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News Article | February 15, 2017
Site: news.yahoo.com

To eat soy or not: That's the question many U.S. women have been asking. Tofu, miso paste and other soybean-based foods are high-quality sources of protein that are low in calories and saturated fat. And studies have shown that they can help prevent cancer. Yet many doctors recommend that women who have, or are at risk of developing, a common form of breast cancer called estrogen-receptor-positive breast cancer  avoid eating soybean-based foods because they contain compounds called isoflavones. Some studies suggest that isoflavones can mimic the hormone estrogen and encourage tumor growth. Now, in an animal study, researchers at the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., have uncovered a possible reason for the apparent Jekyll-and-Hyde nature of soy — how it can both prevent cancer and fuel its spread. [Top 10 Cancer-Fighting Foods] The researchers found that rats that were given soybean isoflavones to eat throughout their lives — in particular, one type of soybean isoflavone called genistein — had improved immunity against cancer. But rats that weren't given the isoflavone until after developing breast cancer didn't have that same immune response to kill cancer cells. Instead, these rats had higher rates of cancer growth and higher rates of recurrence after their tumors were removed. The study may explain why women in Asian countries, who tend to consume high amounts of soybean-based foods throughout their lifetime, have rates of breast cancer that are five times lower than those of women in the United States, the researchers said. The findings were published today (Feb. 1) in the journal Clinical Cancer Research. More than 200,000 U.S. women are diagnosed each year with breast cancer, and the majority have estrogen-receptor-positive breast cancer, according to the Centers for Disease Control and Prevention. One of the most common drugs to combat this type of cancer is tamoxifen, which acts to reduce estrogen's ability to promote cancer growth. In their animal study, the researchers induced cancer growth in rats that had a steady diet of genistein and in rats that never had any genistein until after the cancer developed. All of the rats were then treated with tamoxifen to kill the cancer. The researchers found that the rats raised on genistein had only a 7 percent chance of breast cancer recurrence after tamoxifen treatment, but the rats that were recently given genistein had a 33 percent recurrence rate. It's not clear why genistein would have this effect but it may be related to the body's immune system being activated by the isoflavone, recognizing it as a nutrient from its longtime consumption, said study senior author Leena Hilakivi-Clarke, a professor of oncology at the Georgetown Lombardi Comprehensive Care Center. "The immune system was not activated in animals that started consuming genistein for the first time with tamoxifen," Hilakivi-Clarke told Live Science. This may have resulted in the genistein appearing more like the cancer-fueling estrogen and less like a tumor-fighting agent, she said. In other words, the paradox is in the timing. It may be that soy consumption is protective only if started before cancer develops. Despite the lingering ambiguity of whether the same is true in humans, Hilakivi-Clarke thinks the animal study can inform doctors and their patients. "We have solved the puzzle of genistein and breast cancer in our rat model, which perfectly explains the paradox seen in earlier animal studies and patients," Hilakivi-Clarke said. "While many oncologists advise their patients not to take isoflavone supplements or consume soy foods, our findings suggest a more nuanced message — if these results hold true for women. Our results suggest that breast cancer patients [who ate soy before their diagnosis] should continue consuming soy foods after diagnosis, but not to start them if they have not consumed genistein previously." [6 Foods That May Affect Breast Cancer Risk] Maggie Neola, a staff dietitian for the Barnard Medical Center and Physicians Committee in Washington, who wasn't part of the study, said that findings from animal experiments often don't translate to humans and that she'd like to see research from population studies with women.


