Author Interviews, Gastrointestinal Disease, JAMA, Stem Cells / 16.12.2015
Stem Cell Therapy May Be Most Effective, and Most Toxic, Treatment For Crohn’s Disease
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Dr. Chris Hawkey[/caption]
MedicalResearch.com Interview with:
Dr. Chris J. Hawkey, DM, FRCP, FMedSci.
University of Nottingham and Nottingham University Hospital
England
Medical Research: What is the background for this study?
Dr. Hawkey: ASTIC (The Autologous Stem Cell Transplantation International Crohn's Disease) systematically investigated the effect of immunoablation and autologous haemopoietic stem cell transplantation (HSCT) on objective signs of disease, symptoms and need for treatment and is the only controlled trial to have done so. The body’s immune system normally protects us from infections but in Crohn’s disease it turns on itself. The treatment involves wiping out the body’s immune system (immunoablation) and replacing it with the patient’s own (autologous haemopoietic stem cell transplantation) innocent stem cells, a sort of immunological spring clean. Patients were randomly assigned to undergo transplantation (n=23) or just continue on best conventional treatment (n=22).
ASTIC was stimulated by reports which suggested that long-term regression of disease amounting to potential cure could be achieved. But the treatment is hazardous with major potentially lethal risks, so recruitment to the trial was cautious and only the most resistant cases were studied. And we used the most stringent criteria ever developed for the trial’s primary endpoint.
Medical Research: What are the main findings?
Dr. Hawkey: In fact the criteria we used for success were so stringent (no symptoms, no signs of disease on total bowel examination and no need for treatment) that few patients achieved them. Nevertheless, there were improvements in the individual measures underlying this composite endpoint. Objective signs of disease disappeared so that the gut looked normal from mouth to anus in about a quarter of actively treated patients vs no controls. Eight vs two patients were adjudicated free of active disease on endoscopy and radiology at final assessment (p=0.054). Patients were able to come off drug treatments: by the end of a year 61% of HSCT patients off immunosuppressive drugs for >3 months vs 23% of controls (p=0.012). Ten vs two patients had lost symptoms of active disease, eight vs two for of them for > 3 months (p=0.052).
But treatment was challenging: there were 76 serious adverse events in HSCT patients (particularly infections) vs 38 in controls. One HSCT patient died.
Dr. Chris Hawkey[/caption]
MedicalResearch.com Interview with:
Dr. Chris J. Hawkey, DM, FRCP, FMedSci.
University of Nottingham and Nottingham University Hospital
England
Medical Research: What is the background for this study?
Dr. Hawkey: ASTIC (The Autologous Stem Cell Transplantation International Crohn's Disease) systematically investigated the effect of immunoablation and autologous haemopoietic stem cell transplantation (HSCT) on objective signs of disease, symptoms and need for treatment and is the only controlled trial to have done so. The body’s immune system normally protects us from infections but in Crohn’s disease it turns on itself. The treatment involves wiping out the body’s immune system (immunoablation) and replacing it with the patient’s own (autologous haemopoietic stem cell transplantation) innocent stem cells, a sort of immunological spring clean. Patients were randomly assigned to undergo transplantation (n=23) or just continue on best conventional treatment (n=22).
ASTIC was stimulated by reports which suggested that long-term regression of disease amounting to potential cure could be achieved. But the treatment is hazardous with major potentially lethal risks, so recruitment to the trial was cautious and only the most resistant cases were studied. And we used the most stringent criteria ever developed for the trial’s primary endpoint.
Medical Research: What are the main findings?
Dr. Hawkey: In fact the criteria we used for success were so stringent (no symptoms, no signs of disease on total bowel examination and no need for treatment) that few patients achieved them. Nevertheless, there were improvements in the individual measures underlying this composite endpoint. Objective signs of disease disappeared so that the gut looked normal from mouth to anus in about a quarter of actively treated patients vs no controls. Eight vs two patients were adjudicated free of active disease on endoscopy and radiology at final assessment (p=0.054). Patients were able to come off drug treatments: by the end of a year 61% of HSCT patients off immunosuppressive drugs for >3 months vs 23% of controls (p=0.012). Ten vs two patients had lost symptoms of active disease, eight vs two for of them for > 3 months (p=0.052).
But treatment was challenging: there were 76 serious adverse events in HSCT patients (particularly infections) vs 38 in controls. One HSCT patient died.
Dr. Roger Stupp[/caption]
MedicalResearch.com Interview with:
Roger Stupp, MD
Professor & Chairman
Department of Oncology & Cancer Center
University of Zurich & University Hospital Zurich (USZ)
Zürich / Switzerland
Medical Research: What is the background for this study?
