AACR, Author Interviews, Biomarkers, MD Anderson / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47785" align="alignleft" width="200"]Vassiliki Papadimitrakopoulou, MDProfessor of MedicineDepartment of Thoracic/Head and Neck Medical OncologyMD Anderson Cancer Center in Houston Dr. Papadimitrakopoulou[/caption] Vassiliki Papadimitrakopoulou, MD Professor of Medicine Department of Thoracic/Head and Neck Medical Oncology MD Anderson Cancer Center in Houston MedicalResearch.com: What is the background for this study? What are the main findings? Response: 30% of patients with newly diagnosed advanced NSCLC can be treated successfully with targeted therapies, often yielding higher response rates than chemotherapy or immune checkpoint inhibitors. Selecting first-line therapy for patients with NSCLC requires assessment of an expanding list of guideline-recommended genomic biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET amplification and exon 14 skipping, and ERBB2, with NTRK newly added) Standard-of-care (SOC) testing relies on tissue, which is limited by biopsy-related risks, specimen insufficiency, and lab processing duration, which hamper timely optimal treatment selection -          NILE is a large, prospective, multicenter, head-to-head study of SOC tissue-based genomic testing to plasma-based comprehensive cfDNA genomic testing (Guardant360®). For the four biomarkers with FDA approved therapies, up to 34% of patients were tested by SOC tissue testing versus 95% with cfDNA testing. NILE met its primary endpoint - cfDNA performed similar to tissue in the detection of guideline-recommended biomarkers and cfDNA results were delivered significantly faster than SOC tissue testing (median 9 days vs. 15 days).Using cfDNA testing first, 87% of patients with a guideline-recommended biomarker would have been detected, compared to 67% if SOC tissue testing was first.
AACR, Author Interviews, Colon Cancer / 04.03.2019

MedicalResearch.com Interview with: Ronit Yarden, PhD, MHSA Director of Medical Affairs Colorectal Cancer Alliance, a patient advocacy organization Washington, D.C.  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The colorectal Cancer Alliance is a patient advocacy group (the largest advocacy group for colorectal cancer) and its mission is to provide support to patients, survivors, their caregivers and family members as well as advocate on their behalf for.  The organization is also committed to raise awareness for screening and early detection of colorectal cancer to help save lives and to provide funding for innovative colorectal cancer research. As part of our support we sought to identify some of the clinical, emotional and financial experiences and unmet needs of patients under 50 years old.  We conducted an online survey that was promoted through social media and 1195 patients and survivors completed our survey. 
Author Interviews, Biomarkers, CT Scanning, JAMA, Lung Cancer, Medical Imaging / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47730" align="alignleft" width="200"]Martin C. Tammemägi   PhDSenior Scientist | Cancer Care Ontario | Prevention & Cancer Control | Scientific Lead | Lung Cancer Screening Pilot for People at High RiskProfessor (Epidemiology) | Brock University | Department of Health SciencesOntario  Canada Dr. Tammemägi[/caption] Martin C. Tammemägi PhD Senior Scientist Cancer Care Ontario | Prevention & Cancer Control Scientific Lead Lung Cancer Screening Pilot for People at High Risk Professor (Epidemiology) | Brock University Department of Health Sciences Ontario, Canada MedicalResearch.com: What is the background for this study? Response: Some prediction models can accurately predict lung cancer risk (probability of developing lung cancer during a specified time). Good model predictors include sociodemographic, medical and exposure variables. In recent years, low dose computed tomography (LDCT) lung cancer screening has become widespread in trials, pilots, demonstration studies, and public health practice. It appears that screening results provides added valuable, independent predictive information regarding future lung cancer risk, aside from the lung cancers directly detected from the diagnostic investigations resulting from positive screens.
ASCO, Author Interviews, Cancer Research, NEJM, Prostate Cancer / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47619" align="alignleft" width="180"]Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy Prof. Fizazi[/caption] Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important. 
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Chemotherapy, NEJM / 24.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47551" align="alignleft" width="135"]Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician, Massachusetts General Hospital Cancer Center Harvard Medical School, Boston, MA 02114 Dr. Bardia[/caption] Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician Massachusetts General Hospital Cancer Center Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? Response: Metastatic triple negative breast cancer is associated with aggressive tumor biology, and tends to affect younger patients and African Amerians. The response rate with standard chemotherapy regimens in patients with pre-treated metastatic TNBC ranges from 10-15%, and median progression-free survival ranges from 3-4 months. The median survival of metastatic TNBC is around 12 months and has not changed in the past 20 years. Thus, treatment of metastatic triple negative breast cancer represents an unmet clinical need.  
