Author Interviews, Gout, Rheumatology / 14.06.2020

MedicalResearch.com Interview with:https://www.horizontherapeutics.com/Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon TherapeuticsMedicalResearch.com: What is the background for this study? Response: Pegloticase is an infused biologic approved to treat uncontrolled gout. The drug is highly effective, but patients can develop anti-drug antibodies that may accelerate clearance of pegloticase from the circulation. Randomized clinical trials have shown that 42% of patients treated with bi-weekly pegloticase had a serum uric acid (sUA) below 6.0 mg/dl at 3 and 6 months. Mild-to-moderate immunomodulation has been shown to lower the prevalence of anti-drug antibody formation in patients with other autoimmune diseases (rheumatoid arthritis, Crohn’s disease, juvenile idiopathic arthritis). Case reports and case series in the literature suggest that low to-moderate doses of methotrexate or azathioprine may also decrease anti-drug antibody formation in uncontrolled gout patients treated with pegloticase.(more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Melanoma / 13.06.2020

MedicalResearch.com Interview with: Yuanbin Chen, MD, PhD Cancer & Hematology Centers of Western MichiganMedicalResearch.com: What is the background for this study? What are the main findings?
    • Response: The CASPIAN trial was a randomized, open-label, multi-center global Phase III trial in the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). The trial compared IMFINZI in combination with etoposide and either carboplatin or cisplatin chemotherapy, or IMFINZI and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone – the primary endpoint being overall survival (OS). After a median follow up of more than two years, the latest results for IMFINZI plus chemotherapy demonstrate a sustained and clinically meaningful OS benefit for patients with extensive-stage small cell lung cancer (ES-SCLC), maintaining a 25% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy.
      • In a post-hoc analysis, 22.2% of patients treated with IMFINZI plus chemotherapy remained alive after 24 months, versus 14.4%, for chemotherapy alone.
      • Post-hoc analysis also showed that for IMFINZI plus chemotherapy, 11.0% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy alone.
      • IMFINZI plus chemotherapy maintained a high confirmed objective response rate (ORR) (68% versus 58%) and in a post-hoc analysis, duration of response (DoR) for IMFINZI at 24 months was 13.5% versus 3.9% for chemotherapy alone.
      • At 24 months, 12% of patients in the IMFINZI plus chemotherapy arm remained on IMFINZI treatment.]
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ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale / 13.06.2020

MedicalResearch.com Interview with: Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
  • In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
  • DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
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ASCO, Author Interviews, Cancer Research / 12.06.2020

MedicalResearch.com Interview with: Alex Spira, MD, PhD, FACPMedical Oncologist Virginia Cancer Specialists and Chair of the US Oncology Research Executive CommitteeMedicalResearch.com: What is the background for this study? Would you explain what the conjugate consists of and what types of cancer it may target?What are the main findings?Response: The concept of the CX072 and CX2029 studies is that they use what’s called a probody molecule that gets broken down only at the tumor site. This is completely novel in that it helps diminish toxicity by not having less systemic absorption. In the case of CX2029, this target was previously undruggable, meaning the systemic toxicity was too high. By limiting it to activity at the tumor, that is significantly abated.(more…)
ASCO, Author Interviews, OBGYNE, Ovarian Cancer / 12.06.2020

MedicalResearch.com Interview with: Robert L. Coleman, MD, FACOG, FACSChief Scientific Officer US Oncology ResearchMedicalResearch.com: What is the background for this study? Response: For years, there has been general support for surgery in patients with recurrent ovarian cancer supported by reams of retrospective studies that suggest patients live longer if they have surgery preceding chemotherapy. Suggested hypotheses from these trials were that patients most likely to benefit from the procedure were those with good performance status (could tolerate the procedure), had long platinum-free interval (surrogate for potential for chemotherapy response) and those in whom all disease could be resected. Each of these are also characteristics that would portend a good prognostic cohort in general and would likely do better than other patients without these characteristics. So there was a strong selection bias in these retrospective surveys. Thus, the call for randomized trials.GOG-213 was launched in 2007 with 2 primary endpoints: 1. Determine the impact of adding bevacizumab to paclitaxel/carboplatin in patients with platinum-sensitive recurrent ovarian cancer, and 2. Determine if surgery increases overall survival.(more…)
Author Interviews, Dermatology / 12.06.2020