News Article | November 3, 2016
Site: www.eurekalert.org

WASHINGTON -- Using prominent, graphic pictures on cigarette packs warning against smoking could avert more than 652,000 deaths, up to 92,000 low birth weight infants, up to 145,000 preterm births, and about 1,000 cases of sudden infant deaths in the U.S. over the next 50 years, say researchers from Georgetown Lombardi Comprehensive Cancer Center. Their study, published online Nov. 3 in the journal Tobacco Control, is the first to estimate the effects of pictorial warnings on cigarette packs on the health of both adults and infants in the U.S Although more than 70 nations have adopted or are considering adopting the World Health Organization's Framework Convention for Tobacco Control to use such front and back of-the-pack pictorial warnings -- an example is a Brazilian photo of a father with a tracheotomy -- they have not been implemented in the US. Pictorial warnings have been required by law, but an industry lawsuit stalled implementation of this requirement. Currently, a text-only warning appears on the side of cigarette packs in the U.S. The study used a tobacco control policy model, SimSmoke, developed by Georgetown Lombardi's David T. Levy, PhD, which looks at the effects of past smoking policies as well as future policies. SimSmoke is peer-reviewed, and has been used and validated in more than 20 countries. In this study, Levy and his colleagues, who included investigators at the University of Waterloo, Ontario, and the University of South Carolina, looked at changes in smoking rates in Australia, Canada and the United Kingdom, which have already implement prominent pictorial warning labels (PWLs). For example, eight years after PWLs were implemented in Canada, there was an estimated 12 percent - 20 percent relative reduction in smoking prevalence. After PWLs began to be used in Australia in 2006, adult smoking prevalence fell from 21.3 percent in 2007 to 19 percent in 2008. After implementation in the UK in 2008, smoking prevalence fell 10 percent in the following year. The researchers used these and other studies and, employing the SimSmoke model, estimated that implementing PWLs in the U.S. would directly reduce smoking prevalence in relative terms by 5 percent in the near term, increasing to 10 percent over the long-term. If implemented in 2016, PWLs are estimated to reduce the number of smoking attributable deaths (heart disease, lung cancer and COPD) by an estimated 652,800 by 2065 and to prevent more than 46,600 cases of low-birth weights, 73,600 cases of preterm birth, and 1,000 SIDS deaths. "The bottom line is that requiring large pictorial warnings would help protect the public health of people in the United States," says Levy, a professor of oncology. "There is a direct association between these warnings and increased smoking cessation and reduced smoking initiation and prevalence. That would lead to significant reduction of death and morbidity, as well as medical cost." The study was funded by a grant from the National Institute on Drug Abuse (R01DA036497) and the National Cancer Institute (UO1-CA97450). Co-authors include Darren Mays, PhD, MPH, and Zhe Yuan, MS, both from Georgetown, David Hammond, PhD, from the University of Waterloo, and James F. Thrasher, PhD, MS, MA, from the University of South Carolina. Hammond has served as a paid expert witness on behalf of governments in tobacco litigation, including challenges to health warning regulations. The other co-authors report no potential conflicts or related financial interests. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


