ASCO, Author Interviews, Cancer Research, J&J-Janssen, NEJM, Prostate Cancer / 01.06.2019

MedicalResearch.com Interview with: Dr. Kim Chi. MD Professor of Medicine Medical Oncologist and Medical Director at BC Cancer – Vancouver University of British Columbia, Principal Investigator of the TITAN Study. MedicalResearch.com: What is the background for this study? Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS).  (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 19.05.2019

MedicalResearch.com Interview with: Nina Niu Sanford, M.D.  Assistant Professor UT Southwestern Department of Radiation Oncology Dallas TX 75390  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that we know cancer survivors are at risk for uninsurance or underinsurance and the most commonly cited reason for this is cost of insurance.  However, there have been no prior studies assessing from the patient perspective the reasons for not having insurance. In addition, there has been further recent controversy over the Affordable Care Act, including threats from the current administration to dismantle it.  Thus assessing the impact of the ACA among at risk populations including cancer survivors is timely. (more…)
Author Interviews, Cancer Research, HPV, Urology / 13.05.2019

MedicalResearch.com Interview with: Lael SReinstatler, MD, MPH. PGY 4 Urology Residency Dartmouth Hitchcock MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Human Papillomavirus is an oncogenic virus associated with other genitourinary cancers including penile cancer. HPV is detectable in urine and in urethral swabs and it interacts with stratified squamous epithelium which lines the majority of the genitourinary tract. Prior research has identified HPV in bladder tumors but detection methods are inconsistent. In this study, we looked for an association with HPV serology (indicating prior HPV systemic exposure) and bladder cancer. (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer, JAMA, Karolinski Institute / 13.05.2019

MedicalResearch.com Interview with: Louise Olsson MD PhD Senior researcher Department of Molecular Medicine and Surgery Colorectal Surgery Karolinski Institute Stockholm, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I read a very interesting paper back in 2006 “Detection and quantification of mutation in the plasma of patients with colorectal cancer”. Only some 60 % of patients with early colorectal cancer were detectable in this way whereas patients with stage IV disease all had a high concentration of APC mutations in their plasma. So the prospects of using the method for example, screening of primary colorectal cancer seemed limited but I thought wow, this is the test to detect recurrences and generalized disease during follow-up after surgery for colorectal cancer. After some discussion we started to collect plasma samples from patients at the hospital where I worked and that´s how my research began. (more…)
Author Interviews, Cancer Research, Environmental Risks, University Texas, Urology / 08.05.2019

MedicalResearch.com Interview with: Stephen B. Williams, MD, FACS Chief, Division of Urology Associate Professor, Urology and Radiology Robert Earl Cone Professorship Director of Urologic Oncology Director of Urologic Research Co-Director Department of Surgery Clinical Outcomes Research Program University of Texas Medical Branch at Galveston MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite prior studies evaluating cancer in those living near and working in oil refineries, there remains a gap in knowledge regarding proximity to oil refineries and risk of bladder cancer. Aromatic amines have been associated with increased risk of various cancers including bladder cancer. Texas is a home to the largest numbers of oil refineries in the US. Our goal was to evaluate if there was a link between bladder cancer and living in close proximity to an oil refinery in Texas. Our data did suggest that living within 10 miles of an oil refinery was associated with a small increase in risk of bladder cancer. These data support further research to validate these findings. (more…)
Author Interviews, Cancer Research, Colon Cancer, JAMA / 07.05.2019

MedicalResearch.com Interview with: Prof. Dr. med. Hermann Brenner Clinical Epidemiology and Aging Research Division Head German Cancer Research Center Foundation under Public Law Germany  MedicalResearch.com: What is the background for this study? Response: Colorectal cancer is the third most common cancer globally, accounting for almost 900.000 deaths every year. Most of these deaths could be prevented by screening colonoscopy with early detection and removal of precursors of the cancer. However, capacities and use of screening colonoscopy are limited in most parts of the world, and low-cost but reliable noninvasive screening tests are important alternative primary screening tests. The currently best established noninvasive tests are fecal immunochemical tests for hemoglobin (FITs) which are offered for colorectal cancer screening in an increasing number of countries. Although FITs detect the majority of colorectal cancers they detect approximately one out of four advanced adenomas only, the precursors of most colorectal cancers. We hypothesized that this proportion could be increased by taking a single pill of aspirin two days prior to collecting the stool sample for FIT, because the well-established antithrombotic effects of aspirin might favor detecting occult bleeding from colorectal cancer or its precursors. (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA, Technology / 30.04.2019

