Author Interviews, COVID -19 Coronavirus, Pediatrics / 04.06.2020

MedicalResearch.com Interview with: Dr. Terrence Sanger MD Pediatric Neurology Vice president of Research and Chief Scientific Office CHOC Children's UC Irvine School of Medicine MedicalResearch.com: What is the background for this study? Response: During the current pandemic, publicly available data on the prevalence of COVID-19 infection among healthcare workers has been limited. This study sought to determine the COVID-19 viral prevalence in a population of healthcare workers within a pediatric emergency department in Orange County, Calif., during a time interval that overlapped with the state’s projected peak coronavirus-related use of hospital resources. (more…)
ASCO, Author Interviews, Cancer Research, Colon Cancer / 04.06.2020

MedicalResearch.com Interview with: Salvatore Siena, MD Director, Falck Division of Medical Oncology Department of Hematology and Oncology, and Niguarda Cancer Center Grande Ospedale Metropolitano Niguarda, Milano, I Full Professor of Medical Oncology, Department of Oncology and Hemato-Oncology Università degli Studi di Milano   MedicalResearch.com: What is the background for this study? Response: There remains a significant unmet clinical need in treating patients with HER2 positive advanced colorectal cancer (CRC) who progressed on previous therapies. Exploratory clinical studies in CRC with HER2-amplification documented that patients with tumors with this molecular characteristic may benefit from HER2-targeted therapies  (reviewed in Siena S et al Ann Oncol 2018). In particular, the phase 1 DS8201-A-J101 dose-expansion study of the cohort of patients with HER2 expressing non-breast/non-gastric or HER2 mutant solid tumors who received the 6.4 mg/kg dose of T-DXd, there were 20 patients with CRC. In this studythe experimental drug T-DXd (trastuzumab deruxtecan) showed clinical benefit and manageable safety profile.
  • Investigator-assessed ORR (Objective Response Rate) of 15.0% (95% CI, 3.2-37.9), DCR (Disease Control Rate) of 80.0% (95% CI, 56.3-94.3), and median PFS (Progression Free Survival) of 4.1 months (95% CI, 2.1-5.9) was reported
  • Common TEAEs (Treatment Emergent Adverse Events) include gastrointestinal (low grade) and hematological, which is consistent with overall T-DXd safety profile across various tumors
  • ILD (Interstitial Lung Disease) was reported in 2 patients (Tsurutani et al. 2020)
Given the unmet need in the treatment of patients with HER2 positive advanced CRC who progressed on previous therapies and the clinical observations from the phase 1 DS8201-A-J101 study (see previous paragraph) , the phase 2 DESTINY-CRC01 trial was conducted to evaluate the efficacy and safety of T-DXd in patients with HER2 expressing CRC who were previously treated with at least 2 lines of therapy.  (more…)
ASCO, AstraZeneca, Author Interviews, Breast Cancer, Cancer Research / 02.06.2020

MedicalResearch.com Interview with: Josefa Briceno, MD Medical Head, DDR/ADC Franchise AstraZenca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In January 2018, the US FDA expanded the approved use of LYNPARZA to treat patients with HER2- negative metastatic breast cancer with germline BRCA mutations based on positive results from the Phase III OlympiAD trial, which demonstrated the benefit of LYNPARZA over standard of care in physician’s choice chemotherapy in this patient population. LUCY is a Phase IIIb interim analysis aimed to evaluate the clinical effectiveness and safety of LYNPARZA in a real-world setting and has been expanded to include a group of patients with somatic BRCA mutations. A total of 252 patients with HER2-negative metastatic breast cancer with germline BRCA mutations were enrolled in the open-label, single-arm, Phase IIIb study. Patients received a taxane and/or anthracycline in the (neo)adjuvant/metastatic setting, and ≤2 lines of chemotherapy. The primary end point of the study was investigator-defined progression-free survival (PFS), and secondary end points included overall survival, time to first subsequent therapy or death, and investigator-assessed clinical response rate. The interim analysis was planned to take place after 160 progression-free survival events. Overall, treatment lasted for a median of 7.9 months, and the median progression-free survival was 8.1 months (95% confidence interval of 6.9-8.7; 166 progression-free survival events). In addition, the median time to first subsequent therapy or death was 9.7 months (95% confidence interval of 8.7-11.1) and the investigator-assessed clinical response rate was 48.6% (95% confidence interval of 42.2-55.0). Adverse events of all grades were reported in >20% of patients were nausea, anemia, asthenia, vomiting, and fatigue. Grade ≥3 adverse events were reported in 24.6% of patients, and 4.4% of patients had an adverse event that led to treatment discontinuation. (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Ovarian Cancer / 02.06.2020