Author Interviews, Genetic Research, JAMA, Prostate Cancer / 24.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47572" align="alignleft" width="160"]Masaki Shiota MD, PhD Department of Urology, Graduate School of Medical Sciences Kyushu University Fukuoka , Japan Dr. Shiota[/caption] Masaki Shiota MD, PhD Department of Urology Graduate School of Medical Sciences Kyushu University Fukuoka , Japan MedicalResearch.com: What is the background for this study? What are the main findings? Response:  3β-hydroxysteroid dehydrogenase-1 encoded by HSD3B1 is a rate-limiting enzyme required for all pathways of dihydrotestosterone synthesis, as well as converts abiraterone into Δ4-abiraterone (D4A), which blocks multiple steroidogenic enzymes and antagonizes the androgen receptor. A mutation (1245A>C) in HSD3B1 is shown to be resistant to proteasomal degradation, causing substantial accumulation of this enzyme and gain-of-function. Although the HSD3B1 (1245C) allele can be acquired by mutation, germ-line single nucleotide polymorphism (SNP; rs1047303) is also known to exist. Then, in this study, we investigated the significance of missense polymorphism in HSD3B1 gene among men treated with primary ADT or abiraterone. The results showed men carrying variant allele showed higher risk of progression in primary androgen-deprivation therapy, but vulnerable to abiraterone treatment.
Author Interviews, Colon Cancer, Gastrointestinal Disease / 23.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47628" align="alignleft" width="200"]Dr. Michael Epstein Dr. Michael Epstein[/caption] Dr. Michael Epstein MD Dr. Epstein has over 30 years of experience in the field of Gastroenterology with extensive medical training as a practicing clinician, including treating patients with a range of gastroenterological conditions, such as Inflammatory Bowel Disease (IBD), Crohn’s disease, Ulcerative Colitis, Hepatology and Liver diseases. Dr. Epstein is also the founder and principle physician at Digestive Disorders Associates and is the president of the Maryland Diagnostic and Therapeutic Endo Center, both in Annapolis, Maryland. He is board certified by the American Board of Internal Medicine with a sub-specialty in Gastroenterology. He is a fellow of the American Gastroenterology Association and the American College of Gastroenterology, and a member of the Society of Gastrointestinal Surgeons.  MedicalResearch.com: What is the importance of colonoscopy Response: We lose more people to colon cancer each year than who have died in the Vietnam WarI believe that colon cancer has become a public health issue and there is a great need to increase public awareness around screening. It is so important for patients to take part in routine screenings as the symptoms of colon cancer are often silent. Sadly, often times people do not know they have colon cancer until the cancer is in an advanced state. A colonoscopy is important because it is the only test that can currently detect and treat this type of cancer that is also one of the leading killers in the United States. Not only can we often detect pre-cancerous polyps, but we can often remove these polyps during the procedure. 
Author Interviews, Cancer Research, Dermatology, Radiation Therapy / 23.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47622" align="alignleft" width="145"]William I. Roth MD Dermatology and Dermatological Surgery Boynton Beach, FL Dr. Roth[/caption] William I. Roth MD Dermatology and Dermatological Surgery Boynton Beach, FL MedicalResearch.com: What is the background for this study?
  • This retrospective study reviewed medical records of patients with biopsy-proven, primary cutaneous basal and squamous cell carcinoma (BCC and SCC) lesions on the lower extremities. These patients were treated with the Sensus Healthcare’s Superficial Radiation Therapy SRT-100 Unit between 2011 and 2014. The SRT-100 is most amenable for treating non-melanoma skin cancer (NMSC) in patients aged 65 and older although many younger patients are treated as well when a non-scarring method is desired.
  • The types of skin cancers treated included superficial, well differentiated and moderately differentiated squamous cell carcinomas, squamous cell carcinoma in situ and basal cell carcinomas including infiltrative basal cell carcinomas. Higher energy linear accelerator radiation units have been reported to have a high incidence of healing problems. With the SRT-100 the radiation is concentrated primarily in the higher layers of the skin where the skin cancer is located and thus the treatments are well tolerated.
