Author Interviews, Dermatology, Melanoma / 08.05.2020

MedicalResearch.com Interview with: Neelam A. Vashi, MD Associate Professor of Dermatology Director, Boston University Center for Ethnic Skin Director, Cosmetic and Laser Center Boston University School of Medicine and Daniela P.Sanchez BS Boston Medical Center Boston, MA 02118 MedicalResearch.com: What is the background for this study? Response: Although melanoma most commonly affects Caucasians, Hispanics are disproportionately affected by greater morbidity and mortality rates when diagnosed. Poor prognosis in Hispanic patients is likely multifactorial, and may be secondary to lack of knowledge or misconceptions about melanoma risk, atypical presentation, impaired access to care, and language barriers, ultimately resulting in a delay in diagnosis. (more…)
Author Interviews, Cancer Research, JAMA / 04.05.2020

MedicalResearch.com Interview with: Emerson Y. Chen, MD Assistant Professor of Medicine, Medical Oncology Knight Cancer Institute, Oregon Health & Science University Portland, OR 97239 MedicalResearch.com: What is the background for this study? Response: Our research group had previously studied how oncology drugs are approved in these two previous papers listed below. One is focused on the time delay trade-off from surrogate endpoints (i.e. response rate and progression-free survival) over definite endpoints (i.e. overall survival and quality of life). The other is focused on how promising the response rate of a drug candidate have to be to be considered for oncology drug approval.  (more…)
Author Interviews, Cancer Research, Genetic Research / 04.05.2020

MedicalResearch.com Interview with: Rebecca Nagy Vice President Medical Affairs Guardant Health  MedicalResearch.com: What is the background for this study? Response: Hormone receptor positive (HR+) breast cancer comprises roughly 75% of all cancers of the  breast. While many of these cancers can be cured through multi-modality therapy, there remain many deaths due to metastatic spread to distant organs. These metastatic cancers are marked by their resilience in the face of potent targeted therapies and chemotherapies, with many tumors displaying an initial drug response followed by resistance. Recently, genomic sequencing has identified recurrent, oncogenic alterations in HR+ metastatic breast cancer (MBC) with mutations in the catalytic alpha subunit of PI3K (PI3Kα, PIK3CA gene), in over 40% of cases. This has raised hopes for more durable disease control through precise inhibition of this driver oncogene. The SOLAR-1 Phase III study of alpelisib combined with fulvestrant in PIK3CA-mutated HR+ MBC showed a markedly improved PFS over fulvestrant monotherapy but pervasive resistance nonetheless. To characterize the basis for such resistance to combination hormone plus PIK3CA targeted therapy, we conducted a detailed, longitudinal analysis of tumor and plasma circulating cell-freetumor DNA (ctDNA) among patients with HR+ MBC who participated in a phase I/II dose escalation study of alpelisib in combination with letrozole or exemestane.  (more…)
Author Interviews, Cancer Research, Genetic Research, Melanoma / 29.04.2020

MedicalResearch.com Interview with: Dr. Matthew H. Law, PhD Senior Research Officer, Statistical Genetics QIMR Berghofer MedicalResearch.com: What is the background for this study? Response: A large genetic study of melanoma involving a global collaboration of scientists, co-led by QIMR Berghofer, the University of Leeds in the UK, and the National Cancer Institute in the US which is part of the National Institutes of Health, has been published in the prestigious journal Nature Genetics. Melanoma is a sometimes-deadly skin cancer, with an estimated 350,000 cases worldwide in 2015, resulting in nearly 60,000 deaths. Melanoma begins in melanocytes, cells in the skin responsible for making the pigment melanin that gives colour to the skin. Melanin is able to block some of the harmful effects of UV radiation, which is why people with pale skin are at a higher risk of skin cancer, but the protection is not complete. Moles also develop from melanocytes, and having a high number of moles is a risk factor for melanoma. UK based co-lead author, Dr Mark Iles from the University of Leeds’s Institute for Data Analytics, said the researchers examined DNA from 37,000 people who had been diagnosed with melanoma and compared their genetic information to that of nearly 400,000 people with no history of the disease.” Joint study leader and QIMR Berghofer statistical geneticist Associate Professor Matthew Law said the researchers identified 33 new regions of the genome and confirmed another 21 previously reported regions that are linked to a person’s risk of developing melanoma of the skin. Two of the new regions we’ve discovered that are linked to melanoma have previously been linked to autoimmune disorders. This provides further evidence that the immune system plays an important role in a person developing melanoma. We also found an association between melanoma and common genetic variants in the gene TP53, which is a gene critical in controlling DNA repair when cells divide, and in suppressing cancer.” Co-lead author on the study and senior investigator at the National Cancer Institute, Dr Maria Teresa Landi, said the research also uncovered other important clues to the genetic causes of melanoma. We used the relationship between moles, pigmentation, and melanoma to identify 31 additional gene regions that potentially influence melanoma risk. For example, one of the regions we identified is involved in melanocyte growth,” Dr Landi said. “Moreover, we also included people from Mediterranean populations involved in the MelaNostrum Consortium. Most studies of melanoma use people with northern or western European ancestry (e.g. British) and by expanding our analysis to include Mediterranean populations, we will gain a greater understanding of the genetics of melanoma in this highly sun exposed group.” (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, COVID -19 Coronavirus, Lung Cancer / 27.03.2020