News Article | December 15, 2016
Site: www.eurekalert.org

WASHINGTON (Dec. 15, 2016) -- For the first time, researchers have been able to grow, in a lab, both normal and primary cancerous prostate cells from a patient, and then implant a million of the cancer cells into a mouse to track how the tumor progresses. The achievement, say researchers at Georgetown University Medical Center who led the research, represents a critical advance in the effort to understand the origin and drivers of this puzzling cancer -- the most common in men. The study was published online today in Oncotarget. "This is a new and much-needed platform for prostate cancer research. By matching normal and cancer cells from a patient, we can now study the differences -- what molecules are key to tumor development and growth, and, ultimately, match treatments that might disable this cancer," says the study's senior investigator, associate professor of pathology, Xuefeng Liu, MD, a member of the Center for Cell Reprogramming (CCR) at Georgetown University Medical Center. The breakthrough was possible because the research team used conditional reprogramming (CR), a laboratory technique, developed and described by Liu, Richard Schlegel, MD, PhD, director of the CCR, and their colleagues at Georgetown in 2011, that makes it possible to continuously grow cells in a laboratory indefinitely. The method uses special "feeder" cells and a chemical inhibitor. "This is the only system that can grow healthy and cancer cells as if they were just extracted from a patient, and expand them -- a million new cells can be grown in a week -- as long as needed," he says. The CR method is being developed for a number of uses, such as living biobanks, personalized and regenerative medicine, and this study, using donated tissue from a 57 year-old man who underwent a radical prostatectomy, demonstrates the first steps needed towards those goals in prostate cancer. Previous studies have proven the utility of CR in a variety of tissue types, including breast, lung, and colon cancer. Liu says many labs around the world are now using this technique, which is called "conditional reprogramming." "Prostate cancer is highly heterogenetic -- it is different person to person, can be slow growing or rapidly aggressive, or both over time. We really don't understand the basic biology of prostate cancer and that makes it very difficult to find targeted therapies," Liu says. "The use of matched patient-derived cells provides a unique model for studies of early prostate cancer." In this proof-of-principle study, the researchers showed, using DNA sequencing and karyotyping technologies, that the patient's unique cell characteristics were maintained in both normal and tumor CR laboratory cells. This means nothing genetically changed due to the CR laboratory technique, the researchers say. Investigators also demonstrated the malignant properties of tumor cells compared to the matched normal cells. These are all hallmarks of tumor development, Liu says. "Now we can compare what is different between the patient's normal and cancerous cells, and what changes when the cancer cells are allowed to morph into an advancing tumor," he says. "We will then use this technique to explore prostate tissues from other cancer patients. Comparisons between what happens within an individual patient's tissue, and then between patients, will give us priceless information about how we can best diagnose this baffling disease and treat it appropriately." Study co-authors include Olga A. Timofeeva, PhD, Nancy Palechor-Ceron, DMD, Hang Yuan, PhD, Ewa Krawczyk, PhD, Geeta Upadhyay, PhD, Aleksandra Dakic, PhD, Songtao Yu, MD, Shuang Fang, MD, Sujata Choudhury, PhD, Xueping Zhang, PhD, Yun-Ling Zheng, MD, PhD, Chris Albanese, PhD, Richard Schlegel, MD, PhD, Xiaogang Zhong, PhD, Andrew Ju, MD, and Anatoly Dritschilo, MD, from Georgetown University Medical Center; Guanglei Li, Geng Liu, and Yong Hou from Beijing Genome Research Institute, Shenzhen, Guangdong, China; Myeong-Seon Lee from Cheongju University, the Republic of Korea; Han C Dan, from the University of Maryland; and Youngmi Ji and Johng Rhim, MD, from the Uniformed Services University of the Health Sciences, Bethesda, Maryland. Georgetown University has pending patent applications in US and internationally for conditional cell reprogramming and has been awarded a US patent by the United States Patent Office (9,279,106). This technology has been licensed exclusively to a company for further development and commercialization. Georgetown University and the inventors (Liu and Schlegel) receive payments and potential royalties from Propagenix. Schlegel is also a co-founder in the company that has a license to this technology. This work was partially supported by grants from the National Institutes of Health (R33CA177466, R21CA180524, P30 CA051008, TL1-TR001431), the Department of Defense (PC140268 and W81XWH-13-1-0327), and with internal grant support from Center for Cell Reprogramming at GUMC. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