ASCO, Author Interviews, Prostate Cancer / 22.02.2019

MedicalResearch.com Interview with: Kim Nguyen Chi, MD FRCPC Professor of Medicine, University of British Columbia Regional Medical Director, BC Cancer - Vancouver MedicalResearch.com: What is the background for this study? What are the main findings? Response: For over 70 years, androgen deprivation therapy (ADT) has been the main treatment therapy for metastatic prostate cancer patients. This Phase 3 final analysis study looked at adding abiraterone acetate and prednisone to ADT for patients with metastatic prostate cancer, with the primary objectives being to assess improvements in overall survival and radiographic progression-free survival. At the first interim analysis reported in 2017, both primary endpoints were met, and the study was unblinded and patients on the ADT and placebos arm crossed over to receive ADT with abiraterone and prednisone. This study is the final analysis reporting on overall survival. The study findings found abiraterone acetate and prednisone plus ADT continued to demonstrate an improvement in overall survival, hazard ratio (HR) = 0.66, meaning a 34% decrease in the risk of death associated with the use of ADT with abiraterone and prednisone. The median overall survival, which had not been reached before in the ADT with abiraterone and prednisone arm, was 53.3 months compared to 36.5 months for ADT plus placebo, prolonging median overall survival by 16.8 months.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Hepatitis - Liver Disease, JAMA / 22.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47600" align="alignleft" width="200"]Xuehong Zhang, MD, ScD Assistant Professor in Medicine | Harvard Medical School Associate Epidemiologist | Brigham and Women's Hospital Boston, MA Dr. Xuehong Zhang[/caption] Xuehong Zhang, MD, ScD Assistant Professor in Medicine Harvard Medical School Associate Epidemiologist Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? Response: In the United States., liver cancer incidence is rapidly increasing and over 42,200 new cases were projected to be diagnosed in 2018. The majority of individuals with liver cancer are diagnosed at a late stage, are not eligible for curative therapy, and die within 1 year of diagnosis. Established risk factors for liver cancer are limited to hepatitis B and C virus (HBV/HCV) infections, metabolic disorders, and smoking. Clearly, identification of novel risk factors, particularly those that are modifiable, is urgently needed. Dietary factors have been suspected as important, but only excessive alcohol use and aflatoxin-contaminated foods are considered to be established dietary risk factors for hepatocellular carcinoma (HCC). Consumption of whole grains and dietary fiber, especially cereal fiber, have been associated with lower risk of obesity, type 2 diabetes, and nonalcoholic fatty liver disease, which are known predisposing factors for HCC. We thus hypothesized that long-term intake of whole grains and dietary fiber may lower the risk of developing hepatocellular carcinoma (HCC) and tested this hypothesis using data from two large prospective cohort studies, the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS).
Author Interviews, Emory, JAMA, Prostate Cancer, Radiation Therapy / 15.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47492" align="alignleft" width="200"]Deborah Watkins Bruner RN, PhD, FAAN Senior Vice President of Research Emory University Professor and Robert W. Woodruff Chair in Nursing Nell Hodgson Woodruff School of Nursing Professor, Department of Radiation Oncology Emory University School of Medicine Dr. Bruner[/caption] Deborah Watkins Bruner RN, PhD, FAAN Senior Vice President of Research Emory University Professor and Robert W. Woodruff Chair in Nursing Nell Hodgson Woodruff School of Nursing Professor, Department of Radiation Oncology Emory University School of Medicine MedicalResearch.com: What is the background for this study? Response: In a randomized clinical trial entitled, “Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy” the NRG Oncology Group previously demonstrated that men with low risk prostate cancer had  similar 5-year disease- free survival of about 85%  when treated with either conventional radiotherapy  (C-RT) of 73.8 Gy in 41 fractions over 8.2 weeks, or with  hypofractionated radiotherapy (H-RT) of 70 Gy in 28 fractions over 5.6  weeks. However, late physician reported side effects of mild bowel and bladder symptoms were increased in patients treated  with H-RT and raised questions if the H-RT arm is acceptable to patients. The current study asked the patient’s directly about their bowel, bladder, sexual function, anxiety, depression and general quality of life using valid patient reported questionnaires. These questionnaires have been found to be more accurate for reporting patient symptoms than physician report alone.
