Monday, May 20, 2013
CHAPEL HILL, N.C. -- Intensity-modulated radiation therapy has become the most commonly used type of radiation in prostate cancer, but research from the University of North Carolina suggests that the therapy may not be more effective than older, less expensive forms of radiation therapy in patients who have had a prostatectomy.
The comparative effectiveness study, published online May 20 by JAMA Internal Medicine, evaluated the long-term outcomes of prostate cancer patients who received radiation treatments following prostatectomies using conformal radiation therapy (CRT) against the newer and more expensive intensity-modulated radiation therapy (IMRT). Study lead Ronald Chen, MD, MPH, assistant professor of Radiation Oncology in the UNC School of Medicine, said the results showed little difference in the long-term health of patients who used the newer and older radiation therapies.
“Many prostate cancer patients need radiation treatment after prostatectomy, the surgical removal of the prostate, either because the cancer is aggressive or for recurrence. In prostate cancer, we have seen a trend in our healthcare system where new technologies are adopted quickly, maybe because there is a belief that newer treatments are better, but often there is a lack of studies to actually compare patient outcomes from older vs. newer treatments,” said Dr. Chen.
The study used Medicare data to compare the outcomes of 457 IMRT and 557 CRT patients treated between 2002 and 2007. The patients, 66 years of age or older who underwent radical prostatectomy and subsequent radiation therapy within three years of their surgery, showed no difference in regards to urinary side effects, bowel side effects, sexual dysfunction and other long-term side effects or cancer control.
“For patients with newly diagnosed prostate cancer who have chosen to receive curative radiation treatment, our prior study showed that IMRT was associated with less long-term side effects and better cancer control than CRT. However, for patients who have had a prostatectomy already, and subsequently need radiation treatment, this study shows that IMRT and CRT seemed to have similar outcomes,” said Dr. Chen.
Prostate cancer is the most common malignancy among American men. Each year, 240,000 men are diagnosed and 30,000 die from the disease. Health care costs for treating prostate cancer have risen by $350 million a year, fueled in part by the adoption of new technology. This rise led the Institute of Medicine to identify comparative effectiveness research in prostate cancer as a top research priority.
Radiotherapy using IMRT offers promise because of its ability to deliver precise doses of radiation to the tumor. The ability of the radiation machine to deliver high doses of radiation to the tumor while minimizing the radiation exposure of surrounding tissues led to its rapid adoption as a clinical therapy for prostate cancer, because the prostate is situated near sensitive organs such as the bladder and rectum.
A lot of men across the United States who need radiation therapy after prostatectomy are not getting it, said Dr. Chen, and he speculates that the cost of treatment may play a factor. While research shows that as many as one-third to one-half of the patients undergoing surgery for prostate cancer may benefit from radiation treatments subsequently to achieve a cure, Dr. Chen said that the data show only 10 to 15 percent of those who could benefit actually receive the therapy.
“If 3D conformal radiation provides an effective and safe treatment for these patients, then we can probably show that radiation is a very cost effective treatment and potentially remove one of the large obstacles to patients being able to get this necessary treatment after surgery,” said Dr. Chen.
A newly published paper reports that individuals with radiographic knee osteoarthritis (OA) who had a specific pattern of gene variations in the interleukin-1 receptor antagonist gene (IL1RN), which is involved in controlling inflammation, were more likely to progress to severe disease than those without the gene variations.
In addition, higher body mass index, often associated with increased risk for developing severe OA, was only predictive for progression of OA in subjects who had the IL1RN gene variations.
The study was done under the direction of Dr. Joanne Jordan, director of the Thurston Arthritis Research Center at the University of North Carolina School of Medicine. “Progression of knee osteoarthritis often leads to severe disability and total knee replacement in many patients. The factors determining progression are poorly understood,” said Dr. Jordan, “and the genetic markers we reported appear to substantially improve our ability to identify which knee OA patients are more likely to progress. Our goal of course is to use such information to improve drug development and medical management for our OA patients.”
The study was published online by the journal Osteaoarthritis and Cartilage on April 18, 2013. It evaluated radiographic progression of knee OA using data from UNC's ongoing Johnston County Osteoarthritis Project, a well characterized population in North Carolina. Of 1,153 subjects, 154 had radiographic signs of knee OA initially. If they had the specific pattern of IL1RN gene variations that is found in approximately 40 percent of Caucasians they were more than twice as likely to have radiographic progression of the disease during the 4 to 11 years monitoring period than all other individuals with knee OA.
