental in helping patients with breast cancer-related lymphedema, a chronic, debilitating and often irreversible side effect of cancer treatment, which can develop weeks, months, or even years after surgery or radiation. This painful condition can be prevented or greatly improved if caught in its earliest stages and managed through a comprehensive physical therapy program.
The Walk to Fight Breast Cancer was initiated in 1994 by former City of Alexandria Manager Vola Lawson and has become a popular tradition in Alexandria among the community's business leaders and individuals. To date, the Walk Fund has helped more than 5,000 women receive mammograms and other diagnostic procedures.
For more information about The Walk to Fight Breast Cancer visit alexcancerwalk.
Source
American Physical Therapy Association
October is both National Physical Therapy Month and National Breast Cancer Awareness Month. During this time APTA sheds light on the role that physical therapists play in the treatment of women living with breast cancer and the side effects of cancer treatment.
"Early detection is key to decreasing the progression of this disease to more advanced stages and APTA is proud to support the city of Alexandria in its effort to help women obtain these critical screenings," said APTA CEO John Barnes.
When surgery is required, physical therapists help patients regain strength and range of motion in the shoulders and arms throughout the healing process. They also provide scar massage to help keep the tissue flexible and develop quality cancer-specific exercise programs for post-surgical patients and those dealing with fatigue caused by chemotherapy and radiation to keep them moving.
Physical therapists are also instrumental in helping patients with breast cancer-related lymphedema, a chronic, debilitating and often irreversible side effect of cancer treatment, which can develop weeks, months, or even years after surgery or radiation. This painful condition can be prevented or greatly improved if caught in its earliest stages and managed through a comprehensive physical therapy program.
The Walk to Fight Breast Cancer was initiated in 1994 by former City of Alexandria Manager Vola Lawson and has become a popular tradition in Alexandria among the community's business leaders and individuals. To date, the Walk Fund has helped more than 5,000 women receive mammograms and other diagnostic procedures.
For more information about The Walk to Fight Breast Cancer visit alexcancerwalk.
Source
American Physical Therapy Association
среда, 27 апреля 2011 г.
Treatment Delays Result In Poor Outcomes For Men With Breast Cancer
Men who develop breast cancer are often not treated until the disease has spread to the point that treatment becomes difficult, new results show.
Although most breast cancer patients are women, men make up roughly 1% of cases, Dr. Marina Garassino from the Orion Collaborative Group reported at the ESMO Conference Lugano (ECLU), organized by the European Society for Medical Oncology.
Her group conducted a retrospective analysis of 146 men with invasive breast cancer who were diagnosed between 1990 and 2007 across the 12 institutions in the ORION collaborative group.
What they found was that the disease often had already reached an advanced stage when the men were diagnosed. In 50% of cases the cancer had already reached the lymph nodes, a development that increases the likelihood of metastatic spread to other parts of the body.
All the men underwent surgery to remove their cancer. After surgery, 48 received radiotherapy and 100 received adjuvant chemotherapy or hormone therapy. After a median follow-up of 5.2 years, the estimated 10-year disease-free survival rates were 80% for men with the earliest stages of disease, and 44% for those with the largest tumors.
When the researchers looked at the characteristics of the tumors, they found that 73% were positive for estrogen receptors and/or progesteron receptors. Among a sub-group of 41 patients, 48.7% had tumors that overexpressed the protein HER-2/neu, which is an indication of an aggressive tumor.
"Male breast cancer is a rare disease and not well known," Dr. Garassino said. "It is treated the same way as female breast cancer, although our large retrospective series suggests that it has somewhat different histological characteristics."
If treated early enough, the disease is highly responsive to hormone therapy, Dr. Garassino said. In those cases, the prognosis may even be better than in women, she added. An ongoing case-control trial is examining this suggestion.
"What is important for people to know is that most of the patients in our study had a delay in their diagnosis due to the fact that a mass in their breast was misunderstood," Dr. Garassino said. "Therefore it is important that every mass in a man's breast must immediately be considered suspicious."
"Better understanding of male breast cancer will also provide better insights for treating these patients with modern targeted therapies", the researcher added. "We are currently conducting a molecular study on tissues to define help characteristics that might be important for this purpose."
ESMO Conference Lugano
Source: Vanessa Pavinato
European Society for Medical Oncology
Although most breast cancer patients are women, men make up roughly 1% of cases, Dr. Marina Garassino from the Orion Collaborative Group reported at the ESMO Conference Lugano (ECLU), organized by the European Society for Medical Oncology.
Her group conducted a retrospective analysis of 146 men with invasive breast cancer who were diagnosed between 1990 and 2007 across the 12 institutions in the ORION collaborative group.
What they found was that the disease often had already reached an advanced stage when the men were diagnosed. In 50% of cases the cancer had already reached the lymph nodes, a development that increases the likelihood of metastatic spread to other parts of the body.
All the men underwent surgery to remove their cancer. After surgery, 48 received radiotherapy and 100 received adjuvant chemotherapy or hormone therapy. After a median follow-up of 5.2 years, the estimated 10-year disease-free survival rates were 80% for men with the earliest stages of disease, and 44% for those with the largest tumors.
When the researchers looked at the characteristics of the tumors, they found that 73% were positive for estrogen receptors and/or progesteron receptors. Among a sub-group of 41 patients, 48.7% had tumors that overexpressed the protein HER-2/neu, which is an indication of an aggressive tumor.
"Male breast cancer is a rare disease and not well known," Dr. Garassino said. "It is treated the same way as female breast cancer, although our large retrospective series suggests that it has somewhat different histological characteristics."
If treated early enough, the disease is highly responsive to hormone therapy, Dr. Garassino said. In those cases, the prognosis may even be better than in women, she added. An ongoing case-control trial is examining this suggestion.
"What is important for people to know is that most of the patients in our study had a delay in their diagnosis due to the fact that a mass in their breast was misunderstood," Dr. Garassino said. "Therefore it is important that every mass in a man's breast must immediately be considered suspicious."
"Better understanding of male breast cancer will also provide better insights for treating these patients with modern targeted therapies", the researcher added. "We are currently conducting a molecular study on tissues to define help characteristics that might be important for this purpose."
ESMO Conference Lugano
Source: Vanessa Pavinato
European Society for Medical Oncology
вторник, 26 апреля 2011 г.
Breast Cancer Research Highlights From The American Association Of Physicists In Medicine Meeting In Anaheim, July 26-30
Half of all Americans will be diagnosed at some point in their lives with cancer, the number two killer in the United States. One of the most common types, especially among women, is breast cancer. According to the National Cancer Institute, 192,370 women will be diagnosed with breast cancer in 2009, and more than 40,000 women will die from the disease this year alone.
One of the professions at the frontlines in the battle against breast cancer is medical physics. Medical physicists help to develop new imaging technologies and improve existing ones. They devise new therapeutic techniques, and they create methods to assess the safety and effectiveness of treatments that are already in use.
Included below are highlights of a few of the presentations related to breast cancer research at the 51st annual meeting of the American Association of Physicists in Medicine (AAPM), which takes place from July 26 - 30 in Anaheim, CA.
A NEW SCREENING TOOL FOR BREAST CANCER
Mammography has proven to be very effective at lowering mortality related to breast cancer, but it does not work equally well in all women. It frequently misses tumors that are there at the time of screening -- particularly in women who have dense breast tissue that can hide tumors from doctors. The National Cancer Institute reports that mammograms miss up to 20 percent of breast cancers that are present at the time of screening. Doctors often recommend women with dense breasts undergo magnetic resonance imaging (MRI), which is more expensive but better at detecting cancer in dense tissue.
Now doctors at the Mayo Clinic in Rochester, MN have developed a less expensive "molecular imaging" technique for detecting cancer in dense breast tissue using radioactive tracers. In Anaheim, Michael O'Connor, a professor of radiologic physics at Mayo, will describe the science behind this technique as well as the latest results from ongoing clinical trials, including one involving 1,000 women who all received the molecular imaging.
The technique has shown to be highly sensitive at detecting breast cancer, says O'Connor. The key now is to make sure that the doses administered are as low as possible -- equivalent to what you would receive in a mammogram. A study supported by the Susan G. Komen Foundation will begin enrolling 1,000 women in a few months to see how effective the technique is with low-dose formulations.
The talk, "Molecular Imaging of the Breast" is at 10:30 a.m. on Tuesday, July 28 in room 210A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11931
PHOTON COUNTING
When women have routine mammograms to screen for breast cancer, their doctors and health care providers use X-rays to detect tumor masses. This is an extremely safe way of detecting breast cancer, and the National Cancer Institute recommends that all women over the age of 40 should have mammograms every one to two years. The benefits of doing so are enormous because mammography is effective at detecting breast cancer early, when it is most treatable.
Because mammography uses X-rays, however, there is an extremely small but finite risk those X-rays will damage DNA and cause secondary malignancies months or years later. Even though this risk is very small, more than 100 million women have mammograms every year, and a small number of them will be at risk for these secondary cancers. Minimizing the radiation from mammography is a way of mitigating this risk.
A few years ago, Mats Danielsson was a physicist at the European Organization for Nuclear Research (CERN), where scientists have access to very efficient and extremely sensitive detectors that can detect single photons -- a necessity for modern particle physics experiments. He thought that this same technology might allow doctors to lower the dose of X-rays women undergoing mammography receive. So Danielsson, who is now a professor at the Royal Institute of Technology in Sweden, founded a company that built such sensitive detectors. Clinical trials in Europe a couple years ago concluded that the detectors could effectively lower radiation doses by half while still diagnosing cancers effectively.
These detectors are now installed in some 150 clinical centers in 15 different countries, and work is ongoing in order to win approval by the Food and Drug Administration, which regulates medical devices in the Unites States. In Anaheim, Danielsson will present his latest data on how the detectors can help to resolve different tissues in the breast. He and his colleagues are in the midst of a large, multicenter clinical trial that seeks to get information on cancers by analyzing the energy of the X-rays.
The talk, "Photon Counting Detectors for Mammography" is at 1:30 p.m. on Monday, July 27 in room 210A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11927
BREAST CT SCANNERS FOR THERAPY
Since 2004, a group of researchers at the University of California, Davis led by John M. Boone, Professor and Vice Chair of Radiology and Professor of Biomedical Engineering, has been developing a new technology for diagnosing breast cancer in women that promises to be more comfortable than conventional mammography but just as safe.
The discomfort of a mammogram can drive some women to avoid the valuable screening, occasionally with dire consequences. But the new procedure, based on computed tomography (CT), promises to take the pain out of breast cancer detection. In the cone beam breast CT scanner, a woman lies face down on a special table with one breast suspended through an opening. A CT scanner rotates around the breast, collecting data that are reconstructed into a three-dimensional image. The total dose of radiation is the same as in a conventional mammogram.
Boone and his colleagues have scanned more than 200 women with their prototype scanner. Now they are teaming up with radiation oncologists to explore whether the same system can be used to treat breast cancer. By carefully rotating the CT cone beam around the breast, they can deliver a lethal dose of X-rays to cancer cells inside a tumor while sparing healthy tissue. So far, they have measured dose distribution and performed simulations to show the feasibility of such a system, which Boone will describe in Anaheim.
The talk, "Breast CT as a Platform for Image Guided Therapies of Breast Cancer" is at 4:55 p.m. on Tuesday, July 28 in room 303A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11896
UPDATE ON DIGITAL MAMMOGRAPHY
In the last few years, digital mammography has become a popular alternative to conventional film-screen mammography systems. According to Kalpana Kanal, an assistant professor of radiology at the University of Washington, about half of all mammography systems in the United States today are digital -- up from about a third just a year ago.
Though digital systems are about four times more expensive, they offer significant advantages over film, says Kanal. Moreover, a 2005 article published in the New England Journal of Medicine based on the DMIST study of 50,000 women compared digital with film mammography and showed that the overall diagnostic accuracy as a means of screening is similar for both technologies. However, digital mammography is more accurate for women under the age of 50, women with dense breasts, and premenopausal and perimenopausal women.
In Anaheim, Kanal will give an overview of the various digital mammography systems available in the United States and discuss their advantages and disadvantages and the benefits of going digital.
The talk, "Digital Mammography Update: Design and Characteristics of Current Systems" is at 8:30 a.m. on Monday, July 27 in room 303A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11958
Source:
Jason Bardi
American Institute of Physics
One of the professions at the frontlines in the battle against breast cancer is medical physics. Medical physicists help to develop new imaging technologies and improve existing ones. They devise new therapeutic techniques, and they create methods to assess the safety and effectiveness of treatments that are already in use.
Included below are highlights of a few of the presentations related to breast cancer research at the 51st annual meeting of the American Association of Physicists in Medicine (AAPM), which takes place from July 26 - 30 in Anaheim, CA.
A NEW SCREENING TOOL FOR BREAST CANCER
Mammography has proven to be very effective at lowering mortality related to breast cancer, but it does not work equally well in all women. It frequently misses tumors that are there at the time of screening -- particularly in women who have dense breast tissue that can hide tumors from doctors. The National Cancer Institute reports that mammograms miss up to 20 percent of breast cancers that are present at the time of screening. Doctors often recommend women with dense breasts undergo magnetic resonance imaging (MRI), which is more expensive but better at detecting cancer in dense tissue.
Now doctors at the Mayo Clinic in Rochester, MN have developed a less expensive "molecular imaging" technique for detecting cancer in dense breast tissue using radioactive tracers. In Anaheim, Michael O'Connor, a professor of radiologic physics at Mayo, will describe the science behind this technique as well as the latest results from ongoing clinical trials, including one involving 1,000 women who all received the molecular imaging.
The technique has shown to be highly sensitive at detecting breast cancer, says O'Connor. The key now is to make sure that the doses administered are as low as possible -- equivalent to what you would receive in a mammogram. A study supported by the Susan G. Komen Foundation will begin enrolling 1,000 women in a few months to see how effective the technique is with low-dose formulations.
The talk, "Molecular Imaging of the Breast" is at 10:30 a.m. on Tuesday, July 28 in room 210A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11931
PHOTON COUNTING
When women have routine mammograms to screen for breast cancer, their doctors and health care providers use X-rays to detect tumor masses. This is an extremely safe way of detecting breast cancer, and the National Cancer Institute recommends that all women over the age of 40 should have mammograms every one to two years. The benefits of doing so are enormous because mammography is effective at detecting breast cancer early, when it is most treatable.
Because mammography uses X-rays, however, there is an extremely small but finite risk those X-rays will damage DNA and cause secondary malignancies months or years later. Even though this risk is very small, more than 100 million women have mammograms every year, and a small number of them will be at risk for these secondary cancers. Minimizing the radiation from mammography is a way of mitigating this risk.
A few years ago, Mats Danielsson was a physicist at the European Organization for Nuclear Research (CERN), where scientists have access to very efficient and extremely sensitive detectors that can detect single photons -- a necessity for modern particle physics experiments. He thought that this same technology might allow doctors to lower the dose of X-rays women undergoing mammography receive. So Danielsson, who is now a professor at the Royal Institute of Technology in Sweden, founded a company that built such sensitive detectors. Clinical trials in Europe a couple years ago concluded that the detectors could effectively lower radiation doses by half while still diagnosing cancers effectively.
These detectors are now installed in some 150 clinical centers in 15 different countries, and work is ongoing in order to win approval by the Food and Drug Administration, which regulates medical devices in the Unites States. In Anaheim, Danielsson will present his latest data on how the detectors can help to resolve different tissues in the breast. He and his colleagues are in the midst of a large, multicenter clinical trial that seeks to get information on cancers by analyzing the energy of the X-rays.
The talk, "Photon Counting Detectors for Mammography" is at 1:30 p.m. on Monday, July 27 in room 210A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11927
BREAST CT SCANNERS FOR THERAPY
Since 2004, a group of researchers at the University of California, Davis led by John M. Boone, Professor and Vice Chair of Radiology and Professor of Biomedical Engineering, has been developing a new technology for diagnosing breast cancer in women that promises to be more comfortable than conventional mammography but just as safe.