MedicalResearch.com Interview with: Mark Sims US Franchise Head Women’s Cancer & DNA Damage Response AstraZeneca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: SOLO2 is a Phase III, randomized, double-blind, multicenter trial designed to determine the efficacy and safety of LYNPARZA tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. The trial met its primary endpoint in October 2016, showing maintenance treatment with LYNPARZA significantly improved progression-free survival to a median of 19.1 months vs 5.5 months with placebo (a hazard ratio of 0.30; a 95% confidence interval of 0.22 to 0.41; a p value of <0.0001). (more…)
Author Interviews, COVID -19 Coronavirus / 02.06.2020

MedicalResearch.com Interview with: Margaret A. Turk, MD Vice-Chairman, PM&R Distinguished Service Professor Departments of Physical Medicine & Rehabilitation, Pediatrics, Public Health & Preventive Medicine SUNY Upstate Medical University All authors contributed to these responses. (Margaret A. Turk MD, Scott D. Landes PhD, Margaret K. Formica PhD, Katherine D. Goss MPH) MedicalResearch.com: What is the background for this study? Response: Throughout this pandemic, there have been published reports related to vulnerable populations and severity of disease with COVID-19, however disability populations have not been studied. People with disabilities in fact report many of the risk factors for severe outcomes from this virus, usually at younger ages. One such population is people with intellectual and developmental disability (IDD), with estimates of  2.6 to 4 million people living in the US – and also with reported high prevalence of hypertension, diabetes, and pulmonary conditions. These comorbid health conditions are reported as common risk factors for severe outcomes with COVID-19, along with older age. (more…)
Author Interviews, CMAJ, Endocrinology, OBGYNE / 02.06.2020

MedicalResearch.com Interview with: Lois Donovan MD FRCPC Clinical Professor Cumming School of Medicine Division on Endocrinology and Metabolism and Department of Obstetrics and Gynecology University of Calgary MedicalResearch.com: What is the background for this study? 1) We observed in our clinical practices that minor TSH elevations in early pregnancy frequently normalized without intervention. 2) Recent randomized control trials have failed to show benefit of treating women with levothyroxine with minor TSH elevations in pregnancy  (more…)
Author Interviews, Nutrition, Weight Research / 01.06.2020

MedicalResearch.com Interview with: Zachary Zeigler PhD College of Science, Engineering, and Technology Grand Canyon University. Phoenix, AZ  MedicalResearch.com: What is the background for this study? Response: We already know that during the COVID-19 pandemic, children alter eating, sleep, and activity behaviors in a manner that promotes weight gain.  Additionally, the unprecedented self-quarantine mandate during the COVID-19 pandemic has led to widespread concern that adults may gain weight during the current pandemic. (more…)
Author Interviews, Cost of Health Care, Diabetes, JAMA, Pediatrics / 01.06.2020

MedicalResearch.com Interview with: Kao-Ping Chua, M.D., Ph.D. Assistant Professor, Pediatrics, Medical School Susan B. Meister Child Health Evaluation and Research Center University of Michigan MedicalResearch.com: What is the background for this study? Response: Due to high and rising prices, insulin has become increasingly unaffordable for patients with type 1 diabetes who must pay out-of-pocket for this life-saving medication. Over the past 5 months, many states and insurers have taken steps to cap insulin out-of-pocket spending. For example, Cigna imposed a $25 monthly cap earlier this year. This week, the Centers for Medicare and Medicare Services announced a $35 monthly cap for many Medicare Part D beneficiaries. (more…)
Author Interviews, Cost of Health Care, Diabetes / 01.06.2020