“This study was a critical validation of the importance of IL-1 receptor antagonist genetic variations in knee osteoarthritis that we have seen in other cohorts,” said Dr. Kenneth Kornman, chief executive officer of Interleukin Genetics and a co-author of the study. “We hope to start using this genetic information in partnerships to help guide therapeutic development to improve the management of knee OA.”
Three researchers at the University of North Carolina School of Medicine are starting a 5-year study, funded by the National Institutes of Health (NIH), that's aimed at understanding the role of oxytocin in postpartum depression and bonding between mothers and babies.
The new 5-year study is based on a smaller study published recently in the Journal of Women's Health.
"The conventional wisdom is that breastfeeding reduces postpartum depression — yet we see tremendous overlap between moms who struggle with breastfeeding and moms who have postpartum depression or anxiety symptoms," said Alison Stuebe, MD, first author of the pilot study and assistant professor in UNC's Department of Obstetrics and Gynecology. She is also assistant professor in the Department of Maternal and Child Health in the UNC Gillings School of Global Public Health.
"In this study, we measured levels of oxytocin, the 'love hormone', in mothers with mild anxiety or depression and in normal controls. The mothers who were more anxious had lower oxytocin levels during breastfeeding. We can't tell from this study whether feeling anxious reduces oxytocin, or whether not having enough oxytocin causes anxiety, but the results suggest that the two problems are connected. It may be that a problem with oxytocin both contributes to postpartum depression symptoms and makes breastfeeding less enjoyable," Stuebe said.
Co-authors of the article in the Journal of Women's Health were Karen M. Grewen, PhD, assistant professor, and Samantha Meltzer-Brody, MD, MPH, associate professor, both in the UNC Department of Psychiatry.
]]>Thursday, May 9, 2031
CHAPEL HILL, N.C. – A large new study finds that taking omega-3 fatty acid supplements has no effect on slowing the progression of age-related macular degeneration (AMD).
However, for people with low levels of lutein or zeaxanthin in their diets, supplementation with lutein and zeaxanthin may slow the progression of AMD, the study found.
Four researchers in the Department of Ophthalmology in the University of North Carolina School of Medicine contributed to the Age-related Eye Disease Study (AREDS) 2. Results from AREDS 2 were published online May 5 in the Journal of the American Medical Association.
“Many patients ask whether they should be taking lutein and omega-3 fatty acids for their age-related macular degeneration (AMD),” said Odette Houghton, MD, associate professor and one of the UNC researchers. The others were Seema Garg, MD, PhD, Maurice B. Landers III, MD and Travis M. Meredith, MD, chair emeritus of the Department of Ophthalmology.
“The AREDS 2 results indicate that if you have low levels of lutein or zeaxanthin in your diet, or if you take the original AREDS vitamins without beta-carotene, then supplementation with lutein and zeaxanthin may slow the progression of AMD. However, omega-3 fatty acids appear to have no beneficial or harmful effect on AMD,” Houghton said.
The AREDS2 study suggests that lutein and zeaxanthine are safer alternatives to beta-carotene in those people who have a history of smoking. There was a higher incidence of lung cancer in participants that had a history of smoking and who took AREDS supplements with beta-carotene.
“We have no control over some of the major risk factors for the advancement of AMD, such as age and family history,” Houghton said. “Regular dilated eye exams, avoidance of smoking and taking AREDS2 supplements when indicated are ways we may be able to reduce the risk of blindness from AMD.”
However, the AREDS supplements have only been shown to be effective in people who already have an intermediate stage of AMD. These supplements do not benefit people who have no AMD or mild AMD. A dilated eye exam by an eye care provider is the only way to detect AMD, Houghton said.
The American Academy of Ophthalmology recommends that adults get a baseline eye disease screening at age 40. The necessary interval for follow-up exams can be based on the results of this screening. Everyone age 65 and over should have complete eye exams every one to two years.
Written by Nathan Clendenin for UNC Health Care
Have you ever been stung by a bee? Did it hurt? I'd be willing to bet that avoiding stings is about the only thought you've had about bees, unless it was about honey! If you're like Dr. Jonathan Kirsch, a hospitalist at UNC Health Care, you'd also be interested in bees pollinating the fruit trees in your yard! If you talked to him about his bees, you'd likely become fascinated, as I did, at how bees work in their hive to produce honey, defend the hive, repair it, take care of the baby bees and everything else to ensure they can survive a cold winter. It's an amazing social organism to learn about, and an even more amazing one to see first hand.