The discomfort of a mammogram can drive some women to avoid the valuable screening, occasionally with dire consequences. But the new procedure, based on computed tomography (CT), promises to take the pain out of breast cancer detection. In the cone beam breast CT scanner, a woman lies face down on a special table with one breast suspended through an opening. A CT scanner rotates around the breast, collecting data that are reconstructed into a three-dimensional image. The total dose of radiation is the same as in a conventional mammogram.
Boone and his colleagues have scanned more than 200 women with their prototype scanner. Now they are teaming up with radiation oncologists to explore whether the same system can be used to treat breast cancer. By carefully rotating the CT cone beam around the breast, they can deliver a lethal dose of X-rays to cancer cells inside a tumor while sparing healthy tissue. So far, they have measured dose distribution and performed simulations to show the feasibility of such a system, which Boone will describe in Anaheim.
The talk, "Breast CT as a Platform for Image Guided Therapies of Breast Cancer" is at 4:55 p.m. on Tuesday, July 28 in room 303A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11896
UPDATE ON DIGITAL MAMMOGRAPHY
In the last few years, digital mammography has become a popular alternative to conventional film-screen mammography systems. According to Kalpana Kanal, an assistant professor of radiology at the University of Washington, about half of all mammography systems in the United States today are digital -- up from about a third just a year ago.
Though digital systems are about four times more expensive, they offer significant advantages over film, says Kanal. Moreover, a 2005 article published in the New England Journal of Medicine based on the DMIST study of 50,000 women compared digital with film mammography and showed that the overall diagnostic accuracy as a means of screening is similar for both technologies. However, digital mammography is more accurate for women under the age of 50, women with dense breasts, and premenopausal and perimenopausal women.
In Anaheim, Kanal will give an overview of the various digital mammography systems available in the United States and discuss their advantages and disadvantages and the benefits of going digital.
The talk, "Digital Mammography Update: Design and Characteristics of Current Systems" is at 8:30 a.m. on Monday, July 27 in room 303A. See: aapm/meetings/09AM/PRAbs.asp?mid=42&aid=11958
Source:
Jason Bardi
American Institute of Physics
Kaiser Health News, L.A. Times Discuss Possibility Of Revoked Approval Of Breast Cancer Drug
Some advocacy groups and lawmakers are urging FDA not to revoke its approval of Roche's Avastin for treatment of advanced breast cancer, arguing that such a decision would limit women's access to the drug by prompting insurers to reject coverage for it, the Fiscal Times/Kaiser Health News reports. FDA is currently reviewing an advisory committee's recommendation to revoke the drug's approval for breast cancer treatment after a pair of recent studies showed the drug did not extend patients' lives.
View drug information on Avastin; Mylotarg.
Avastin is designed to restrict the formation of new blood vessels that contribute to the rapid growth of certain cancer tumors. The drug was granted "accelerated approval" in 2008 for treatment of advanced breast cancer after a single clinical trial showed that a combination of Avastin and chemotherapy increased delayed tumor progression by five months. The accelerated approval process allowed Roche to market the drug to breast cancer patients under the condition that it conduct new trials to confirm that Avastin actually postponed death. The evidence cited in the two follow-up studies indicated that although tumor growth in breast cancer patients taking Avastin was delayed one to three months, there was little or no change in life expectancy.
Even if FDA revokes Avastin's approval as a breast cancer treatment, it would remain on the market for treatment of other cancers, meaning that doctors could prescribe it off-label to breast cancer patients. However, insurers -- including Medicaid and Medicare -- likely would refuse to cover Avastin for breast cancer patients if FDA disproves of its use, according to the Fiscal Times/Kaiser Health News. One year of Avastin treatment can cost up to $100,000.
The threat of reduced access to a breast cancer treatment has prompted some advocacy groups and lawmakers to pressure FDA not to revoke Avastin's approval. In a letter to the agency last week, Susan B. Komen for the Cure CEO Nancy Brinker wrote, "We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer. However, we do know that for some women, Avastin offers a greater than modest benefit."
In a recent Washington Post article, Sen. David Vitter (R-La.) said he is concerned "this is the beginning of a slippery slope leading to more and more rationing under the government takeover of health care" (Goozner, Fiscal Times/Kaiser Health News, 8/16).
Opinion Piece Calls Accelerated Approval Process Beneficial
FDA is "likely to accept" the advisory panel's recommendation and revoke approval of Avastin to treat advanced breast cancer, "which would be entirely appropriate" because the "essence of the 'quick-on, quick-off' accelerated approval pathway is that the standard for approval is lenient but confirmation is required," American Council on Science and Health Associate Director Jeff Stier and Stanford University Hoover Institution fellow Henry Miller write in a Los Angeles Times opinion piece.
It is "worthy of emphasis that the vast majority of drugs marketed after accelerated approval are found in subsequent studies to be safe and effective," they argue, noting that FDA "had never withdrawn any of the 90 or so drugs on the market that had been given accelerated approval" until June, when it removed the leukemia drug Mylotarg. "And given that only medicines for 'serious or life-threatening diseases' that address an 'unmet medical need' are eligible for this pathway, accelerated approval has offered huge benefits to patients for almost 20 years by making important medicines available far earlier than they would be otherwise," they continue.
FDA "has a narrow mandate -- the assessment of the safety and efficacy of drugs," Miller and Stier write, adding that "[d]eterminations of cost-effectiveness and questions of reimbursement lie outside its expertise and mandate and must be decided by other agencies and in other forums." They conclude, "Amid controversies such as the one over Avastin, we should not lose sight of the fact that accelerated approval works" (Miller/Stier, Los Angeles Times, 8/17).
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.
© 2010 National Partnership for Women & Families. All rights reserved.
View drug information on Avastin; Mylotarg.
понедельник, 25 апреля 2011 г.
Signaling Pathway Crucial To Acute Lung Injury Discovered By Researchers
Researchers at National Jewish Health have discovered a signaling pathway that is crucial to the devastating effects of acute lung injury (ALI). The data, obtained from cells, animals and ALI patients, suggest several potential therapeutic targets. Experimental blockade of one of the targets significantly reduced flooding of the lungs that is the hallmark of ALI.
"Acute lung injury is a devastating disease, with 40 percent mortality and no beneficial therapies," said first author James Finigan, MD, Assistant Professor of Medicine at National Jewish Health. "Our study identifies several promising targets for therapy, including HER2, which is already targeted by existing breast-cancer medications."
About 200,000 people in the United States suffer acute lung injury (ALI) every year. It is caused by either direct injury to the lungs or as a result of other conditions, often pneumonia or systemic infection. In ALI, large amounts of protein-rich fluid flow from the capillaries into the lungs, leading to flooding of the airspaces and reduced ability to deliver oxygen to the blood. Severe ALI is often referred to as acute respiratory distress syndrome or ARDS. Currently there is no approved therapy for the disease. Care of ALI patients is supportive only, in which doctors try to maintain blood-oxygen levels. Approximately 40 percent of patients with ALI, or 90,000 people per year in the US, die.
Dr. Finigan and his colleagues had previously shown that HER2, a receptor involved in cell development and growth, participates in recovery of mice from chemically-induced lung injury. They hypothesized that it may also play a role in the earlier inflammatory phase of lung injury, which resembles ALI in mice. The researchers also knew that the inflammatory molecule interleukin-1ОІ is a central player in ALI and the permeability of capillaries.
In a series of experiments in cell culture and animal models they connected interleukin-1ОІ to HER2, which triggers a cascade of signals within epithelial cells. Those signals cause blood vessel walls to become permeable and allow the flood of fluid into the lung airspaces. When researchers blocked production of NRG-1, one of the molecules in the signaling pathway, they reduced flow of molecules through a cellular barrier by 52 percent.
The researches then examined lung fluid from ALI patients, and found heightened levels of NRG-1, adding clinical evidence to their data supporting an important role for this pathway. They published their findings January 19 in the online version of the Journal of Biological Chemistry.
Two existing medications, herceptin and tykerb, already target a malfunctioning HER2 in some cases of breast-cancer. Several medications targeting ADAM17 are also in development.
"Our work suggests several very promising avenues of research that may finally bring help to ALI patients," said senior author Jeffrey Kern, MD, Professor of Medicine at National Jewish Health.
Source:
William Allstetter
National Jewish Health
View drug information on Herceptin; Tykerb.
"Acute lung injury is a devastating disease, with 40 percent mortality and no beneficial therapies," said first author James Finigan, MD, Assistant Professor of Medicine at National Jewish Health. "Our study identifies several promising targets for therapy, including HER2, which is already targeted by existing breast-cancer medications."
About 200,000 people in the United States suffer acute lung injury (ALI) every year. It is caused by either direct injury to the lungs or as a result of other conditions, often pneumonia or systemic infection. In ALI, large amounts of protein-rich fluid flow from the capillaries into the lungs, leading to flooding of the airspaces and reduced ability to deliver oxygen to the blood. Severe ALI is often referred to as acute respiratory distress syndrome or ARDS. Currently there is no approved therapy for the disease. Care of ALI patients is supportive only, in which doctors try to maintain blood-oxygen levels. Approximately 40 percent of patients with ALI, or 90,000 people per year in the US, die.
Dr. Finigan and his colleagues had previously shown that HER2, a receptor involved in cell development and growth, participates in recovery of mice from chemically-induced lung injury. They hypothesized that it may also play a role in the earlier inflammatory phase of lung injury, which resembles ALI in mice. The researchers also knew that the inflammatory molecule interleukin-1ОІ is a central player in ALI and the permeability of capillaries.
In a series of experiments in cell culture and animal models they connected interleukin-1ОІ to HER2, which triggers a cascade of signals within epithelial cells. Those signals cause blood vessel walls to become permeable and allow the flood of fluid into the lung airspaces. When researchers blocked production of NRG-1, one of the molecules in the signaling pathway, they reduced flow of molecules through a cellular barrier by 52 percent.
The researches then examined lung fluid from ALI patients, and found heightened levels of NRG-1, adding clinical evidence to their data supporting an important role for this pathway. They published their findings January 19 in the online version of the Journal of Biological Chemistry.
Two existing medications, herceptin and tykerb, already target a malfunctioning HER2 in some cases of breast-cancer. Several medications targeting ADAM17 are also in development.
"Our work suggests several very promising avenues of research that may finally bring help to ALI patients," said senior author Jeffrey Kern, MD, Professor of Medicine at National Jewish Health.
Source:
William Allstetter
National Jewish Health
View drug information on Herceptin; Tykerb.
Advanced Breast Cancer May Be Diagnosed Earlier With Help Of Biomarker
Researchers have identified a molecule that may be more accurate than existing biological signposts used to predict which breast cancers will develop into advanced forms of the disease.
Detailed in an early online edition of the International Journal of Cancer, the discovery could one day influence therapy decisions and prevent patients from unnecessarily undergoing aggressive cancer treatments.
When diagnosing breast cancer, pathologists currently look for elevated levels of three standard molecules known to make tumors grow in the breast. These molecules -- estrogen receptor (ER), progesterone receptor (PR) and HER2 -- are used as "biomarkers" for diagnosis and individually detect only a fraction of breast cancers.
"The problem with these biomarkers is that many of them are present at some level in the normal breast," says Georg Weber, MD, PhD, lead investigator of the new study and associate professor of pharmacy at the University of Cincinnati. "In addition, they are surface molecules that support growth so they are not necessarily a good predictor of tumor metastasis."
Weber and his team have identified a molecule, osteopontin-c, that is absent from the normal breast and appears to more accurately predict breast cancer that will become metastatic and spread to distant organs from the original tumor site.
In normal levels, osteopontin is a protein used by the immune system to help cells move and migrate. There are three forms of osteopontin -- a, b and c -- which are formed by splicing, or "cutting and pasting," ribonucleic acid (RNA) molecules to make variations of the original gene. Osteopontin-a is the normal form that helps with immune functions. Little is known about osteopontin-b, but if present its levels are very low. Osteopontin-c is the molecule Weber and his team discovered is a good biomarker of breast cancer.
In a two-year evaluation of 178 breast tumors, normal and abnormal tissue samples, they found that osteopontin-c was present in 78 percent of cancers and in 36 percent of the surrounding tissues. It was not detected at all in normal tissues.
In 56 breast cancers, 20 were positive and 36 were negative for estrogen receptor, 19 were positive and 37 were negative for progesterone receptor, and 26 were positive for HER2 with 30 negative.
"Osteopontin-c was present in a substantially higher number of breast cancers than the three biomarkers traditionally used to diagnose breast cancer," says Weber. "We also found that the cancers containing osteopontin-c correlated with a higher tumor grade, meaning they were more likely to become aggressive cancer."
"If we know that this molecule is not present in a patient with breast cancer, it's more likely that we can treat them with conservative therapy rather than breast surgery, hormone therapy or chemotherapy because we know it's less likely to metastasize," he adds. "On the other hand, if we know that a patient has this molecule early in their diagnosis, we can treat it more aggressively because we know their cancer is likely to become invasive."
The study was funded by grants from U.S. Department of Defense Breast Cancer Program and the UC cancer research program. The tissue procurement was supported by a grant from the National Institute of Health.
Collaborators include UC's Mana Mirza and Elizabeth Shaughnessy, MD, John Hurley, Kristie Vanpatten and Gary Pestano of Ventana Medical Systems in Tucson, Ariz., as well as Bin He, MD, of the North Shore Medical Center in, Salem, Mass.
Source: Jamie Davis Kaun
University of Cincinnati
Detailed in an early online edition of the International Journal of Cancer, the discovery could one day influence therapy decisions and prevent patients from unnecessarily undergoing aggressive cancer treatments.
When diagnosing breast cancer, pathologists currently look for elevated levels of three standard molecules known to make tumors grow in the breast. These molecules -- estrogen receptor (ER), progesterone receptor (PR) and HER2 -- are used as "biomarkers" for diagnosis and individually detect only a fraction of breast cancers.
"The problem with these biomarkers is that many of them are present at some level in the normal breast," says Georg Weber, MD, PhD, lead investigator of the new study and associate professor of pharmacy at the University of Cincinnati. "In addition, they are surface molecules that support growth so they are not necessarily a good predictor of tumor metastasis."
Weber and his team have identified a molecule, osteopontin-c, that is absent from the normal breast and appears to more accurately predict breast cancer that will become metastatic and spread to distant organs from the original tumor site.
In normal levels, osteopontin is a protein used by the immune system to help cells move and migrate. There are three forms of osteopontin -- a, b and c -- which are formed by splicing, or "cutting and pasting," ribonucleic acid (RNA) molecules to make variations of the original gene. Osteopontin-a is the normal form that helps with immune functions. Little is known about osteopontin-b, but if present its levels are very low. Osteopontin-c is the molecule Weber and his team discovered is a good biomarker of breast cancer.
In a two-year evaluation of 178 breast tumors, normal and abnormal tissue samples, they found that osteopontin-c was present in 78 percent of cancers and in 36 percent of the surrounding tissues. It was not detected at all in normal tissues.
In 56 breast cancers, 20 were positive and 36 were negative for estrogen receptor, 19 were positive and 37 were negative for progesterone receptor, and 26 were positive for HER2 with 30 negative.
"Osteopontin-c was present in a substantially higher number of breast cancers than the three biomarkers traditionally used to diagnose breast cancer," says Weber. "We also found that the cancers containing osteopontin-c correlated with a higher tumor grade, meaning they were more likely to become aggressive cancer."
"If we know that this molecule is not present in a patient with breast cancer, it's more likely that we can treat them with conservative therapy rather than breast surgery, hormone therapy or chemotherapy because we know it's less likely to metastasize," he adds. "On the other hand, if we know that a patient has this molecule early in their diagnosis, we can treat it more aggressively because we know their cancer is likely to become invasive."
The study was funded by grants from U.S. Department of Defense Breast Cancer Program and the UC cancer research program. The tissue procurement was supported by a grant from the National Institute of Health.