MedicalResearch.com Interview with: Amir Meiri, MD MPH Atrius Health/Department of Population Medicine (DPM) | Delivery System Science Fellow HMS and HPHCI, DPM | General Internal Medicine Fellow Atrius Health Kenmore | Urgent Care Physician VA Boston Healthcare | Attending in Internal Medicine and Emergency Medicine  MedicalResearch.com: What is the background for this study? Response: There has been significant media reporting about rising insulin prices and the health impacts of those exorbitant prices. However, it was not clear how these insulin prices may impact out-of-pocket costs among commercially insured patients; though it is clear that those without insurance are affected per previous media reports. Our study examines the difference between insulin manufacturer-set prices and what patients actually pay, the out-of-pocket cost, in the context of the type of insurance patients have. (more…)
Author Interviews, Dermatology, Genetic Research / 01.06.2020

MedicalResearch.com Interview with: Sarah E. Millar, Ph.D. Director, Black Family Stem Cell Institute Professor, Departments of Cell, Developmental and Regenerative Biology and Dermatology Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: One of the major roles of the skin is to serve as a protective barrier, both preventing external insults, such as toxins and pathogens, from entering the body, and helping to retain moisture. The mechanisms required for appropriate skin barrier formation remain incompletely understood. Elucidating these processes is important for understanding and developing improved treatments for dermatological diseases in which the skin barrier is dysfunctional, such as eczema and psoriasis. Understanding epigenetic regulators, proteins that modify the structure of genetic material, is an area of scientific interest, as many new drugs target these proteins. Importantly, multiple epigenetic regulators have been shown to be important in skin development. My lab has focused on one group of epigenetic regulators, histone deacetylases (HDACs), because HDAC inhibitors show promise for treating several different cancers and other disorders in which cell proliferation is poorly controlled. We previously showed that HDACs 1 and 2 are required for normal skin development. In the current study, we investigated whether the related protein HDAC3 is also important in establishing the skin barrier.  (more…)
ASCO, Author Interviews, Cancer Research / 30.05.2020

MedicalResearch.com Interview with: Cardinale Smith, MD, PhD Associate Professor Medicine, Hematology and Medical Oncology and Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York  MedicalResearch.com: What is the background for this study? Response: Cancer patients are often hospitalized with complications from cancer and cancer treatment. Physical decline is common among hospitalized cancer patients and contributes to poorer outcomes including increased length of stay, excess days, readmissions and patient experiences.  Therefore, increased activity and mobilization during hospitalization are essential to prevent functional decline. Whereas previous research has focused on risk factors that limit mobility and interventions for enhancing mobility in well-functioning, community dwelling older adults, there have been limited interventions on the mobility of hospitalized cancer patients. (more…)
ASCO, Author Interviews, Cancer Research, Electronic Records / 30.05.2020

MedicalResearch.com Interview with: Debra A. Patt, MD, PhD, MBA, FASCO Editor-in-chief of the Journal of Clinical Oncology - Clinical Cancer Informatics Medical oncologist at Texas Oncology, and US Oncology Research Breast Cancer Committee member MedicalResearch.com: What is the background for this study? Response: Cancer care is increasing in complexity with differentiation of cancer subtypes, new treatments, and treatment sequences and combinations.  Complying with evidence based therapy has become an increasing challenge.  We see that compliance with guideline based care across the country is highly variable. Our study evaluated an electronic health record based Clinical Decision Support System to facilitate compliance with evidence based guidelines--or pathways--to deliver care to adult patients with cancer. (more…)
Author Interviews, CDC, Dental Research / 30.05.2020

MedicalResearch.com Interview with: Marcia L. Parker, DMD Division of Oral Health National Center for Chronic Disease Prevention and Health Promotion CDC MedicalResearch.com: What is the background for this study? Response: This report reviewed three measures of tooth loss among adults over 50 years old with selected chronic conditions. The report analyzed data from the 2011–2016 cycles of the National Health and Nutrition Examination Survey (NHANES) to compare the rates of total tooth loss, severe tooth loss (less than 8 teeth), and lacking functional dentition (less than 20 teeth) among people with and without selected chronic conditions. (more…)
Author Interviews, Blood Clots, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 29.05.2020