Dr. Stupp: Tumor Treating Fields are an entirely novel modality in cancer treatment. Over 10 years ago researchers demonstrated that alternating electrical fields will block cell growth, interfere with organelle assembly, in particular perturb the spindle apparatus and cell division, all leading to mitotic arrest and ultimately apoptosis. This was shown in vitro, but importantly also in vivo animal models including not only mice and rats, but also hamsters and rabbits with deep seated solid tumours. So the question was whether we can demonstrate such an effect also in the clinic.
Glioblastoma are locally invasive and aggressive tumours in the brain. They usually do not metastasise however they grow diffusely within the CNS and despite the best possible surgery, radiation and chemotherapy virtually always recur. We thus applied alternating electrical fields therapy, so called Tumor Treating Fields to the scalp of patients with newly diagnosed glioblastoma. After the end of standard chemoradiotherapy (TMZ/RT), patients were randomized to receive either standard maintenance TMZ-chemotherapy alone or in combination with TTFields. Almost 700 patients were randomized, here we report on a preplanned interim analysis looking at the first 315 patients included once they were followed for at least 18 months. The data on the first 315 patients are mature and allowed the IDMC to conclude that the trial should be stopped and the results made available.
Medical Research: What are the main findings?
Dr. Stupp: The study demonstrated a consistent prolongation of both progression-free and also of overall survival for patients who have been treated with TTFields in addition to standard therapy. The median progression-free survival and overall survival were prolonged by 3 months, translating to an absolute increase in overall survival at 2 years of 14%, from 29% to 43%. Or a hazard ratio of 0.74 for overall survival and of 0.62 for progression-free survival.
Dr. Meghan Jeffres[/caption]
MedicalResearch.com Interview with:
Meghan Jeffres, PharmD
Assistant Professor | Dept of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Science
University of Colorado Anschutz Medical Campus
Aurora, CO 80045
Medical Research: What is the background for this study? What are the main findings?
Dr. Jeffres: There are over 500,000 hospitalizations annually in the U.S. in which patients will have a reported allergy against first line antibiotics. Beta-lactams are the largest group of antibiotics which include penicillins, cephalosporins, and carbapenems. These antibiotics are the first line treatment against most serious bacterial infections; however, they are also the class of antibiotics to which patients are most commonly allergic. Patients labeled as allergic to one of these antibiotics are often prescribed second line antibiotics. Previous studies have shown that the use of second line antibiotics are more expensive, result in more adverse events, and longer hospital stays.
We theorized that patients labeled as penicillin, cephalosporin, or carbapenem allergic treated with non-beta-lactams would have higher rates of clinical failure, but lower rates of allergic reactions, than patients treated with beta-lactams. Analysis of the data revealed that patients treated with non-beta-lactams did indeed have higher rates of clinical failure. Unexpected findings of the study were the low number of new 
Dr. Camron Bryant[/caption]
MedicalResearch.com Interview with:
Camron D. Bryant, Ph.D.
Assistant Professor
Laboratory of Addiction Genetics
Department of Pharmacology and Experimental Therapeutics & Psychiatry
Boston University School of Medicine
Boston, MA 02118
Medical Research: What is the background for this study? What are the main findings?
Dr. Bryant: The addictions, including addiction to psychostimulants such as methamphetamine and cocaine, are heritable neuropsychiatric disorders. However, the genetic factors underlying these disorders are almost completely unknown. We used an unbiased, discovery-based genetic approach to fine map a novel candidate genetic factor influencing the acute stimulant response to methamphetamine in mice. We then directly validated the causal genetic factor using a gene editing approach. The gene - Hnrnph1 (heterogeneous nuclear ribonucleoprotein H1) - codes for an RNA binding protein that is involved in alternative splicing of hundreds of genes in the brain. Based on a genome-wide transcriptome analysis of differentially expressed genes within the striatum - a crucial brain region involved in the stimulant properties of amphetamines - we predict that Hnrnph1 is essential for proper neural development of the dopamine circuitry in the brain. These findings could have implications for understanding not only the addictions but also other neuropsychiatric disordersthat involve perturbations in the dopaminergic circuitry. (e.g., ADHD and schizophrenia) as well as neurodegenerative disorders such as Parkinson's disease.