Collaborators include UC's Mana Mirza and Elizabeth Shaughnessy, MD, John Hurley, Kristie Vanpatten and Gary Pestano of Ventana Medical Systems in Tucson, Ariz., as well as Bin He, MD, of the North Shore Medical Center in, Salem, Mass.
Source: Jamie Davis Kaun
University of Cincinnati
воскресенье, 24 апреля 2011 г.
Risk Assessment Plays Key Role In Long Term Treatment Of Breast Cancer
Breast cancer patients and their physicians may make more informed, long-term treatment decisions using risk assessment strategies to help determine probability of recurrence, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reported in the Aug. 12 online issue of the Journal of the National Cancer Institute.
The 2,838 women studied were diagnosed with Stage I through III breast cancers and had been treated with adjuvant systemic therapy (AST), such as chemotherapy and or tamoxifen between 1985 and 2001, and were in the M. D. Anderson Tumor Registry. The patients in the study were five years from the start of their AST and were cancer-free. The researchers calculated the residual or remaining risk of recurrence from the benchmark of five years from the start of AST and determined the factors that contributed to a higher residual risk of recurrence.
"Understandably, one of the most common questions posed by breast cancer survivors is 'What are the chances of it coming back?'," said the study's lead author, Abenaa Brewster, M.D., assistant professor in M. D. Anderson's Department of Clinical Cancer Prevention. "Now we can tell some women within a certain percentage their future risk of recurrence and clinicians may be able to make more informed decisions regarding prescription of extended adjuvant endocrine therapy."
Data analysis revealed that 89 percent of the study populations did not experience a recurrence at five years (approximately 10 years after a woman's initial diagnosis), and 80 percent did not experience a recurrence at 10 years (approximately 15 years after diagnosis).
Brewster commented that, while reassuring for most of the five-year survivors, the percentage of the population who had a recurrence is significant to oncologists.
"The magnitude of risk of recurrence should indicate a need for us to consider extended endocrine treatment for eligible women to further lower their risks," said Brewster. Additionally, the study did not include women who received adjuvant systemic therapy with trastuzamab or five years of aromatase inhibitor treatment and therefore the residual risk of recurrence among those groups of patients could not be determined.
Median follow-up time for women in the study was 28 months. During that time, 216 of the women experienced a recurrence. The five-year residual risks of recurrence for patients with Stage I, II and III cancers were 7 percent, 11 percent and 13 percent respectively. Patients with Stage II or III versus Stage I disease and patients with grade I versus grade III tumors had a higher risk of late recurrence. Patients who had estrogen receptor-positive tumors who received adjuvant endocrine therapy also had a higher risk of recurrence than those with hormone receptor-negative tumors but the difference was not found to meet statistical significance.
The study also indicated a need for the continued development of risk-reduction strategies for pre-menopausal breast cancer survivors because of lack of available therapies in this younger age group. Currently, extended adjuvant endocrine therapy with letrozole (Femara) is available only for post-menopausal patients with hormone receptor positive tumors who have completed five years of tamoxifen therapy.
Co-authors with Brewster are: Francisco J. Esteva, M.D., Ph.D.; Gabriel N. Hortobagyi, M.D.; Banu K. Arun, M.D.; Aman U. Buzdar, M.D.; Daniel J. Booser, M.D.; Vicente Valero, M.D.; and Shu-Wan C. Kau, B.S.N. of M. D. Anderson's Department of Breast Medical Oncology; Melissa L. Bondy, Ph.D., of M. D. Anderson's Department of Epidemiology; Kristine R. Broglio of M. D. Anderson's Division of Quantitative Sciences; and Cesar A. Santa-Maria of The University of Texas Health Science Center at Houston.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 41 Comprehensive Cancer Centers designated by the National Cancer Institute. For six of the past nine years, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News and World Report.
University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd., Box 229
Houston, TX 77030
United States
mdanderson
View drug information on Femara.
The 2,838 women studied were diagnosed with Stage I through III breast cancers and had been treated with adjuvant systemic therapy (AST), such as chemotherapy and or tamoxifen between 1985 and 2001, and were in the M. D. Anderson Tumor Registry. The patients in the study were five years from the start of their AST and were cancer-free. The researchers calculated the residual or remaining risk of recurrence from the benchmark of five years from the start of AST and determined the factors that contributed to a higher residual risk of recurrence.
"Understandably, one of the most common questions posed by breast cancer survivors is 'What are the chances of it coming back?'," said the study's lead author, Abenaa Brewster, M.D., assistant professor in M. D. Anderson's Department of Clinical Cancer Prevention. "Now we can tell some women within a certain percentage their future risk of recurrence and clinicians may be able to make more informed decisions regarding prescription of extended adjuvant endocrine therapy."
Data analysis revealed that 89 percent of the study populations did not experience a recurrence at five years (approximately 10 years after a woman's initial diagnosis), and 80 percent did not experience a recurrence at 10 years (approximately 15 years after diagnosis).
Brewster commented that, while reassuring for most of the five-year survivors, the percentage of the population who had a recurrence is significant to oncologists.
"The magnitude of risk of recurrence should indicate a need for us to consider extended endocrine treatment for eligible women to further lower their risks," said Brewster. Additionally, the study did not include women who received adjuvant systemic therapy with trastuzamab or five years of aromatase inhibitor treatment and therefore the residual risk of recurrence among those groups of patients could not be determined.
Median follow-up time for women in the study was 28 months. During that time, 216 of the women experienced a recurrence. The five-year residual risks of recurrence for patients with Stage I, II and III cancers were 7 percent, 11 percent and 13 percent respectively. Patients with Stage II or III versus Stage I disease and patients with grade I versus grade III tumors had a higher risk of late recurrence. Patients who had estrogen receptor-positive tumors who received adjuvant endocrine therapy also had a higher risk of recurrence than those with hormone receptor-negative tumors but the difference was not found to meet statistical significance.
The study also indicated a need for the continued development of risk-reduction strategies for pre-menopausal breast cancer survivors because of lack of available therapies in this younger age group. Currently, extended adjuvant endocrine therapy with letrozole (Femara) is available only for post-menopausal patients with hormone receptor positive tumors who have completed five years of tamoxifen therapy.
Co-authors with Brewster are: Francisco J. Esteva, M.D., Ph.D.; Gabriel N. Hortobagyi, M.D.; Banu K. Arun, M.D.; Aman U. Buzdar, M.D.; Daniel J. Booser, M.D.; Vicente Valero, M.D.; and Shu-Wan C. Kau, B.S.N. of M. D. Anderson's Department of Breast Medical Oncology; Melissa L. Bondy, Ph.D., of M. D. Anderson's Department of Epidemiology; Kristine R. Broglio of M. D. Anderson's Division of Quantitative Sciences; and Cesar A. Santa-Maria of The University of Texas Health Science Center at Houston.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 41 Comprehensive Cancer Centers designated by the National Cancer Institute. For six of the past nine years, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News and World Report.
University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd., Box 229
Houston, TX 77030
United States
mdanderson
View drug information on Femara.
суббота, 23 апреля 2011 г.
Breast Cancer Conference Highlights
GENE SIGNATURE IDENTIFIES BREAST CANCER PATIENTS WHO WILL RESPOND TO CHEMOTHERAPY
Researchers have identified a genetic signature that can predict which breast cancer patients will respond well to treatment with epirubicin, a widely used form of chemotherapy. Although among the most effective chemotherapies in breast cancer, a small proportion of women suffer severe side-effects. By identifying those women who are most likely to benefit from treatment, doctors may be able to ensure fewer women are unnecessarily exposed to that risk. The new study shows that this goal can be achieved by developing more sophisticated ways to use older drugs.
GENE SIGNATURE PREDICTS GOOD OUTCOME IN BREAST CANCER
Researchers have identified a genetic signature that can predict an improved clinical outcome in patients with breast cancer, and which could help in the development of new targeted therapies. By analysing the expression of different genes induced by a specific mutation in a molecule called PIK3CA, a critical part of the pathway commonly deregulated in breast cancer, they found that these genes were correlated with an improved clinical outcome in over 1500 women with the disease.
GENETIC TEST REDUCES NEED FOR SECOND SURGERY IN BREAST CANCER TREATMENT
A new rapid test can confirm quickly and accurately that breast cancer has most likely not spread into adjacent lymph nodes, offering reassurance to patients and reducing the need for a second operation. The new technique allows you to make the diagnosis of micro metastases while the surgery is underway, meaning the patient does not have to suffer the disruption of undergoing another operation.
ANDROGEN-RECEPTOR: A NEW DRUG TARGET IN BREAST CANCER
New results may help scientists develop treatments for women with a type of breast cancer that currently does not respond to targeted therapies. Some cancers (triple-negative tumors) generally do not respond to receptor-targeted treatments. In recent years, scientists have begun looking for new targets in these "triple-negative" cancers. One that has been identified is the androgen-receptor.
Source:
ESMO Press Office
European Society for Medical Oncology
Researchers have identified a genetic signature that can predict which breast cancer patients will respond well to treatment with epirubicin, a widely used form of chemotherapy. Although among the most effective chemotherapies in breast cancer, a small proportion of women suffer severe side-effects. By identifying those women who are most likely to benefit from treatment, doctors may be able to ensure fewer women are unnecessarily exposed to that risk. The new study shows that this goal can be achieved by developing more sophisticated ways to use older drugs.
GENE SIGNATURE PREDICTS GOOD OUTCOME IN BREAST CANCER
Researchers have identified a genetic signature that can predict an improved clinical outcome in patients with breast cancer, and which could help in the development of new targeted therapies. By analysing the expression of different genes induced by a specific mutation in a molecule called PIK3CA, a critical part of the pathway commonly deregulated in breast cancer, they found that these genes were correlated with an improved clinical outcome in over 1500 women with the disease.
GENETIC TEST REDUCES NEED FOR SECOND SURGERY IN BREAST CANCER TREATMENT
A new rapid test can confirm quickly and accurately that breast cancer has most likely not spread into adjacent lymph nodes, offering reassurance to patients and reducing the need for a second operation. The new technique allows you to make the diagnosis of micro metastases while the surgery is underway, meaning the patient does not have to suffer the disruption of undergoing another operation.
ANDROGEN-RECEPTOR: A NEW DRUG TARGET IN BREAST CANCER
New results may help scientists develop treatments for women with a type of breast cancer that currently does not respond to targeted therapies. Some cancers (triple-negative tumors) generally do not respond to receptor-targeted treatments. In recent years, scientists have begun looking for new targets in these "triple-negative" cancers. One that has been identified is the androgen-receptor.
Source:
ESMO Press Office
European Society for Medical Oncology
пятница, 22 апреля 2011 г.
Hypnosis Can Help Control Pain Among Women With Metastatic Breast Cancer, UB Researcher Finds
Hypnosis can help alleviate the pain and suffering experienced by women being treated for breast cancer, according to a study by a University at Buffalo School of Social Work professor.
The randomized trial measured pain and suffering, frequency of pain and degree of constant pain among 124 women with metastatic breast cancer, according to Lisa D. Butler, associate professor in UB's School of Social Work, a faculty member in the Buffalo Center for Social Research and first author of the study.
Researchers recorded levels of pain at four-month intervals for a year. Women who were assigned to the treatment group received group psychotherapy, as well as instruction and practice in hypnosis to moderate their pain symptoms. They reported "significantly less increase in the intensity of pain and suffering over time," compared with a control group, who did not receive the group psychotherapy intervention.
However, those using hypnosis reported no significant reduction in the frequency or constancy of pain episodes.
"The results of this study suggest that the experience of pain and suffering for patients with metastatic breast cancer can be successfully reduced with an intervention that includes hypnosis in a group therapy setting," according to Butler. "These results augment the growing literature supporting the use of hypnosis as an adjunctive treatment for medical patients experiencing pain."
The study was published last year in an issue of the American Psychological Association journal Health Psychology.
The researchers also found that, within the treatment group, those patients who could be hypnotized more easily - a group the researchers said demonstrated "high hypnotizability" - reported greater benefits from hypnosis. These patients used hypnosis more overall, including outside of the group sessions, and in some cases used it to address other symptoms related to their cancer.
"These results suggest that although hypnosis is not at present standard practice for treating a wide range of symptoms that trouble cancer patients, it is worth examining that potential," Butler says. "Together, these findings suggest that there may be a number of benefits to the use of hypnosis in cancer care including, but not necessarily limited to, its more traditional application for pain control."
Butler joined the UB faculty in January 2009, after doing research at Stanford University's School of Medicine. She was hired at UB to strengthen the university's research focus on "extreme events" as part of the UB 2020 strategic planning initiative. She recently published a nationally recognized study on how some people living through an extremely traumatic event - including the 9/11 terrorist attacks - have the ability to recover or even grow in personal and interpersonal functioning.
Source:
Charles Anzalone
University at Buffalo
The randomized trial measured pain and suffering, frequency of pain and degree of constant pain among 124 women with metastatic breast cancer, according to Lisa D. Butler, associate professor in UB's School of Social Work, a faculty member in the Buffalo Center for Social Research and first author of the study.
Researchers recorded levels of pain at four-month intervals for a year. Women who were assigned to the treatment group received group psychotherapy, as well as instruction and practice in hypnosis to moderate their pain symptoms. They reported "significantly less increase in the intensity of pain and suffering over time," compared with a control group, who did not receive the group psychotherapy intervention.
However, those using hypnosis reported no significant reduction in the frequency or constancy of pain episodes.
"The results of this study suggest that the experience of pain and suffering for patients with metastatic breast cancer can be successfully reduced with an intervention that includes hypnosis in a group therapy setting," according to Butler. "These results augment the growing literature supporting the use of hypnosis as an adjunctive treatment for medical patients experiencing pain."
The study was published last year in an issue of the American Psychological Association journal Health Psychology.
The researchers also found that, within the treatment group, those patients who could be hypnotized more easily - a group the researchers said demonstrated "high hypnotizability" - reported greater benefits from hypnosis. These patients used hypnosis more overall, including outside of the group sessions, and in some cases used it to address other symptoms related to their cancer.
"These results suggest that although hypnosis is not at present standard practice for treating a wide range of symptoms that trouble cancer patients, it is worth examining that potential," Butler says. "Together, these findings suggest that there may be a number of benefits to the use of hypnosis in cancer care including, but not necessarily limited to, its more traditional application for pain control."
Butler joined the UB faculty in January 2009, after doing research at Stanford University's School of Medicine. She was hired at UB to strengthen the university's research focus on "extreme events" as part of the UB 2020 strategic planning initiative. She recently published a nationally recognized study on how some people living through an extremely traumatic event - including the 9/11 terrorist attacks - have the ability to recover or even grow in personal and interpersonal functioning.
Source:
Charles Anzalone
University at Buffalo
четверг, 21 апреля 2011 г.
Study Finds No Relationship Between PCR Rate And Race In Women With Breast Cancer
Locally advanced breast cancer patients who received the same class of neoadjuvant chemotherapy were found to have no evidence of disease at the time of their surgery, or achieved pathological complete response, at the same rate regardless of race, according to researchers at The University of Texas M. D. Anderson Cancer Center.
The study, presented in a poster discussion session at the 2009 Breast Cancer Symposium in San Francisco, is the largest in a homogenous group of breast cancer patients evaluating pathological complete response (pCR) according to race. Only one other study, also conducted at M. D. Anderson but limited to triple negative breast cancer patients (estrogen and progesterone receptor negative, HER2 negative), has analyzed the relationship between the two.
"Our findings confirm pathological complete response is a strong prognostic indicator and a surrogate for good survival, despite a patient's race, and that it's vital we continue to strive towards achieving this milestone for all women with breast cancer," said Mariana Chavez Mac Gregor, M.D., a medical oncology fellow at M. D. Anderson. "The study also mandates that we continue to research the differences across races in breast cancer."