News Article | February 15, 2017
Site: www.eurekalert.org

WASHINGTON -- In the first successful randomized trial of its kind, researchers have provided preliminary evidence that telephone-based smoking cessation counseling given to smokers shortly after undergoing lung cancer screening can be effective at helping people stop smoking. "We found that at this teachable moment -- a time when smokers are thinking about their health and may be ready to make a change -- offering help makes a difference, and may help save lives," says the study's lead researcher, Kathryn L. Taylor, PhD, a behavioral scientist and a professor of oncology at Georgetown Lombardi Comprehensive Cancer Center. The study, led by researchers at Georgetown Lombardi, was conducted with 92 participants at three centers -- MedStar Georgetown University Hospital in Washington, DC, Hackensack University Medical Center in New Jersey, and Lahey Hospital and Medical Center in Massachusetts. "Millions of current smokers are now eligible for lung cancer screening, so this setting represents an important opportunity to exert a large public health impact on cessation among smokers who are at very high risk for multiple tobacco-related disorders," she says. "This is a great way to engage smokers who have not sought out cessation help." These study findings were so promising that investigators have been funded through NIH to conduct a much larger study of telephone-based cessation counseling. It will enroll 1,300 patients at five medical centers nationwide. Lung cancer screening recommendations issued in 2013 by the U.S. Preventive Services Task Force suggest that people who have smoked long enough to have accumulated a minimum of 30 pack-years (i.e., one pack per day for 30 years, or two packs per day for 15 years, etc.) should have an annual low-dose CT lung cancer screening test. The idea is to intervene early enough that disease spotted on the screening can be effectively treated. In the U.S., lung cancer is the leading cancer killer in both men and women -- almost 160,000 Americans were expected to die from lung cancer in 2016, according to the American Lung Association. Taylor points out that the NIH has said that effective smoking cessation programs should be a part of screening programs, and has funded several groups of researchers to develop effective strategies. In this preliminary study, 92 people about to undergo lung cancer screening agreed to receive either telephone counseling or standard of care (a list of free and low-cost cessation resources). Once participants received their screening results, they were randomized to one of the two groups, each with 46 participants. Each group had an equal number of participants with abnormal screening findings, indicating possible precancerous lesions or chronic obstructive pulmonary disease (COPD). Each group also contained an equal number of participants with minor abnormalities on their screen, as well as those with normal results. None of the participants were diagnosed with lung cancer. Participants in the telephone-counseling group were given their first session after finding out their screening results. Over the next three months, six 10-15 minute sessions were conducted. At the end of the study, a nicotine saliva test was given to participants who said they had quit in order to confirm their abstinence. Researchers found that eight (17 percent) people in the telephone counseling group had verifiably quit, compared to two (4 percent) in the other group. "If this preliminary study is replicated, telephone counseling has the potential to improve cessation in a setting that reaches a large number of hard-to-reach, long-term smokers who are at very high risk for multiple tobacco-related diseases," Taylor says. Charlotte Hagerman, who along with Taylor, offered the telephone counseling to participants, describes the counseling as "a motivational intervention. Everyone acknowledged that smoking is very harmful to their health, but some people thought it was too late to change their fate. Counseling helped them understand that it is not too late." Population-based studies have shown that older smokers who quit can have an increased life expectancy, Taylor says. Hagerman says there were also a number of participants who "were ready to quit, and were very excited to receive the help we were offering. I found this very gratifying, and felt that what we were doing was important and mattered to people," says Hagerman, who was trained as a tobacco treatment specialist for the study. "More than 50 percent of participants said in their first interview that they were not ready to quit, yet some of these people did quit. This finding indicates that it is important to offer the cessation intervention to everyone who undergoes lung cancer screening, and not only those who are already considering quitting. This is exactly what we hope for - to be able to reach the people who are not already planning to quit on their own," says Taylor. In addition to Taylor and Hagerman, co-authors from Georgetown University Medical Center include George Luta, PhD; Paula G. Bellini, MA; and Cassandra Stanton, PhD. David B. Abrams, PhD, and Ray Niaura, PhD, are Georgetown faculty and also affiliated with the Schroeder Institute for Tobacco Research and Policy Studies. Jenna A. Kramer, NP and Eric D. Anderson, MD are from MedStar Georgetown University Hospital in Washington, DC; Shawn Regis, PhD, Andrea McKee, MD, and Brady McKee, MD, are from Lahey Hospital and Medical Center, Burlington, MA; and Harry Harper, MD and Michael Ramsaier, BS are from Hackensack University Medical Center, Hackensack, NJ. The authors report having no personal financial interests related to the study. The study was supported by the Prevent Cancer Foundation and Georgetown Lombardi's NCI Cancer Center Support Grant P30 CA051008. Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute as a comprehensive cancer center -- the only cancer center of its kind in the Washington, DC area. A part of Georgetown University Medical Center and MedStar Georgetown University Hospital, Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer). Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).