While we didn't have a chance to talk about it in the video, Dr. Kirsch shared with me that bees have recently been dying off in large numbers. This is a big deal because bees are the No. 1 pollinators of all the fruits and vegetables we consume in the United States. Without them, our food wouldn't reproduce! Nobody is exactly sure why this is happening, but in Europe they just recently banned a certain pesticide that is believe to be one of the causes. If they see a change in bee population in the next two years while the ban is in effect, then they'll know it was causing it. For more in-depth information about this, check out this article.
Check out this episode of real doctors, real people!
Media contact: Tom Hughes, (919) 966-6047, tahughes@unch.unc.edu
Wednesday, May 8, 2013
CHAPEL HILL, N.C. - The Patient-Centered Outcomes Research Institute (PCORI) has approved a research award to the University of North Carolina School of Medicine to study the role of glucose monitoring in patients with type 2 diabetes using oral medications. The three-year project will focus on assessing the impact of three different types of blood sugar or glucose home testing approaches on outcomes important to patients with type 2 diabetes treated in a community-based clinic setting.
Katrina Donahue, MD, MPH, associate professor of family medicine, and Laura Young, MD, PhD, assistant professor of medicine, will lead the research project. Both are members of the North Carolina Clinical and Translational Institute, academic home of the National Institute of Health’s Clinical and Translational Science Awards (CTSA). John Buse, MD, PhD, professor of medicine and deputy director of the CTSA, will lead the stakeholder advisory team comprising patients and community members as well as representatives from industry, advocacy groups and state government. The contract from PCORI is for $2,090,699.80.
“Given the time and resource-intensive nature of glucose self-monitoring, to test or not to test is a critically important question facing the millions of patients living with non-insulin-treated type 2 diabetes,” said study leaders Drs. Donahue and Young in a written statement. “Patients often receive mixed messages about blood glucose self-monitoring. We are excited that PCORI has recognized the lack of consensus around the utility of glucose monitoring in patients with type 2 diabetes not treated with insulin.”
The researchers stated that this important, patient-centered project will help patients and those that care for them make better, evidence-based decisions about whether or not blood glucose monitoring can improve the outcomes they value most. They also said that the results will shape future decision-making in diabetes-care practice and guidelines.
The study is part of a portfolio of patient-centered research that addresses PCORI’s national research priorities and will provide patients with information that will help them make better informed decisions about their care.
UNC is well placed to manage the study because of the collaborative network and research infrastructure provided by the NIH CTSA as well as UNC’s well-known work in the area of patient-centered care. Dr. Donahue practices in the UNC Family Medicine Center, an NCQA-certified Patient Centered Medical Home. Study participants will come from counties in central North Carolina, through partnerships with the UNC Physician Network practices.
The UNC study is one of 51 projects totaling more than $88.5 million approved for funding by PCORI’s Board of Governors on May 6. All were selected through a highly competitive review process in which scientists, patients, caregivers, and other stakeholders helped to evaluate more than 400 applications for funding. Proposals were evaluated on the basis of scientific merit, how well they engage patients and other stakeholders, their methodological rigor, and how well they fit within PCORI’s national research priorities.
The awards are part of PCORI’s second cycle of primary research funding. This new round of funding follows PCORI’s initial approval of $40.7 million in support for 25 projects under the institute’s national research priorities. All awards in this most recent round of funding were approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
For more information about PCORI’s Funding Announcements, visit www.pcori.org/funding-opportunities.
#####
About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.
About NC TraCS/UNC CTSA
The North Carolina Translational and Clinical Sciences (NC TraCS) Institute, the integrated home of the Clinical and Translational Science Awards (CTSA) program at UNC-CH, is supported through the National Institutes of Health (NIH), grant ULTR000083. The CTSA program is led by the NIH’s National Center for Advancing Translational Sciences (NCATS).
]]>Thursday, May 2, 2013
CHAPEL HILL, N.C. – A new study led by University of North Carolina School of Medicine researchers is the first to identify a genetic risk factor for persistent pain after traumatic events such as motor vehicle collision and sexual assault.
In addition, the study contributes further evidence that persistent pain after stressful events has a specific biological basis. A manuscript of the study was published online ahead of print by the journal Pain on April 29.
“Our study findings indicate that mechanisms influencing chronic pain development may be related to the stress response, rather than any specific injury caused by the traumatic event,” said Samuel McLean, MD, MPH, senior author of the study and assistant professor of anesthesiology. “In other words, our results suggest that in some individuals something goes wrong with the body’s ‘fight or flight’ response or the body's recovery from this response, and persistent pain results.”
