AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
AACR, Author Interviews, Bayer, Cancer Research / 08.05.2020

MedicalResearch.com Interview with: David S Hong, M.D Department of Investigational Cancer Therapeutics Division of Cancer Medicine MD Anderson, University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. A variety of NTRK genes have been identified in various tumor types including fusions and non-fusions (e.g., amplifications, rearrangements, deletions, slice variants). In the analysis presented at AACR 2020, we sought to evaluate this pooled data to determine the efficacy of larotrectinib in patients with non-fusion alterations in NTRK genes.  (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, JAMA / 08.05.2020

MedicalResearch.com Interview with: Anurag K. Singh MD Professor of Oncology Director of Radiation Research Leader, Cell Stress and Biophysical Therapy Program Associate Dean Graduate Medical Education, Research Roswell Park Comprehensive Cancer Center Buffalo NY MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early stage breast cancer with high recurrence scores (RS) have RS of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guideline currently recommends either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear.   (more…)
Author Interviews, Colon Cancer, Gastrointestinal Disease, Infections / 08.05.2020

MedicalResearch.com Interview with: Ulrik Stenz Justesen, MD, DMSc Senior consultant at Department of Clinical Microbiology Odense University Hospital Denmark  MedicalResearch.com: What is the background for this study? Response: Anaerobic bacteria are bacteria that do not require oxygen for energy production, and live in various environments including the human gut, where they usually do not cause infections directly. Previous studies have reported an association between bacteria from the Bovis group streptococci, Clostridium septicum and colorectal cancer (CRC). Recently associations between different Bacteroides species., Fusobacterium nucleatum and CRC have also been reported. We aimed to investigate this further in a large-scale study.  (more…)
Author Interviews, Colon Cancer, Gastrointestinal Disease, Pancreatic / 17.04.2020

MedicalResearch.com Interview with: Dr Cristina Bosetti PhD Head of the Unit of Cancer Epidemiology Mario Negri Department of Oncology Milan Italy MedicalResearch.com: What is the background for this study? Response: Aspirin has been known since long time to have a beneficial effect in the primary and secondary prevention of cardiovascular diseases. Additional evidence indicates that it has also a favorable role on the risk of various cancers. (more…)
ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology / 10.04.2020

MedicalResearch.com Interview with: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Would you explain what is meant by switch maintenance immunotherapy? Response: For decades, platinum-based chemotherapy has been standard first-line treatment for metastatic urothelial (bladder) cancer. The standard approach to first-line chemotherapy is to administered approximately 6 cycles of treatment (in the absence of disease progression or prohibitive side effects), and then to stop treatment and monitor. Unfortunately, virtually all patients with metastatic disease will experience disease progression after stopping chemotherapy. However, we know that if we just continue the same platinum-based chemotherapy until progression of cancer (rather than stopping after ~6 cycles), the side effects continue to accumulate but the benefits plateau. Approximately 5 years ago, the first new systemic therapies were approved to treatment metastatic urothelial cancer in decades, immune checkpoint inhibitors (PD-1 or PD-L1 inhibitors). In fact, 5 PD-1/PD-L1 inhibitors have been approved by the FDA for the treatment of patients with metastatic urothelial cancer progressing despite prior platinum-based chemotherapy. Given that these drugs are non-cross resistant with chemotherapy in at least a subset of patients (i.e., they can provide benefit even when chemotherapy is no longer working), and because they are well tolerated by a large proportion of patients, a logical question is rather than waiting until cancer progresses after stopping first-line chemotherapy, what if we started immunotherapy immediately. Switch maintenance refers to switching from chemotherapy to a different class of drug (e.g., immunotherapy) and maintenance refers to trying to "maintain" the response achieved with initial chemotherapy. (more…)
Author Interviews, Bristol Myers Squibb, Cancer Research, Pharmaceutical Companies / 19.03.2020