Author Interviews, BMJ, Cancer Research, HPV, OBGYNE / 13.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47478" align="alignleft" width="200"]Matejka Rebolj, PhD King’s College London, London, UK Dr. Rebolj[/caption] Matejka Rebolj, PhD King’s College London, London, UK [caption id="attachment_47479" align="alignleft" width="139"]Henry Kitchener, MD FRCOG FRCS University of Manchester, Manchester, UK Dr. Kitchener[/caption]   Professor Henry Kitchener, MD FRCOG FRCS University of Manchester, Manchester, UK   MedicalResearch.com: What is the background for this study? Response: We now have reliable and affordable technologies to detect human papillomavirus (HPV), a virus which is universally accepted as the cause of cervical cancer. Various large trials confirmed that cervical screening could be improved by replacing the smear (cytology) test that has been in use for decades, with HPV testing. Many countries are now making the switch. In England, this is planned for the end of 2019. To test how to run HPV testing within the English National Health Service, a pilot was initiated in 2013 in six screening laboratories. We also wanted to determine whether the encouraging findings from the trials could be translated to everyday practice. This is important not only because we will be using different HPV tests, but also because women undergoing screening in trials are much more selected than those who are invited to population-based screening. 
Author Interviews, JAMA, Prostate Cancer, Radiation Therapy / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47468" align="alignleft" width="200"]Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles Dr. Kishan[/caption] Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles MedicalResearch.com: What is the background for this study? What are the main findings? Response: Typical external beam radiation courses range up to 8-9 weeks in length (39-45 treatments). There are data that shorter courses, delivering a higher dose per day, may be just as effective. Stereotactic body radiotherapy (SBRT) really pushes this concept by condensing the treatment to just four to five treatments, with a high dose per day. Here, we present the pooled results of the outcomes of 2142 men with low and intermediate risk prostate cancer and a median of 6.9 years of followup. We demonstrate a very favorable efficacy and safety profile. Specifically, the rates of recurrences were 4.5% and 10.2% for low and intermediate risk disease at 7 years, and rates of late severe toxicity were 2.4% for urinary toxicity and 0.4% for gastrointestinal toxicity.
Author Interviews, MRI, Prostate Cancer, Technology / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47464" align="alignleft" width="130"]Gaurav Pandey, Ph.D. Assistant Professor Department of Genetics and Genomic Sciences Icahn Institute of Data Science and Genomic Technology Icahn School of Medicine at Mount Sinai, New York  Dr. Pandey[/caption] Gaurav Pandey, Ph.D. Assistant Professor Department of Genetics and Genomic Sciences Icahn Institute of Data Science and Genomic Technology Icahn School of Medicine at Mount Sinai, New York  MedicalResearch.com: What is the background for this study?  Response: Multiparametric magnetic resonance imaging (mpMRI) has become increasingly important for the clinical assessment of prostate cancer (PCa), most routinely through PI-RADS v2, but its interpretation is generally variable due to its relatively subjective nature. Radiomics, a methodology that can analyze a large number of features of images that are difficult to study solely by visual assessment, combined with machine learning methods have shown potential for improving the accuracy and objectivity of mpMRI-based prostate cancer assessment. However, previous studies in this direction are generally limited to a small number of classification methods, evaluation using the AUC score only, and a non-rigorous assessment of all possible combinations of radiomics and machine learning methods.
Author Interviews, Cancer Research, Prostate Cancer, Radiation Therapy / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47453" align="alignleft" width="132"]Graham Kelly, BSc (Vet) (Hons, BVSc (Hons), PhD Managing Director and Chief Executive Officer Noxopharm  Dr. Kelly[/caption] Graham Kelly, BSc (Vet) (Hons, BVSc (Hons), PhD Managing Director and Chief Executive Officer Noxopharm  MedicalResearch.com: What is the background for this announcement? What are the main findings? Response: Veyonda is an experimental drug being developed as a means of enhancing the anti-cancer effect of radiotherapy. The Phase 1b DARRT-1 study is assessing the ability of Veyonda to boost a palliative dose of external beam radiotherapy (EBRT) applied to a single lesion, to result in a systemic response in non-irradiated lesions (known as an abscopal response) in men with metastatic, end-stage prostate cancer. The aim is to provide at the least better palliation, and at best a survival advantage. The reported data concerns the study’s initial dose-finding arm involving three different dosages of Veyonda. This arm involves 12 subjects and the report concerns their clinical status at 12-weeks post-irradiation. The data provide clinical evidence of an abscopal effect in at least half of the eight subjects receiving the two highest Veyonda dosages and demonstrate that the combination of Veyonda and palliative radiotherapy was well-tolerated. The 1200 mg dosage was confirmed as the therapeutic dose.