Racial disparities in breast cancer are known: the American Cancer Society (ACS) estimates that 19,540 blacks and 14,200 Hispanics will be diagnosed with the disease in 2009. While the overall incidence rate is 10 percent lower in blacks than whites, in 2001-2005, they had a 37 percent higher death rate. ACS also reports that overall breast cancer mortality rates are lower in Hispanic women than white women.
Understanding the reasons for such disparities - be it access to care and screening, biological differences in tumors and/or breast cancer subtypes - is the focus of ongoing research efforts across the cancer community, explained Chavez Mac Gregor, the study's first author.
"While these disparities are known, we also understand that breast cancer patients who achieve pathological complete response have better outcomes," said Chavez-Mac Gregor. "What we didn't understand until now was if pathological complete response rates had any relationship with race. If a specific ethnic group had a better or worse response rate, maybe we could then determine which groups may be in need of additional and /or improved therapies."
Using the M. D. Anderson Breast Medical Oncology database, the retrospective study identified 2,074 patients diagnosed with Stages II and III breast cancer and treated at the institution between 1994 and 2008. Of the patients, 1,334 (64.3 percent) were white, 302 (14.6 percent) black, 316 (15.2 percent) Hispanic, and 122 (5.9 percent) were classified as "other" race groups. The median age of the women was 50. All received neoadjuvant anthracycline- and taxane-based chemotherapy; receiving similar class of therapy was an important component in the design of the study, said Chavez Mac Gregor.
At the time of surgery, the researchers found no difference of statistical significance in pCR rates among racial groups: 12.3 percent in whites; 12.5 percent in blacks; 14.24 percent in Hispanics; 11.5 percent in other.
Among all patients, at a median follow-up of 30 months, there were 438 recurrences and 327 deaths. The five year unadjusted recurrence-free (RFS) and overall survival (OS) rates were: 71 percent and 79 percent in whites; 60 percent and 57 percent in blacks; 76 percent and 79 percent in Hispanics; and 75 percent and 84 percent in "other," respectively. Lack of achieving pCR, HER2-positive and triple-negative subtypes, lymph node involvement were all found to be independent predictors of worse RFS and OS.
In further analysis, the study reconfirmed what had been noted in literature - although not statistically significant, blacks tended to have poorer outcomes, while Hispanics had improved outcomes compared to whites, said Chavez Mac Gregor.
The study is not without limitations, she noted: in design, it was both retrospective and a single-institution study, and race was self-reported. In addition, the research focus was until the time of surgery, with less attention towards patients' experience post-surgery, such as compliance to hormone therapies or other adjuvant treatments, other than RFS and OS.
In the same cohort of patients, Chavez Mac Gregor plans further analysis of patients who did not achieve pCR to better understand why they might not have reached this milestone.
The study was funded by grants from the National Cancer Institute and Susan G. Komen for the Cure.
In addition to Chavez Mac Gregor, M. D. Anderson authors on the study include: Gabriel N. Hortobagyi, M.D.; Ana Maria Gonzalez-Angulo, M.D., the study's senior author; Jennifer Litton, M.D.; Vicente Valero, M.D.; and Huiqin Chen, all of the Department of Breast Medical Oncology; Funda Meric-Bernstam, M.D., Department of Surgery; and Melissa Bondy, Ph.D., Department of Epidemiology. Other authors include: Clifford A. Hudis, M.D., Memorial Sloan Kettering; and Antonio C. Wolff, M.D., The Sidney Kimmel Comprehensive Cancer Center.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 40 comprehensive cancer centers designated by the National Cancer Institute. For six of the past eight years, including 2009, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News & World Report.
Source: University of Texas M. D. Anderson Cancer Center
The study, presented in a poster discussion session at the 2009 Breast Cancer Symposium in San Francisco, is the largest in a homogenous group of breast cancer patients evaluating pathological complete response (pCR) according to race. Only one other study, also conducted at M. D. Anderson but limited to triple negative breast cancer patients (estrogen and progesterone receptor negative, HER2 negative), has analyzed the relationship between the two.
"Our findings confirm pathological complete response is a strong prognostic indicator and a surrogate for good survival, despite a patient's race, and that it's vital we continue to strive towards achieving this milestone for all women with breast cancer," said Mariana Chavez Mac Gregor, M.D., a medical oncology fellow at M. D. Anderson. "The study also mandates that we continue to research the differences across races in breast cancer."
Racial disparities in breast cancer are known: the American Cancer Society (ACS) estimates that 19,540 blacks and 14,200 Hispanics will be diagnosed with the disease in 2009. While the overall incidence rate is 10 percent lower in blacks than whites, in 2001-2005, they had a 37 percent higher death rate. ACS also reports that overall breast cancer mortality rates are lower in Hispanic women than white women.
Understanding the reasons for such disparities - be it access to care and screening, biological differences in tumors and/or breast cancer subtypes - is the focus of ongoing research efforts across the cancer community, explained Chavez Mac Gregor, the study's first author.
"While these disparities are known, we also understand that breast cancer patients who achieve pathological complete response have better outcomes," said Chavez-Mac Gregor. "What we didn't understand until now was if pathological complete response rates had any relationship with race. If a specific ethnic group had a better or worse response rate, maybe we could then determine which groups may be in need of additional and /or improved therapies."
Using the M. D. Anderson Breast Medical Oncology database, the retrospective study identified 2,074 patients diagnosed with Stages II and III breast cancer and treated at the institution between 1994 and 2008. Of the patients, 1,334 (64.3 percent) were white, 302 (14.6 percent) black, 316 (15.2 percent) Hispanic, and 122 (5.9 percent) were classified as "other" race groups. The median age of the women was 50. All received neoadjuvant anthracycline- and taxane-based chemotherapy; receiving similar class of therapy was an important component in the design of the study, said Chavez Mac Gregor.
At the time of surgery, the researchers found no difference of statistical significance in pCR rates among racial groups: 12.3 percent in whites; 12.5 percent in blacks; 14.24 percent in Hispanics; 11.5 percent in other.
Among all patients, at a median follow-up of 30 months, there were 438 recurrences and 327 deaths. The five year unadjusted recurrence-free (RFS) and overall survival (OS) rates were: 71 percent and 79 percent in whites; 60 percent and 57 percent in blacks; 76 percent and 79 percent in Hispanics; and 75 percent and 84 percent in "other," respectively. Lack of achieving pCR, HER2-positive and triple-negative subtypes, lymph node involvement were all found to be independent predictors of worse RFS and OS.
In further analysis, the study reconfirmed what had been noted in literature - although not statistically significant, blacks tended to have poorer outcomes, while Hispanics had improved outcomes compared to whites, said Chavez Mac Gregor.
The study is not without limitations, she noted: in design, it was both retrospective and a single-institution study, and race was self-reported. In addition, the research focus was until the time of surgery, with less attention towards patients' experience post-surgery, such as compliance to hormone therapies or other adjuvant treatments, other than RFS and OS.
In the same cohort of patients, Chavez Mac Gregor plans further analysis of patients who did not achieve pCR to better understand why they might not have reached this milestone.
The study was funded by grants from the National Cancer Institute and Susan G. Komen for the Cure.
In addition to Chavez Mac Gregor, M. D. Anderson authors on the study include: Gabriel N. Hortobagyi, M.D.; Ana Maria Gonzalez-Angulo, M.D., the study's senior author; Jennifer Litton, M.D.; Vicente Valero, M.D.; and Huiqin Chen, all of the Department of Breast Medical Oncology; Funda Meric-Bernstam, M.D., Department of Surgery; and Melissa Bondy, Ph.D., Department of Epidemiology. Other authors include: Clifford A. Hudis, M.D., Memorial Sloan Kettering; and Antonio C. Wolff, M.D., The Sidney Kimmel Comprehensive Cancer Center.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 40 comprehensive cancer centers designated by the National Cancer Institute. For six of the past eight years, including 2009, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News & World Report.
Source: University of Texas M. D. Anderson Cancer Center
среда, 20 апреля 2011 г.
Radiation Lowers Relapse Risk In Noninvasive Breast Cancer
A new review confirms that the addition of radiation therapy to lumpectomy in the treatment of ductal carcinoma in situ (DCIS), a noninvasive early form of breast cancer, substantially decreases the risk of recurrence of either DCIS or invasive breast cancer in the affected breast.
In addition, there appear to be no long-term side effects from the radiation, such as damage to the heart or lungs.
Co-author Dr. Annabel Goodwin and colleagues from the Westmead Hospital in Australia and the University of Sydney looked at recent studies that evaluated the addition of radiation therapy after lumpectomy in the treatment of DCIS.
"We wanted to assess whether breast conserving surgery followed by radiotherapy is better than breast conserving surgery alone," Goodwin said. "We also wanted to investigate if there was any short- or long-term toxicity from the use of radiotherapy to determine the balance between benefit and harm."
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The researchers identified four high-quality studies that compared breast-conserving surgery with or without radiation therapy in patients with DCIS. The review included data from 3,925 women.
DCIS is different from invasive breast cancer in that abnormal, precancerous cells form within the milk duct of the breast but do not spread to other parts of the breast. If treated, it is usually curable. However, if left untreated, it substantially increases a woman's chance of developing invasive breast cancer.
Women usually cannot feel a lump in the breast with DCIS usually cannot be felt as a lump in the breast, but a mammogram can often detect it. Breast-conserving surgery where only the affected part of the breast is removed followed by radiation, is successful for most.
The reviewers found that the addition of radiation therapy after breast conserving surgery decreases the risk of recurrence of either DCIS or invasive breast cancer in the treated breast by 51 percent.
"This means that for every nine women having breast-conserving surgery [for DCIS], if they all had radiotherapy, one woman would be spared from having a local recurrence of her breast cancer because of the radiotherapy," Goodwin said. She added that the results of two included studies suggested that women over 50 had a greater benefit from the addition of radiotherapy than younger women did.
The researchers found no evidence of increased long-term toxicity from the radiation treatment. "Newer techniques of radiation therapy reduce the dose of radiation to the surrounding normal tissues such as the lungs and heart," Goodwin said. "This is likely to reduce the potential long term side effects, but longer term follow up of patients in these studies is needed to confirm this."
Surgical oncologist and breast cancer expert Monica Morrow, M.D., from the Memorial Sloan-Kettering Cancer Center, said that the review confirms what most physicians currently recommend for their patients with DCIS who opt for breast-conserving treatment. "The best way to minimize the chance of recurrence is with radiation," she said.
Survival rates the percentage of women who are alive after a certain period after diagnosis are excellent for women with DCIS, no matter whether they choose mastectomy or breast-conserving therapy. In patients who have breast-conserving therapy with or without radiation therapy, survival rates range from 90 percent to 99 percent at 10 years.
Doctors overwhelmingly favor breast-conserving therapy for DCIS, Morrow said. However, many women in the United States choose more aggressive treatment with mastectomy.
"Studies show that the bigger the patient's role in decision-making, the greater the likelihood the patient will end up with mastectomy," she said. "This is because most patients don't distinguish between DCIS and invasive breast cancer, because a lot of the stuff they find on the Internet is written about invasive cancer."
While it is true that the risk of having a recurrence of breast cancer after a mastectomy is lower than after breast conserving therapy in DCIS, Morrow said there is not much difference in survival rates. "What I tend to emphasize to my patients with DCIS is that no matter which treatment they choose, their risk over the next 15 years of dying of something else is greater than their risk of dying of breast cancer. In the end the difference of survival, if there is any, is on the order of a percent or two."
Goodwin A, et al. Post-operative radiotherapy for ductal carcinoma in situ of the breast. Cochrane Database of Systematic Reviews 2009, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit cochrane for more information.
Health Behavior News Service
Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210
Washington
DC 20009
United States
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In addition, there appear to be no long-term side effects from the radiation, such as damage to the heart or lungs.
Co-author Dr. Annabel Goodwin and colleagues from the Westmead Hospital in Australia and the University of Sydney looked at recent studies that evaluated the addition of radiation therapy after lumpectomy in the treatment of DCIS.
"We wanted to assess whether breast conserving surgery followed by radiotherapy is better than breast conserving surgery alone," Goodwin said. "We also wanted to investigate if there was any short- or long-term toxicity from the use of radiotherapy to determine the balance between benefit and harm."
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The researchers identified four high-quality studies that compared breast-conserving surgery with or without radiation therapy in patients with DCIS. The review included data from 3,925 women.
DCIS is different from invasive breast cancer in that abnormal, precancerous cells form within the milk duct of the breast but do not spread to other parts of the breast. If treated, it is usually curable. However, if left untreated, it substantially increases a woman's chance of developing invasive breast cancer.
Women usually cannot feel a lump in the breast with DCIS usually cannot be felt as a lump in the breast, but a mammogram can often detect it. Breast-conserving surgery where only the affected part of the breast is removed followed by radiation, is successful for most.
The reviewers found that the addition of radiation therapy after breast conserving surgery decreases the risk of recurrence of either DCIS or invasive breast cancer in the treated breast by 51 percent.
"This means that for every nine women having breast-conserving surgery [for DCIS], if they all had radiotherapy, one woman would be spared from having a local recurrence of her breast cancer because of the radiotherapy," Goodwin said. She added that the results of two included studies suggested that women over 50 had a greater benefit from the addition of radiotherapy than younger women did.
The researchers found no evidence of increased long-term toxicity from the radiation treatment. "Newer techniques of radiation therapy reduce the dose of radiation to the surrounding normal tissues such as the lungs and heart," Goodwin said. "This is likely to reduce the potential long term side effects, but longer term follow up of patients in these studies is needed to confirm this."
Surgical oncologist and breast cancer expert Monica Morrow, M.D., from the Memorial Sloan-Kettering Cancer Center, said that the review confirms what most physicians currently recommend for their patients with DCIS who opt for breast-conserving treatment. "The best way to minimize the chance of recurrence is with radiation," she said.
Survival rates the percentage of women who are alive after a certain period after diagnosis are excellent for women with DCIS, no matter whether they choose mastectomy or breast-conserving therapy. In patients who have breast-conserving therapy with or without radiation therapy, survival rates range from 90 percent to 99 percent at 10 years.
Doctors overwhelmingly favor breast-conserving therapy for DCIS, Morrow said. However, many women in the United States choose more aggressive treatment with mastectomy.
"Studies show that the bigger the patient's role in decision-making, the greater the likelihood the patient will end up with mastectomy," she said. "This is because most patients don't distinguish between DCIS and invasive breast cancer, because a lot of the stuff they find on the Internet is written about invasive cancer."
While it is true that the risk of having a recurrence of breast cancer after a mastectomy is lower than after breast conserving therapy in DCIS, Morrow said there is not much difference in survival rates. "What I tend to emphasize to my patients with DCIS is that no matter which treatment they choose, their risk over the next 15 years of dying of something else is greater than their risk of dying of breast cancer. In the end the difference of survival, if there is any, is on the order of a percent or two."
Goodwin A, et al. Post-operative radiotherapy for ductal carcinoma in situ of the breast. Cochrane Database of Systematic Reviews 2009, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit cochrane for more information.
Health Behavior News Service
Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210
Washington
DC 20009
United States
hbns
Scientists Test New Drug Combo Against Breast Cancer
The American Cancer Society estimates 192,000 new cases of breast cancer will be diagnosed in the United States this year with more than 40,000 individuals dying from the disease. In New Jersey alone 6,400 new cases are expected with 1,400 deaths. In an effort to combat such statistics, researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial, which will evaluate a new drug combination for patients with breast cancer who are set to undergo surgery to remove the tumor. At focus is the process of stopping angiogenesis (blood vessel growth), which is necessary for cancer tumors to grow and spread. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.
CINJ is one of the participating centers in the United States and Canada conducting the study, which is sponsored by the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. This trial will look at the effects of an investigational drug called pazopanib when given with chemotherapy before surgery and when given without chemotherapy after surgery. Pazopanib, which does not yet have the approval of the U.S. Food and Drug Administration, possibly blocks new blood vessel growth in cancer tumors and also targets and halts certain proteins that help cancer cells grow.