MedicalResearch.com Interview with: https://www.cgen.com/ Anat Cohen-Dayag, Ph.D. President and CEO Compugen MedicalResearch.com: What is the background for this announcement? Would you discuss Compugen’s underlying cancer hypothesis regarding the targeting of multiple checkpoint pathways to enhance tumor response? Response: Cancer immunotherapy has revolutionized the landscape for cancer treatments by providing new drug options leading to lasting benefits for patients. Yet, response rates vary greatly across different cancer indications, leaving a significant unmet medical need for many patients and a continuing challenge to discover new biological pathways that can serve for the development of new cancer immunotherapies for non-responsive and refractory patients. Using a computational approach which is designed to discover new biological pathways and drug targets, we identified PVRIG as a novel immune checkpoint and a newly discovered inhibitory pathway in the DNAM axis. Our hypothesis is that PVRIG and TIGIT (another inhibitory pathway discovered by us and others) are two parallel and complementary inhibitory pathways in the DNAM axis and that in certain tumor types and patient populations, there may be a need to block both PVRIG and TIGIT in order to enhance anti-tumor immune responses. Moreover, reported molecular intersections between the DNAM axis and the PD-1 pathway, the most prevalent pathway targeted by approved immunotherapies, suggest that there is a linkage between these three pathways. As such, our PVRIG inhibitor may work in synergy with PD-1 and TIGIT inhibitors, suggesting that various drug combinations may be required to address these three pathways based on their dominance in different cancer patients and cancer indications. With this recently announced Phase 1/2 triple combination study, we will be directly testing our hypothesis of an intersection between the three parallel immune checkpoint pathways – PVRIG, TIGIT and PD-1 – and that the simultaneous blockade of these pathways has the potential to synergistically enhance anti-tumor immune response and expand the reach of cancer immunotherapy to patients non-responsive or refractory to approved immunotherapies.  (more…)
Author Interviews, Cancer Research, JAMA / 13.03.2020

MedicalResearch.com Interview with: Alyson Haslam, PhD Nutritional Epidemiologist Center for Indigenous Health Research and Policy Oklahoma State University MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor drugs for the treatment of cancers have received a lot of attention in recent years because of their ability to induce responses in certain tumors. To quantify the eligibility and response of these drugs in the US population, we published an article about a year ago (https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2732329). Since that publication, there were several confirmatory studies that failed to show a benefit in important outcomes such as overall survival or progression-free survival, and the US FDA made some revisions to certain checkpoint inhibitor drug labels. This prompted us to re-evaluate the eligibility of these drugs. (more…)
Author Interviews, Heart Disease, Omega-3 Fatty Acids / 03.03.2020

MedicalResearch.com Interview with: Lee Hooper PhD, RD Reader in Research Synthesis, Nutrition & Hydration Norwich Medical School Norwich, UK  MedicalResearch.com: What is the background for this study? Response: Polyunsaturated fats are common healthy eating choices, and fish oil (long-chain omega-3 including EPA and DHA) and flaxseed (containing alpha-linolenic acid, ALA, a plant-based omega-3) supplements are commonly consumed. Worldwide cardiovascular disease was responsible for 37% of premature deaths due to non-communicable disease in 2012, and cancers were responsible for 27%.  Small effects of omega-3 and polyunsaturated fats on cardiovascular diseases and cancers could have big effects on worldwide health. (more…)
AACR, Author Interviews, Cancer Research, Genetic Research, Yale / 27.02.2020

MedicalResearch.com Interview with: Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director, Breast Cancer Translational Research Co-Director, Yale Cancer Center Genetics and Genomics Program Yale Cancer Center Yale School of Medicine New Haven, CT 05620  MedicalResearch.com: What is the background for this study? Response: We analyzed breast cancer tissues obtained before any therapy and the same cancers after 20 weeks of chemotherapy. This setting is ideal to find out what genomic changes have occurred in cancers that survived therapy. Due to the paucity of such specimens few other studies exist in this space. (more…)
Author Interviews, Cancer Research, Dermatology, JAMA / 19.02.2020