Author Interviews, Dermatology, JAMA, Kidney Disease, Melanoma, Transplantation / 11.02.2019

MedicalResearch.com Interview with "Kidney Model 9" by GreenFlames09 is licensed under CC BY 2.0. To view a copy of this license, visit: https://creativecommons.org/licenses/by/2.0Donal JSextonMD, PhD Department of Nephrology and Kidney Transplantation Beaumont Hospital Royal College of Surgeons in Ireland Dublin, Ireland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Patients who receive a kidney transplant as treatment for end stage kidney disease are at risk of malignancy due to immunosuppression. In contrast to other solid organ transplant types, when kidney transplants fail it is possible for recipients to return to dialysis. Immunosuppression is usually reduced or completely stopped when  the allograft fails due to the risk of infection on dialysis. We decided to investigate what the trajectory of risk for non-melanoma skin cancer and invasive cancers overall (composite group) looked like for patients who have received multiple consecutive kidney transplants with intervening periods of graft failure. We compared cancer risk during periods of allograft failure and periods of functioning kidney transplants.  
Author Interviews, Cancer Research, Dermatology, Global Health, Melanoma / 08.02.2019

MedicalResearch.com Interview with: [caption id="attachment_39763" align="alignleft" width="125"]Melanoma CDC/ Carl Washington, M.D., Emory Univ. School of Medicine; Mona Saraiya, MD, MPH Example of one type of melanoma[/caption] Dr. Catherine M. Olsen Associate Professor Cancer Control Group QIMR Berghofer Medical Research Institute MedicalResearch.com: What is the background for this study? Response: Melanoma incidence and mortality rates are increasing globally. Public health campaigns aiming to reduce sun exposure and use of sunbed have been implemented in many parts of the world, but there is significant variability in terms of the history and reach of these campaigns across countries. We examined melanoma incidence rates in eight different countries with different patterns of sun exposure and varying approaches to melanoma control.
Author Interviews, Compliance, Electronic Records, Lung Cancer, Race/Ethnic Diversity / 07.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47364" align="alignleft" width="200"]Samuel Cykert, MD Professor of Medicine and Director of the Program on Health and Clinical Informatics UNC School of Medicine, and Associate Director for Medical Education, NC AHEC Program Chapel Hill, NC Dr. Cykert[/caption] Samuel Cykert, MD Professor of Medicine and Director of the Program on Health and Clinical Informatics UNC School of Medicine, and Associate Director for Medical Education, NC AHEC Program Chapel Hill, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Reports going as far back as the early 1990’s through reports published very recently show that Black patients with early stage, curable lung cancer are not treated with aggressive, curative treatments as often as White patients. These type of results have been shown in other cancers also. It’s particularly important for lung cancer because over 90% of these patients are  dead within 4 years if left untreated. In 2010, our group published a study in the Journal of the American Medical Association that showed that Black patients who had poor perceptions of communication (with their provider), who did not understand their prognosis with vs. without treatment, and who did not have a regular source of care ( a primary care doctor) were much less likely to get curative surgery. Also our results suggested that physicians who treated lung cancer seemed less willing to take the risk of aggressive treatments in treating Black patients (who they did not identify with as well) who had other significant illnesses. Because of the persisting disparities and our 2010 findings, we worked with a community group, the Greensboro Health Disparities Collaborative to consider potential solutions.  As these omissions were not overt or intentional because of race on the part of the patients or doctors, we came up with the idea that we needed transparency to shine light on treatment that wasn’t progressing and better communication to ensure that patients were deciding on good information and not acting on mistrust or false beliefs.  We also felt the need for accountability – the care teams needed to know how things were going with patients and they needed to know this according to race. To meet these specifications, we designed a system that received data from electronic health records about patients’ scheduled appointments and procedures. If a patient missed an appointment this umbrella system triggered a warning. When a warning was triggered, a nurse navigator trained specially on communication issues, re-engaged the patient to bring him/her back into care. In the system, we also programmed the timing of expected milestones in care, and if these treatment milestones were not reached in the designated time frame, a physician leader would re-engage the clinical team to consider the care options. Using this system that combined transparency through technology, essentially our real time warning registry, and humans who were accountable for the triggered warnings, care improved for both Black and White patients and the treatment disparity for Black patients was dramatically reduced. In terms of the numbers, at baseline, before the intervention, 79% of White patients completed treatment compared to 69% of Black patients. For the group who received the intervention, the rate of completed treatment for White patients was 95% and for Black patients 96.5%. 