Dr. Boolbol[/caption]
MedicalResearch.com Interview with:
Susan K. Boolbol, MD, FACS
Chief, Division of Breast Surgery
Chief, Appel-Venet Comprehensive Breast Service
Co-Director, Breast Surgery Fellowship
Mount Sinai Beth Israel
Associate Professor of Surgery
Icahn School of Medicine at Mount Sinai
New York, NY 10003
Medical Research: What is the background for this study? What are the main findings?
Dr.Boolbol: The background for this study is predicated on the USPSTF's recommendations that there is insufficient evidence to continue the use of screening mammography in women over the age of 75. According to the American College of Radiology, cancer detection rates via screening mammography should be at least 2.5 per 1000 mammograms at an institution, with reported rates as high as 4.7 cases per 1000. We reviewed 2057 screening mammograms in women aged 75 and older. We found 10 cases of breast cancer in this group. Of these cancers, 60% were
Dr. Alison Cooke[/caption]
MedicalResearch.com Interview with:
Dr Alison Cooke PhD, MRes, BMidwif (Hons), RM
Lecturer in Midwifery (Teaching and Research)
School of Nursing, Midwifery & Social Work
The University of Manchester
Oxford Road Manchester
Medical Research: What is the background for this study? What are the main findings?
Dr. Cooke: The use of topical oils for the management of newborn dry skin or for massage is a common practice across the globe. In the UK, olive oil and sunflower oil are commonly recommended by maternity service health professionals for baby dry skin, yet there is no evidence to support this practice. The OBSeRvE study was conducted to investigate the effect of these two oils on healthy term newborn baby skin barrier function. The study found that both oils impeded the development of the skin barrier function from birth.
Dr. Martin[/caption]
MedicalResearch.com Interview with:
Dr Anne Martin PhD
Research Associate/Research Fellow
Physical Activity for Health Research Centre (PAHRC)
Institute for Sport, PE & Health Sciences
University of Edinburgh
TeleScot Research Group
Usher Institute for Population Health Sciences and Informatics
Edinburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Martin: Impairments in cognitive development during childhood can have detrimental effects on health behaviour, educational attainment, and socio-economic status later in life. Epidemiological evidence indicates an association between childhood obesity and cognition and educational attainment. Knowledge of when obesity related deficits in cognition and attainment emerge, and how large the deficits are at various ages, may be useful to support arguments for school-based obesity prevention initiatives and in translating evidence on this topic into policy aimed at preventing obesity.
In this study we explored whether the adverse association between obesity and cognition emerges in early childhood. Measures of cognitive abilities included visuo-spatial skills, expressive language skills and reasoning skills. Our findings indicated that obesity in the pre-school years may be weakly associated with some poorer cognitive outcomes at age 5 years in boys, independently of socioeconomic status.
Stronger relationships between obesity and 
Dr. Meri Tulic[/caption]
MedicalResearch.com Interview with:
Meri K Tulic PhD
Université de Nice Sophia-Antipolis
Immune Tolerance
Nice, France
The International Inflammation 'in-FLAME' Network
Worldwide Universities Network
Medical Research: What is the background for this study? What are the main findings?
Dr. Tulic: We know that damaged epithelial gut barrier is a hallmark of gut inflammatory diseases including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). It has been long known that respiratory allergens such as house-dust mites (HDM) are the main causes of epithelial destruction in the lungs and initiation of allergic airway disease such as asthma. We set out to test whether house-dust mites may also be present in the human gut and may contribute to intestinal barrier dysfunction. In this paper, we have shown that house-dust mites is found in the gastrointestinal system of ~50% of all healthy subjects tested and it has detrimental effect on gut barrier function. The mechanisms include its direct destruction of tight-junction proteins which normally hold adjoining epithelial cells together, resulting in increased gut permeability. This process is driven by cysteine-proteases contained within the mite. In healthy individuals this effect is likely to be regulated by increased production of regulatory IL-10 (an anti-inflammatory mediator); our preliminary data indicate that a defect in regulatory responses may exist in IBS patients.
Dr. Javed Butler[/caption]
MedicalResearch.com Interview with:
Javed Butler MD MPH
Chief, Division of Cardiology
Stony Brook University
Health Sciences Center
SUNY at Stony Brook, NY
Medical Research: What is the background for this study? What are the main findings?
Dr. Butler: There is a lot of emphasis on reducing the risk of readmission after heart failure hospitalization. The main focus is on early readmissions as the risk for readmission is highest earlier post discharge. In this study, we described the fact that certainly there is some increased risk post discharge, the majority of the risk is actually dependent on the patient and disease characteristics at the time of discharge as opposed to true reduction in risk over time, which is partially related to differential attrition of high risk patients earlier post discharge.