Antoinette R. Tan, MD, a medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the national study chair for the trial and the lead investigator of the study at CINJ. She notes, "In adding pazopanib to the standard of care, this new combination may improve our ability to reduce the size of breast cancer tumors. By targeting blood vessel growth in particular, we can cut off a key lifeline that enables tumors to grow and spread."
Before taking part in the trial, interested participants will undergo various examinations including a general physical and routine blood and urine tests. Selected patients will receive pazopanib with chemotherapy prior to breast surgery and will receive pazopanib by itself after surgery. Pazopanib is taken by mouth, while chemotherapy is given through a vein. Patients will keep a medication diary and continue with standard testing such as blood work and physical exams throughout their participation in the trial, which is expected to be about two years. Some 100 participants total are being sought from all sites
Women at or over age 18, who have breast cancer and have not yet undergone surgery to remove the tumor are eligible to take part in the trial, although other criteria must be met.
Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.
As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 1,000 patients on clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.
About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey is the state's first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ's physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.
The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, and Jersey Shore University Medical Center. Affiliate Hospitals: Bayshore Community Hospital, CentraState Healthcare System, Cooper University Hospital*, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter's University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton.
Source: Cancer Institute of New Jersey
CINJ is one of the participating centers in the United States and Canada conducting the study, which is sponsored by the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. This trial will look at the effects of an investigational drug called pazopanib when given with chemotherapy before surgery and when given without chemotherapy after surgery. Pazopanib, which does not yet have the approval of the U.S. Food and Drug Administration, possibly blocks new blood vessel growth in cancer tumors and also targets and halts certain proteins that help cancer cells grow.
Antoinette R. Tan, MD, a medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the national study chair for the trial and the lead investigator of the study at CINJ. She notes, "In adding pazopanib to the standard of care, this new combination may improve our ability to reduce the size of breast cancer tumors. By targeting blood vessel growth in particular, we can cut off a key lifeline that enables tumors to grow and spread."
Before taking part in the trial, interested participants will undergo various examinations including a general physical and routine blood and urine tests. Selected patients will receive pazopanib with chemotherapy prior to breast surgery and will receive pazopanib by itself after surgery. Pazopanib is taken by mouth, while chemotherapy is given through a vein. Patients will keep a medication diary and continue with standard testing such as blood work and physical exams throughout their participation in the trial, which is expected to be about two years. Some 100 participants total are being sought from all sites
Women at or over age 18, who have breast cancer and have not yet undergone surgery to remove the tumor are eligible to take part in the trial, although other criteria must be met.
Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.
As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 1,000 patients on clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.
About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey is the state's first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ's physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.
The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, and Jersey Shore University Medical Center. Affiliate Hospitals: Bayshore Community Hospital, CentraState Healthcare System, Cooper University Hospital*, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter's University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton.
Source: Cancer Institute of New Jersey
Breast Cancer: Researchers Unveil Strategy For Creating Actively-programmed Anti-cancer Molecules
The new study, which was published July 5 in an advanced, online edition of the Proceedings of the National Academy of Sciences, achieved a significant enhancement of the treatment of metastatic breast cancer in animal models. The study showed the new hybrid compound remained in circulation for a week. In comparison, the small molecule drug was cleared in a matter of minutes.
"Although the study focused specifically on breast cancer, these new findings could have broad application in the treatment of a number of other cancers, potentially increasing the efficacy of a number of existing or undeveloped small molecule therapies," said Subhash C. Sinha, Ph.D., associate professor in the Scripps Research Department of Molecular Biology and the Skaggs Institute for Chemical Biology, who led the research with Scripps Research President Richard A. Lerner, M.D., Lita Annenberg Hazen Professor of Immunochemistry, Cecil H. and Ida M. Green Chair in Chemistry, and a member of the Skaggs Institute for Chemical Biology.
In the study, the scientists created what is known as a "chemically programmed antibody" by using small cell-targeting molecules and a non-targeting catalytic monoclonal aldolase antibody in a novel self-assembly strategy. Antibodies are proteins produced by immune cells that are designed to recognize foreign pathogens harmful to the body; monoclonal antibodies are produced in the laboratory from a single cloned B-cell, the immune system cell that makes antibodies.
"By bringing together chemistry and biology, our approach provides a way to break the traditional one antibody-one target axiom of immunochemistry," said Lerner. "This new hybrid technology offers great possibilities for the enhanced treatment and diagnosis of a variety of diseases, including cancer."
Preventing Breast Cancer Metastasis
In the study, the researchers used the unique assembly strategy to create a novel compound to combat metastatic breast cancer.
Breast cancer can be a treatable disease, but only if diagnosed early. Since the prognosis grows considerably worse once the cancer has spread to other organs, the prevention of metastasis-the phenomenon in which cancer cells separate from a tumor mass, move through the bloodstream, anchor down in a distant tissue or organ to begin a new cancer-remains a critically important goal. The most recent figures from the Centers for Disease Control and Prevention indicate that more than 200,000 U.S. women are diagnosed with new cases of invasive breast cancer each year and that more than 40,000 of these women will die of the disease-usually the end result of metastasis.
The therapeutic use of monoclonal antibodies has expanded rapidly over the last several years precisely because of their long half-life, combined with their overall lack of toxicity and the fact that they can be easily designed and produced. For cancer treatment, the ability of antibodies to direct immune system responses to specific tumor types is one of the factors that have led to their increased use.
Until recently, it had been widely accepted that while antibodies possess a number of therapeutically advantageous traits, treatment with monoclonals required a different antibody for each specific target. However, the paper's authors have been showing that scientists can use different small molecule targeting agents-called programming agents or adapters-to selectively direct the same antibody to different sites for different uses so that only a single antibody is required for multiple tasks.
Recent research led by Scripps Research Professor Carlos F. Barbas III, for example, used the chemically programmed antibody approach in a melanoma model, dramatically enhancing the effectiveness of a small molecule drug (International Journal of Cancer 119 (5), 1194-1207, March 28, 2006).
In the new study, the researchers used a self-assembly process to link small synthetic molecules and a well-known catalytic monoclonal antibody, mAb38C2, through chemical bonding, a modification that resulted in the reprogramming of the specificity of the antibody to match the binding specificity of the small molecule. In this way, the antibodies were directed to the target avb3 integrin-a cell membrane protein expressed on a variety of cancers and the vasculatures they produce.
"Key to this unique approach is the ability of the small molecule targeting agents-called programming agents or adapters-to selectively react in the antibody binding sites without compromising the targeting property of the adapters," notes Sinha.
The results showed those mice treated with the new compound developed significantly fewer metastases than those treated with other similar compounds or the antibody alone. These results, the study noted, were a "significant enhancement in the therapeutic efficacy" of the integrin antagonist directly attributable to the chemically programmed antibody approach.
Moreover, the study indicated that this approach allows for the effective assembly of chemically programmed antibodies in vivo or in vitro, widening the possibilities for their therapeutic application. The compound could be created in vitro and delivered as a conventional single therapy. Alternately, the small molecule and antibody could be injected separately, with the new complex formed in vivo. The authors note that even though the administration of two separate compounds might complicate regulatory approval, the regimen could have advantages-for example, an imaging agent could be attached to the small molecule, allowing a physician to monitor localization of a drug before arming the agent with the antibody molecule.
In addition to Sinha and Lerner, the authors of the new study, entitled "Breaking the one antibody-one target axiom," include Fang Guo and Sanjib Das of The Scripps Research Institute and its Skaggs Institute for Chemical Biology; Barbara M. Mueller of La Jolla Institute for Molecular Medicine; and Carlos F. Barbas III of The Scripps Research Institute and its Skaggs Institute for Chemical Biology.
The study was supported by The Skaggs Institute for Chemical Biology, a grant from the Department of Defense, and the National Institutes of Health.
About The Scripps Research Institute
The Scripps Research Institute, headquartered in La Jolla, California, in 18 buildings on 40 acres overlooking the Pacific Ocean, is one of the world's largest independent, non-profit biomedical research organizations. It stands at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its research into immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel.
Scripps Florida, a 364,000 square-foot, state-of-the-art biomedical research facility, will be built in Palm Beach County. The facility will focus on basic biomedical science, drug discovery, and technology development. Palm Beach County and the State of Florida have provided start-up economic packages for development, building, staffing, and equipping the campus. Scripps Florida now operates with approximately 160 scientists, technicians, and administrative staff at 40,000 square-foot lab facilities on the Florida Atlantic University campus in Jupiter.
Contact: Keith McKeown
Scripps Research Institute
"Although the study focused specifically on breast cancer, these new findings could have broad application in the treatment of a number of other cancers, potentially increasing the efficacy of a number of existing or undeveloped small molecule therapies," said Subhash C. Sinha, Ph.D., associate professor in the Scripps Research Department of Molecular Biology and the Skaggs Institute for Chemical Biology, who led the research with Scripps Research President Richard A. Lerner, M.D., Lita Annenberg Hazen Professor of Immunochemistry, Cecil H. and Ida M. Green Chair in Chemistry, and a member of the Skaggs Institute for Chemical Biology.
In the study, the scientists created what is known as a "chemically programmed antibody" by using small cell-targeting molecules and a non-targeting catalytic monoclonal aldolase antibody in a novel self-assembly strategy. Antibodies are proteins produced by immune cells that are designed to recognize foreign pathogens harmful to the body; monoclonal antibodies are produced in the laboratory from a single cloned B-cell, the immune system cell that makes antibodies.
"By bringing together chemistry and biology, our approach provides a way to break the traditional one antibody-one target axiom of immunochemistry," said Lerner. "This new hybrid technology offers great possibilities for the enhanced treatment and diagnosis of a variety of diseases, including cancer."
Preventing Breast Cancer Metastasis
In the study, the researchers used the unique assembly strategy to create a novel compound to combat metastatic breast cancer.
Breast cancer can be a treatable disease, but only if diagnosed early. Since the prognosis grows considerably worse once the cancer has spread to other organs, the prevention of metastasis-the phenomenon in which cancer cells separate from a tumor mass, move through the bloodstream, anchor down in a distant tissue or organ to begin a new cancer-remains a critically important goal. The most recent figures from the Centers for Disease Control and Prevention indicate that more than 200,000 U.S. women are diagnosed with new cases of invasive breast cancer each year and that more than 40,000 of these women will die of the disease-usually the end result of metastasis.
The therapeutic use of monoclonal antibodies has expanded rapidly over the last several years precisely because of their long half-life, combined with their overall lack of toxicity and the fact that they can be easily designed and produced. For cancer treatment, the ability of antibodies to direct immune system responses to specific tumor types is one of the factors that have led to their increased use.
Until recently, it had been widely accepted that while antibodies possess a number of therapeutically advantageous traits, treatment with monoclonals required a different antibody for each specific target. However, the paper's authors have been showing that scientists can use different small molecule targeting agents-called programming agents or adapters-to selectively direct the same antibody to different sites for different uses so that only a single antibody is required for multiple tasks.
Recent research led by Scripps Research Professor Carlos F. Barbas III, for example, used the chemically programmed antibody approach in a melanoma model, dramatically enhancing the effectiveness of a small molecule drug (International Journal of Cancer 119 (5), 1194-1207, March 28, 2006).
In the new study, the researchers used a self-assembly process to link small synthetic molecules and a well-known catalytic monoclonal antibody, mAb38C2, through chemical bonding, a modification that resulted in the reprogramming of the specificity of the antibody to match the binding specificity of the small molecule. In this way, the antibodies were directed to the target avb3 integrin-a cell membrane protein expressed on a variety of cancers and the vasculatures they produce.
"Key to this unique approach is the ability of the small molecule targeting agents-called programming agents or adapters-to selectively react in the antibody binding sites without compromising the targeting property of the adapters," notes Sinha.
The results showed those mice treated with the new compound developed significantly fewer metastases than those treated with other similar compounds or the antibody alone. These results, the study noted, were a "significant enhancement in the therapeutic efficacy" of the integrin antagonist directly attributable to the chemically programmed antibody approach.
Moreover, the study indicated that this approach allows for the effective assembly of chemically programmed antibodies in vivo or in vitro, widening the possibilities for their therapeutic application. The compound could be created in vitro and delivered as a conventional single therapy. Alternately, the small molecule and antibody could be injected separately, with the new complex formed in vivo. The authors note that even though the administration of two separate compounds might complicate regulatory approval, the regimen could have advantages-for example, an imaging agent could be attached to the small molecule, allowing a physician to monitor localization of a drug before arming the agent with the antibody molecule.
In addition to Sinha and Lerner, the authors of the new study, entitled "Breaking the one antibody-one target axiom," include Fang Guo and Sanjib Das of The Scripps Research Institute and its Skaggs Institute for Chemical Biology; Barbara M. Mueller of La Jolla Institute for Molecular Medicine; and Carlos F. Barbas III of The Scripps Research Institute and its Skaggs Institute for Chemical Biology.
The study was supported by The Skaggs Institute for Chemical Biology, a grant from the Department of Defense, and the National Institutes of Health.
About The Scripps Research Institute
The Scripps Research Institute, headquartered in La Jolla, California, in 18 buildings on 40 acres overlooking the Pacific Ocean, is one of the world's largest independent, non-profit biomedical research organizations. It stands at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its research into immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel.
Scripps Florida, a 364,000 square-foot, state-of-the-art biomedical research facility, will be built in Palm Beach County. The facility will focus on basic biomedical science, drug discovery, and technology development. Palm Beach County and the State of Florida have provided start-up economic packages for development, building, staffing, and equipping the campus. Scripps Florida now operates with approximately 160 scientists, technicians, and administrative staff at 40,000 square-foot lab facilities on the Florida Atlantic University campus in Jupiter.
Contact: Keith McKeown
Scripps Research Institute
FDA Approves Tykerb® (Lapatinib) In Combination With Xeloda® (Capecitabine) For The Treatment Of Advanced Or Metastatic Breast Cancer
GlaxoSmithKline plc [NYSE: GSK, LSE: GSK] announced today that the United States Food and Drug Administration (FDA) approved TYKERB® (lapatinib), in combination with Xeloda® (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. TYKERB was granted Priority Review by the FDA in November 2006.
"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."
This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. TYKERB inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, TYKERB is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. TYKERB will be available in the United States within two weeks and, as an oral therapy, offers added convenience for patients.
"The approval of TYKERB is an important milestone in our commitment to become a major oncology company that focuses on scientific innovation and genuine patient needs," said Chris Viehbacher, President, US Pharmaceuticals at GSK. "Our rich pipeline of oncology medicines underscores our commitment to cancer patients. This commitment extends to programs to help ensure that women who may benefit from TYKERB will have access to it."
TYKERB Patient Support
To support patient access, GSK has established a single source for information and support called Tykerb® CARES. Through this comprehensive program, knowledgeable consultants are available to answer product-related questions from patients and physicians, and can assist them with obtaining TYKERB. Additionally, Tykerb® CARES reimbursement counselors will help patients understand their insurance coverage and, if appropriate, assist in identifying alternative financial support.
TYKERB Clinical Results
This approval was based on the pivotal Phase III trial of 399 patients which showed that the median time to disease progression as assessed by independent reviewers was 27.1 weeks on the combination of TYKERB and capecitabine versus 18.6 weeks on capecitabine alone in women with advanced or metastatic HER2 (ErbB2) positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The hazard ratio of 0.57 (95% CI: 0.43, 0.77, p = 0.00013) represents a 43 percent reduction in the risk of progression for the patients on the combination arm.1 Differences between treatment groups based on unblinded investigator assessments were smaller but continued to be clinically and statistically significant.
Adverse events (AEs) leading to discontinuation were similar in the TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone (14 percent). Most commonly reported AEs in the TYKERB-capecitabine combination arm included diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure of the strength of the heart's pumping capacity, was monitored during the study. Among 198 patients who received the TYKERB-capecitabine combination treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.