Author Interviews, JAMA, Thyroid, Thyroid Disease / 04.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47320" align="alignleft" width="120"]Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc. Assistant Clinical Investigator/Assistant Professor Metabolic Disease Branch/NIDDK/NIH Bethesda, MD Dr. Klubo-Gwiezdzinska[/caption] Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc. Assistant Clinical Investigator/Assistant Professor Metabolic Disease Branch/NIDDK/NIH Bethesda, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: People with intermediate- and high-risk differentiated thyroid cancer (DTC) are treated with surgical removal of the thyroid gland and radioactive iodine therapy.  After surgery and initial treatment, the thyroid hormone levothyroxine is used for long-term management not only to replace appropriate physiologic thyroid hormones post-surgery, but also to suppress thyrotropin (TSH) release from the pituitary gland at supraphysiologic doses. The current recommended American Thyroid Association TSH suppression goal in patients with a high-risk differentiated thyroid cancer presenting with distant metastases is less than 0.1mIU/ml, and between 0.1-0.5 mIU/ml for patients with intermediate-risk DTC presenting with local metastases to the neck lymph nodes. This TSH goal is much lower than physiologic TSH level, which ranges between 0.4-4.1 mIU/ml, depending on the measurement method and person’s age. TSH suppression is used because some preclinical evidence suggests that TSH can stimulate growth of cancer cells.  However, several preclinical studies show that thyroid hormones may also stimulate cancer growth. In addition, too much levothyroxine, leading to TSH suppression, may cause side effects such as abnormal heart rhythms and decreased bone mass. In this study, based on a large multicenter database analysis, we found that continuous TSH suppression with levothyroxine was not associated with better progression-free survival and overall survival in patients with either intermediate- and high-risk differentiated thyroid cancer. The patients were followed for an average of 7 years after surgical thyroid cancer removal and radioactive iodine therapy. 
Author Interviews, Cancer Research, Global Health, Lancet, Weight Research / 04.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47252" align="alignleft" width="128"]Hyuna Sung, PHD Principal Scientist, Surveillance Research American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303  Dr. Sung[/caption] Hyuna Sung, PHD Principal Scientist, Surveillance Research American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303  MedicalResearch.com: What is the background for this study? Response: This project was motivated by our previous finding on the rise of colorectal cancer among young adults before age 55. Changes in cancer trends among young age group have significant implications because the newly introduced carcinogenic agents are likely to affect trends among young people before they affect those among older people. Owing to this relationship, cancer trends among young people can be often considered as a bellwether for future disease burden. Given the dramatic increase of the obesity prevalence during 3-4 decades in the US, we wanted to expand the colorectal cancer finding to the more comprehensive list of cancers and explain them in the context of obesity epidemic.
Author Interviews, Cancer, Cancer Research, Supplements / 30.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47225" align="alignleft" width="166"]Dr. Scott Litofsky, MD  Division of Neurological Surgery University of Missouri-Columbia School of Medicine Columbia, MO 65212  Dr. Litofsky[/caption] Dr. Scott Litofsky, MD Division of Neurological Surgery University of Missouri-Columbia School of Medicine Columbia, MO 65212  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many patients take over-the-counter medications to held their cancers. Some of these remedies may be helpful; others are potentially harmful. Anti-oxidant medications are frequently selected by patients as they are inexpensive and available. We were approached by a high school student, Macy Williams (one of the authors) to do some research in our laboratory when she won a research scholarship (the 2016 Emperor Science Award) from Stand Up to Cancer. She worked with us several times per week doing experiments during her senior year of high school. When she graduated, we continued the work that she started. We studied effects of Vitamin D3, Melatonin, and alpha-Lipoic Acid on glioblastoma cells, a highly malignant brain tumor. We included experiments of these agents alone and in combination with Temozolomide, a chemotherapy agent used as standard of care in glioblastoma. The work was done in cultured cells, measuring growth and survival of cells. We used concentrations that could be achieved by oral intake of the drugs. We found that antioxidant medications, particularly alpha Lipoic Acid, had synergistic effects with Temozolomide – that is Temozolomide impair glioblastoma cell growth and survival better when combined with an antioxidant. The mechanism of action may be through reactive oxygen species. 