Dr. Lee Ellis[/caption]
MedicalResearch.com Interview with:
Lee Ellis PhD
Department of Anthropology
University of Malaya
Kuala Lumpur Malaysia
Medical Research: What is the background for this study? What are the main findings?
Dr. Ellis: Sexual orientation appears to be highly influenced by prenatal neurohormonal factors (as opposed to social experiences throughout life). However, the specifics continue to elude scientific comprehension. Over the past two decades, researchers began to explore the possibility that a putative measure of prenatal testosterone exposure, called the 2D:4D finger length ratio, might be predictive of variations in sexual orientation. The results have been mixed. In the present study, colleagues and I obtained multiple measures of prenatal testosterone exposure (including a 2D:4D measure) from large samples of college students in two countries and factor analyzed these measures. Analyses revealed two apparent prenatal testosterone exposure variables, one largely pertaining to bone growth (that included our 2D:4D measure), and the other mainly pertaining to muscular growth and coordination. It was this second factor, not the first one, that appeared to be mainly responsible for variations in sexual orientation.
Dr. Vicente Salar[/caption]
MedicalResearch.com Interview with:
Néstor Vicente Salar, PhD.
Profesor Asociado UMH/ UMH Part-time Assistant Professor
Doctor en Biología
Diplomado en Nutrición Humana y Dietética (CV00195)
Miembro del GE-NuDAFD (AEDN)
Medical Research: What is the background for this study? What are the main findings?
Response: Nowadays, the practising of endurance sport is increasing, running being the sport chosen by many people who decide to start doing exercise. Distances and time are important factors to take in account in amateur as well as in professional runners. Among others, these factors are directly related to the risk of oxidative damage. In fact, oxidative stress has two faces: beneficial and deleterious. Helpful effects include the defence against infectious agents or the function as intracellular signaling molecules in many processes. On the other hand, high and persistent levels of oxidative stress can produce harmful effects if the antioxidant defences are overwhelmed, resulting in structural damage.
Antioxidants from diet, for example pomegranate juice, seem to control oxidative stress disorders. However, the studies about the role of pomegranate juice in oxidative stress modulation in athletes are scarce. We have demonstrated that the intake of this kind of juice during 22 days in endurance athletes is capable to modulate the structural damage in macromolecules as proteins and lipids.
Dr. Erik Alexander[/caption]
MedicalResearch.com Interview with:
Dr. Erik K. Alexander, MD FACP
Chief, Thyroid Section, Division of Endocrinology
Brigham & Women's Hospital
Associate Professor of Medicine, Harvard Medical School
Medical Research: What is the background for this study? What are the main findings?
Dr. Alexander: Thyroid nodular disease has become an increasingly common medical illness, with prevalence reported to range between 26-67% in the adult. Though advancing age is known to influence the formation of thyroid nodules, their precise relationship remains unclear. Furthermore, it is uncertain whether age influences the risk that any thyroid nodule may prove cancerous. Thus we conducted a study to determine the impact of patient age on nodule formation, the number of 
Dr. Eric Christensen[/caption]
MedicalResearch.com Interview with:
Dr. Eric W. Christensen, PhD
Health Economist
Children’s Hospitals and Clinics of Minnesota
Minneapolis, MN
Medical Research: What is the background for this study?
Dr. Christensen: National healthcare expenditures are up from 5.0% of gross domestic product in 1960 to 17.4% in 2013. We must find ways to control cost while maintaining quality. Accountable care organizations (ACOs) were designed to control a population’s health care cost while maintaining or improving quality. This study was an examination of one ACO exclusively covering a pediatric Medicaid population.
Medical Research: What are the main findings?
Dr. Christensen: We found that health care utilization and cost patterns were associated with the length of time patients were attributed to this 
Lindsey Torre[/caption]
MedicalResearch.com Interview with:
Lindsey Torre, MSPH
Epidemiologist, Surveillance Research
Surveillance Research group at the American Cancer Society
Medical Research: What is the background for this study? What are the main findings?
Response: This study updates a previous study published in 2010 using the latest available data on cancer incidence and mortality from cancer and vital registration around the world. We found that while high-income countries still have the highest cancer rates in the world, some low- and middle-income countries now also have elevated cancer rates. Also, mortality rates for common cancers such as lung, breast, and colorectum are declining in high-income countries, while they are increasing in low-income countries. At the same time, low-income countries still have a disproportionate burden of infection-related cancers, such as stomach, liver, and cervix.