MedicalResearch.com Interview with: Dr. Amy C. Moore PhD Director of Science and Research GO2 Foundation for Lung Cancer MedicalResearch.com: What is the mission of the GO2 Foundation for Lung Cancer? Response: GO2 Foundation for Lung Cancer’s mission is to transform survivorship by  saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. (more…)
Author Interviews, Melanoma, NYU / 25.03.2020

MedicalResearch.com Interview with: David Polsky, MD, PhD Professor of Dermatology and Pathology Alfred W. Kopf MD, Professor of Dermatologic Oncology Director, Pigmented Lesion Section The Ronald O. Perelman Department of Dermatology New York University Grossman School of Medicine Perlmutter Cancer Center Joan and Joel Smilow Research Center New York, NY 10016 MedicalResearch.com: What is the background for this study? Response: The background for the study was to determine the extent to which new treatments for metastatic melanoma were impacting melanoma mortality rates for the United States population. Multiple clinical trials have demonstrated that several new agents were highly effective at prolonging survival. These treatments belong to two different groups of medications: those targeting the biological pathway activated by mutation in the BRAF oncogene, which occurs in just under 50% of metastatic melanomas; and those targeting the immune system, called checkpoint inhibitors. These drugs prevent melanomas from suppressing the immune response to the tumors. Ten treatments were approved beginning in 2011, including six treatments between 2011 and 2014. We examined mortality rates between 1986 and 2016, prior to and after FDA approval of these agents. (more…)
Author Interviews, Genetic Research, Nature, Prostate Cancer, Vanderbilt / 24.03.2020

MedicalResearch.com Interview with: Jeffrey R. Smith, MD PhD Department of Medicine, Division of Genetic Medicine Vanderbilt-Ingram Cancer Center, and Vanderbilt Genetics Institute Vanderbilt University Medical Center Medical Research Service Tennessee Valley Healthcare System, Veterans Administration Nashville, TN MedicalResearch.com: What is the background for this study?   Response: Roughly 20% of men with prostate cancer have a family history of the disease, and 5% meet criteria for hereditary prostate cancer. Although prostate cancer has the greatest heritability of all common cancers (twice that of breast cancer), extensive heterogeneity of its inherited causes has presented a considerable obstacle for traditional pedigree-based genetic investigative approaches. Inherited causes across, as well as within families are diverse. This study introduced a new familial case-control study design that uses extent of family history as a proxy for genetic burden. It compared a large number of men with prostate cancer, each from a separate family with a strong history of the disease, to screened men with no personal or family history. The study comprehensively deconstructs how the 8q24 chromosomal region impacts risk of hereditary prostate cancer, introducing several new analytical approaches. The locus had been known to alter risk of prostate, breast, colon, ovarian, and numerous additional cancers. (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, Lung Cancer, Occupational Health / 18.03.2020

MedicalResearch.com Interview with: Theresa S. Emory MD Department of Pathology, Peninsula Pathology Associates Newport News, VA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cosmetic talc products can contain asbestos, which is the primary cause of malignant mesothelioma. We investigated 75 individuals with malignant mesothelioma, whose only known exposure to asbestos was repeated exposures to cosmetic talcum powder. 83% of the individuals were female and several occurred in barbers/cosmetologists. 16% occurred in individuals younger than 45 years old, and on average the subjects were 11 years younger than predicted, based on SEER data. The asbestos fibers in tissue samples that were examined in 11 cases were identical (anthophyllite and tremolite) to those identified in cosmetic talc. (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, Colon Cancer, JAMA, Weight Research / 13.03.2020