MedicalResearch.com Interview with: Steven J.M. Jones, Professor, FRSC, FCAHS Co-Director & Head, Bioinformatics Genome Sciences Centre British Columbia Cancer Research Centre Vancouver, British Columbia, Canada and Jasleen Grewal, BSc.Genome Sciences CentreBritish Columbia Cancer Research CentreVancouver, British Columbia, CanadaJasleen Grewal, BSc. Genome Sciences Centre British Columbia Cancer Research Centre Vancouver, British Columbia, Canada MedicalResearch.com: What is the background for this study? Response: Cancer diagnosis requires manual analysis of tissue appearance, histology, and protein expression. However, there are certain types of cancers, known as cancers of unknown primary, that are difficult to diagnose based purely on their appearance and a small set of proteins. In our precision medicine oncogenomics program, we needed an accurate approach to confirm diagnosis of biopsied samples and determine candidate tumour types for where the primary site of the cancer was uncertain.  We developed a machine learning approach, trained on the gene expression data of over 10,688 individual tumours and healthy tissues, that has been able to achieve this task with high accuracy. Genome sequencing offers a high-resolution view of the biological landscape of cancers. RNA-Seq in particular quantifies how much each gene is expressed in a given sample. In this study, we used the entire transcriptome, spanning 17,688 genes in the human genome, to train a machine learning method for cancer diagnosis. The resultant method, SCOPE, takes in the entire transcriptome and outputs an interpretable confidence score from across a set of 40 different cancer types and 26 healthy tissues.  (more…)
Author Interviews, Cancer Research, JAMA, MD Anderson, Radiation Therapy / 30.04.2019

MedicalResearch.com Interview with: Quynh-Nhu Nguyen, MD Department of Radiation Oncology The University of Texas MD Anderson Cancer Center Houston MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This is the first non-spine bone metastases trial comparing higher dose single fraction radiotherapy vs multifraction standard fractionated radiotherapy for patients with painful bone metastases. The results of this trial demonstrated more durable pain relief and superior local control for patients treated in the higher dose(12 Gy-16 Gy)  single fraction RT compared to standard 30 Gy/10 fractions multifractionated regimen.  This trial supports the previous multiple randomized trials which recommend single fraction should be standard palliative radiotherapy regimen for bone metastases.  This trial is unique in that it addressed previous criticism that single fraction does not provide durable palliation with lower 8 gy single fraction and result in higher re-irradiation rates.  This trial on the contrary with the utilization of modern radiotherapy techniques, demonstrated we can safely and more effectively deliver a higher single fraction radiotherapy regimen for improvement in the quality of life for patients.  This higher dose should be the new standard single fraction regimen for patients who are functional and have a longer life expectancy.  (more…)
Author Interviews, Cancer Research, CMAJ, Emergency Care / 29.04.2019

MedicalResearch.com Interview with: Keerat Grewal, MD, MSc, FRCPC Schwartz/Reisman Emergency Medicine Institute Mount Sinai Hospital Toronto, ON  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Patients with cancer have complex care requirements and often use the emergency department. The purpose of our study was to determine whether continuity of care, cancer expertise, or both, impact outcomes among cancer patients in the emergency setting. Using administrative data we looked at adult patients with cancer who received chemotherapy or radiation therapy in the 30 days prior to an emergency department visit.  (more…)
Author Interviews, Cancer Research, Colon Cancer, Genetic Research, Surgical Research / 22.04.2019

MedicalResearch.com Interview with: Valentine N. Nfonsam, MD, MS, FACS Associate Professor of Surgery Program Director, General Surgery Residency Colon and Rectal Surgery Division of Surgical Oncology University of Arizona, Tucson  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The overall incidence of colon cancer in the United states has gone down in the last few decades. However, there has been a significant increase in the incidence of sporadic colon cancer is young patients (<50 years old). The etiology of this phenomenon is likely multi-factorial. These young patients do present with more advanced disease and with aggressive features. We demonstrated in our study that the colon cancer tumor biology was different between young and older patients. We also singled out a particular gene, Cartilage oligomeric Matrix Protein (COMP) which was significantly over-expressed in young patients and demonstrated its role in cancer proliferation and metastasis and also its potential as a prognostic biomarker since we were able to detect it in plasma. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA, Radiation Therapy, Technology / 19.04.2019