News Article | February 19, 2017
Site: www.eurekalert.org

WASHINGTON (Feb. 19, 2017) -- Can statistics increase the value of science to society? Georgetown University's Rochelle Tractenberg, PhD, MPH, PhD, chair of the Committee on Professional Ethics of the American Statistical Association, will discuss "Promoting Ethical Science and Policy With Ethical Statistical Practice" on a panel presenting three disciplinary perspectives on Sunday, February 19, from 8:00 am to 9:30 am as part of a day long symposium titled Scientific Reproducibility and Social Responsibility at the AAAS 2017 Annual Meeting in Boston. A survey of more than 1,500 investigators, published in a 2016 issue of Nature, showed that more than 70 percent of researchers have tried and failed to reproduce other scientists' experiments, and more than half have failed to reproduce their own experiments. Additional studies have come to similar conclusions, says Tractenberg, associate professor of neurology at Georgetown University Medical Center with secondary appointments in biostatistics, bioinformatics and biomathematics, and rehabilitation medicine. "Irreproducible results do harm that can be difficult to discover and even more difficult to undo," she said. A consulting statistician and practicing scientist for the past 20 years, Tractenberg started pursuing her interest in promoting ethical research skills in 2009 after being invited to join a GUMC task force to explore these challenges. Tractenberg has worked with colleagues at GUMC and other institutions around the country to promote this brand of responsible research, and she'll have a larger stage later this month. Tractenberg will discuss responsible research, and its relevance for all statisticians, data analysts and data scientists, in a symposium she organized for the AAAS 2017 Annual Meeting. When most investigators have taken just a single course in statistics, and are therefore laymen when it comes to statistics - for typical experiments or if they wish to participate in big data analyses - it is perhaps not surprising that so many studies cannot be replicated, nor results reproduced, Tractenberg says. "My focus on promoting ethical statistical practice arose because a scientific credibility crisis is emerging due partly to scientists who do not conduct - or insist upon - appropriate statistical analysis or interpretation, or both," she says. "If ethical statistical practice becomes the norm across statistics and data science, it may then be taken up into other domains where data analysis makes important contributions." Several elements of a study can lead to irreproducible results, including incorrect analysis, improper interpretation of data, cherry picking results, or failing to transparently report the number of analyses that were done, Tractenberg says. Avoiding these are principles of ethical statistical practice as well as responsible conduct in research. "Although it can often seem that data analysis is secondary to the 'main' science or study purpose, the analytic method and its interpretation are essential attributes of both rigor and reproducibility, and this is true for their own work and for their peer review of others' work," says Tractenberg. A large number of these irreproducible studies may have never been published if peer reviewers that were unable to evaluate the statistics "just told the editor they don't feel qualified to evaluate the study's statistical argument, and that a formal statistical review is needed," she says. Having a formal statistical review does not guarantee reproducibility or rigor, but not having or insisting on one virtually guarantees the continuation of the reproducibility crisis. A faculty member at Georgetown since 2002, Tractenberg was appointed to the national Committee on Professional Ethics of the American Statistical Association (ASA) in 2013, a committee that she now chairs. In her 90-minute panel at the AAAS meeting, "How Ethical Science Supports Ethical Policy: Disciplinary Perspectives," she will discuss the ASA Ethical Guidelines for Statistical Practice, which all those who analyze data can utilize, whether dealing with "small" or "big" data. She says that ethical statistical practice - by every data analyst - is integral to maintaining the value of science in society. Tractenberg's panel will also bring together specialists in engineering and economics to describe their efforts to establish and promote ethical practices and policies within their disciplines. These three perspectives will then be discussed with respect to their potential to influence and support ethical policy and decision making. "All scientific fields have different relationships to data and how the data should be interpreted," Tractenberg says. "But the core of all in this work is the data and its analysis, and I firmly believe these must be dealt with ethically. Otherwise, decisions that are based on these results may be incorrect or indefensible, or both." "The data analyst, whether a professional statistician or just the group member who is most skilled with the analysis software, has an obligation to treat and interpret the data ethically," Tractenberg says. "In a post-truth world, this may be the best way to promote scientific integrity." Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook, Twitter @gumedcenter and Instagram (@gumedcenter.