MedicalResearch.com Interview with: Dr Laurent Bailly MD, PhD Département de Santé Publique, CHU Nice, Hôpital Archet 1. Niveau1 NICE France  MedicalResearch.com: What is the background for this study? Response: Obesity is known to increase cancer incidence and notably colorectal cancer incidence. Bariatric surgery is an effective treatment of obesity however the association of this surgery with the colorectal cancer remained controversial. We used the French National Health Insurance Information System to conduct a nationwide retrospective cohort study, between 2009 and 2018, of patients hospitalized in France with a diagnosis of obesity. We followed more than 1 million obese individuals aged 50 to 75 years and free of colorectal cancer at baseline, some of them did undergo bariatric surgery and others did not. (more…)
Author Interviews, Breast Cancer, Genetic Research, JAMA, Stanford / 12.03.2020

MedicalResearch.com Interview with: Allison W. Kurian, M.D., M.Sc. Associate Professor of Medicine (Oncology) and of Epidemiology and Population Health Director, Women’s Clinical Cancer Genetics Program Stanford University School of Medicine Stanford, CA 94305-5405 MedicalResearch.com: What is the background for this study? Response: Genetic testing is increasingly relevant for the care of cancer patients. However, little was known about the prevalence of inherited mutations in cancer susceptibility genes among the most common group of women with breast cancer: those diagnosed after menopause and without a strong family history of cancer.  (more…)
Author Interviews, Cancer Research, Columbia, OBGYNE / 11.03.2020

MedicalResearch.com Interview with: Matthew E. Spotnitz, MD, MPH Departments of Biomedical Informatics and Obstetrics and Gynecology Columbia University Medical Center Observational Health Data Sciences and Informatics, and Medical Informatics Services New York-Presbyterian Hospital, New York, New York MedicalResearch.com: What is the background for this study? Response: Our take home message is that copper and hormonal IUDs may have different physiological effects on the female genitourinary system. (more…)
Author Interviews, Biomarkers, Lung Cancer, Stanford / 09.03.2020

MedicalResearch.com Interview with: Professor Dr. Andreas Keller Stanford University School of Medicine Office Department of Neurology and Neurological Sciences Chair for Clinical Bioinformatics Saarbrücken, Germany MedicalResearch.com: What is the background for this study? Response: Lung cancer is among the three most common cancers and the leading cause of cancer-related deaths worldwide. The overall low survival rate of patients with lung cancer calls for improved detection tools to enable better treatment options and improved patients’ outcomes. To detect lung tumors, liquid biopsy-based strategies are increasingly explored, that are biomarkers, which are identifiable in body fluids such as human blood. The clinical application of biomarkers is, however, largely hampered by the relatively small numbers of cases that have been analyzed in the majority of the preclinical studies including the studies on lung cancer.  (more…)
Author Interviews, Melanoma, Psychological Science / 05.03.2020

MedicalResearch.com Interview with: Dr. Sinead Langan. FRCP MSc PhD Professor of Clinical Epidemiology Wellcome Senior Clinical Fellow Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine London, U.K. MedicalResearch.com: What is the background for this study? Response: Psychological stress is commonly cited as a risk factor for melanoma, but clinical evidence is limited. We wanted to test the hypothesis that acute severe stress increases the risk of melanoma and melanoma progression. (more…)
Author Interviews, BMC, Breast Cancer, Cancer Research, Weight Research / 27.02.2020

MedicalResearch.com Interview with: Carolyn Ee PhD NICM Health Research Institute Western Sydney University Australia MedicalResearch.com: What is the background for this study? Response: Worldwide and in Australia, breast cancer is the most common cancer in women. Weight gain is common after diagnosis of breast cancer and may increase tumour recurrence risk, mortality rate, and worsen quality of life. As there was no national data on the prevalence of weight gain after breast cancer in Australia, we undertook a national survey which was open to any woman living in Australia who had breast cancer. (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, Breast Cancer, Radiation Therapy / 25.02.2020

MedicalResearch.com Interview with: Jennifer Sims-Mourtada, Ph.D. Senior Rsearch Scientist Director of Translational Breast Cancer Research Center for Translational Cancer Research ChristianaCare MedicalResearch.com: What is the background for this study? Response: Cancer stem cells are resistant cancer cells that are able to continuously grow and are very resistant to radiation and chemotherapy. Cancer stem cells can also escape to the blood stream and travel to another site causing metastasis. (more…)
Annals Internal Medicine, Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Cancer Research, Mammograms / 25.02.2020