Ongoing Trials
GSK has a comprehensive clinical program that is actively studying TYKERB in other breast cancer settings and other cancers to better identify patient populations that may respond to TYKERB.
Marketing applications for lapatinib (TYKERB/TYVERB) have been filed around the world, including the European Union, Switzerland, Canada, Brazil, Australia, and South Korea.
About Tykerb
TYKERB, a small molecule that is administered orally, inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.
About GlaxoSmithKline
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 company information, visit GlaxoSmithKline at gsk.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.
TYKERB® is a registered trademark of the GlaxoSmithKline group of companies in the United States.
TYVERB® is a registered trademark of the GlaxoSmithKline group of companies in Europe and is the proposed trade name in certain markets, pending regulatory approval.
Herceptin® is a registered trademark of Genentech, Inc. in the U.S.and Roche Pharmaceuticals in Europe.
Xeloda® is a registered trademark of Roche Pharmaceuticals.
To access the latest GSK Oncology media materials, visit gsk/media or gskcancermedia.
References
1. Data on file, GlaxoSmithKline, King of Prussia.
View drug information on Herceptin; Tykerb; Xeloda.
"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."
This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. TYKERB inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, TYKERB is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. TYKERB will be available in the United States within two weeks and, as an oral therapy, offers added convenience for patients.
"The approval of TYKERB is an important milestone in our commitment to become a major oncology company that focuses on scientific innovation and genuine patient needs," said Chris Viehbacher, President, US Pharmaceuticals at GSK. "Our rich pipeline of oncology medicines underscores our commitment to cancer patients. This commitment extends to programs to help ensure that women who may benefit from TYKERB will have access to it."
TYKERB Patient Support
To support patient access, GSK has established a single source for information and support called Tykerb® CARES. Through this comprehensive program, knowledgeable consultants are available to answer product-related questions from patients and physicians, and can assist them with obtaining TYKERB. Additionally, Tykerb® CARES reimbursement counselors will help patients understand their insurance coverage and, if appropriate, assist in identifying alternative financial support.
TYKERB Clinical Results
This approval was based on the pivotal Phase III trial of 399 patients which showed that the median time to disease progression as assessed by independent reviewers was 27.1 weeks on the combination of TYKERB and capecitabine versus 18.6 weeks on capecitabine alone in women with advanced or metastatic HER2 (ErbB2) positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The hazard ratio of 0.57 (95% CI: 0.43, 0.77, p = 0.00013) represents a 43 percent reduction in the risk of progression for the patients on the combination arm.1 Differences between treatment groups based on unblinded investigator assessments were smaller but continued to be clinically and statistically significant.
Adverse events (AEs) leading to discontinuation were similar in the TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone (14 percent). Most commonly reported AEs in the TYKERB-capecitabine combination arm included diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure of the strength of the heart's pumping capacity, was monitored during the study. Among 198 patients who received the TYKERB-capecitabine combination treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.
Ongoing Trials
GSK has a comprehensive clinical program that is actively studying TYKERB in other breast cancer settings and other cancers to better identify patient populations that may respond to TYKERB.
Marketing applications for lapatinib (TYKERB/TYVERB) have been filed around the world, including the European Union, Switzerland, Canada, Brazil, Australia, and South Korea.
About Tykerb
TYKERB, a small molecule that is administered orally, inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.
About GlaxoSmithKline
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 company information, visit GlaxoSmithKline at gsk.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.
TYKERB® is a registered trademark of the GlaxoSmithKline group of companies in the United States.
TYVERB® is a registered trademark of the GlaxoSmithKline group of companies in Europe and is the proposed trade name in certain markets, pending regulatory approval.
Herceptin® is a registered trademark of Genentech, Inc. in the U.S.and Roche Pharmaceuticals in Europe.
Xeloda® is a registered trademark of Roche Pharmaceuticals.
To access the latest GSK Oncology media materials, visit gsk/media or gskcancermedia.
References
1. Data on file, GlaxoSmithKline, King of Prussia.
View drug information on Herceptin; Tykerb; Xeloda.
News From Annals Of Internal Medicine: Dec. 15, 2009
1. Less Invasive Core Needle Biopsy Almost as Effective as Open Surgical Biopsy for Breast Lesion Diagnosis
Women suspected of having breast cancer are usually referred for a breast biopsy to determine whether the lesion is cancerous. In most cases, breast lesions are not cancers and do not require further treatment. Biopsies may be performed using minimally invasive core needle biopsy or open surgical biopsy. Researchers reviewed more than 70 published articles to assess the risks and benefits of these two different methods. They found that core needle biopsy was able to distinguish between malignant and benign lesions with approximately the same accuracy as open surgical biopsy but was associated with a lower risk of severe complications (less than 1 percent compared to 2 to 10 percent). When making the decision about which kind of biopsy to have, women should talk to their physicians about the benefits and harms of each method. The location of the lesion, the type of lesion, and the patient's risk factors may dictate which type of biopsy should be performed, but in many cases patient preference will be the most important factor in the decision.
2. Teaching Health Centers Could Help Bring Care to the Underserved
The United States is facing a serious shortage of primary care physicians. Currently, at least 65 million citizens live in areas underserved by primary care. Many of these citizens receive care in one of 1,200 federally-qualified community health centers that operate in approximately 6,000 urban and rural sites in every U.S. state and territory. Community health centers provide an optimal training environment for graduate medical education, given their close faculty supervision and the emphasis on patient-centered care. Researchers suggest that increasing the number of resident physicians who receive training at community health centers would expand community health centers' clinical capacity and potentially replenish the pipeline of primary care physicians. According to the researchers, expanding the teaching role of community health centers could be a major step in forging a link between achieving fiscal feasibility of universal coverage and giving patients access to primary care.
3. Researchers Recommend Less Stringent Glycemic Control in Older Diabetics with Coexisting Conditions
Studies of the relationship between intense glucose control and cardiovascular events in diabetic patients have had mixed results with some showing that tight control reduces these events and others suggesting that it does not. Researchers conducted an observational study of 2,613 patients with type 2 diabetes over five years to determine if attaining a blood glucose level of less than 7 percent was associated with different benefits for patients with high versus low-to-moderate levels of comorbidity. The researchers found that intensive glucose control in younger, patients with low levels of comorbid illnesses was associated with a lower incidence of cardiovascular events within the five-year period. Conversely, this association was not present in older patients with high levels of comorbidity. The results suggest that any reduction of risk for cardiovascular events associated with tight glycemic control may not be uniform across patient subgroups.
Source: Angela Collom
American College of Physicians
Women suspected of having breast cancer are usually referred for a breast biopsy to determine whether the lesion is cancerous. In most cases, breast lesions are not cancers and do not require further treatment. Biopsies may be performed using minimally invasive core needle biopsy or open surgical biopsy. Researchers reviewed more than 70 published articles to assess the risks and benefits of these two different methods. They found that core needle biopsy was able to distinguish between malignant and benign lesions with approximately the same accuracy as open surgical biopsy but was associated with a lower risk of severe complications (less than 1 percent compared to 2 to 10 percent). When making the decision about which kind of biopsy to have, women should talk to their physicians about the benefits and harms of each method. The location of the lesion, the type of lesion, and the patient's risk factors may dictate which type of biopsy should be performed, but in many cases patient preference will be the most important factor in the decision.
2. Teaching Health Centers Could Help Bring Care to the Underserved
The United States is facing a serious shortage of primary care physicians. Currently, at least 65 million citizens live in areas underserved by primary care. Many of these citizens receive care in one of 1,200 federally-qualified community health centers that operate in approximately 6,000 urban and rural sites in every U.S. state and territory. Community health centers provide an optimal training environment for graduate medical education, given their close faculty supervision and the emphasis on patient-centered care. Researchers suggest that increasing the number of resident physicians who receive training at community health centers would expand community health centers' clinical capacity and potentially replenish the pipeline of primary care physicians. According to the researchers, expanding the teaching role of community health centers could be a major step in forging a link between achieving fiscal feasibility of universal coverage and giving patients access to primary care.
3. Researchers Recommend Less Stringent Glycemic Control in Older Diabetics with Coexisting Conditions
Studies of the relationship between intense glucose control and cardiovascular events in diabetic patients have had mixed results with some showing that tight control reduces these events and others suggesting that it does not. Researchers conducted an observational study of 2,613 patients with type 2 diabetes over five years to determine if attaining a blood glucose level of less than 7 percent was associated with different benefits for patients with high versus low-to-moderate levels of comorbidity. The researchers found that intensive glucose control in younger, patients with low levels of comorbid illnesses was associated with a lower incidence of cardiovascular events within the five-year period. Conversely, this association was not present in older patients with high levels of comorbidity. The results suggest that any reduction of risk for cardiovascular events associated with tight glycemic control may not be uniform across patient subgroups.
Source: Angela Collom
American College of Physicians
Some Routine Cancer Screenings Not Proven To Reduce Deaths, Experts Say
Routine screenings for cancers -- including breast cancer in younger women -- have not proven to reduce the chance of death for people without specific symptoms or risk factors, and experts suggest that some tests could lead to harm, the New York Times reports.
According to Ned Calonge, chair of the United States Preventive Services Task Force, screening is only useful if it prevents enough deaths to outweigh harm from treatments that are not medically necessary. He said that although screening in some cases will detect life-threatening cancers that respond to intervention, it also can result in false positives that cause needless worry and unnecessary procedures. Screening also might fail to diagnose an existing cancer, causing patients to ignore symptoms; find slow-growing or stable cancers that are not life-threatening and normally do not need treatment; or find aggressive, life-threatening cancers that do not respond to treatment, Calonge said. Only a handful of screening tests have been proven to significantly reduce death among certain age groups: pap tests to screen for cervical cancer beginning no later than age 21; mammograms to screen for breast cancer starting at age 40; and colon cancer screening beginning at age 50. According to the Centers for Disease Control and Prevention, there is no medical proof that routine screening for many other cancers -- including ovarian cancer -- reduces deaths.
The Times reports that the Breast Cancer Education and Awareness Requires Learning Young Act of 2009 (HR 1740) -- also known as the Early Act -- has become a central issue in the debate because it would create a breast cancer detection campaign for women younger than age 45. Rep. Debbie Wasserman-Schultz (D-Fla.) introduced the bill in March, and it now has more than 350 co-sponsors. The bill would provide $45 million over five years for teaching young women and their physicians to check for abnormalities; promote healthy lifestyle choices; and provide grants to groups supporting women with breast cancer. The bill focuses on certain ethnic or racial groups at higher risk of developing aggressive tumors. CDC would oversee an expert panel to create the campaign based on the latest medical research, Wasserman-Schultz said.
Critics of the bill say that the legislation promotes techniques, such as self-exams, that have not proven to detect cancer at earlier stages or reduce deaths. They also argue that self-exams could lead to many insignificant nodules being biopsied, which can cause scarring and make it harder to detect breast cancer when women are older. According to Susan Love -- a breast cancer surgeon who has encouraged Wasserman-Schultz to abandon the bill -- the public health campaign could cause younger women to overestimate their chances of dying of breast cancer (Singer, New York Times, 7/17).
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.
© 2009 The Advisory Board Company. All rights reserved.
According to Ned Calonge, chair of the United States Preventive Services Task Force, screening is only useful if it prevents enough deaths to outweigh harm from treatments that are not medically necessary. He said that although screening in some cases will detect life-threatening cancers that respond to intervention, it also can result in false positives that cause needless worry and unnecessary procedures. Screening also might fail to diagnose an existing cancer, causing patients to ignore symptoms; find slow-growing or stable cancers that are not life-threatening and normally do not need treatment; or find aggressive, life-threatening cancers that do not respond to treatment, Calonge said. Only a handful of screening tests have been proven to significantly reduce death among certain age groups: pap tests to screen for cervical cancer beginning no later than age 21; mammograms to screen for breast cancer starting at age 40; and colon cancer screening beginning at age 50. According to the Centers for Disease Control and Prevention, there is no medical proof that routine screening for many other cancers -- including ovarian cancer -- reduces deaths.
The Times reports that the Breast Cancer Education and Awareness Requires Learning Young Act of 2009 (HR 1740) -- also known as the Early Act -- has become a central issue in the debate because it would create a breast cancer detection campaign for women younger than age 45. Rep. Debbie Wasserman-Schultz (D-Fla.) introduced the bill in March, and it now has more than 350 co-sponsors. The bill would provide $45 million over five years for teaching young women and their physicians to check for abnormalities; promote healthy lifestyle choices; and provide grants to groups supporting women with breast cancer. The bill focuses on certain ethnic or racial groups at higher risk of developing aggressive tumors. CDC would oversee an expert panel to create the campaign based on the latest medical research, Wasserman-Schultz said.
Critics of the bill say that the legislation promotes techniques, such as self-exams, that have not proven to detect cancer at earlier stages or reduce deaths. They also argue that self-exams could lead to many insignificant nodules being biopsied, which can cause scarring and make it harder to detect breast cancer when women are older. According to Susan Love -- a breast cancer surgeon who has encouraged Wasserman-Schultz to abandon the bill -- the public health campaign could cause younger women to overestimate their chances of dying of breast cancer (Singer, New York Times, 7/17).
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.
© 2009 The Advisory Board Company. All rights reserved.
BC Cancer Agency Study Tests Value Of Online Emotional Support, Canada
The BC Cancer Agency, an agency of the Provincial Health Services Authority, is launching a new pilot study, the first of its kind in Canada, to test the value of online emotional support in improving the quality of life of young women with breast cancer.
In the study, Moving Forward After Breast Cancer, eligible young women with breast cancer will be randomized to join one of two trial groups. Participants in the first group will connect with each other in a 10-week internet skills and support group led by a professional counselor while also completing a self-directed at home coping skills program. The second group will only complete the at home coping skills program.
"The internet is a powerful tool with the potential to reduce geographical and other barriers; and by comparing the two trial groups in this study, we can test whether an online resource is an effective way of providing counseling support for cancer patients," says Dr. Joanne Stephen, a researcher who is leading this study at the BC Cancer Agency.
"While there are existing support groups and educational resources for young women, these are often limited to those living in major cities," explains Dr. Stephen. "With an online resource, young women regardless of where they live will be able to benefit from accessing companionship and information."
The study will investigate whether the online skills and support group can reduce distress, change perception of how much breast cancer interferes with the physical well-being, and increase participants' confidence in coping with future challenges.
Participants will discuss issues and share information specific to young breast cancer patients, and learn about goal setting and other coping skills in a professionally-led environment.
"By evaluating the outcome of this study, we can optimize the uptake of online support in other areas of cancer care," adds Dr. Stephen.
For Denise Graham, the internet was the first place she turned to for information when diagnosed with breast cancer at age 34, several years ago. "I felt very alone and needed answers to what I should expect during and after treatment. Unfortunately, I wasn't able to find much tailored for women my age."
"A web-based community is a great idea since the internet is really a second language for most young people," says Graham, who celebrated her five year anniversary as a breast cancer survivor this June. "We simply don't have time to access face-to-face support."
Young women with breast cancer face issues unique to their older counterparts, such as the medical and physical consequences of treatment including chemotherapy-induced menopause, and changes with sexuality and fertility; and problems related to returning to work and family relations.
"I received advice to slow down and to do only as much as I can," adds Graham, recalling her experience at support groups for older women. "I kept thinking to myself, I still have so much to do! The reality is I'm still young; I still have to work and support a mortgage."
The study, funded by the Canadian Breast Cancer Foundation, is open to breast cancer patients who have completed treatment for up to three years or are close to completing treatment. Participants need to be under the age of 46 who live in BC or the Yukon. For more information, please visit canada.thewellnesscommunity. Core support for research at the BC Cancer Agency is provided by the BC Cancer Foundation.