MedicalResearch.com Interview with: Raymond H Mak, MD Radiation Oncology Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? 
  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be
(more…)
Author Interviews, Cancer Research, JAMA, Pain Research / 19.04.2019

MedicalResearch.com Interview with: Robert C. Miller, MD, MS, MBA Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida University of Maryland School of Medicine, Baltimore MedicalResearch.com: What is the background for this study? What are the main findings? Response: "Magic Mouthwash" is one of the most commonly prescribed medications for oral mucositis pain during cancer therapy, but there has not been good evidence in the past to support its use. This trial is the first large randomized controlled trial to demonstrate that both "Magic" mouthwash and doxepin rinse reduce patient reported pain during cancer therapy. (more…)
Author Interviews, Cancer Research, Race/Ethnic Diversity / 18.04.2019

MedicalResearch.com Interview with: Farhad Islami, MD PhD Scientific Director, Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303  MedicalResearch.com: What is the background for this study? Response: Despite a continuous decline in cervical cancer incidence rates, earlier studies reported an increase in cervical adenocarcinoma incidence rates. However, those reports had major limitations, as they did not account for changes in hysterectomy prevalence and used cancer occurrence data covering only 10%-12% of the U.S. population (which may not be representative of the entire population, especially racial/ethnic minorities). Further, the most recent study examined the trends by age and histology through 2010. We examined contemporary trends in cervical cancer incidence rates in the U.S. (1999-2015) by age, race/ethnicity, major histological subtypes, and stage at diagnosis using up-to-date nationwide data after accounting for hysterectomy prevalence. (more…)
Author Interviews, Cancer Research, Genetic Research / 18.04.2019

MedicalResearch.com Interview with: Rachid Karam, PhD Director, Ambry Translational Genomics Lab Ambry Genetics  MedicalResearch.com: What is the background for this study? Response: DNA genetic testing (DGT) for hereditary cancer genes is now a well accepted clinical practice; however, the interpretation of DNA variation remains a challenge to laboratories and medical providers. RNA genetic testing (RGT) as a supplement to DGT is a means to clarify the clinical actionability of variants in hereditary cancer genes, improving our ability to accurately apply known strategies for cancer risk reduction. (more…)
Author Interviews, Cancer Research, Health Care Systems, JAMA, Outcomes & Safety, Surgical Research, Yale / 12.04.2019

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prominent cancer hospitals have been sharing their brands with smaller hospitals in the community.  We conducted a series of nationally representative surveys and found that a significant proportion of the U.S. public assumes that the safety of care is the same at all hospitals that share the same respected brand.  In an effort to determine if safety was in fact the same, we examined complex surgical procedures in the Medicare database. We compared the chance of dying within 90 days of surgery between top-ranked hospitals, and the affiliate hospitals that share their brands.  When taking into account differences in patient age, health, and type of procedure, Medicare patients were 1.4 times more likely to die after surgery at the affiliate hospitals, compared to those having surgery at the top-ranked cancer hospitals. (more…)
Author Interviews, Cancer Research, JAMA, UT Southwestern / 11.04.2019

MedicalResearch.com Interview with: Nina Niu Sanford, M.D. Assistant Professor UT Southwestern Department of Radiation Oncology Dallas TX 75390 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There has been increasing interest in use of complementary and alternative medicine in the oncology population – both in terms of its potential efficacy and harms. The main finding of this study is that approximately 1/3 of cancer patients and survivors self-reported using complementary or alternative medicine over the past year, the most common being herbal supplements. Of these patients, approximately 1/3 did not disclose to their physicians that they were doing so. (more…)
Author Interviews, Cancer Research, JAMA, Vitamin D / 09.04.2019

MedicalResearch.com Interview with: Mitsuyoshi Urashima MD, PhD, MPH Professor of Molecular Epidemiology Jikei University School of Medicine Tokyo, JAPAN MedicalResearch.com: What is the background for this study?   Response: Serum levels of vitamin D, increase in response to exposure to sunlight, a vitamin D-rich diet, or vitamin D supplementation. In 1989, the risk of colon cancer was estimated to be 70% lower in people with serum vitamin D levels ≥ 20 ng/mL, compared with those < 20 ng/mL. In a cohort study, higher vitamin D levels were associated with lower total cancer incidence and lower total cancer mortality, particularly digestive system cancer mortality. However, because of the studies’ observational nature, whether lower levels of vitamin D is merely a precursor to relapse and death or causally related to shorter survival cannot be determined. To clarify this, a randomized, double-blind, placebo-controlled trial using vitamin D supplement was performed in patients with digestive tract cancer from esophagus to rectum; this is the first trial designed to evaluate the effect of vitamin D on survival of these patients.  (more…)
Author Interviews, Cancer Research, Genetic Research / 08.04.2019