MedicalResearch.com Interview with: Xabier Garcia-De-Albeniz MD PhD Research Associate Department of Epidemiology Harvard T.H. Chan School of Public Health Mongan Institute for Health Policy Massachusetts General Hospital  MedicalResearch.com: What is the background for this study? Response: The goal of breast cancer screening is to reduce deaths from breast cancer by finding breast cancer at early, more treatable stages. The main way to screen for breast cancer is periodic mammography, which is an x-ray of the breast that can show tumors before they are large enough to feel. High-quality studies called clinical trials have shown that screening women in their 50s and 60s decreases breast cancer deaths. However, the point at which women can safely stop screening because it no longer decreases breast cancer deaths has not been studied. More than half of women in the United States continue screening mammography after age 75 years.  (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, University of Pennsylvania / 20.02.2020

MedicalResearch.com Interview with: Samuel Takvorian, MD, MS Instructor in the Division of Hematology and Oncology LDI Associate Professor University of Pennsylvania Perelman School of Medicine MedicalResearch.com: What is the background for this study? Response: The Affordable Care Act’s Medicaid expansions have been associated with improved access to care, affordability, and for certain surgical and medical conditions, health outcomes. However, studies have also suggested unintended consequences such as lengthened wait times, and there is continued debate about the overall impact of the expansions. (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, Cancer Research, Environmental Risks, Melanoma / 19.02.2020

MedicalResearch.com Interview with: Farhad Islami, MD PhD Scientific Director, Surveillance Research American Cancer Society, Inc  MedicalResearch.com: What is the background for this study? Response: Many cases of cutaneous melanoma (melanoma) in the United States have been attributed to ultraviolet (UV) radiation, but there was little information on the state-by-state burden of melanoma due to UV exposure. We estimated numbers, proportions and age-standardized incidence rates of malignant melanomas attributable to UV radiation in each US state by calculating the difference between observed melanomas during 2011–2015 and expected cases based on rates in a population with theoretically minimum UV exposure. As there is no population completely unexposed to UV radiation, the reference rates we used were historical melanoma incidence rates in Connecticut during 1942–1954, when the melanoma burden was low. For most adults, melanomas diagnosed in that period likely reflected UV exposure accumulated in the 1930s or earlier, when exposure was minimized by clothing style and limited recreational exposure. We estimated that 338,701 melanoma cases (91.0% of total, 372,335) in the United States during 2011–2015 were attributable to UV exposure; 94.3% of all these UV-attributable cases (or 319,412 cases) occurred in non-Hispanic whites. UV-attributable melanoma incidence rates and cases were higher among males than females, but attributable rates and cases in ages <45 years were higher among females. (more…)
ASCO, Author Interviews, Bayer, Cancer Research / 13.02.2020

MedicalResearch.com Interview with: Dr. David S. Hong MD Deputy Chair Department of Investigational Cancer Therapeutics Division of Cancer MedicineThe University of Texas MD Anderson Cancer Center Houston, TX    MedicalResearch.com: What is the background for this study? What are the main findings?
  • A rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion is a primary oncogenic driver that causes TRK fusion cancer, which has been found in a variety of common tumor types, including GI cancers such as colon, cholangiocarcinoma, pancreatic, and appendiceal cancers. In patients with gastrointestinal (GI) cancer, including pancreatic cancer and colorectal cancer, NTRK gene fusions are estimated to have a frequency of ~0.3%.
  • Larotrectinib is an oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion. Under the brand name Vitrakvi®, it is the first and only approved TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion with approval in the US in 2018 and other worldwide markets in 2019.
  • At ASCO GI 2020, we presented results of a new analysis of the efficacy and safety of larotrectinib specifically in patients with TRK fusion with gastrointestinal cancers, which is an often underdiagnosed patient group. The subset included 14 adult patients with GI tumor types with NTRK gene fusions, including colon, cholangiocarcinoma, pancreas, appendix and hepatic; of the eight patients with colon cancer, seven were microsite instability (MSI)-high.
  • In this subset of patients, the overall response rate (ORR) was 43%. Additionally, median overall survival was 33.4 months at 19 months of follow-up (range 2.8–36.5), median progression-free free survival (PFS) was 5.3 months (range 2.2-9.0) and median time to response was 1.8 months (range 1.7-2.1). In colon cancer patients, the ORR was 50% and the median PFS ranged from 1.5+ to 16.7+ months. 
(more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, Gender Differences, JAMA, Melanoma / 12.02.2020