The study assessed the role of the hypothalamic-pituitary adrenal (HPA) axis, a physiologic system of central importance to the body's response to stressful events. The study evaluated whether the HPA axis influences musculoskeletal pain severity six weeks after motor vehicle collision (MVC) and sexual assault. Its findings revealed that variation in the gene encoding for the protein FKBP5, which plays an important role in regulating the HPA axis response to stress, was associated with a 20 percent higher risk of moderate to severe neck pain six weeks after a motor vehicle collision, as well as a greater extent of body pain. The same variant also predicted increased pain six weeks after sexual assault.
"Right now, if an someone comes to the emergency department after a car accident, we don't have any interventions to prevent chronic pain from developing," McLean said. Similarly, if a woman comes to the emergency department after sexual assault, we have medications to prevent pregnancy or sexually transmitted disease, but no treatments to prevent chronic pain. This is because we understand what causes pregnancy or infection, but we have no idea what the biologic mechanisms are that cause chronic pain. Chronic pain after these events is common and can cause great suffering, and there is an urgent need to understand what causes chronic pain so that we can start to develop interventions. This study is an important first step in developing this understanding."
"In addition, because we don't understand what causes these outcomes, individuals with chronic pain after traumatic events are often viewed with suspicion, as if they are making up their symptoms for financial gain or having a psychological reaction," McLean said. "An improved understanding of the biology helps with this stigma," McLean said.
The study was conducted by a multidisciplinary team of investigators from thirteen institutions. Co-lead authors on the study were Andrey Bortsov, MD, PhD, assistant research professor in the UNC Department of Anesthesiology, and Jennifer Smith, BS, a UNC medical student and former Doris Duke Fellow.
Today’s agreement follows many months of careful consideration by the Caldwell Memorial Hospital Board of Directors on how to strengthen its position as a provider while responding to the changing health care environment. Since first announcing their intention to merge, both Caldwell Memorial Hospital and UNC Health Care have completed the complex process of due diligence to ensure a successful transaction.
“We explored solutions for our community that will advance local health care, build upon our legacy of service in Caldwell County and preserve our mission of providing high-quality, cost-effective care,” said Boyd Wilson, chair of the Caldwell Memorial Hospital Board of Directors in 2012 when this process began. “After evaluating numerous options, it became clear that UNC Health Care will share and protect our vision to grow and strengthen our hospital for the long term.”
Caldwell invited UNC Health Care to submit a proposal because of its management resources and successful track record in improving community hospitals. Other compelling attributes include UNC Health Care’s cultural understanding of the state and region, experience in building stronger physician relationships, and ability to connect patients to highly sub-specialized care including clinical research and trials.
“We are pleased to welcome Caldwell Memorial into our System,” said David Strong, chief operating officer for System affiliations for UNC Health Care. “This partnership combines a legacy of successful health care delivery at Caldwell Memorial with the clinical and research capabilities of UNC Health Care. Caldwell Memorial also will advance our missions of providing care, training the next generation of North Carolina’s physicians and conducting groundbreaking research. In short, this is a win for patients in the Caldwell County area and UNC Health Care.”
Under the terms of the agreement, UNC Health Care will:
“Today is a very special day in our life together, for a new friend has just moved into the neighborhood," said Parker Williamson, current chair of the Caldwell Memorial Hospital Board of Directors. "Our partnership with UNC Health Care will enrich this community in countless ways. This partnership will secure, strengthen and ennoble health care for all of our people and for generations yet to come.”
Caldwell Memorial Hospital is the private, not-for-profit community hospital located in Lenoir, North Carolina. Since opening in January of 1951, it has continued to grow and change in order to meet the healthcare needs of its community. Anchored by a high-quality, 110-bed, acute care hospital and a provider network of more than fifty primary and specialty care physicians and advanced practice professionals, the mission of Caldwell Memorial Hospital is to provide safe, effective, compassionate care and to promote healthy lifestyles to its community.
UNC Health Care is a not-for-profit integrated health care system owned by the state of North Carolina and based in Chapel Hill. It exists to further the teaching mission of the University of North Carolina and to provide state-of-the-art patient care. UNC Health Care comprises UNC Hospitals, ranked consistently among the best medical centers in the country; the UNC School of Medicine, a nationally eminent research institution; community practices; home health and hospice services in seven central North Carolina counties; Pardee Hospital in Hendersonville, NC; Chatham Hospital in Siler City, NC; High Point Regional Medical Center in High Point, NC; and Rex Healthcare and its provider network in Wake County.