MedicalResearch.com Interview with: Eunhee Yi, Ph.D. Postdoctoral Associate The Jackson Laboratory MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Recurrence after therapy for glioblastoma (GBM) is unavoidable. There are substantial differences among the cells of GBM tumors in the abundance and types of genetic materials. This heterogeneity is a major driver of therapy failure and disease progression. We previously reported that extrachromosomal DNA (ecDNA) elements, which reside outside the linear genome and represent a mechanism to amplify and activate oncogenes, is a potential cause of the increasing genetic diversity in GBM. Our current study is focused on the development of a novel cytogenetic tool to visualize ecDNA to visualize the behavior of these elements in live cells. We have leveraged the unique properties of ecDNA to develop a CRISPR-based “ecDNA tracing toolbox (EDTB)”.  (more…)
AACR, Author Interviews, Breast Cancer, Cancer Research, Surgical Research / 08.04.2019

MedicalResearch.com Interview with: Sharon S. Lum, MD, FACS, Professor Department of Surgery-Division of Surgical Oncology Medical Director of the Breast Health Center Loma Linda University Health Loma Linda University School of Medicine  MedicalResearch.com: What is the background for this study?   Response: Anecdotally, we observed that many patients with advanced HER2+ breast cancer have had tremendous responses to the new targeted therapies and the oncologists were referring them back to surgeons for consideration of local regional therapy. While traditionally surgeons have avoided operating on metastatic breast cancer patients due to the patient’s likelihood of dying from their metastatic disease, these HER2+ patients seemed to be doing so well that surgery might make sense. In our surgical oncology clinic, we seemed to be operating more on these patients. Since these patients seemed to be living longer, they might survive long enough for their primary tumor to become a problem for them. However, we did not have any data to support doing surgery in these cases. Prior studies have demonstrated mixed results regarding the survival benefit from surgery for stage IV breast cancer patients, but these were completed prior to routine use of anti-HER targeted therapies, so we wanted to further examine the role of surgery in HER2+ stage IV breast cancer patients. (more…)
Author Interviews, BMJ, Cancer Research, HPV, OBGYNE, Sexual Health, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Dr. Tim Palmer Honorary Senior Lecturer Department of Pathology University of Edinburgh Edinburgh, UK  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: High risk HPV infection is the obligate cause of between 70 and 90% of cervical cancers, depending upon the country. The development of vaccines against the commonest hr-HPV types has the potential to reduce the burden of cervical cancer, especially in low and middle income countries that cannot afford screening programmes. Cervical cancer affects predominantly women in their 30s and is a major public health issue even in countries with well-established screening programmes. Scotland has had a successful immunisation programme since 2008, and women immunised at age 12 to13 have been screened since 2015. We can therefore demonstrate the effect of hr-HPV immunisation on the pre-invasive stages of cervical cancer. (more…)
AACR, Author Interviews, Cancer Research, HPV, University of Michigan, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Diane Harper, M.D., M.P.H., M.S. Professor of Family Medicine and Obstetrics and Gynecology Senior Associate Director, Michigan Institute for Clinical and Health Research Physician Director for Community Outreach, Engagement and Health Disparities, Rogel Cancer Center Michigan Medicine  MedicalResearch.com: What is the background for this study? Response: There is no current cure for women with HPV infection that has progressed to CIN 2/3 disease. The only treatment is for the diseased cervix, and does not eliminate the risk of another CIN 2/3 from the HPV infection 15-20 years later. This vaccine is made from a live virus that has 3 genes inserted:  human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins. When the vaccine is injected subcutaneously, the proteins for HPV 16/E6 and E7 and the cytokine LI-2 proteins are made. These proteins trigger the immune response.  This is very different form imiquimod which is topical and not specific for HPV. (more…)
Author Interviews, Cancer Research, FDA, JAMA / 01.04.2019