MedicalResearch.com Interview with: David Granville PhD, FAHA Professor, Pathology and Laboratory Medicine, UBC Associate Director, Vancouver Coastal Health Research Institute, VGH-UBC Associate Director, BC Professional Firefighters Burn & Wound Healing Group, Department of Surgery, UBC Principal Investigator, iCORD and UBC Centre for Heart Lung InnovationMedicalResearch.com: What is the background for this study? Response: Atopic dermatitis (aka. eczema) is a chronic inflammatory skin condition characterized by patches of dry, red, itchy skin. These patches can come and go - a process often referred to as 'flare ups'. Often when these flare ups occur, people avoid going out, or to work, resulting in lost productivity and reduced quality of life. While the cause of these flare-ups is not completely understood, a loss of the skin's protective barrier function is believed to be a triggering event. This is because the outer layer of skin (epidermis) acts as a barrier to allergens and other foreign entities from getting into the skin. When this outer barrier is lost, allergens are able to cross and penetrate the deeper layers of skin. This triggers an inflammatory response. The inflammatory response, in turn, can release factors that cause further disruption of the barrier thereby exacerbating the flare up.The outer skin barrier can be thought of in terms of a brick wall in which the 'bricks', or skin cells in this case, are held together by a molecular 'grout' known as adhesion proteins. If these adhesion proteins, which tightly anchor the skin cells together, are lost, the skin becomes more permeable to the outer environment, allowing foreign antigens to enter in, and conversely, moisture to escape out resulting in skin dryness and shedding (more…)
Author Interviews, Pediatrics / 12.06.2020

MedicalResearch.com Interview with: Dr Joanna Garstang Consultant Community Paediatrician / Designated Doctor for Child Death Allenscroft Children's Centre Kings Heath, Birmingham UKMedicalResearch.com: What is the background for this study? Response: Each year in England and Wales there around 3-400 babies die unexpectedly, in many cases the cause of death remains unexplained and these deaths are called Sudden Infant Death Syndrome (SIDS). Parents are understandably anxious about the risks for future children, the Care of Next Infant (CONI) programme was set up to offer support for families. In this study, we looked at records of families registered with CONI between 2000-2015 to determine the frequency and causes for repeat unexpected infant deaths.(more…)
Author Interviews, COVID -19 Coronavirus / 11.06.2020

MedicalResearch.com Interview with: Robin Gelburd President, FAIR HealthMedicalResearch.com: What is the background for this study? Response: As a result of the COVID-19 pandemic, healthcare professionals have been under prolonged stress, including the financial stress of widespread deferral of elective procedures. To investigate the pandemic’s impact on professionals’ utilization and revenue, FAIR Health analyzed data from its database of over 31 billion private healthcare claim records, the nation’s largest such repository, which is growing by over 2 billion claim records per year.(more…)
Author Interviews, COVID -19 Coronavirus, Weight Research / 11.06.2020

MedicalResearch.com Interview with: Sarah Messiah, PhD, MPH Professor of epidemiology, human genetics, and environmental sciences UTHealth School of Public Health DallasMedicalResearch.com: What is the background for this study? Response: Given that obesity is a prevalent, serious, complex, chronic, and relapsing disease, and severe obesity is a deepening crisis, it is important to pay special attention to these challenges during the COVID-19 pandemic. This will avoid placing an even greater burden on individuals, health systems, and society in the post-COVID-19 recovery phase. Thus, it is critically important to document, in real time, how socioecological determinants of health are impacting behaviors among those with obesity. Before our study, how the COVID-19 pandemic is impacting weight management, health behaviors, and psychosocial health in particular among people with obesity was unknown. (more…)
Author Interviews, Endocrinology, Thyroid Disease / 11.06.2020

MedicalResearch.com Interview with:https://www.horizontherapeutics.com/ Elizabeth H.Z. Thompson, Ph.D. Group vice president, Clinical Development and External Search Horizon Therapeutics MedicalResearch.com: What is the background for this study? Response: This study provides the first U.S.-based validation of the Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire. For your background, Graves’ Ophthalmopathy is another term used to describe Thyroid Eye Disease (TED). The GO-QOL questionnaire includes eight questions, each on visual functioning and appearance-related impacts of TED on patients. Though widely used and validated in Europe, the relevance of the questions for patients in the United States hasn’t previously been explored.For this evaluation, 13 eligible TED patients completed the questionnaire and then underwent a separate cognitive QOL-related interview. (more…)
Author Interviews, COVID -19 Coronavirus, Environmental Risks, JAMA / 11.06.2020