MedicalResearch.com Interview with: Nikolai Dyrberg Loft MD, Ph.D.-fellow Department of Dermatology and Allergy Gentofte Hospital Hellerup MedicalResearch.com: What is the background for this study? Response: Epidemiological studies examining the association between psoriasis or psoriatic arthritis and cancer have reported conflicting results. Some studies report an increased risk of cancer in individuals with psoriasis or psoriatic arthritis and others do not. Whether individuals with psoriasis or psoriatic arthritis have an increased risk of cancer is important as this might help guiding in clinical practice. In order to determine if there is an increased risk of cancer and the magnitude of this risk, a systematic review of the literature and meta-analysis is needed.  (more…)
Author Interviews / 23.01.2020

MedicalResearch.com Interview with: Dr. Lindsay Sabik, Ph.D. Associate Professor Graduate School of Public Health Department of Health Policy and Management University of Pittsburgh  MedicalResearch.com: What is the background for this study? Response: In 2006, Massachusetts passed a health insurance reform law with the aim of providing health care access to nearly all of its residents. My colleagues and I pulled data from the Massachusetts Cancer Registry on all colorectal and breast cancer cases in people ages 50- to 64-years-old from 2001 through 2013. We selected those two cancers for our study because both are common, have routine screening guidelines and have high survival rates when caught early. The age range captured people covered by the recommended screening guidelines but not old enough to qualify for Medicare. We also pulled similar data from several other states for comparison. (more…)
Author Interviews, Cancer Research, Gender Differences, Genetic Research / 21.01.2020

MedicalResearch.com Interview with: Alejandro Cáceres PhD Juan R. González, PhD Barcelona Institute for Global Health (ISGlobal) Barcelona, Spain. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Men have more risk and worse prognosis to cancer than women. There are many environmental factors but also biological differences. We find that the loss of function of six genes (DDX3Y, EIF1AY, KDM5D, RPS4Y1, UTY and ZFY) in chromosome Y is one of the biological factors for the differences between sexes in relation to cancer risk and prognosis.  (more…)
Author Interviews, Breast Cancer, Cost of Health Care, JAMA, Race/Ethnic Diversity / 09.01.2020

MedicalResearch.com Interview with: Naomi Y Ko, MD Director, Inpatient Medical Operations Assistant Professor of Medicine, Department of Medicine Boston University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is to help understand the association between risk of more advanced cancer in racial minorities and insurance.   (more…)
Author Interviews, Cancer Research, Radiation Therapy, University of Pennsylvania / 09.01.2020

MedicalResearch.com Interview with: Keith A. Cengel, M.D., Ph.D. Associate Professor of Radiation Oncology Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: FLASH radiotherapy involves delivering the treatment dose at a rate that is 1000s of times faster than standard radiotherapy.  Scientists have studied the differential biological effects of various dose rates for dose rates for the past ~80 years, but the unique effects of FLASH dose rates have only been appreciated in the last few years. While the mechanism(s) and applications of FLASH radiotherapy remain an area of active investigation,  t is clear so far that FLASH dose rates can provide similar levels of tumor control with less toxicity to normal tissues when compared to the same dose of radiotherapy delivered at a standard dose rate. (more…)
AACR, Author Interviews, Cancer Research / 19.12.2019

MedicalResearch.com Interview with: Dr. Samir Parekh, MBBS Associate Professor Medicine, Hematology and Medical Oncology Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by 'neoantigens'? How might they be used to stimulate immunity in a multiple myeloma patients?  Response: Myeloma is considered a “cold” tumor for immunotherapy (as compared to some solid tumors such as melanoma) given the relatively fewer DNA mutations in an average myeloma patient. Our clinical experience suggests that this may not be totally correct.  Our findings focus on mutations that can become antigens (neo-antigens) and challenges the stereotype. We can create vaccines based on peptides resulting from these mutations to stimulate immune responses. (more…)
Author Interviews, Cancer Research, Genetic Research / 18.12.2019