Dr. Manali Patel[/caption]
MedicalResearch.com Interview with:
Manali Patel, MD, MPH
Instructor in the Division of Oncology
Department of Medicine
Stanford University School of Medicine
Researcher at the Clinical Excellence Research Center and the Primary Care and Outcomes Research Group at Stanford
Staff oncologist at the Veterans Administration and a researcher in the Palo Alto Veterans Administration Health Services & Research Development group.
Medical Research: What is the background for this study?
Dr. Patel: Racial and ethnic disparities in Acute Leukemia are well documented in the literature but the reasons underlying the disparities remain largely unknown. In our previous work, we demonstrated mortality disparities for minorities with Acute Myeloid Leukemia despite favorable prognostic demographic and molecular factors. We have also shown that differences in receipt of treatment may partially explain a large component of these disparities. The purpose of this study is to determine how socioeconomic status factors influence mortality from Acute Leukemia using a population-based novel linked dataset of the Surveillance Epidemiology and End Results Database and the National Longitudinal Mortality Study.
Medical Research: What are the main findings?
Dr. Patel: We found a total of 121 patients with Acute Lymphoid Leukemia and 438 patients with Acute Myeloid Leukemia in the linked dataset. After adjusting for socioeconomic status factors, there were increased risk of mortality among Hispanic and decreased risk of mortality among Asian Pacific Islander patients as compared with non-Hispanic white patients in Acute Lymphocytic Leukemia. Among patients with Acute Myeloid Leukemia, we found no associations of mortality by race/ethnicity and socioeconomic status.
Dr. Dusetzina[/caption]
MedicalResearch.com Interview with:
Dr. Stacie B. Dusetzina, PhD
Assistant professor in the Division of Pharmaceutical Outcomes and Policy
Eshelman School of Pharmacy
University of North Carolina
Medical Research: What is the background for this study? What are the main findings?
Dr. Dusetzina: As part of the Affordable Care Act the Medicare Part D “doughnut hole” is closing – reducing Medicare beneficiaries out-of-pocket expenses during this phase of coverage from 100% of drug costs to 25% between 2010 and 2020. In this study we analyzed 3,344 Medicare formularies that spell out how insurers cover prescription drugs. We found that in 2010, a typical course of oral chemotherapy drugs costs patients on average up to $8,100 per year. When the doughnut hole closes in 2020, patients will still have to pay on average $5,600 out of pocket per year, more than what the average Medicare beneficiary’s household spends on food each year. Even after the doughnut hold is closed oral chemotherapy drugs will still be out of reach for millions of Americans.
Dr. Chavez-MacGregor[/caption]
MedicalResearch.com Interview with:
Mariana Chavez Mac Gregor, MD, MSC
Assistant Professor
Breast Medical Oncology Department
Health Services Research Department
The University of Texas MD Anderson Cancer Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Chavez Mac Gregor: Adjuvant chemotherapy has proven to significantly decrease the risk of recurrence among breast cancer patients, however the optimal time to start adjuvant chemotherpay remains unknown. There are biological resasons to believe that a delay in the initiation of systemic therapy can be associated with adverse outcomes. In this large study we evaluated the impact of a delay in the initiation of time to chemotherapy (TTC). We analyzed data from 24,843 patients with invasive breast cancer (stages I to III) from the California Cancer Registry and observed that compared with patients who received chemotherapy within 31 days of surgery, no adverse outcomes were associated with time to chemotherapy of 31 to 90 days of surgery. However, there was a 34 % increase in the risk of death and a 27% increase in the risk of 
Dr. Zaccardi[/caption]
MedicalResearch.com Interview with:
Francesco Zaccardi, MD
Diabetes Research Centre
Leicester General Hospital,
Leicester, United Kingdom
Medical Research: What is the background for this study?
Dr. Zaccardi: Nowadays there are different classes of drugs for the treatment of hyperglycaemia in patients with type 2 diabetes and, within the same class, multiple drugs are available.Glucagon-like peptide-1 receptors (GLP-1RAs) are a relatively new class of treatments that improve glucose control and reduce body weight, without an increased risk for hypoglycaemia. To date, however, no direct comparisons between once-weekly GLP-1RAs have been reported. In this view, the aim was to assess the comparative efficacy and safety profile of GLP-1RAs using a network meta-analysis, a methodology that allows the estimation of the comparative effectiveness of multiple treatments in the absence of direct evidence.
Medical Research: What are the main findings?