Atkins M.B.,Georgetown Lombardi Comprehensive Cancer Center | Larkin J.,Royal Marsden Hospital
Journal of the National Cancer Institute | Year: 2016

The advent of newer immunotherapeutic and molecularly targeted agents has provided a number of effective options for cancer treatment but has also added much complexity in selecting the best initial treatment or treatment plan for each patient. Molecularly targeted agents offer selectivity and are the cornerstone for "precision medicine." While targeted agents are associated with high tumor response rates, patients inevitably develop resistance to these drugs. Immunotherapies exploit the endogenous immune system to eradicate cancer and can produce durable disease control that results in long-term, treatment-free survival in some patients. Guidelines for treatment selection in patients with specific tumor types and clinical features are routinely being reconsidered in order to accommodate the increasingly complex treatment landscapes. Here, we review current perspectives on the use of immunotherapeutic agents, particularly immune checkpoint inhibitors (nivolumab, pembrolizumab, and ipilimumab), in combination or in sequence with molecularly targeted agents in patients with advanced melanoma as well as other tumor types. We further discuss remaining unmet needs for patient selection and treatment with approved therapies. © 2016 The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.


News Article | November 4, 2016
Site: www.sciencedaily.com

Using prominent, graphic pictures on cigarette packs warning against smoking could avert more than 652,000 deaths, up to 92,000 low birth weight infants, up to 145,000 preterm births, and about 1,000 cases of sudden infant deaths in the U.S. over the next 50 years, say researchers from Georgetown Lombardi Comprehensive Cancer Center. Their study, published online Nov. 3 in the journal Tobacco Control, is the first to estimate the effects of pictorial warnings on cigarette packs on the health of both adults and infants in the U.S Although more than 70 nations have adopted or are considering adopting the World Health Organization's Framework Convention for Tobacco Control to use such front and back of-the-pack pictorial warnings -- an example is a Brazilian photo of a father with a tracheotomy -- they have not been implemented in the US. Pictorial warnings have been required by law, but an industry lawsuit stalled implementation of this requirement. Currently, a text-only warning appears on the side of cigarette packs in the U.S. The study used a tobacco control policy model, SimSmoke, developed by Georgetown Lombardi's David T. Levy, PhD, which looks at the effects of past smoking policies as well as future policies. SimSmoke is peer-reviewed, and has been used and validated in more than 20 countries. In this study, Levy and his colleagues, who included investigators at the University of Waterloo, Ontario, and the University of South Carolina, looked at changes in smoking rates in Australia, Canada and the United Kingdom, which have already implement prominent pictorial warning labels (PWLs). For example, eight years after PWLs were implemented in Canada, there was an estimated 12 percent -- 20 percent relative reduction in smoking prevalence. After PWLs began to be used in Australia in 2006, adult smoking prevalence fell from 21.3 percent in 2007 to 19 percent in 2008. After implementation in the UK in 2008, smoking prevalence fell 10 percent in the following year. The researchers used these and other studies and, employing the SimSmoke model, estimated that implementing PWLs in the U.S. would directly reduce smoking prevalence in relative terms by 5 percent in the near term, increasing to 10 percent over the long-term. If implemented in 2016, PWLs are estimated to reduce the number of smoking attributable deaths (heart disease, lung cancer and COPD) by an estimated 652,800 by 2065 and to prevent more than 46,600 cases of low-birth weights, 73,600 cases of preterm birth, and 1,000 SIDS deaths. "The bottom line is that requiring large pictorial warnings would help protect the public health of people in the United States," says Levy, a professor of oncology. "There is a direct association between these warnings and increased smoking cessation and reduced smoking initiation and prevalence. That would lead to significant reduction of death and morbidity, as well as medical cost." The study was funded by a grant from the National Institute on Drug Abuse (R01DA036497) and the National Cancer Institute (UO1-CA97450). Co-authors include Darren Mays, PhD, MPH, and Zhe Yuan, MS, both from Georgetown, David Hammond, PhD, from the University of Waterloo, and James F. Thrasher, PhD, MS, MA, from the University of South Carolina. Hammond has served as a paid expert witness on behalf of governments in tobacco litigation, including challenges to health warning regulations. The other co-authors report no potential conflicts or related financial interests.