MedicalResearch.com Interview with: Dr. Aaron Elliott, PhD CEO Ambry Genetics Dr. Elliott discusses The New York State Clinical Laboratory Evaluation Program (CLEP) approval of +RNAinsight™, a new genetic test for hereditary cancer risk.  MedicalResearch.com: What is the background for this announcement? What types of cancers can be genetically tested for predisposition? To whom should the testing be offered?  Response: The New York State Clinical Laboratory Evaluation Program (CLEP) has approved +RNAinsight™, which enables clinicians – for the first time ever – to conduct both DNA and RNA genetic testing at the same time. This is the first genetic testing advancement in over a decade to significantly increase the diagnostic yield (meaning the number of patients identified with a specific hereditary risk for cancer) in genes like BRCA1 and BRCA2. With +RNAinsight, Ambry is the first and only lab to offer this paired RNA and DNA genetic testing. Genetics may contribute to individuals’ risk of developing a number of cancers, including breast, ovarian, prostate, colorectal, and others. Approximately five to 10 percent of cancer cases are hereditary, according to the National Cancer Institute. The National Society of Genetic Counselors (NSGC) guidelines indicate who should receive genetic testing to learn whether they have increased risks to develop hereditary cancer. For example, someone with close family members who developed cancer at young ages may be a good candidate. (more…)
Author Interviews, Cancer Research, Genetic Research, Pharmaceutical Companies / 26.11.2019

MedicalResearch.com Interview with: Ambry GeneticsRachid Karam, MD PhD Director, Ambry Translational Genomics Lab Ambry Genetics MedicalResearch.com: What is the background for this study? Response: Standard DNA testing for hereditary cancer risk excludes large portions of DNA, thereby missing some mutations. In addition, DNA testing can produce inconclusive results and fail to determine that an error in our DNA increases cancer risk. These limitations impact patients and their families because doctors may not have the information needed to recommend appropriate preventive, early detection, or therapeutic steps. Additionally, relatives may not be referred for genetic testing and obtain the care they would otherwise have gotten if they had learned they had mutations. The study looked at how the addition of RNA genetic testing to standard DNA testing for hereditary cancer risk was able to increase diagnostic yield. The study looked at the first 2,500 patients that received Ambry Genetics +RNAinsight™, paired RNA and DNA genetic testing for hereditary cancer risk. The data from this study showed that the addition of RNA genetic testing to DNA testing (1) identified new mutations that would have been missed with DNA testing alone, and (2) clarified inconclusive results as disease-causing. (more…)
Author Interviews, Cancer Research, HPV / 20.11.2019

MedicalResearch.com Interview with: Ashish Deshmukh, PhD, MPH Assistant Professor UTHealth School of Public Health Houston MedicalResearch.com: What is the background for this study? Response: Anal cancer is one of the six human papillomavirus associated cancers.  Rates of anal cancer are increasing in the US, but no prior study quantified the contemporary trends (i.e., increase in rates over time) in anal cancer incidence. It was unknown whether the rise is real or driven by increased screening in some high-risk populations. Incidence trends according to age and stage at diagnosis was also never comprehensively studied. Furthermore, it was unknown whether the rise in incidence has led to a rise in mortality. Our objective was to answer these questions. (more…)
Allergies, Author Interviews, Cancer Research, Pediatrics / 13.11.2019

MedicalResearch.com Interview with: Sairaman Nagarajan, MD Clinical Fellow at State University New York (SUNY) Downstate Medical Center College of Medicine MedicalResearch.com: What is the background for this study? Response: The impetus for this study came from our previous research linking asthma, hay-fever and overall cancer diagnoses using the CDC’s National Health Interview Survey database. The division of Allergy and Immunology at SUNY Downstate has also conducted two pilot studies on the relationship between parental cancer and childhood asthma in Brooklyn’s population; one from Lutheran Medical Center focusing on Hispanics and Asian patients, and the other on African-American and Afro-Caribbean patients. (more…)
Author Interviews, Cancer Research / 03.10.2019