Dr. Zaccardi: There are several differences in the efficacy and safety profiles of once-weekly glucagon-like peptide-1 receptor agonists (GLP-1RAs). Some of these drugs evidenced a better glucose control or body weight reduction, while other had an increased risk of side effects, such as nausea. Compared to other once-weekly GLP-1RAs, dulaglutide 1.5mg, once weekly exenatide, and taspoglutide 20mg showed a greater reduction of HbA1c, fasting plasma glucose, and body weight. Marginal or no differences were found for blood pressure and blood lipid levels. While taspoglutide 20mg had the highest risk of nausea, the risk of hypoglycaemia among once-weekly GLP-1RAs was comparable.
Dr. Ralph Caraballo[/caption]
MedicalResearch.com Interview with:
Ralph S. Caraballo, PhD MPH
Branch Chief, Epidemiology Branch
Office on Smoking and Health
National Center for Chronic Disease Prevention and Health Promotion
CDC Atlanta GA
Medical Research: What is the background for this study? What are the main findings?
Dr. Caraballo: Electronic nicotine delivery system (ENDS) use has increased rapidly in the U.S. in recent years. The availability and use of ENDS raise new issues for public health practice and tobacco regulation, as it is unknown whether patterns of ENDS use enhance, deter, or have no impact on combustible tobacco product use. This study assessed past-month, lifetime, and frequency of ENDS use among current, former, and never adult cigarette smokers.
In 2014, overall lifetime and past-month ENDS use was 14.1% and 4.8%, respectively. By smoking status, 49.5% of current, 14.7% of former, and 4.1% of never cigarette smokers had used ENDS in their lifetime, whereas 20.6% of current, 4.0% of former, and 0.8% of never smokers used ENDS in the past month. Among current and former cigarette smokers who ever used ENDS, 44.1% and 44.7% reported using ENDS >10 days in their lifetime, respectively.
Dr. Franco Radaelli[/caption]
MedicalResearch.com Interview with:
Dr Franco Radaelli
Division of Digestive Endoscopy and Gastroenterology
Valduce Hospital
Como, Italy
Medical Research: What is the background for this study?
Dr. Radaelli: Split regimens of bowel preparation are strongly recommended by European and American Guidelines as they have been associated with a higher level of colon cleansing. However, there is still uncertainty on whether the higher level of cleansing associated with a split regimen also results in a higher proportion of subjects with at least one adenoma (adenoma detection rate, ADR), that represents by far a more relevant quality indicator than the level of cleansing itself.
On this background, we designed a randomized investigator-blinded controlled trial to evaluate whether a “split regimen” of low-volume 2-L PEG-ascorbate solution was superior to the traditional “full dose, the day before regimen” in terms of ADR. Differently from other studies on bowel preparation, we considered adenoma detection rate instead of the level of colon cleansing, the primary study end-point, and we designed the sample size accordingly. A precise estimation of the sample size was facilitated by including an homogeneous population of asymptomatic subjects undergoing first colonoscopy after positive-FIT within CRC organized screening program. Besides, ADR represents a very solid end-point due to the very low inter-pathology variability in the differential diagnosis between neoplastic and non-neoplastic lesions, while the assessment of the level of cleansing is hampered by unavoidable degree of subjectivity and higher degree of inter-operator variability.
Dr. Shervin Assari[/caption]
MedicalResearch.com Interview with:
Shervin Assari, MD, MPH
Faculty, research investigator
Department of Psychiatry and
Center for Research on Ethnicity, Culture, and Health
University of Michigan School of Public Health
University of Michigan
Ann Arbor, MI
Medical Research: What is the background for this study? What are the main findings?
Dr. Assari: Literature has consistently shown that a single question that asks individuals to rate their health strongly predicts risk of mortality net of traditional risk factors. Our study shows that self rated health that very well predicts risk of death over a 25 year for Whites does not have any predictive value for Blacks. The results are important because Blacks have a worse self rated health and also shorter life expectancy in the United States, but those 2 health problems have weaker link among Blacks as Whites.
Dr. Ajay Bhatnagar[/caption]
MedicalResearch.com Interview with
Dr. Ajay Bhatnagar MD
Radiation Oncologist
Medical director of 21st Century Oncology of Arizona
MedicalResearch.com: What is the background for this report? What are the main findings?
Dr. Bhatnagar: I recently presented updated data regarding my research at the American Society for Radiation Oncology (ASTRO) annual meeting in a poster titled “Electronic brachytherapy for the treatment of Non-Melanoma Skin Cancer: Results up to 5 years.”