MedicalResearch.com Interview with: Dr Tristan Morichau-Beauchant, MD. Intensive Care Unit Centre Cardiologique du Nord Saint-Denis, France MedicalResearch.com: What is the background for this study? Response: During the spread of the COVID-19 epidemic in France, early reports on severe patients stated a highly increased inflammatory response associated with procoagulant changes in coagulation pathways and high D-Dimer levels. Preliminary reports from the intensive care community signaled frequent events of deep vein thrombosis (DVT) among this population. We decided to perform prospectively a venous ultrasonogram of the inferior limbs for all patients with severe COVID-19 pneumonia at admission in our ICU.  All patients had acute respiratory distress syndrome according to the Berlin definition an required mechanical ventilation. Considering the high prevalence of venous thrombosis at admission we repeated a venous ultrasonography after 48 hours if the first exam was normal. All patients received standard anticoagulant prophylaxis since hospital admission. (more…)
ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA / 28.05.2020

MedicalResearch.com Interview with: Soumya Sen PhD McKnight Presidential Fellow Mary & Jim Lawrence Fellow of Carlson School Director of Research, MIS Research Center Associate Professor, Information & Decision Sciences Carlson School of Management University of Minnesota, Minneapolis, MN MedicalResearch.com: What is the background for this study? Response: As the Covid-19 pandemic unfolded across the United States, one of the greatest barriers to understanding the extent of the problem was the lack of reliable and consistent data. Some of the metrics being reported, such as case count and death, are insufficient for hospital capacity planning. Case count is a conservative estimate of the actual number of infected individuals in the absence of community-wide serologic testing, while death count is a lagging metric and insufficient for proactive hospital capacity planning. A more valuable metric for assessing the effects of public health interventions on the health care infrastructure is hospitalizations. Therefore, the Medical Industry Leadership Institute (MILI) and the Management Information Systems Research Center (MISRC) at the Carlson School of Management launched the COVID-19 hospitalization tracking project in March to consistently track and report daily hospitalizations from all reporting states. Tracking daily hospitalization data is a major step forward in quantifying the current impact on local hospital systems, modeling and  forecasting future utilization needs, and tracking the rate of change in the disease severity. It is also useful for understanding the role of health policy interventions in slowing or reducing the impact of the pandemic. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
Author Interviews, COVID -19 Coronavirus / 27.05.2020

MedicalResearch.com Interview with: Jianfeng Zhou MD, PhD Department of Hematology, Tongji Hospital Tongji Medical College Huazhong University of Science and Technolog Wuhan, Hubei, China MedicalResearch.com: What is the background for this study? Response:  There is accumulating evidence on the key pathophysiological role of cytokines during the severe stage of COVID-19. In the context of lack of vaccine and specific antiviral agents, testing of immunomodulatory agents to reduce excessive or uncontrolled inflammation before it results in irreversible multi-organ dysfunction infection has received increasing research attention. Although several important papers have proposed JAK inhibitors as potential therapeutic targets, the role of JAK inhibitors on COVID-19 patients needs to be clarified quickly, especially in severe COVID-19 patients. (more…)
Author Interviews, Nutrition, Pediatrics, Pediatrics, Weight Research / 26.05.2020

MedicalResearch.com Interview with: Megan H. Pesch, MD, MS, FAAP Assistant Professor C.S. Mott Children’s Hospital University of Michigan MedicalResearch.com: What is the background for this study? Response: Picky eating is common among children and is often both concerning to parents. Healthcare providers may reassure parents that their child will “outgrow” picky eating, however there have been few longitudinal studies examining the trajectories of picky eating in children, as well as associated trends in their growth. In our study we examined the trajectories of picky eating in US children over a 5 year period. We also examined how these picky eating trends were associated with child characteristics, weight status and mother’s feeding behaviors. (more…)
Annals Internal Medicine, Author Interviews, Colon Cancer / 26.05.2020