MedicalResearch.com Interview with: Arash Mostaghimi, MD, MPA, MPH Director, Inpatient Dermatology , Brigham and Women's Hospital Instructor, Harvard Medical School Department of Dermatology Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Smaller studies have demonstrated increased risk for skin cancer among gay men.  Prior to this study this data had not been confirmed in a nationally representative database. (more…)
ASCO, Author Interviews, Bayer, Cancer Research / 11.02.2020

MedicalResearch.com Interview with: bayer-pharmaceuticalsDr. Kirhan Ozgurdal Global Medical Affairs Physician Oncology, Bayer MedicalResearch.com: What is the background for this study? What are the main findings?
  • Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis, oncogenesis, metastasis and tumor immunity. It is approved for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The safety and effectiveness of regorafenib is being evaluated in patients with unresectable hepatocellular carcinoma (uHCC),a liver tumor not eligible for curative treatment approaches such as surgery, given the extent of disease.
  • Following the Phase 3 RESORCE trial, which showed that regorafenib significantly improves overall survival versus placebo in patients with uHCC who progressed on prior sorafenib therapy, we conducted an interim analysis (the first 500 of 1000 patients) of the global REFINE observational trial to evaluate the safety and effectiveness of regorafenib in uHCC in the real-world setting.
  • The REFINE study shows a more varied patient population than the Phase 3 RESORCE trial, including a higher proportion of patients with ECOG performance status ≥1, and a higher proportion with Child–Pugh B liver function.
  • The incidence of regorafenib-related grade ≥3 treatment-emergent adverse events were lower than that reported in the RESORCE trial, possibly indicating improved adverse event management with the use of regorafenib in clinical practice.
  • The median overall survival was longer than that reported in RESORCE, but the proportion of censored patients was high in this interim analysis; the median progression free survival was similar to that reported in RESORCE.
(more…)
Author Interviews, Cancer Research, CT Scanning, Lung Cancer / 04.02.2020

MedicalResearch.com Interview with: Carlijn M. van der Aalst, Ph.D. MPH Department of Public Health Erasmus MC MedicalResearch.com: What is the background for this study? Response: Lung cancer is the leading cause of cancer-related mortality among both men and women. About 70% of patients with lung cancer are diagnosed with advanced disease, which results in only 15% surviving five years. About 70% of patients with lung cancer are diagnosed with advanced disease, a stage in which cure is problematic. This results in only 15% surviving five years. Although quit smoking is most effective in preventing lung cancer, about half of all lung cancers are currently diagnosed in former smokers, who remain at high risk for decades after quitting smoking. The National Lung Screening Trial (NLST; U.S.) reported a 20% lung cancer-related mortality reduction and a 6.7% reduction in all-cause mortality for CT screening compared with chest radiography screening for lung cancer in 53,454 enrolled subjects at high risk for lung cancer.1 As a consequence, the United States Preventive Services Task Force (USPSTF) requested an independent review and a modelling study. Based on these NLST data, an efficient strategy with a reasonable harm-benefit ratio could be established, resulting in the recommendation to annually screen persons aged 55-80 with ≥30 pack-years of smoking history, who currently smoke or quit smoking <15 years ago. However, data of only one trial provides limited evidence and more trial data are needed. NELSON is the second largest lung cancer screening trial that is adequately designed to provide the evidence that is needed to conclude whether CT screening can reduce lung cancer mortality. (more…)
Author Interviews, Cancer Research, Colon Cancer, Gastrointestinal Disease, JAMA / 03.02.2020

MedicalResearch.com Interview with: Jordan J. Karlitz, MD Staff Gastroenterologist Southeast Louisiana Veterans Health Care System Associate Professor, Division of Gastroenterology Director, GI Hereditary Cancer and Genetics Program, Tulane University School of Medicine MedicalResearch.com: What is the background for this study? Response: Currently, there is debate over whether average-risk colorectal cancer screening should begin at age 45 or 50. Given this controversy, we sought to conduct a colorectal cancer incidence rate analysis by yearly-age, as opposed to age range blocks (i.e. 30-39, 40-49 etc.) as has been done in the past. We believed that this type of "high definition" analysis would allow a better understanding of incidence rates of those approaching or at screening in age.  We were particularly interested in the transition from age 49 to 50 as this is when average risk screening has historically been recommended.  (more…)