The BC Cancer Agency, an agency of the Provincial Health Services Authority, is committed to reducing the incidence of cancer, reducing the mortality from cancer, and improving the quality of life of those living with cancer. It provides a comprehensive cancer control program for the people of British Columbia by working with community partners to deliver a range of oncology services, including prevention, early detection, diagnosis and treatment, research, education, supportive care, rehabilitation and palliative care. The BC Cancer Foundation raises funds to support research and enhancements to patient care at the BC Cancer Agency.
bccancer.bc.ca
In the study, Moving Forward After Breast Cancer, eligible young women with breast cancer will be randomized to join one of two trial groups. Participants in the first group will connect with each other in a 10-week internet skills and support group led by a professional counselor while also completing a self-directed at home coping skills program. The second group will only complete the at home coping skills program.
"The internet is a powerful tool with the potential to reduce geographical and other barriers; and by comparing the two trial groups in this study, we can test whether an online resource is an effective way of providing counseling support for cancer patients," says Dr. Joanne Stephen, a researcher who is leading this study at the BC Cancer Agency.
"While there are existing support groups and educational resources for young women, these are often limited to those living in major cities," explains Dr. Stephen. "With an online resource, young women regardless of where they live will be able to benefit from accessing companionship and information."
The study will investigate whether the online skills and support group can reduce distress, change perception of how much breast cancer interferes with the physical well-being, and increase participants' confidence in coping with future challenges.
Participants will discuss issues and share information specific to young breast cancer patients, and learn about goal setting and other coping skills in a professionally-led environment.
"By evaluating the outcome of this study, we can optimize the uptake of online support in other areas of cancer care," adds Dr. Stephen.
For Denise Graham, the internet was the first place she turned to for information when diagnosed with breast cancer at age 34, several years ago. "I felt very alone and needed answers to what I should expect during and after treatment. Unfortunately, I wasn't able to find much tailored for women my age."
"A web-based community is a great idea since the internet is really a second language for most young people," says Graham, who celebrated her five year anniversary as a breast cancer survivor this June. "We simply don't have time to access face-to-face support."
Young women with breast cancer face issues unique to their older counterparts, such as the medical and physical consequences of treatment including chemotherapy-induced menopause, and changes with sexuality and fertility; and problems related to returning to work and family relations.
"I received advice to slow down and to do only as much as I can," adds Graham, recalling her experience at support groups for older women. "I kept thinking to myself, I still have so much to do! The reality is I'm still young; I still have to work and support a mortgage."
The study, funded by the Canadian Breast Cancer Foundation, is open to breast cancer patients who have completed treatment for up to three years or are close to completing treatment. Participants need to be under the age of 46 who live in BC or the Yukon. For more information, please visit canada.thewellnesscommunity. Core support for research at the BC Cancer Agency is provided by the BC Cancer Foundation.
The BC Cancer Agency, an agency of the Provincial Health Services Authority, is committed to reducing the incidence of cancer, reducing the mortality from cancer, and improving the quality of life of those living with cancer. It provides a comprehensive cancer control program for the people of British Columbia by working with community partners to deliver a range of oncology services, including prevention, early detection, diagnosis and treatment, research, education, supportive care, rehabilitation and palliative care. The BC Cancer Foundation raises funds to support research and enhancements to patient care at the BC Cancer Agency.
bccancer.bc.ca
Breast Cancer Treatment Can Be Undermined By The Dietary Supplement Genistein
Women taking aromatase inhibitors to treat breast cancer or prevent its recurrence should think twice before also taking a soy-based dietary supplement, researchers report.
Genistein, a soy isoflavone that mimics the effects of estrogen in the body, can negate the effectiveness of aromatase inhibitors, which are designed to reduce the levels of estrogens that can promote tumor growth in some types of breast cancer.
The new study, which included researchers from the University of Illinois, Virginia Polytechnic and State University and the National Center for Toxicological Research, appears in the journal Carcinogenesis.
Aromatase inhibitors are a mainstay of breast cancer treatment in post-menopausal women. These drugs work by interfering with the enzyme aromatase, which catalyzes a crucial step in converting precursor molecules to estradiol, the main estrogen in the body.
About two-thirds of all cases of breast cancer diagnosed in the U.S. are estrogen dependent or estrogen sensitive, which means that the tumors grow more rapidly in the presence of estrogen.
Most women diagnosed with breast cancer are post-menopausal, so their ovaries are no longer producing normal levels of estrogen. Other tissues, however, produce a steroid hormone, androstenedione (AD), which - with the help of aromatases - is converted to testosterone and estrogens. The estrogens produced from AD can stimulate the growth of some types of breast cancer tumors.
The researchers conducted several trials in a mouse model of estrogen-dependent post-menopausal breast cancer. First, they gave the mice AD, which was converted to estrogen and created a high estrogen environment.
This helped the researchers determine the maximum growth rate of the breast cancer tumors.
Next, they added Letrozole, an aromatase inhibitor widely prescribed to post-menopausal women with estrogen-dependent breast cancer. This treatment (Letrozole) effectively blocked the effects of AD and the breast cancer tumors stopped growing.
But when they added genistein (a plant estrogen or "phytoestrogen" present in many dietary supplements) to the mix, the researchers observed a dose-dependent reduction in the effectiveness of the breast cancer drug. Specifically, the tumors began to grow again. They grew fastest at the highest dietary doses of genistein.
"To think that a dietary supplement could actually reverse the effects of a very effective drug is contrary to much of the perceived benefits of soy isoflavones, and unsettling," said William Helferich a professor of food science and human nutrition at Illinois and principal investigator on the study. "You have women who are taking these supplements to ameliorate post-menopausal symptoms and assuming that they are as safe as consuming a calcium pill or a B vitamin."
Many women take genistein supplements to control hot flashes and other symptoms of menopause. The researchers found that the doses commonly available in dietary supplements were potent enough to negate the effectiveness of aromatase inhibitors.
"These compounds have complex biological activities that are not fully understood," Helferich said. "Dietary supplements containing soy-based phytoestrogens provide high enough dosages that it could be a significant issue to breast cancer patients and survivors."
Plant estrogens from soy are not the only ones of concern, Helferich said. In a recent study, he and his colleagues found that certain mixtures of estrogenic botanical components and extracts marketed as supplements to assist "female libido enhancement" and sold without a prescription appeared to spur breast cancer tumor growth at low doses, while having no effect on tumors at high doses.
That study appeared last year in Food and Chemical Toxicology.
"We are just starting to understand the complex effects of the dietary supplements that contain phytoestrogens," Helferich said. "There is an ongoing human experiment in which the outcome is unknown. These findings raise serious concerns about the potential interaction of the estrogenic dietary supplements with current breast cancer therapies."
Source: Diana Yates
University of Illinois at Urbana-Champaign
View drug information on Estradiol.
Genistein, a soy isoflavone that mimics the effects of estrogen in the body, can negate the effectiveness of aromatase inhibitors, which are designed to reduce the levels of estrogens that can promote tumor growth in some types of breast cancer.
The new study, which included researchers from the University of Illinois, Virginia Polytechnic and State University and the National Center for Toxicological Research, appears in the journal Carcinogenesis.
Aromatase inhibitors are a mainstay of breast cancer treatment in post-menopausal women. These drugs work by interfering with the enzyme aromatase, which catalyzes a crucial step in converting precursor molecules to estradiol, the main estrogen in the body.
About two-thirds of all cases of breast cancer diagnosed in the U.S. are estrogen dependent or estrogen sensitive, which means that the tumors grow more rapidly in the presence of estrogen.
Most women diagnosed with breast cancer are post-menopausal, so their ovaries are no longer producing normal levels of estrogen. Other tissues, however, produce a steroid hormone, androstenedione (AD), which - with the help of aromatases - is converted to testosterone and estrogens. The estrogens produced from AD can stimulate the growth of some types of breast cancer tumors.
The researchers conducted several trials in a mouse model of estrogen-dependent post-menopausal breast cancer. First, they gave the mice AD, which was converted to estrogen and created a high estrogen environment.
This helped the researchers determine the maximum growth rate of the breast cancer tumors.
Next, they added Letrozole, an aromatase inhibitor widely prescribed to post-menopausal women with estrogen-dependent breast cancer. This treatment (Letrozole) effectively blocked the effects of AD and the breast cancer tumors stopped growing.
But when they added genistein (a plant estrogen or "phytoestrogen" present in many dietary supplements) to the mix, the researchers observed a dose-dependent reduction in the effectiveness of the breast cancer drug. Specifically, the tumors began to grow again. They grew fastest at the highest dietary doses of genistein.
"To think that a dietary supplement could actually reverse the effects of a very effective drug is contrary to much of the perceived benefits of soy isoflavones, and unsettling," said William Helferich a professor of food science and human nutrition at Illinois and principal investigator on the study. "You have women who are taking these supplements to ameliorate post-menopausal symptoms and assuming that they are as safe as consuming a calcium pill or a B vitamin."
Many women take genistein supplements to control hot flashes and other symptoms of menopause. The researchers found that the doses commonly available in dietary supplements were potent enough to negate the effectiveness of aromatase inhibitors.
"These compounds have complex biological activities that are not fully understood," Helferich said. "Dietary supplements containing soy-based phytoestrogens provide high enough dosages that it could be a significant issue to breast cancer patients and survivors."
Plant estrogens from soy are not the only ones of concern, Helferich said. In a recent study, he and his colleagues found that certain mixtures of estrogenic botanical components and extracts marketed as supplements to assist "female libido enhancement" and sold without a prescription appeared to spur breast cancer tumor growth at low doses, while having no effect on tumors at high doses.
That study appeared last year in Food and Chemical Toxicology.
"We are just starting to understand the complex effects of the dietary supplements that contain phytoestrogens," Helferich said. "There is an ongoing human experiment in which the outcome is unknown. These findings raise serious concerns about the potential interaction of the estrogenic dietary supplements with current breast cancer therapies."
Source: Diana Yates
University of Illinois at Urbana-Champaign
View drug information on Estradiol.
AviaraDx Confirms That Combination Of Two Molecular Biomarkers Improves Prediction Of Disease Recurrence In Early Stage Breast Cancer Patients
AviaraDx, Inc. announced the
publication of an article describing the discovery, development and
validation of a new molecular biomarker, Aviara MGI(SM) (Molecular Grade
Index), that improves the accuracy of breast cancer tumor grading for the
prediction of distant disease recurrence. The authors also report that
combining Aviara MGI with Aviara H/I(SM) (HOXB13:IL17BR), a biomarker
previously shown to predict endocrine benefit, provides superior
stratification of recurrence risk. The article, "A Five-Gene Molecular
Grade Index and HOXB13:IL17BR Are Complementary Prognostic Factors in Early
Stage Breast Cancer," appeared in the May 1, 2008 edition of Clinical
Cancer Research.
The Aviara MGI and Aviara H/I ("H over I") biomarkers measure specific,
independent and clinically relevant aspects of tumor biology. According to
the paper published this month, the combination of these markers provides
superior risk stratification as it relates to endocrine benefit and
treatment outcome. After development and testing, the combination was
clinically validated through retrospective analyses of 239 ER-positive,
lymph-node negative patients treated at Massachusetts General Hospital,
Boston, MA, and an independent cohort of 84 patients from John Radcliffe
Hospital, Oxford (UK).
Aviara MGI is a new molecular assay comprising only five genes that are
activated at different cell cycle stages and are involved in invasive tumor
growth. This assay assists pathologists and oncologists by improving the
accuracy of tumor grading.
To predict tumor aggressiveness and a potential response to
chemotherapy, pathologists traditionally evaluate a breast cancer biopsy by
light microscopy and assign a tumor grade. Patients with more aggressive,
high grade (Grade 3) tumors have been shown to derive varying degrees of
benefit from chemotherapy, while patients with less aggressive, low grade
(Grade 1) tumors usually derive no benefit. However, approximately 50
percent of all early stage breast cancer patients are diagnosed with an
intermediate tumor grade (Grade 2). For these patients the appropriate
choice of therapy is unclear. The clinical data published this month
demonstrate that Aviara MGI accurately identifies Grade 1 and 3 tumors, and
successfully re-classifies intermediate tumor grade (Grade 2) into cases
with Grade 1-like or Grade 3-like outcomes.
"The importance of accurate tumor grading cannot be understated," said
Dennis C. Sgroi, director of breast pathology at Massachusetts General
Hospital and associate professor of pathology at Harvard Medical School, a
senior author of the article. "A molecular tool such as MGI that can help
separate intermediate-grade tumors into two distinct prognostic groups will
go a long way in stratifying risk and improving treatment selection for
breast cancer patients."
Researchers combined Aviara MGI and Aviara H/I in order to assess the
overall impact of both molecular tumor grade and endocrine therapy benefit
on patient outcome. H/I is a well-established biomarker that has been shown
to predict both recurrence risk and endocrine benefit in more than 2,000
patients in numerous clinical studies. It assesses the likelihood of a
patient to benefit from endocrine therapy by measuring the functionality of
the estrogen signaling pathway inside the tumor cell itself. As such, H/I
goes beyond conventional estrogen and progesterone receptor (ER/PR)
testing. While patients who are ER/PR positive are assumed to benefit from
endocrine therapy, the therapy fails in approximately 25 percent of those
patients.
"Other gene-signature assays developed for breast cancer provide an
improvement over tumor grade as a measure of breast cancer aggressiveness
and likely benefit from chemotherapy. These different proliferation gene
signatures are essentially redundant, and they do not go beyond ER/PR in
determining the likelihood of responding to endocrine therapy," said
Antonius Schuh, PhD, chief executive officer of AviaraDx, Inc. "H/I and MGI
together provide a more complete diagnostic picture that should help
clinicians make more appropriate treatment decisions for their breast
cancer patients."
"This is the first analysis linking H/I to our new, five-gene tumor
grading index, MGI," said Mark Erlander, PhD, chief scientific officer for
AviaraDx, Inc. "For patients whose tumors have high MGI values, it is
important to measure H/I in order to determine likely benefit from
endocrine therapy within the setting of a highly proliferating tumor."
The authors conclude that these two markers together should enable
oncologists to identify a large subgroup of women with low risk of
recurrence who may be spared from toxic chemotherapy regimens. In addition,
they may also identify a significant population of patients for whom
intensive chemotherapy regimens or new therapeutic agents should be
considered.
"As molecular diagnostics enable the personalization of patient care,
we will help patients and clinicians determine appropriate therapies and
avoid both over- and under-treatment," added Schuh.
Approximately 100,000 women present with ER-positive, node-negative
breast cancer in the United States every year. The data included in this
month's Clinical Cancer Research publication show that the combination of
Aviara MGI and Aviara H/I provides objective information to better assess
both recurrence risk and potential for response to systemic therapies in
these early stage breast cancer patients. The combination of these two
biomarkers is now commercially available as the Aviara Breast Cancer
Index(SM).
About AviaraDx, Inc.
AviaraDx discovers, develops, and commercializes new molecular
diagnostic tests in oncology, enabling physicians to personalize cancer
treatment through better understanding of the molecular biology underlying
a patient's tumor. The company's current offerings include a molecular
cancer classification assay, Aviara CancerTYPE ID(SM) capable of
classifying up to 39 tumor types; Aviara H/I(SM), which predicts endocrine
benefit in breast cancer; and Aviara MGI(SM), a molecular grade index to
objectively measure tumor grade. Aviara H/I and Aviara MGI are available
separately, or can be combined in the Aviara Breast Cancer Index(SM).
Additional tests are in development. AviaraDx offers these diagnostic tests
to qualified physicians or laboratories through its CLIA-certified, CAP
accredited laboratory service operations. For more information, visit
aviaradx.
AviaraDx, Inc.
aviaradx
publication of an article describing the discovery, development and
validation of a new molecular biomarker, Aviara MGI(SM) (Molecular Grade
Index), that improves the accuracy of breast cancer tumor grading for the
prediction of distant disease recurrence. The authors also report that
combining Aviara MGI with Aviara H/I(SM) (HOXB13:IL17BR), a biomarker
previously shown to predict endocrine benefit, provides superior
stratification of recurrence risk. The article, "A Five-Gene Molecular
Grade Index and HOXB13:IL17BR Are Complementary Prognostic Factors in Early
Stage Breast Cancer," appeared in the May 1, 2008 edition of Clinical
Cancer Research.