MedicalResearch.com Interview with: Mohammad Sajadi, MD Associate Professor Institute of Human Virology Global Virus Network Center of Excellence University of Maryland School of Medicine Baltimore, MD 21201MedicalResearch.com: What is the background for this study? Response: Because of geographical proximity and significant travel connections, epidemiological modeling of the epicenter predicted that regions in Southeast Asia, and specifically Bangkok would follow Wuhan, and China in the COVID-19 epidemic. When we saw this did not happen, we suspected that SARS-CoV-2 might be acting like a seasonal respiratory virus.(more…)
Author Interviews, JAMA, Pain Research / 11.06.2020

MedicalResearch.com Interview with: Tobias Kurth, MD, ScD (Pronouns: he/him) Professor of Public Health and Epidemiology Director, Institute of Public Health Charité – Universitätsmedizin BerlinMedicalResearch.com: What is the background for this study? Response: Migraine (with aura) has been associated with increased risk of cardiovascular disease but its absolute contribution in relation to other major vascular risk factors was not unclear. (more…)
AstraZeneca, Author Interviews, Rheumatology / 11.06.2020

MedicalResearch.com Interview with: Richard Alan Furie, MD Professor, Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases Feinstein Institutes for Medical Research Chief, Division of Rheumatology, Northwell Health Professor of Medicine, Donald and Barbara Zucker School of Medicine Hofstra/NorthwellMedicalResearch.com: What is the background for this study? Response: It has been known for decades that type I interferons play a role in SLE pathogenesis, and therefore the burning question has been whether inhibitors of these pro-inflammatory cytokines would reduce SLE disease activity and could be used as a therapeutic. There are several strategies for inhibiting the type I interferon pathway, but a conventional approach is to create an antibody against the target protein. The first few clinical trials in SLE evaluated monoclonal antibodies to alpha interferon. Results were modest at best. Since this approach only inhibited one (alpha) of five type I interferon subtypes, there were still four subtypes unaffected that could provoke inflammation. A rather crucial piece of information is that all five subtypes bind to the same receptor. Therefore, if the receptor is blocked as opposed to a single cytokine, the entire type I interferon family of proteins would be prevented from binding the receptor. This was accomplished with anifrolumab.The phase 2 study in SLE (known as MUSE), which yielded very robust results, was reported several years ago. It served as a foundation for the phase 3 program, which consisted of two pivotal studies known as TULIP-1 and TULIP-2. Both studies were reported at the 2019 American College of Rheumatology meeting in November, 2019. Although TULIP-1 did not achieve the primary endpoint, several secondary endpoints were met. TULIP-2 was successful. Between all three studies, approximately 1000 patients were enrolled. Taking advantage of these large numbers, additional analyses of the combined datasets afforded our ability to answer questions about the effects of anifrolumab that were not previously addressed with greater power.In the narrative that accompanied my presentation, I stated “In lupus, disease activity begets damage, and damage begets more damage. The long-term sequelae of heightened disease activity, better known as flare, are significant. Regardless of how flare is defined or measured, a major goal is to prevent flare.It is quite justified to think a drug that reduces lupus disease activity should also prevent flares. Well, the proof is in the pudding.In this analysis, we evaluated the effects of anifrolumab on flares. Recall that anifrolumab targets the type I interferon receptor, blocking all 5 type I subtypes. The phase 2 MUSE study yielded robust results as did the phase 3 TULIP-2 study. While, the phase 3 TULIP-1 study did not achieve its primary endpoint, many secondary endpoints showed benefit.In this study, we focused on flare, and examined TULIP-1 and 2 individually as well as pooled data from both studies.” (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 11.06.2020