]]>Wednesday, May 1, 2013
Anna Spagnoli, MD, a professor of pediatrics in the UNC School of Medicine, has been named a 2013 fellow of the prestigious Hedwig van Ameringen Executive Leadership in Academic Medicine® (ELAM) Program at Drexel University College of Medicine. As the only program in North America dedicated to preparing senior women faculty for institutional leadership roles at academic health centers, acceptance into the ELAM® fellowship is highly competitive.
“Dr. Spagnoli is an accomplished clinician, teacher and scientist, already held in high esteem for her dedication to UNC and natural leadership ability,” said Wesley Burks, MD, chair of pediatrics in the UNC School of Medicine and chief physician of N.C. Children’s Hospital. “I know I echo the sentiments of administrative leaders throughout the institution when I extend my congratulations and pledge our support as she pursues this rigorous and very prestigious program.”
Dr. Spagnoli is chief of the division pediatric endocrinology, recognized by U.S. News & World Report as one of the nation’s best for treating children with diabetes and other endocrine disorders. She directs the pediatric fellowship program within the division of pediatric endocrinology and is a member of the mentoring program within the Department of Pediatrics. As a clinician, she directs UNC’s pediatric bone clinic, the only clinic in North Carolina offering dedicated pediatric endocrine expertise for children with bone disorders.
She is also an accomplished, internationally-known investigator leading a large research program in bone/cartilage development and regeneration. She has been extensively funded by National Institutes of Health, as well as by several foundations and private sector agencies, and has authored landmark publications in the bone/cartilage regenerative medicine field.
ELAM's mission is to increase the number of women in senior leadership positions in medical academia, and, in so doing, change the culture of academic health institutions to become more inclusive of different perspectives and more responsive to changing social agendas. That mission is what attracted Spagnoli to the program when she applied for the first time this year, endorsed by William Roper, MD, MPH, dean of the UNC School of Medicine and UNC Health Care System CEO.
“I am thrilled by the learning and networking opportunities that ELAM can offer to me,” said Dr. Spagnoli, who will begin the program in May. “I hope participating in ELAM will advance my leadership skills as my career progresses; broaden my perspective regarding the spectrum of career options available outside my personal knowledge and comfort zone; and enrich my networking with women leaders from whom I can learn and seek advice and counsel.”
The intensive year-long curriculum fosters on-the-job opportunities and resources to enhance leadership. Fellows gain a deeper understanding of the challenges facing academic health centers through meetings with national leaders in the field, interactions with peers in the program, and collaborations with a range of senior officers at their own institutions. Fellows also undertake an Institutional Action Project, developed in collaboration with the senior leadership. Each project is designed to address a strategic institutional priority while providing an opportunity for the fellow to gain greater visibility as an academic leader.
As Diane Magrane, MD, director of Drexel’s International Center for Executive Leadership in Academics, which supports the program, explains, “The fellows’ projects not only help them understand the challenges facing academic health centers and the skills a leader must possess to address these challenges, but also often result in concrete, positive changes at their institutions.”
Upon completion of the one-year fellowship in May 2014, Spagnoli will be among 54 members of the 2013-2014 class that join a highly accomplished community of ELAM alumnae, over 800 strong. Graduates of the program serve in a variety of leadership positions around the world, including department chairs, research center directors, deans and college presidents as well as chief executives in health care and accrediting organizations.
Wednesday, May 1, 2013
CHAPEL HILL, N.C. – In a study using mice, researchers from the University of North Carolina School of Medicine found that a hormone, adrenomedullin, plays a crucial role in preventing the pregnancy complication preeclampsia. Surprisingly, this hormone protects women from preeclampsia when emitted by the fetus, not the mother, during the most critical times in pregnancy.
“We’ve identified the fact that the baby is important in protecting the mom from preeclampsia,” said the study’s senior author, Kathleen M. Caron, PhD, assistant dean for research at the UNC School of Medicine and an associate professor in the Department of Cell Biology and Physiology. “If the baby’s cells are not secreting this hormone, the mother’s blood vessels don’t undergo the dilation that they should.”
Preeclampsia affects roughly one in fifteen pregnancies. An important characteristic of the condition is that blood vessels in the placenta fail to enlarge, or dilate, to accommodate increased blood flow to the fetus. Untreated, it can threaten the life of both mother and baby.
“We really don’t know that a pregnant woman is going to get preeclampsia until she has it,” said Caron. Because the condition has numerous risk factors and causes, it’s difficult for doctors to know which patients are at highest risk. “Identifying molecules that could predict preeclampsia would be really important.”