Author Interviews, Cancer Research, Gender Differences, JAMA, UCLA / 25.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47094" align="alignleft" width="200"]Dr. Ann Raldow MD MPH Assistant Professor Department of Radiation Oncology David Geffen School of Medicine UCLA Dr. Raldow[/caption] Dr. Ann Raldow MD MPH Assistant Professor Department of Radiation Oncology David Geffen School of Medicine UCLA  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Similar to women in other historically male-dominated fields, female radiation oncologists face unique obstacles in achieving many metrics of career success, including equal salary, research funding, and academic promotion. Our study of industry payments found that female radiation oncologists were less likely than their male colleagues to receive payments from industry and that these payments tended to be of smaller monetary value.
Author Interviews, Cancer Research, HPV, Infections / 25.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47138" align="alignleft" width="151"]Prof. J. (Hans) Berkhof PhD Vrije Universiteit Amsterdam  Prof. Berkhof[/caption] Prof. J. (Hans) Berkhof PhD Vrije Universiteit Amsterdam  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In most countries, the Pap test is used for cervical cancer screening but recently several countries have switched from Pap testing to HPV testing. Like the Pap test, the HPV test requires a cervical sample to be taken by a clinician. Vaginal self-sampling is also used, but only in underscreened women. We know that self-sampling increases screening participation in underscreened women and it is likely that many women that attend screening also prefer self-sampling if it had been offered to them. We studied whether an HPV self-sampling test is an accurate alternative to a regular HPV test in women invited for routine screening. We randomized about 14,000 women, invited for screening, to self-sampling or clinician-sampling. Women with a positive HPV test result also received the other HPV test. We found that the HPV self-sampling test yielded similar performance as the regular HPV test for detection of cervical pre-cancerous lesions (CIN3 and CIN2). 
Author Interviews, Cancer Research, Genetic Research, Weight Research / 24.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47128" align="alignleft" width="200"]Brian R. Lane MD PhD Division of Urology Spectrum Health Grand Rapids, Michigan Dr. Lane[/caption] Brian R. Lane MD PhD Division of Urology Spectrum Health Grand Rapids, Michigan MedicalResearch.com: Can you explain how you conducted your study, and what the main findings were? Response:  We used large-scale genome-wide association studies (GWAS) to identify genetic variants associated with obesity measures, blood pressure, lipids, type 2 diabetes, insulin, and glucose. these genetic variants were used as proxies for the above-mentioned risk factors and evaluated in relation to renal cell carcinoma risk (kidney cancer) using GWAS data from 10,000 RCC patients and 20,000 control participants. -          Based on these genetic data, we found that multiple measures of obesity, as well as diastolic blood pressure (DBP) and fasting insulin, are associated with renal cell carcinoma risk. In contrast, we found little evidence for an association with RCC risk for systolic blood pressure (SBP), circulating lipids, overall diabetes, or fasting glucose. 
Author Interviews, Breast Cancer, Cancer Research, JAMA, Leukemia / 21.01.2019

MedicalResearch.com Interview with: medicalresearch.comDr. Marie Joelle Jabagi, PharmD, MPH University of Paris Sud, Paris-Saclay University, Paris Health Product Epidemiology Department French National Agency for Medicines and Health Products Safety Saint-Denis, France MedicalResearch.com: What is the background for this study? Response: Secondary hematologic malignant neoplasms that develop months or years after the diagnosis of breast cancer may be a consequence of genetic predisposition, environmental factors, previous cancer treatments or a combination of all those factors. These secondary malignant neoplasms are increasingly becoming a concern given that the population of breast cancer survivors is growing substantially. However, their frequency in real life has been poorly investigated to date. The aims of our research were to estimate the frequency of various types of hematologic malignant neoplasm following a diagnosis of primary breast cancer among women aged 20 to 85 years in France during the past decade, and to compare it to the corresponding frequency in women of the French general population.