For this clinical study, I have been using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® which is FDA cleared, CE marked and licensed in Canada for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers, and nonmelanoma skin cancer (NMSC) including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
For the treatment of nonmelanoma skin cancer, the Xoft System uses a proprietary, miniaturized x-ray source to deliver a precise dose of targeted radiation directly to the surface lesion. This treatment uses electronic brachytherapy (eBx) to target cancerous cells while sparing healthy tissue. It is painless, non-invasive and offers a number of patient benefits, including fewer treatments than traditional radiation therapy.
According to my findings, the Xoft System is safe and effective for the treatment of nonmelanoma skin cancer, with low rates of recurrence and excellent clinical outcomes.
Dr. De Brito[/caption]
MedicalResearch.com Interview with:
Stephane De Brito, PhD
Birmingham Fellow
School of Psychology
Robert Aitken Building, Room 337a
University of Birmingham UK
Medical Research: What is the background for this study? What are the main findings?
Dr. De Brito: In the last decade, an increasing number of neuroimaging studies have used structural magnetic resonance imaging (sMRI) to examine the brains of youths who show behavioural problems that include antisocial and aggressive behaviour. Those studies have mostly relied on a method called voxel-based morphometry (or VBM), which is a whole-brain and automated technique that allows researchers to objectively assess the local composition of brain tissue, such as grey matter volume. The main problem is that the findings from those sMRI studies have been quite disparate and few have been replicated, partly due to differences in sample sizes and characteristics across studies. Therefore, we set out to carry out a meta-analysis of the available data to provide a clearer account of the literature on this topic. A particular strength of our meta-analysis is that we used the original brain imaging maps (also referred to as statistical parametric maps) from 11 of the 13 studies, which makes our analysis more accurate and reliable. The final sample comprised of 394 youths with behavioural problems and 350 typically developing youths, making it the largest study on this topic to date.
Our results showed that, compared to typically developing youths, those with behavioural problems show reduced grey matter volume in the amygdala, the insula, and the prefrontal cortex. These brain areas have been shown to be important for decision-making, empathic responses, processing facial expressions and emotion regulation; key cognitive and affective processes that are shown to be deficient in youths with behavioural problems.
Dr. Röllig[/caption]
MedicalResearch.com Interview with:
Dr. Christoph Röllig
Medizinische Klinik und Poliklinik I
Universitätsklinikum der Technischen Universitä
Dresden, Germany
Medical Research: What is the background for this study? What are the main findings?
Dr. Röllig: When this trial began in 2009, standard treatment for Acute Myelogenous Leukemia (AML) consisted of a combination of cytarabine plus anthracyclin/anthracendion and the need for improvement was obvious in the light of only around 50% long-term survivors even amongst younger patients. Although a promising approach, the use of kinase inhibitors in AML had not been shown to be beneficial and was not widely used. Sorafenib had been shown to be tolerable as single agent and in combination with commonly used chemotherapeutic agents. The results of the trial show that the addition of sorafenib to standard chemotherapy for newly diagnosed AML patients up to the age of 60 years is associated with significant prolongation of event-free survival and relapse-free survival compared to placebo plus standard chemotherapy. That means that patient who took sorafenib had less AML relapses.
To our knowledge, this is the first randomized-controlled showing that integrating a kinase inhibitor into standard intensive chemotherapy of younger patients with AML is associated with significant improvement of relapse-free survival, with no increase in treatment-related mortality. After a decade of evaluating the potential of kinase inhibitors in 
Dr. Diefenbach[/caption]
MedicalResearch.com Interview with:
Dr. Catherine S. M. Diefenbach MD
Assistant Professor of Medicine
NYU Langone
Laura and Isaac Perlmutter Cancer Center
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Diefenbach: The background of the study is that through an understanding of the unique immunobiology of Hodgkin lymphoma we can derive rational treatment strategies which may heighten the efficacy of existing therapies, and improve the outcomes for patients with relapsed disease. In E4412 which is a national study sponsored by the Eastern Cooperative Oncology Group (ECOG-ACRIN) we explore the safety and efficacy of combination of the antibody drug conjugate brentuximab vedotin which targets CD30 on the surface of the Hodgkin lymphoma tumor cells, and immune stimulation of the T cells in the tumor microenvironment using checkpoint inhibitors. We reported the data from the first arm of the study Brentuximab Vedotin and Ipilimumab. To date 23 patients with relapsed Hodgkin lymphoma have been treated; the combination of brentuximab and 
Dr. Weitzman[/caption]
MedicalResearch.com Interview with:
Michael L. Weitzman MD
Professor, Departments of Pediatrics and Environmental Medicine
NYU Langone Medical Center.
Medical Research: What is the background for this study? What are the main findings?