MedicalResearch.com Interview with: Colm Travers, M.D., MSPH Assistant Professor Department of Pediatrics University of Alabama at BirminghamMedicalResearch.com: What is the background for this study? Response: It is known that black mothers are much more likely to deliver preterm and low birth weight infants. The purpose of this study was to determine whether racial/ethnic disparities in care practices and outcomes were decreasing or increasing among extremely preterm infants.These are infants born from 22 to 27 weeks of gestation who have a high risk of death and major illnesses.(more…)
Abuse and Neglect, COVID -19 Coronavirus, Infections / 10.06.2020

MedicalResearch.com Interview with: Edmond A. Hooker, MD, DrPH Professor, Department of Health Services Administration MHSA Associate Director for Accreditation Xavier University Cincinnati, OhioMedicalResearch.com: What is the background for this study? Response: Healthcare acquired infections are still a huge problem in the US. Most hospitals are not following the hospital bed manufacturers guidelines for cleaning these mattresses and bed decks (the metal bed frame). Many use only a single step, when the manufacturers recommend a 5-6 step process (pre-clean any obvious soil, clean, rinse off cleaner, disinfect, rinse off disinfectant, inspect mattress for damage). The problem is that, if done, this takes 45 minutes to 1 hours. Most hospitals turn over a hospital room in less than 30 minutes. The launderable bed cover allows the bed to be cleaned and turned over in minutes, not an hours.(more…)
Author Interviews, Clots - Coagulation, JAMA, Kidney Disease / 09.06.2020

MedicalResearch.com Interview with: Manish M Sood MD FRCPC MSc Jindal Research Chair for the Prevention of Kidney Disease Associate Professor of Medicine, Dept. of Medicine and the School of Epidemiology and Public Health University of Ottawa Scientist, Ottawa Hospital Research Institute Nephrologist, The Ottawa Hospital Ottawa, Ontario, CanadaMedicalResearch.com: What is the background for this study? Response: Early work has suggested a very commonly used antibiotic, clarithromycin, may interfere with the metabolism of the most widely used type of blood thinning medication (called direct oral anticoagulants or DOACs) such that the blood level of the DOAC increases and may place the patient at a higher risk for bleeding. In our study we looked at patients of advanced age (>66 years old) who were given clarithromycin while on a DOAC in Ontario, Canada. We compared patients on clairthromycin-DOAC to patients given a very similar antibiotic, azithromycin, that does not interfere with the metabolism of DOAC. (more…)
Allergies, Author Interviews, JAMA, OBGYNE / 05.06.2020

MedicalResearch.com Interview with: Niklas Andersson MS Department of Epidemiology Research Statens Serum Institut Copenhagen S, DenmarkMedicalResearch.com: What is the background for this study? What are the main findings? Response: Second-generation antihistamines are among the most commonly prescribed drug classes during pregnancy. Fexofenadine is a widely used antihistamine but given the limited fetal safety on the use of antihistamines during pregnancy in general, current clinical guidelines only recommend the use cetirizine and loratadine during pregnancy when needed due to a larger body of fetal safety data for these antihistamines. (more…)
Author Interviews, Endocrinology, Environmental Risks, JCEM, Menopause / 05.06.2020

MedicalResearch.com Interview with: Ning Ding MPH, PhD candidateSung Kyun Park Sc.D, MPH Associate ProfessorDepartment of Epidemiology University of Michigan School of Public Health Ann Arbor, MI 48109MedicalResearch.com: What is the background for this study? Response: Per- and polyfluoroalkyl substances (PFAS), also known as ‘forever chemicals’, are a family of synthetic chemicals used in a wide variety of nonstick and waterproof products and firefighting foams. The main issue is that PFAS are everywhere. It has been estimated that 110 million Americans, 1 out of three, may consume drinking water contaminated with PFAS. PFAS are very persistent and once PFAS enter the body, they don't break down and build up in the body over time.(more…)
Author Interviews, Infections, Pediatrics / 05.06.2020

MedicalResearch.com Interview with: Tracey Vlahovic DPM, FFPM, FCPS Clinical Professor, Department of Podiatric Medicine Stanley and Pearl Landau Faculty Fellow Adjunct Professor, Department of Microbiology, Temple University School of Medicine On Behalf of Ortho DermatologicsMedicalResearch.com: What is the background for this study? Response:JUBLIA® was first approved in 2014 for people 18 years of age and older. However, more and more children are being diagnosed with onychomycosis, so the goal of the study was to determine the safety and efficacy of Jublia in this patient population.(more…)
Author Interviews, JAMA, OBGYNE / 05.06.2020