MedicalResearch.com Interview with: Emerson Chen, MD Chief Fellow, Hematology-Oncology, PGY-6 Oregon Health & Science University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many cancer drugs are approved annually giving the appearance of innovation; however, some drugs may have been approved because of a lower bar. Use of lesser endpoints like response rate (how tumor shrinks) and progression-free survival (how tumor has delayed growth) have been proposed to speed trials when compared against traditional endpoints like overall survival (how long patients might live). Using published trials that led to cancer drug approval from 2006 to 2017, we estimated how long it would take to get each of these three endpoints across all cancer drugs and indications to see how much time we could save by using these weaker but faster endpoints. We see that many trials using overall survival used less time than anticipated, and many trials using response rate or progression-free survival actually took quite a bit of time.  In part that is due to researchers needing to document the duration of the response. But, whatever the reason, the time to get each of the three endpoints is actually more similar than different, and we estimate that our current use of  these faster endpoints are saving us only 11 months compared to using only overall survival. (more…)
Author Interviews, Cancer Research, Infections, STD, Vaccine Studies / 01.04.2019

MedicalResearch.com Interview with: Lisa T. Wigfall, PhD, MCHES(R) Assistant Professor, Health and Kinesiology Texas A&M MedicalResearch.com: What is the background for this study? Response: Human papilloma virus (or HPV) is a very common sexually transmitted infection that can cause some types of cancer. These include anal, cervical, oral, penile, vaginal, and vulvar cancers. Some people such as people who are HIV-positive and men who have sex with men have a greater risk for developing HPV-associated cancers. The risk of developing anal cancer is significantly higher for men who have sex with men who are also HIV-positive. Our study included adults who were at risk for becoming HIV-positive, which included having unprotected anal sex. (more…)
Author Interviews, Cancer Research, Cannabis, End of Life Care, NYU / 28.03.2019

MedicalResearch.com Interview with: Arum Kim, MD Assistant Professor Medicine and Rehabilitation Medicine NYU School of Medicine Director of the Supportive Oncology Program Perlmutter Cancer Center MedicalResearch.com: What is the background for this study?   Response: There is increasing interest in medical marijuana and its applications for patients with cancers. Despite increasing access, little is known regarding doses of cannabinoids - specifically delta-8-tetrahydrocannabinol (delta-8-THC)  and cannabidiol (CBD), methods of drug delivery, and differences in patterns of use between cancer and non-cancer patients. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA / 28.03.2019

MedicalResearch.com Interview with: Isaac Chua MD Instructor of Medicine at Harvard Medical School Boston, Massachusetts  MedicalResearch.com: What is the background for this study?   Response: Opioids are routinely prescribed for cancer-related pain, but little is known about the prevalence of opioid-related hospitalizations for patients with cancer. Although opioid addiction among patients with cancer is estimated to be as high as 7.7%, our understanding of opioid misuse is based on small, preliminary studies. In light of the wider opioid epidemic, oncologists and palliative care clinicians frequently balance providing patients with legitimate access to opioids while protecting them and the general public from the risks of prescribing these medications. (more…)
AACR, Author Interviews, Cancer Research, Dental Research, Pancreatic, Race/Ethnic Diversity / 28.03.2019

MedicalResearch.com Interview with: Julie R. Palmer, ScD Professor, Boston University School of Medicine Associate Director, Slone Epidemiology Center at Boston University Boston, MA 02118  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since 1995, 59,000 African American women from all regions of the U.S. have participated in a Boston University research study of the health of Black women.  Study participants complete mailed or online questionnaires every two years. Our major goal is to identify modifiable risk factors for cancers and nonmalignant conditions that disproportionately affect African Americans (e.g., pancreatic cancer, early-onset breast cancer, type 2 diabetes, uterine fibroids).  The reasons for the higher incidence of pancreatic cancer in African Americans relative to non-Hispanic White women in the U.S. are unknown. I was aware that several recent studies in predominantly White populations had observed a higher incidence of pancreatic cancer in those who had reported poor oral health and wondered whether the higher prevalence of poor oral health among African Americans could play a role in their higher incidence of pancreatic cancer.  We had already asked about gum disease, periodontal disease, and adult tooth loss in several rounds of data collection. After rigorous analysis, we found that women who reported any adult tooth loss had about two times the risk of future development of pancreatic cancer compared with those who had no tooth loss and had never reported periodontal disease. The estimated risk was even greater for those who had lost five or more teeth. A similar association was observed for reports of periodontal disease, but the association was not statistically significant. (more…)
Author Interviews, Cancer Research, Genentech, Leukemia / 25.03.2019

MedicalResearch.com Interview with: Nancy Valente, M.D. VP of Global Hematology Development Genentech Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions. MedicalResearch.com: What is the background for this study? What are the main findings of the Phase III CLL14 study?  Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year. The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil. The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.  (more…)