Dr. Weitzman: While the prevalence of cigarette smoking in the United States has recently seen a steady decline, more and more individuals report hookah (water pipe) usage. Researchers have shown that web queries for ‘hookah’ and ‘hookah bars’ have increased dramatically, but it is unclear whether this interest has led to an increase in the number of hookah bars in a given area. We first tested the website Yelp.com to see whether it could reliably provide us with information – such as the date of establishment of a hookah bar – by comparing the date of the first review written on Yelp.com with the actual opening date. We found that, for 2014 onwards, the first review posting on Yelp.com, on average, occurred within the first month of a hookah bar’s opening date. Additionally, we found a dramatic increase in the number of hookah bars in New York City over the past 5 years. These hookah bars tend to be not randomly distributed, but instead clustered near universities and specific ethnic neighborhoods.
Dr. Eileen Shinn[/caption]
MedicalResearch.com Interview with:
Dr. Eileen H. Shinn PhD
Assistant Professor, Department of Behavioral Science
Cancer Prevention and Population Sciences
MD Anderson Cancer Center
The University of Texas
Houston, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Shinn: Recent studies with leukemia, breast, lung, renal and liver cancer patients have shown that patients with depression have worsened survival. These effect sizes are small, but independent of any of the traditional factors that are known to impact survival, such as extent of cancer, types of treatment administered and baseline health and age of the patient. The current thinking is that cancer patients who are depressed have chronically heightened responses to stress; the constant release of stress hormones trigger changes in the tumor itself (such as noradrenergically-driven tumor angiogenesis) or may weakens the body’s immune function and ability to resist tumor growth.
When we measured depression in newly diagnosed patients with oropharyngeal cancer (cancer of the base of tongue and tonsil), we found that those patients who scored as depressed were 3.5 times more likely to have died within the five year period after their diagnosis, compared to nondepressed patients. We also found that patients who were depressed were also 3.8 times more likely to have their cancer recur within the first five years after diagnosis. We also found that patients who continued to smoke after diagnosis were more likely to recur within the first five years. These effect sizes were larger than those typically found in recent studies. We believe that the larger effect size may be due to the tight eligibility criteria ( e.g., we did not include patients who already had recurrent disease, we only included patients with one specific type of head and neck cancer, oropharyngeal) and also due to controlling other known factors (all patients completed individualized treatment regimens of radiation/ chemoradiation at a comprehensive cancer center and patients with more advanced disease stage were more likely to have received treatment intensification compared to patients with early stage disease). In all, we had 130 patients, one of the largest prospective studies with oropharyngeal cancer to examine the effect of depression on cancer outcome.
Dr. Chagpar[/caption]
MedicalResearch.com Interview with:
Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS
Associate Professor, Department of Surgery
Director, The Breast Center
Smilow Cancer Hospital at Yale-New Haven
Assistant Director -- Global Oncology
Yale Comprehensive Cancer Center
Yale University School of Medicine
Medical Research: What is the background for this study?
Dr. Chagpar: Up to 40% of women undergoing breast conserving surgery for breast cancer will have to return to the operating room due to positive margins (or cancer cells being found at the edge of what was removed at the initial surgery). We recently reported the results of a randomized controlled trial, published in the 
Dr. Elena Santagostino[/caption]
MedicalResearch.com Interview with:
Dr. Elena Santagostino, MD PhD
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center
Ca' Granda Foundation
Maggiore Hospital Policlinico, Milan, Italy
Medical Research: What is the background for this study? What are the main findings?
Dr. Santagostino: Two of our abstracts presented at the 57th ASH Annual Meeting are part of the PROLONG-9FP clinical program evaluating the efficacy and safety of CSL Behring’s investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). The first is an oral presentation on results from two Phase III studies and an ongoing extension study of rIX-FP for routine prophylaxis in previously-treated people with 
Dr. Zachary Kerr[/caption]
MedicalResearch.com Interview with:
Zachary Y. Kerr, PhD, MPH
Sports Injury Epidemiologist
Director, NCAA Injury Surveillance Program
Datalys Center for Sports Injury Research and Prevention
Indianapolis, IN 46202
Medical Research: What is the background for this study? What are the main findings?
Dr. Kerr: The NCAA Injury Surveillance Program has been ongoing since 1982, but the Datalys Center for Sports Injury Research and Prevention began management in 2009. We provide the NCAA sports and medical committees with evidence-based data they can use to make rule and policy decisions aimed at student-athlete health and safety. However, among the research community, there lacks current injury incidence data across the collegiate student-athlete population.
The main findings of this study is that the rate of injury was higher in competitions than in practices. However, the total number of