Dr. Dario Altieri in his lab with Dr. Ekta Agarwal conducting an experimentMedicalResearch.com Interview with: Ekta Agarwal, Ph.D. Postdoctoral fellow in the lab of Dario Altieri, M.D. Wistar president and CEO ,Director of the Institute’s Cancer Center Robert & Penny Fox Distinguished Professor and co-first author on the study. MedicalResearch.com: What is the background for this study?   Response: Mitochondrial reprogramming is one of the hallmarks of cancer cell growth and metastasis. There are several studies correlating mitochondrial dynamics to increased cancer cell motility and invasion. However, therapies that can target molecular markers associated with mitochondrial functions and integrity are still obscure. Thus, it is crucial to identify novel targets and pathways that regulate mitochondrial functions in cancer. This study reveals one such mitochondrial molecular pathway which might serve as an actionable anti-cancer therapy. (more…)
Author Interviews, BMJ, Cancer Research, Infections / 13.09.2019

MedicalResearch.com Interview with: Prof. Kai-feng Pan Director. Department of Cancer Epidemiology Peking University School of Oncology Beijing Cancer Hospital & Institute Peking University Cancer Hospital  MedicalResearch.com: What is the background for this study? Response: Based on a high-risk population in China, we have conducted a large randomized factorial-designed intervention trial (Shandong Intervention Trial) to examine the effect of short-term Helicobacter pylori (H. pylori) treatment and 7.3-year vitamin and garlic supplementation on gastric cancer. During 14.7-years’ follow-up in the trial, 2-week treatment for H. pylori resulted in statistically significant reduction in gastric cancer incidence. Results for gastric cancer mortality and for the effects of garlic and vitamin supplementation, though promising, were not statistically significant. Longer follow-up was needed to determine whether the reductions in gastric cancer incidence from H. pylori treatment would persist and lead to a demonstrable reduction in gastric cancer mortality. It also remained unknown whether vitamin and garlic supplementation would yield a statistically significant reduction in gastric cancer incidence and mortality with additionally extended follow-up. In addition, the entire spectrum of effects of these interventions needs to be understood.  (more…)
Author Interviews, Breast Cancer, JAMA, USPSTF / 12.09.2019

MedicalResearch.com Interview with: Dr. Carol Mangione, M.D., M.S.P.H., F.A.C.P. Division Chief of General Internal Medicine and Health Services Research Professor of Medicine Barbara A. Levey, MD, and Gerald S. Levey, MD, endowed chair in Medicine David Geffen School of Medicine University of California Los Angeles Professor of public health at the UCLA Fielding School of Public Health.  MedicalResearch.com: What is the background for this study? Response: We all want to find better ways to help prevent breast cancer, a disease that impacts the lives of too many women in the United States each year. Fortunately, the Task Force found there are steps that women at increased risk can take to reduce their chances of developing breast cancer. (more…)
Author Interviews, Cancer Research, JAMA, MRI, Prostate Cancer, UCLA / 12.09.2019

MedicalResearch.com Interview with: Rajiv Jayadevan, MD and  Leonard S. Marks, MD Department of Urology UCLA MedicalResearch.com: What is the background for this study? Response: Men with low risk prostate cancer often enter “active surveillance” programs. These programs allow patients to defer definitive treatment (and avoid their associated side effects) until more aggressive disease is detected, if at all. Patients typically undergo a “confirmatory biopsy” 6 to 12 months after diagnosis to verify that their disease is low risk, and then undergo repeat biopsies every 1 to 2 years. These biopsies have traditionally been performed under the guidance of transrectal ultrasonography. Transrectal ultrasonography is unable to accurately visualize tumors within the prostate, necessitating that biopsy cores be obtained systematically from all parts of the prostate. MRI-ultrasonography fusion biopsy is a newer technology that has been shown to characterize biopsy findings more accurately than transrectal ultrasonography, leading to improved disease detection. This technology also allows us to visualize tumors within the prostate, and directly target these tumors during a biopsy session. (more…)
Author Interviews, Biomarkers, JAMA, Pediatrics / 09.09.2019