MedicalResearch.com Interview with: Anjali Kaimal, MD, MAS, Maternal-Fetal Medicine Specialist Associate Professor in the Departments of Obstetrics Massachusetts General Hospital Miriam Kuppermann, PhD, MPH Professor Vice Chair Clinical and Translational Research Director Program for Clinical Perinatal UCSFMedicalResearch.com: What is the background for this study? What are the main findings?Response: Reducing the rate of cesarean delivery is an important public health goal. Nearly one third (31.9%) of deliveries in the US are via cesarean, and dramatic increases in the cesarean rate since the 1990s have been associated with substantial increases in maternal morbidity. One of the reasons for the increased rate of cesarean delivery is the decreasing rate at which women attempt to have a vaginal birth after cesarean (VBAC). Although having a “trial of labor” (in the hopes of giving birth vaginally) after cesarean is safe, and many women say they would prefer a vaginal delivery, most women who have had a previous cesarean plan a scheduled repeat cesarean delivery. While some hospitals do not offer trial of labor after cesarean, even at institutions where this is an option. VBAC rates remain low.We created a patient-facing “decision tool” that provides detailed information on both trial of labor and scheduled repeat cesarean, a personalized risk assessment of the likelihood that the a trial of labor would end in a VBAC, and a series of values clarification exercises, to help women think through their options and engaged in informed, shared decision making with their providers. We then conducted a randomized study in three geographic areas (San Francisco, Boston, and Chicago) to determine whether use of the decision tool affected rates of trial of labor and vaginal birth after cesarean, as well as several aspects of decision quality (knowledge, shared decision making, decisional conflict, and decision satisfaction). (more…)
Author Interviews, COVID -19 Coronavirus, Pediatrics / 04.06.2020

MedicalResearch.com Interview with: Dr. Terence Sanger MD Pediatric Neurology Vice president of Research and Chief Scientific Officer CHOC Children's UC Irvine School of MedicineMedicalResearch.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…)
Author Interviews, COVID -19 Coronavirus, Infections / 04.06.2020

MedicalResearch.com Interview with: Joseph Roth Graduate Student Dr. Roman Engel-Herbert PhD Assoc. Prof. of Materials Science & Engineering, Chemistry and Physics The Pennsylvania State University University Park, PA 16802MedicalResearch.com: What is the background for this study? Response: UV disinfection is currently a hot topic as there have been many studies on its effectiveness against COVID-19. Typically, this disinfection is done with expensive, mercury containing gas discharge lamps that have major downsides including high power requirements, short lifetimes, and bulky form factors.Ideally these disinfection devices would be replaced with high performance UV LEDs that are far more energy efficient, long lasting, and compact. Currently the development of these LEDs is limited by a lack of effective UV transparent electrode materials. The introduction of an effective UV transparent electrode will greatly expedite the process of making UV disinfection devices widely available.(more…)
ASCO, AstraZeneca, Author Interviews, Breast Cancer, Cancer Research / 02.06.2020

MedicalResearch.com Interview with: Josefa Briceno, MD Medical Head, DDR/ADC Franchise AstraZencaMedicalResearch.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 AstraZenecaMedicalResearch.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 LYNPARZAtablets 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 UniversityAll 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, COVID -19 Coronavirus, Lancet / 02.06.2020

MedicalResearch.com Interview with: Holger Schünemann, MD, PhD, FRCPC Professor of Clinical Epidemiology and of Medicine Co-Director, WHO Collaborating Centre for Infectious Diseases, Research Methods and Recommendations Director, Cochrane Canada and McMaster GRADE Centre Department of Health Research Methods, Evidence, and Impact CanadaMedicalResearch.com: What is the background for this study? Response: Many countries and regions have issued conflicting advice about physical distancing to reduce transmission of COVID-19, based on limited information. In addition, the questions of whether masks and eye coverings might reduce transmission of COVID-19 in the general population, and what the optimum use of masks in healthcare settings is, have been debated during the pandemic.(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 CalgaryMedicalResearch.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 PhDCollege of Science, Engineering, and Technology Grand Canyon University. Phoenix, AZMedicalResearch.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 MichiganMedicalResearch.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…)