The researchers studied mice that were genetically programmed to produce either reduced or increased levels of adrenomedullin. The study revealed that in a normal pregnancy, the fetus secretes adrenomedullin into the placenta during the second trimester, signaling special cells called “natural killer cells” to help dilate the mother’s blood vessels and allow more blood to flow to the growing fetus.
The study is one of the first to identify an important chemical message sent from fetus to mother in the womb. Scientists understand more about the mom’s side of the ‘chemical conversation’ that goes on between mother and baby, but much of the hormonal signaling in the placenta remains a mystery.
By identifying the key role of adrenomedullin, the research could pave the way to new methods for detecting and preventing preeclampsia. For example, adrenomedullin levels could potentially be used as a biomarker, or early indicator, to identify which patients might be predisposed to the condition. “Having a biomarker would be wonderful—it could allow the physician to manage a woman differently in the early part of her pregnancy,” said Caron.
As a next step, the researchers plan to build upon their mouse studies to examine patterns of adrenomedullin levels and preeclampsia in pregnant women.
This paper was published online ahead of print on May 1, 2013 in the Journal of Clinical Investigation (JCI). The paper will appear in the June 2013 print edition.
The study’s co-authors include Manyu Li, Nicole M.J. Schwerbrock, Patricia M. Lenhart, Kimberly L. Fritz-Six, Mahita Kadmiel, Kathleen S. Christine, Scott T. Espenschied, Helen H. Willcockson and Christopher P. Mack of UNC and Daniel M. Kraus of Duke University Medical Center.
April 26, 2013
CHAPEL HILL,N.C. — Two antiviral drugs used to treat hepatitis C appear to work as well in the real world as they did during clinical trials, an international research consortium has observed. The consortium also released data that may help inform how doctors and patients manage treatment-related adverse events.
The international effort, known as HCV-TARGET, follows how newly approved therapies for hepatitis C are used and managed in routine practice. It is led jointly by the University of North Carolina at Chapel Hill and the University of Florida. The ongoing research suggests that the safety and efficacy of the antiviral drugs telaprevir and boceprevir are similar for North American patients taking the treatments in real-world settings to what was observed in clinical trials.
The evaluation of data available from November 2011 through April 2013, presented at the 48th Annual Meeting of the European Association for the Study of the Liver in Amsterdam, found that anemia was the most relevant adverse event affecting clinical care. Approximately two-thirds of anemic patients were managed with drug dose reductions, which minimized the need for expensive growth factors and blood transfusions. The analysis also reveals that patients with cirrhosis were at increased risk for treatment-related complications, including severe anemia and significant deterioration of the liver, which often resulted in stopping therapy early.
“We plan to track up to 5,000 patients internationally over five years to continue to assess the benefits and risks of new treatments in real-world settings,” said co-PI Michael W. Fried, MD, professor of medicine at UNC, which serves as the HCV-TARGET data coordinating center. “HCV-TARGET serves as a model for cross-cutting collaborative studies that can rapidly advance knowledge in an important illness of public health concern.”
“This is a long-term study, and we plan to release similar interim analyses each spring and fall to provide clinicians with up-to-date knowledge that can inform how we manage therapy for patients with hepatitis C,” said co-PI David R. Nelson, MD, director of the UF Clinical and Translational Science Institute and professor of medicine at UF, which serves as the clinical coordinating center for HCV-TARGET.
One of the consortium’s priorities for future analyses will be to investigate indicators that may predict adverse outcomes in cirrhotic patients and guide safer use of these drug regimens.
Hepatitis C is a viral liver disease transmitted through contact with an infected person’s blood. Chronic hepatitis C can lead to serious liver problems including liver damage, cirrhosis, liver failure or liver cancer. Because a person with chronic hepatitis C can live symptom-free for many years, many people do not know they are infected.
Globally, the World Health Organization estimates about 150 million individuals are chronically infected with hepatitis C, and more than 350,000 people die each year from hepatitis C-related liver diseases. In the U.S., the Centers for Disease Control and Prevention estimates 3.2 million people are chronically infected with hepatitis C, although a 2011 review article in Liver International suggests the estimate is likely higher – at least 5.2 million people – if U.S. populations not surveyed by the CDC are included, such as the homeless and incarcerated.