MedicalResearch.com Interview with: Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY MedicalResearch.com: What is the background for this study? Response: There has been recent interest in understanding how exposures in childhood and adolescence relate to later-life health outcomes. Although inflammation is thought to play a role in the etiology of various diseases, little is known about the long-term implications of inflammation in early life. We therefore sought to evaluate how erythrocyte sedimentation rate (ESR), a marker of inflammation, measured among ostensibly healthy men in late adolescence, relates to subsequent cause-specific mortality. We found that men with high inflammation in late adolescence experienced increased mortality due to cancer and cardiovascular disease. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Chemotherapy / 04.09.2019

MedicalResearch.com Interview with: Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Cancer drugs are prescribed to the patients based on results from trials. Usually, these are superiority trials meaning the cancer drugs prove that they are better than the treatment we already have. Recently, more and more cancer drugs are approved on the basis of non-inferiority trials. In these trials, the cancer drugs only prove that they are not worse than the treatment we already have ( instead of proving they are better). Such an approach is considered justified if the new drug provides any other benefit such as lower cost, easy to administer or improved quality of life. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Imperial College / 20.08.2019

MedicalResearch.com Interview with: Georgios Giamas, (Dr. Biol. Hum.) Professor of Cancer Cell Signalling Director of Research and Knowledge Exchange University of Sussex -School of Life Sciences Visiting Professor, Imperial College, London MedicalResearch.com: What is the background for this study? Response: This study focuses on Glioblastoma (GBM), which is one of the most aggressive solid tumours for which treatment options and biomarkers are limited. MedicalResearch.com: What are the main findings? - Glioblastoma cells produce nanosized vesicles (aka: extracellular vesicles) that contain specific protein signatures, which can indicate the behaviour and phenotype of the respective cells of origin. -We have identified and described certain vesicle-associated biomarkers that correspond to the most aggressive brain cancers. -Our results can provide insights for the development of new diagnostic and therapeutic methods as well as personalized treatment strategies (more…)
Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019

MedicalResearch.com Interview with: Dr. Graca Dores MD MPH US Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Epidemiology Silver Spring, Maryland Oklahoma City, OK MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for?  Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses. Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database. (more…)
Author Interviews, JAMA, Mayo Clinic, Pancreatic, USPSTF / 14.08.2019

MedicalResearch.com Interview with: Dr. Chyke A. Doubeni, M.D., M.P.H. Dr. Doubeni is a family physician and The inaugural director of the Mayo Clinic Center for Health Equity and Community Engagement Research MedicalResearch.com: What is the background for this study? Response: The U.S. Preventive Services Task Force uses systematic review of existing research to make recommendations on clinical preventive services that are delivered in primary care, with the goal to promote and improve health for all Americans. Although pancreatic cancer is an uncommon condition in the general population, it is often deadly. Pancreatic cancer is now the third most common cause of cancer death in the United States, and could become the second leading cause if current trends continue. The vast majority of people with pancreatic cancer are diagnosed at a late stage and, unfortunately, even when caught early enough when surgery could be most effective, only a little over one-third of patients survive beyond five years. (more…)
Author Interviews, Cancer Research, Coffee / 21.07.2019

MedicalResearch.com Interview with: coffee-smell caffeineMr Jue Sheng Ong,  PhD Student  QIMR Berghofer’s Statistical Genetics Group MedicalResearch.com: What is the background for this study? Response: Previous findings have shown conflicting results on whether coffee is associated with cancer risk. To evaluate whether there’s any evidence for a causal relationship between coffee and cancer outcomes, we performed two types of association analyses using data from the half a million participants in the UK.
  • We first studied whether an individual’s self-reported coffee consumption is related to their overall risk of developing or dying from any cancers.
  • Then, we repeated the analyses using genetically predicted coffee intake (using about 35 genetic markers related with coffee intake) instead of their self-reported consumption: a technique known as mendelian randomization which is commonly used in modern epidemiology to remove bias from environmental confounders.
Using both techniques, we found no evidence to support a relationship between coffee consumption and the risk of developing or dying from cancers. (more…)