Bhatt R.S.,Beth Israel Deaconess Medical Center | Atkins M.B.,Georgetown Lombardi Comprehensive Cancer Center
Clinical Cancer Research | Year: 2014

The vascular endothelial growth factor (VEGF) pathway is critical for tumor angiogenesis. However, VEGF pathway inhibition has been limited by intrinsic and acquired resistance. Simultaneously targeting multiple steps involved in tumor angiogenesis is a potential means of overcoming this resistance. Activin like kinase 1 (ALK1) and endoglin (ENG) have effects on angiogenesis that are distinct from those of VEGF. Whereas VEGF is important for vessel initiation, ALK1 and endoglin are involved in vessel network formation. Thus, ALK1 and endoglin pathway inhibitors are attractive partners for VEGF-based combination antiangiogenic therapy. Genetic evidence supports a role for this receptor family and its ligands, bone morphogenetic proteins (BMP) 9 and 10, in vascular development. Patients with genetic alterations in ALK1 or endoglin develop hereditary hemorrhagic telangiectasia, a disorder characterized by abnormal vessel development. There are several inhibitors of the ALK1 pathway advancing in clinical development for treatment of various tumor types, including renal cell and ovarian carcinomas. Targeting of alternate angiogenic pathways, particularly in combination with VEGF pathway blockade, holds the promise of optimally inhibiting angiogenically driven tumor progression. ©2014 AACR.