HCV-TARGET is an international research consortium created to inform the ongoing transformation of hepatitis C treatment and research. The HCV-TARGET model is rooted in the infrastructure and collaborative network developed through the National Institutes of Health’s Clinical and Translational Science Award (CTSA) program, which is led by the National Center for Advancing Translational Sciences. In addition to UNC and UF, HCV-TARGET includes 23 other CTSA-supported institutions among its 103 academic and community sites in 31 states, Puerto Rico, Canada and Europe. HCV-TARGET also partners with multiple industry sponsors, regulatory agencies and the patient advocacy community.
In 2011, HCV-TARGET established a nationwide registry to observe patients in the United States undergoing hepatitis C treatment over time and to coordinate real-world monitoring on a national scale for new therapies as they enter the market. For patients who agree to be in the study, the project is capturing demographic, clinical, adverse event and virological data. To date approximately 1,900 patients have agreed to participate, including patients with cirrhosis and other populations underrepresented in clinical trials.
“The data coming out of the HCV-TARGET consortium will help inform physicians and patients as they weigh important decisions regarding therapy, decisions that can greatly impact quality of life,” said Donald M. Jensen, M.D., professor of medicine at the University of Chicago and a member of the HCV-TARGET Steering Committee.
HCV-TARGET’s participating patients are treated according to local standards of care. In addition, participants can allow HCV-TARGET to collect their whole blood for DNA and serum and store it at a central biorepository for future research.
The network’s initial study has followed a broad population of adult patients in North America treated with telaprevir or boceprevir, which were newly approved by the U.S. Food and Drug Administration when HCV-TARGET launched. In 2013, HCV-TARGET is expanding its study to include European sites and patients treated with any direct-acting antiviral agent approved by the FDA.
HCV-TARGET (www.hcvtarget.org) receives ongoing industry support from Merck, Genentech, Kadmon, and Vertex.
Dr. Fried receives research grant support and serves as ad hoc consultant to Genentech, Vertex, Merck, Gilead, Bristol Myers Squibb, Janssen and Abbott. Dr. Nelson receives grant support from Genentech, Kadmon, Merck, Vertex Pharmaceuticals, Gilead, Boehringer Ingelheim and Abbott/Abbvie; and payment for the development of educational presentations from Clinical Care Options, Rush University Medical Center, Practice Point Communications and Chronic Liver Disease Foundation.
Hendersonville, N.C. -- The Henderson County Board of Commissioners voted unanimously today on a revised Memorandum of Understanding (MOU) between Pardee Hospital and UNC Health Care that builds upon the current affiliation and strengthens the partnership between the two health care organizations.
The MOU sets the foundation for a revised Management Agreement between Pardee, UNC Health Care, and Henderson County. This agreement replaces the current management agreement between Pardee and UNCHCS by extending the relationship from 10 to 25 years. The MOU allows UNC Health Caregreater direct involvement with Pardee’s clinical, business, and financial operations.
Furthermore, this announcement allows for the potential investment by UNC Health Care in Pardee facilities and operations and potential expansion of clinical facilities at Pardee. The new agreement will also extend the duration of Pardee Hospital’s lease with the county for both the hospital buildings and land.
“From the onset, this affiliation was always intended to improve access and delivery of medical services to Henderson County and beyond,” said Bill Moyer, Pardee Hospital Board Chair. “We’ve seen these benefits first hand and we want to build upon this success. I can’t help reflect upon the 60 years that Pardee has been caring for this region and how we are even more prepared than ever to serve our patients.”
“We are very pleased with the terrific way the Hospital Corporation and UNC Health Care System have worked to make Pardee an even better hospital for this community,” said Henderson County Board of Commissioners Chairman Charlie Messer. “The cooperative arrangement has been extremely effective, and we look forward to greater cooperation in the future to insure that even in a time of great change in healthcare, Pardee will remain a viable and valuable institution for the citizens of the County.”
County Manager, Steve Wyatt, “You have to give a lot of credit to the County Commissioners for recognizing the challenges the County hospital faces in the days to come and for meeting these challenges head on.”
This agreement also revises the structure of the Pardee Hospital Board of Directors. The current board is compromised of 11 members. The new structure expands the board to a total of 15 members with appointments being made by the Henderson County Board of Commissioners and by UNC Health Care System.
Gary L. Park, President of UNC Hospitals, said, “We are thrilled with our relationship with Pardee Hospital. It is an exceptional organization with strong leadership and strong governance. We are a stronger system because of our relationship with Pardee. I have great respect for the Pardee Board and I applaud the county commissioners for their cooperation and their vision."