Author Interviews, Cancer Research, Cost of Health Care / 21.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47059" align="alignleft" width="200"]Zhiyuan "Jason" Zheng PhD Director, Economics and Healthcare Delivery Research American Cancer Society, Inc. Atlanta, GA 30303 Dr. Zheng[/caption] Zhiyuan "Jason" Zheng PhD Director, Economics and Healthcare Delivery Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Historically, the cost of healthcare can be a substantial burden for cancer survivors and their families in the US. Even with health insurance, a cancer diagnosis can impose significant out-of-pocket costs for medical care.  These are partially due to the rising costs of cancer treatments in recent years, moreover, the increasing levels of coinsurance, copayments, and deductibles also shift a significant portion of the burden to cancer patients. We found that younger cancer survivors, those aged 18-49 years, bear a higher burden than their older counterparts. We also found that two-thirds of cancer survivors enrolled in high-deductible health plans did not have health savings accounts, and they are more vulnerable to financial hardship than those in high-deductible health plans with health savings accounts and those covered by low-deductible plans. These findings are important to patients because although cancer patents have benefited from newer and more advanced treatments, financial hardship may lead to emotional distress, cause changes in health behaviors, and jeopardize treatment adherence and health outcomes. 
Author Interviews, Chemotherapy, Colon Cancer / 12.01.2019

MedicalResearch.com interview with: [caption id="attachment_46915" align="alignleft" width="133"]Anders Rabbe CEO of Isofol Medical Anders Rabbe[/caption] Anders Rabbe CEO of Isofol Medical MedicalResearch.com: What is the background for this study? How common is colorectal cancer?  Response: Colorectal cancer (CRC) is one of the most common forms of cancer with more than 1.8 million new cases identified globally every year. Due to a lack of new therapeutic options and a high mortality rate, colorectal cancer is a disease with a significant unmet need for effective new treatments. Isofol is developing arfolitixorin (Modufolin®) to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer. Arfolitixorin is the company’s proprietary drug candidate currently being studied in a global Phase 3 AGENT study (ISO-CC-007) as a first-line treatment for patients with metastatic colorectal cancer (mCRC), which just enrolled its first patient in December of 2018.
Author Interviews, Cancer Research, Esophageal, NEJM, Surgical Research / 11.01.2019

MedicalResearch.com Interview with: [caption id="attachment_46825" align="alignleft" width="130"]Guillaume Piessen, MD, PhD University Hospital Centre Lille, France Prof. Piessen[/caption] Guillaume Piessen, MD, PhD University Hospital Centre Lille, Franc MedicalResearch.com: What is the background for this study? Response: Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIE) with a combined laparoscopy+thoracotomy procedure compared to an open esophagectomy (OE), according to results of the MIRO trial published in the last issue of the New England Journal Of Medicine (link article). This French prospective multi-center randomized controlled study was funded by the French National Cancer Institute (Grant n° 1907). The study was conducted by Pr Mariette who sadely passed away in 2017 and Pr Piessen (Department of Digestive and Oncological Surgery, CHU Lille), under the hauspice of FRENCH (Fédération de Recherche EN Chirurgie) and FREGAT (French Eso-Gastric Tumors) working group (https://www.fregat-database.org/fr/). Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12].
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 08.01.2019

MedicalResearch.com Interview with: [caption id="attachment_46845" align="alignleft" width="200"]Kiu Tay-Teo, PhD World Health Organization Geneva, Switzerland Dr. Kiu Tay-Teo[/caption] Kiu Tay-Teo, PhD World Health Organization Geneva, Switzerland MedicalResearch.com: What are the main findings? Response: High costs and high risks of R&D for drugs have been presented to justify high drug prices, especially for cancer drugs. However, it is unclear whether prices are in fact justifiable compared to the overall return on R&D investment. In this paper, we systematically compared incomes from the sales of cancer drugs with the R&D costs. We quantified the incomes generated from the sales of 99 cancer drugs approved by FDA from 1989–2017. This was based on sales figures reported in the originator companies’ annual financial reports, and where necessary, estimates deduced from the reported figures. The sales incomes were net of rebates and discounts, but without accounting for expenses and taxes. For the R&D costs of bringing one new cancer drug to the market, the literature reported a typical costs of between $219 million and $2.9 billion, after accounting for the costs of failed products that were investigated but not marketed and the opportunity costs. For the main analysis, we used a median cost of $794 million, as reported in the literature. To be clear, this analysis did not estimate profit return because we do not have information about the costs and year-to-year variations in costs (i.e. expenses and taxes) specific to cancer drugs.