The Aviara MGI and Aviara H/I ("H over I") biomarkers measure specific,
independent and clinically relevant aspects of tumor biology. According to
the paper published this month, the combination of these markers provides
superior risk stratification as it relates to endocrine benefit and
treatment outcome. After development and testing, the combination was
clinically validated through retrospective analyses of 239 ER-positive,
lymph-node negative patients treated at Massachusetts General Hospital,
Boston, MA, and an independent cohort of 84 patients from John Radcliffe
Hospital, Oxford (UK).
Aviara MGI is a new molecular assay comprising only five genes that are
activated at different cell cycle stages and are involved in invasive tumor
growth. This assay assists pathologists and oncologists by improving the
accuracy of tumor grading.
To predict tumor aggressiveness and a potential response to
chemotherapy, pathologists traditionally evaluate a breast cancer biopsy by
light microscopy and assign a tumor grade. Patients with more aggressive,
high grade (Grade 3) tumors have been shown to derive varying degrees of
benefit from chemotherapy, while patients with less aggressive, low grade
(Grade 1) tumors usually derive no benefit. However, approximately 50
percent of all early stage breast cancer patients are diagnosed with an
intermediate tumor grade (Grade 2). For these patients the appropriate
choice of therapy is unclear. The clinical data published this month
demonstrate that Aviara MGI accurately identifies Grade 1 and 3 tumors, and
successfully re-classifies intermediate tumor grade (Grade 2) into cases
with Grade 1-like or Grade 3-like outcomes.
"The importance of accurate tumor grading cannot be understated," said
Dennis C. Sgroi, director of breast pathology at Massachusetts General
Hospital and associate professor of pathology at Harvard Medical School, a
senior author of the article. "A molecular tool such as MGI that can help
separate intermediate-grade tumors into two distinct prognostic groups will
go a long way in stratifying risk and improving treatment selection for
breast cancer patients."
Researchers combined Aviara MGI and Aviara H/I in order to assess the
overall impact of both molecular tumor grade and endocrine therapy benefit
on patient outcome. H/I is a well-established biomarker that has been shown
to predict both recurrence risk and endocrine benefit in more than 2,000
patients in numerous clinical studies. It assesses the likelihood of a
patient to benefit from endocrine therapy by measuring the functionality of
the estrogen signaling pathway inside the tumor cell itself. As such, H/I
goes beyond conventional estrogen and progesterone receptor (ER/PR)
testing. While patients who are ER/PR positive are assumed to benefit from
endocrine therapy, the therapy fails in approximately 25 percent of those
patients.
"Other gene-signature assays developed for breast cancer provide an
improvement over tumor grade as a measure of breast cancer aggressiveness
and likely benefit from chemotherapy. These different proliferation gene
signatures are essentially redundant, and they do not go beyond ER/PR in
determining the likelihood of responding to endocrine therapy," said
Antonius Schuh, PhD, chief executive officer of AviaraDx, Inc. "H/I and MGI
together provide a more complete diagnostic picture that should help
clinicians make more appropriate treatment decisions for their breast
cancer patients."
"This is the first analysis linking H/I to our new, five-gene tumor
grading index, MGI," said Mark Erlander, PhD, chief scientific officer for
AviaraDx, Inc. "For patients whose tumors have high MGI values, it is
important to measure H/I in order to determine likely benefit from
endocrine therapy within the setting of a highly proliferating tumor."
The authors conclude that these two markers together should enable
oncologists to identify a large subgroup of women with low risk of
recurrence who may be spared from toxic chemotherapy regimens. In addition,
they may also identify a significant population of patients for whom
intensive chemotherapy regimens or new therapeutic agents should be
considered.
"As molecular diagnostics enable the personalization of patient care,
we will help patients and clinicians determine appropriate therapies and
avoid both over- and under-treatment," added Schuh.
Approximately 100,000 women present with ER-positive, node-negative
breast cancer in the United States every year. The data included in this
month's Clinical Cancer Research publication show that the combination of
Aviara MGI and Aviara H/I provides objective information to better assess
both recurrence risk and potential for response to systemic therapies in
these early stage breast cancer patients. The combination of these two
biomarkers is now commercially available as the Aviara Breast Cancer
Index(SM).
About AviaraDx, Inc.
AviaraDx discovers, develops, and commercializes new molecular
diagnostic tests in oncology, enabling physicians to personalize cancer
treatment through better understanding of the molecular biology underlying
a patient's tumor. The company's current offerings include a molecular
cancer classification assay, Aviara CancerTYPE ID(SM) capable of
classifying up to 39 tumor types; Aviara H/I(SM), which predicts endocrine
benefit in breast cancer; and Aviara MGI(SM), a molecular grade index to
objectively measure tumor grade. Aviara H/I and Aviara MGI are available
separately, or can be combined in the Aviara Breast Cancer Index(SM).
Additional tests are in development. AviaraDx offers these diagnostic tests
to qualified physicians or laboratories through its CLIA-certified, CAP
accredited laboratory service operations. For more information, visit
aviaradx.
AviaraDx, Inc.
aviaradx
Preferred Imaging Brings Positron Emission Mammography To North Dallas/Plano Area
Preferred Imaging Centers has installed the Naviscan PEM scanner into its newest facility in Plano, TX, adding a dedicated breast imaging modality to its array of diagnostic tools. PEM (Positron Emission Mammography) scanners are high-resolution breast PET systems that show the location as well as the metabolic phase of a lesion. The metabolic view assists physicians in making the optimal patient care decision by providing an unprecedented ability to distinguish between benign and malignant lesions, what researchers term "specificity."
Preferred Imaging owns and operates 11 private imaging centers in North Texas. It is committed to providing a unique patient and provider experience by adopting the latest diagnostic imaging technologies. Their centers currently offer CT, MRI as well as imaging for pain management treatment. With the addition of PEM, Preferred Imaging will expand its offerings for breast cancer patients. "In an effort to further serve the physicians and patients in our community, the Naviscan PEM scanner was the right choice," said James Webb, President of Preferred Imaging Centers. "Its capabilities in the diagnosis and monitoring of breast disease are undeniable and, in this time of cost-conscious medicine, the PEM scanner should prove to provide an appropriate return on investment. We look forward to continuing our model of high quality patient care in a patient friendly and supportive environment with the Naviscan PEM scanner."
Results from a recent presentation at the Society of Nuclear Medicine on findings from an NIH-sponsored clinical study comparing PEM with breast MRI further demonstrate PEM's clinical appropriateness. This multi-site study (NIH Grant 5R44CA103102) of hundreds of women with newly diagnosed breast cancer shows that PEM demonstrated a six percent improvement in specificity at comparably high sensitivity, and also recommended fewer unnecessary biopsies. These results are particularly significant for women who cannot tolerate an MRI exam and require an alternate imaging tool. The study is slated for publication in the December issue of the journal Radiology.
"Naviscan is thrilled to be partnering with a group so committed to offering the highest level of diagnostic medical care. With the addition of PEM as their first dedicated breast imaging technology, Preferred Imaging will be providing the best diagnosis by adding the newest tool in the fight against breast cancer," said Paul J. Mirabella, Chairman and CEO, Naviscan, Inc.
Source: Naviscan, Inc
Preferred Imaging owns and operates 11 private imaging centers in North Texas. It is committed to providing a unique patient and provider experience by adopting the latest diagnostic imaging technologies. Their centers currently offer CT, MRI as well as imaging for pain management treatment. With the addition of PEM, Preferred Imaging will expand its offerings for breast cancer patients. "In an effort to further serve the physicians and patients in our community, the Naviscan PEM scanner was the right choice," said James Webb, President of Preferred Imaging Centers. "Its capabilities in the diagnosis and monitoring of breast disease are undeniable and, in this time of cost-conscious medicine, the PEM scanner should prove to provide an appropriate return on investment. We look forward to continuing our model of high quality patient care in a patient friendly and supportive environment with the Naviscan PEM scanner."
Results from a recent presentation at the Society of Nuclear Medicine on findings from an NIH-sponsored clinical study comparing PEM with breast MRI further demonstrate PEM's clinical appropriateness. This multi-site study (NIH Grant 5R44CA103102) of hundreds of women with newly diagnosed breast cancer shows that PEM demonstrated a six percent improvement in specificity at comparably high sensitivity, and also recommended fewer unnecessary biopsies. These results are particularly significant for women who cannot tolerate an MRI exam and require an alternate imaging tool. The study is slated for publication in the December issue of the journal Radiology.
"Naviscan is thrilled to be partnering with a group so committed to offering the highest level of diagnostic medical care. With the addition of PEM as their first dedicated breast imaging technology, Preferred Imaging will be providing the best diagnosis by adding the newest tool in the fight against breast cancer," said Paul J. Mirabella, Chairman and CEO, Naviscan, Inc.
Source: Naviscan, Inc
Mammography Use Deterred By Health Insurance Co-Payments
When faced with even a modest health insurance co-payment for a mammogram, significantly fewer women receive these potentially life-saving breast cancer screenings, according to a new study by Brown University and Harvard Medical School researchers.
In this large-scale investigation of the relationship between health insurance co-payments and mammography rates, researchers found that screening rates were 8 percent lower among women with a co-payment than among women with full insurance coverage. Researchers at The Warren Alpert Medical School of Brown University, with a colleague from Harvard Medical School, publish their results in the current issue of the New England Journal of Medicine.
"The message is simple and it's startling - a small co-payment for a mammogram can lead to a sharp decrease in breast cancer screening rates," said Amal Trivedi, M.D., lead author of the study and assistant professor in the Department of Community Health at Alpert Medical School. "Co-payments as low as $12 deter women from getting mammograms. Because mammograms are critical in the fight against breast cancer, the most common cancer among American women, our findings have important health policy implications."
"Eliminating co-payments for mammograms in the Medicare program has the potential to save lives, because screening detects breast cancers at an earlier, more curable stage," said John Ayanian, M.D., study co-author and professor of medicine and health care policy at Harvard Medical School and Brigham and Women's Hospital.
The effect of insurance co-payments, or consumer cost sharing, on health care use and spending is a topic of intense interest for health policy-makers and researchers. But recent long-term data on the consequences of cost sharing, like deductibles and co-pays are limited. For example, results of the RAND Health Insurance Experiment, a watershed study of cost sharing and its impact on health, were released in 1982.
Trivedi wanted to gather and analyze more recent data because cost sharing is on the rise. According to a 2006 survey by the Henry J. Kaiser Family Foundation and the Health Research and Educational Trust, the most common co-payment for a medical office visit has doubled since 2001 while deductibles have increased an average of 60 percent in employer-based plans.
Trivedi chose to study mammography because the benefits of these X-ray photographs of the breast are widely accepted. The American Cancer Society, for example, recommends that women over 40 get annual mammograms to increase the odds of early breast cancer detection and treatment. Trivedi chose Medicare managed-care health insurance plans for review because the team could study a large number of patients over time.
In their study, Trivedi and colleagues studied coverage for mammography within 174 Medicare managed-care plans from 2001 to 2004. The review included 366,475 women between the ages of 65 and 69 living in 38 states.
The team compared the rates of biennial breast cancer screening within plans requiring co-payments with screening rates for plans with full coverage. They also analyzed data from plans that introduced co-payments over the three-year study period in order to study how mammography rates would change compared to rates in plans without co-payments.
Trivedi and his team found that:
* biennial breast cancer screening rates were 8 to 11 percent lower in cost-sharing plans - a difference that persisted even when adjusting for possible differences due to income, education, race and other factors;
* from 2002 to 2004, screening rates decreased by 6 percent in plans that introduced co-payments while screening rates increased by 3 percent in matched control plans that retained full coverage;
* the number of plans with cost sharing for mammography grew from three to 21 between 2001 and 2004, affecting .5 percent of women in 2001 and 11 percent of women by 2004;
* in cost sharing plans, the range of co-payments for a mammogram was $12.50 to $35, with an average co-payment of $20.
"We've isolated the effect of co-payments on an important preventive health measure," Trivedi said. "Mammograms are an essential service for older women, yet many women avoid that service when they are required to pay out-of-pocket. By eliminating co-payments for mammograms, we could get more women tested. More testing would mean earlier breast cancer treatment and improved chances for breast cancer survival."
William Rakowski, a professor in the Department of Community Health at Brown and a senior investigator in the Center for Gerontology and Health Care Research, was part of the study team.
The Agency for Healthcare Research and Quality funded the work.
Source: Wendy Lawton
Brown University
In this large-scale investigation of the relationship between health insurance co-payments and mammography rates, researchers found that screening rates were 8 percent lower among women with a co-payment than among women with full insurance coverage. Researchers at The Warren Alpert Medical School of Brown University, with a colleague from Harvard Medical School, publish their results in the current issue of the New England Journal of Medicine.
"The message is simple and it's startling - a small co-payment for a mammogram can lead to a sharp decrease in breast cancer screening rates," said Amal Trivedi, M.D., lead author of the study and assistant professor in the Department of Community Health at Alpert Medical School. "Co-payments as low as $12 deter women from getting mammograms. Because mammograms are critical in the fight against breast cancer, the most common cancer among American women, our findings have important health policy implications."
"Eliminating co-payments for mammograms in the Medicare program has the potential to save lives, because screening detects breast cancers at an earlier, more curable stage," said John Ayanian, M.D., study co-author and professor of medicine and health care policy at Harvard Medical School and Brigham and Women's Hospital.
The effect of insurance co-payments, or consumer cost sharing, on health care use and spending is a topic of intense interest for health policy-makers and researchers. But recent long-term data on the consequences of cost sharing, like deductibles and co-pays are limited. For example, results of the RAND Health Insurance Experiment, a watershed study of cost sharing and its impact on health, were released in 1982.
Trivedi wanted to gather and analyze more recent data because cost sharing is on the rise. According to a 2006 survey by the Henry J. Kaiser Family Foundation and the Health Research and Educational Trust, the most common co-payment for a medical office visit has doubled since 2001 while deductibles have increased an average of 60 percent in employer-based plans.
Trivedi chose to study mammography because the benefits of these X-ray photographs of the breast are widely accepted. The American Cancer Society, for example, recommends that women over 40 get annual mammograms to increase the odds of early breast cancer detection and treatment. Trivedi chose Medicare managed-care health insurance plans for review because the team could study a large number of patients over time.
In their study, Trivedi and colleagues studied coverage for mammography within 174 Medicare managed-care plans from 2001 to 2004. The review included 366,475 women between the ages of 65 and 69 living in 38 states.
The team compared the rates of biennial breast cancer screening within plans requiring co-payments with screening rates for plans with full coverage. They also analyzed data from plans that introduced co-payments over the three-year study period in order to study how mammography rates would change compared to rates in plans without co-payments.
Trivedi and his team found that:
* biennial breast cancer screening rates were 8 to 11 percent lower in cost-sharing plans - a difference that persisted even when adjusting for possible differences due to income, education, race and other factors;
* from 2002 to 2004, screening rates decreased by 6 percent in plans that introduced co-payments while screening rates increased by 3 percent in matched control plans that retained full coverage;
* the number of plans with cost sharing for mammography grew from three to 21 between 2001 and 2004, affecting .5 percent of women in 2001 and 11 percent of women by 2004;
* in cost sharing plans, the range of co-payments for a mammogram was $12.50 to $35, with an average co-payment of $20.
"We've isolated the effect of co-payments on an important preventive health measure," Trivedi said. "Mammograms are an essential service for older women, yet many women avoid that service when they are required to pay out-of-pocket. By eliminating co-payments for mammograms, we could get more women tested. More testing would mean earlier breast cancer treatment and improved chances for breast cancer survival."
William Rakowski, a professor in the Department of Community Health at Brown and a senior investigator in the Center for Gerontology and Health Care Research, was part of the study team.
The Agency for Healthcare Research and Quality funded the work.
Source: Wendy Lawton
Brown University
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