MedicalResearch.com Interview with: Dr. Nastazja Dagny Pilonis, MD Maria Sklodowska-Curie Memorial Cancer Center Institute of Oncology, Warsaw, Poland MedicalResearch.com: What is the background for this study? Response: Currently recommended 10-year interval between screening colonoscopies is based on the limited evidence. We decided to assess what is the risk of colorectal cancer and colorectal cancer death after singe negative screening colonoscopy. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity / 21.05.2020

MedicalResearch.com Interview with: Charles H. Hennekens, MD, DrPH Sir Richard Doll Professor Senior Academic Advisor FAU, Boca Raton, FL  MedicalResearch.com: What is the background for this study? Response: Blacks and other disadvantaged minorities in the United States have markedly reduced life expectancies compared with their white counterparts.  As is the case with most fatal diseases, coronavirus disease (COVID-19) is already taking a disproportionate toll on blacks and other disadvantaged minorities. (more…)
Author Interviews, OBGYNE, Pediatrics / 21.05.2020

MedicalResearch.com Interview with: Yanmin Zhu, M.S., Ph.D. Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Animal studies and case reports suggest a potential teratogenic effect associated with the use of high doses of fluconazole during pregnancy. The malformations reported in case reports have a distinct phenotype, including femoral bowing, thin ribs, cleft palate, and abnormal craniofacial ossification. A few controlled studies have examined the risk of congenital malformations associated with the use of fluconazole during the first trimester, but findings are inconsistent. (more…)
AHA Journals, Author Interviews, COVID -19 Coronavirus, NYU / 21.05.2020

MedicalResearch.com Interview with: Shadi Yaghi, MD Assistant Professor Department of Neurology at NYU Grossman School of Medicine Director, Clinical Vascular Neurology Research, NYU Langone Health Director, Vascular Neurology, NYU Langone Hospital-Brooklyn  MedicalResearch.com: What is the background for this study? Response: Our aim was to determine the characteristics of imaging proven ischemic stroke in the setting of COVID-19 infection and compare them to those of ischemic stroke but without COVID-19 infection. (more…)
Author Interviews, Cancer Research, Melanoma, Nature / 21.05.2020

MedicalResearch.com Interview with: Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute     MedicalResearch.com: What is the background for this study? Response: There are approximately 175 new cases a year for melanomas inside the eye called uveal melanomas. These cancers spread to other sites of the body in about half of patients. Uveal melanomas are very different to skin melanomas and so far no effective treatment have been approved to treat uveal melanoma once it has spread. We sequenced uveal melanoma tumours from over 100 different patients to look at what mutations are responsible for tumour growth and development.  (more…)
Author Interviews, Dermatology / 21.05.2020

MedicalResearch.com Interview with: Dr. Melanie D. Palm, MD, MBA Board-certified dermatologist and cosmetic surgeon San Diego, CA Clinical investigator in the Restylane Kysse phase 3 Galaderma trial Dr. Palm discusses the recent announcement that the FDA has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles)  in adults over the age of 21.   MedicalResearch.com: What is the background for this announcement?
    • Restylane® Kysse has been approved and used in Europe and Canada for several years. It is now the first FDA-approved hyaluronic acid (HA) lip filler in the U.S. formulated with XpresHAn Technology™ (pronounced ex-'spre-shan’) for smooth, natural-looking results.
    • It is FDA-approved for use not only in the lip but for improvement of upper lip lines.
    • Restylane Kysse is the third product (following Restylane Defyne and Restylane Refyne) in the Restylane family of fillers to use XpresHAn Technology™ which allows for a gel that integrates into the skin for natural expression in motion
(more…)
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 19.05.2020

MedicalResearch.com Interview with: Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As we know, in Covid-19 pneumonia, especially in its complication “acute respiratory distress syndrome (ARDS)”, a key role is played by the immune system. We know that when we treat a tumor with immunotherapy, it could give side effects because the stimulated immune system produces a series of substances to destroy the tumor. Sometimes, the immune system can also give side effects related to a hypersecretion of some cytokines, such as IL 6, the target of tocilizumab. This condition is called cytokine storm, or better, cytokine release syndrome (CRS).Oncologists use tocilizumab in the management of CRS that can occur following the use of bispecific antibodies, or recently, the use of CAR-T cell therapy, where such drug is approved for CRS treatment.  (more…)