This announcement comes almost two years after the original June 2011 affiliation of Pardee and UNC Health Care. In this time, Pardee and the citizens it serves has benefited from expanding insurance coverage for its patients, a broad range of resources, and access to the growing UNC Health Care network.
A team from the UNC Bone Marrow and Stem Cell Transplant Program led by Tippu Khan, PharmD, BCOP and Nicole Frazier, RN, BSN participated in an epic journey which included leaping over fire, trekking through waste-high mud, tossing spears, dodging attacks and most of all braving near freezing temperatures in the driving rain. What is all this about? It's the Spartan Race, an event of pure primitive craziness that promises it's participants an experience they'll never forget.
Competing as a team of about 15 which included other colleagues and their spouses, Khan and Frazier led the charge on March 23, 2013, in Charlotte, N.C. Despite the many physical obstacles, they also overcame mental barriers to finish the race together, as a team. In true Spartan fashion, they helped each other along the way with a hand up, a steadying arm and most of all an encouraging voice. Not only did they finish the race together, but they had enough energy to crack some smiles and even do a little dancing along the way! The teamwork that carried them through this race, is the same teamwork that makes them an amazing asset to the Bone Marrow and Stem Cell Transplant Program. Many of their patients, fighting extremely difficult battles themselves, cheered the team on with encouragement and high fives leading up to the race.
For the team, this isn't a one and done situation. As Frazier puts it, "Once you do one, it's kind of addicting." They competed again this month in the Rugged Maniac 5k Obstacle Race in Asheboro, N.C. on April 20, and if history is an indication of the future, there will be more to come!
And now we're pleased to present you with real doctors, real people / RN: Real Nurses Spartan Edition!
]]>Friday, April 19, 2013
CHAPEL HILL, N.C. - A monoclonal antibody targeting a protein known as SFPR2 has been shown by researchers at the University of North Carolina to inhibit tumor growth in pre-clinical models of breast cancer and angiosarcoma.
In a paper published in the April 19 issue of Molecular Cancer Therapeutics, a team led by Nancy Klauber-DeMore, MD, professor of surgery and a member of UNC Lineberger Comprehensive Cancer Center, used a monoclonal antibody to target SFRP2 expressed in cells from triple-negative breast cancer and the aggressive blood-vessel malignancy angiosarcoma, reducing the rate of tumor growth. The antibody, created at the University of North Carolina, is the first therapeutic discovered that targets SFRP2.
“We showed in this paper that targeting SFRP2 with a monoclonal antibody in pre-clinical models inhibits tumor growth. This demonstrates that SFRP2 is a therapeutic target for cancer” said Dr. DeMore.
The DeMore lab first discovered the role of SFRP2 in tumor growth while looking to develop an alternative to the FDA-approved anti-angiogenesis drug known as Avastin (bevacizumab). Avastin targets the protein VEGF, which has also been tied to angiogenesis (the production of new blood vessels). Although Avastin is of benefit to some patients with cancer, not all tumors respond to Avastin, and of those that respond, some eventually progress. To find a solution for patients whose tumors are resistant to Avastin, DeMore began looking at other proteins linked to angiogenesis that could be used as therapeutic targets.
“We previously microdissected blood vessels from malignant human breast cancers and compared gene expression to blood vessels microdissected from normal tissue. We found a number of genes that were highly over-expressed in the malignant blood vessels compared to normal. One of those genes was SFRP2,” said Dr. DeMore.
The DeMore lab found that SFRP2 is expressed in a variety of human cancers, including breast, prostate, lung, pancreas, ovarian, colon, kidney tumors, and angiosarcomas, DeMore, working with Dr. Cam Patterson, Ernest and Hazel Craige Distinguished Professor of Cardiovascular Medicine, discovered that SFRP2 acted as a potent stimulator of angiogenesis, leading their team to hypothesize that targeting SFRP2 could inhibit tumor growth. In collaboration with Dr. Russ Mumper, the John A. McNeill Distinguished Professor in the Division of Molecular Pharmaceutics, their group developed a drug to target SFRP2. “Demonstrating that a monoclonal antibody to SFRP2 inhibits tumor growth in pre-clinical models opens up a new potential for drug development. This treatment is not presently available for human studies, but our efforts are focused on obtaining funding for further drug development that would lead to a clinical trial” said DeMore.
This work was supported by National Institute of Health (P50-CA58223, 1R01CA142657-01A1 and R01 HL61656), North Carolina TraCS Large Pilot Award, University Cancer Research Fund, Nancy DeMore Foundation and North Carolina Kickstart Commercialization Collaboration Award.