News Article | November 15, 2016
Site: www.prweb.com

The first evidence-based consensus statement on cancer immunotherapy for the treatment of patients with the most common type of kidney cancer, renal cell carcinoma (RCC), has been published today by the Society for Immunotherapy of Cancer (SITC) in the society’s open access Journal for ImmunoTherapy of Cancer (JITC). This manuscript, entitled “Society for Immunotherapy of Cancer Consensus Statement on Immunotherapy for the Treatment of Renal Cell Carcinoma,” provides expert recommendations and consensus opinion surrounding the use of interferon-α (IFN-α) and interleukin-2 (IL-2) in RCC. In addition, this manuscript includes information on the recent FDA approval of nivolumab and summarizes recent progress of biomarker development in RCC. “Not only does this guidance manuscript provide current consensus opinion on the use of IFN-α and IL-2 in renal cell carcinoma, but it also initiates discussion concerning predictive biomarkers and immune checkpoint inhibition,” said Michael Atkins, MD, Georgetown Lombardi Comprehensive Cancer Center and chair of the SITC Kidney Cancer Task Force. “In doing so, this statement lays the foundation for future updates as more immunotherapy agents become available to treat patients with kidney cancer.” This consensus statement is the second publication to come out of SITC’s Cancer Immunotherapy Guidelines initiative, which was expanded in 2014 to include genitourinary malignancies (kidney, prostate, and bladder cancer), each of which has a dedicated expert Task Force. Within this initiative, the Kidney Cancer Task Force consists of a multidisciplinary group of 20 RCC experts, including academic physicians as well as nurse, patient, and patient advocate representatives. As a result of this multidisciplinary collaboration, this guidance document covers key aspects of clinical management, including patient selection, toxicity management, clinical endpoints and sequencing of therapies. In addition, future directions such as ongoing clinical trials and agents in development are also provided. To generate these guidelines, the Task Force followed a rigorous, systematic process based on the 2011 Institute of Medicine’s (IOM) Standards for Developing Trustworthy Clinical Practice Guidelines. “Due to their broad clinical activity, and the rapid progress in cancer immunotherapy research, there are a growing number of cancer immunotherapies available to treat patients with a variety of malignancies,” said Howard L. Kaufman, MD, FACS, Immediate Past President of SITC who led the original SITC Task Force that developed the guidelines for melanoma. “In light of this exciting progress, SITC has developed Task Forces to address current knowledge gaps and generate a standard set of guiding recommendations for the clinical oncologist in each specific disease setting. The goal of these guidelines is to supplement current cancer treatment guidelines to provide more specific details on the unique aspects of immunotherapy and how best to manage patients electing treatment with immunotherapy. In particular, these guidelines provide consensus thinking for clinicians where data may be limited or even absent,” added Kaufman. As new FDA approvals or significant findings from clinical trials become available, the SITC Kidney Cancer Task Force will update the consensus statement to reflect recommended practice changes. To access the “Society for Immunotherapy of Cancer Consensus Statement on Immunotherapy for the Treatment of Renal Cell Carcinoma,” please visit: http://jitc.biomedcentral.com/articles/10.1186/s40425-016-0180-7 To learn more about the SITC Cancer Immunotherapy Guidelines, please visit: http://www.sitcancer.org/resources/cancer-immunotherapy-guidelines ABOUT SITC Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a non-profit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, healthcare professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. Learn more about SITC, our educational offerings and other resources at sitcancer.org and follow us on Twitter, LinkedIn, Facebook and YouTube. # # #


Philips G.K.,Georgetown University | Atkins M.,Georgetown Lombardi Comprehensive Cancer Center
International Immunology | Year: 2015

Despite extensive investigation over the past three decades, cancer immunotherapy has produced limited success, with few agents achieving approval by the Food and Drug Administration and even the most effective helping only a minority of patients, primarily with melanoma or renal cancer. In recent years, immune checkpoints that maintain physiologic self-tolerance have been implicated in the down-regulation of anti-tumor immunity. Efforts to restore latent anti-tumor immunity have focused on antibody-based interventions targeting CTL antigen 4 (CTLA-4) and programmed cell death protein 1 (PD-1) on T lymphocytes and its principal ligand (PD-L1) on tumor cells. Ipilimumab, an antibody targeting CTLA-4, appears to restore tumor immunity at the priming phase, whereas anti-PD-1/PD-L1 antibodies restore immune function in the tumor microenvironment. Although ipilimumab can produce durable long-term responses in patients with advanced melanoma, it is associated with significant immune-related toxicities. By contrast, antibodies targeting either PD-1 or PD-L1 have produced significant anti-tumor activity with considerably less toxicity. Activity was seen in patients with melanoma and renal cancer, as well as those with non-small-cell lung, bladder and head and neck cancers, tumors not previously felt to be sensitive to immunotherapy. The tolerability of PD-1-pathway blockers and their unique mechanism of action have made them ideal backbones for combination regimen development. Combination approaches involving cytotoxic chemotherapy, anti-angiogenic agents, alternative immune-checkpoint inhibitors, immunostimulatory cytokines and cancer vaccines are currently under clinical investigation. Current efforts focus on registration trials of single agents and combinations in various diseases and disease settings and identifying predictive biomarkers of response. © The Japanese Society for Immunology. 2014. All rights reserved.

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