Author Interviews, Cancer Research, Coffee / 21.07.2019

MedicalResearch.com Interview with: coffee-smell caffeineMr Jue Sheng Ong,  PhD Student  QIMR Berghofer’s Statistical Genetics Group MedicalResearch.com: What is the background for this study? Response: Previous findings have shown conflicting results on whether coffee is associated with cancer risk. To evaluate whether there’s any evidence for a causal relationship between coffee and cancer outcomes, we performed two types of association analyses using data from the half a million participants in the UK.
  • We first studied whether an individual’s self-reported coffee consumption is related to their overall risk of developing or dying from any cancers.
  • Then, we repeated the analyses using genetically predicted coffee intake (using about 35 genetic markers related with coffee intake) instead of their self-reported consumption: a technique known as mendelian randomization which is commonly used in modern epidemiology to remove bias from environmental confounders.
Using both techniques, we found no evidence to support a relationship between coffee consumption and the risk of developing or dying from cancers. (more…)
Author Interviews, Cancer Research, ENT, JAMA, Surgical Research / 18.07.2019

MedicalResearch.com Interview with: Megan Rist Haymart MD Associate Professor Metabolism, Endocrinology and Diabetes Clinic Michigan Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Thyroid cancer is a common malignancy with surgery considered one of the primary treatments. Complications from thyroid surgery can lead to long-term voice problems. However, few studies have used validated scales to quantify the impact of thyroid surgery on patient voice. Prior work has largely focused on single institution studies with high volume surgeons or claims data with reports of specific nerve injury. We surveyed a diverse cohort of patients affiliated with SEER sites Georgia and Los Angeles to identify the prevalence, severity and correlates of poor voice outcomes following surgery for differentiated thyroid cancer. We found that out of 2,325 patients 25.8% reported voice changes lasting greater than 3 months after surgery, 12.7% had abnormal voice per a validated voice scale (Voice Handicap Index- 10), and 4.7% reported a diagnosis of vocal fold motion impairment. We also identified patient factors associated with abnormal voice 2-4 years post op. (more…)
Author Interviews, Cancer Research, Hormone Therapy, JAMA, Prostate Cancer, University of Pennsylvania / 15.07.2019

MedicalResearch.com Interview with: Ravi Jayadevappa, PhD, MS Department of Medicine Perelman School of Medicine University of Pennsylvania Philadelphia, PA 19104-2676  MedicalResearch.com: What is the background for this study? Response: In the US, prostate cancer is the most commonly diagnosed non-skin cancer and the second leading cause of cancer death among men. Research shows that hormone therapy or ADT reduces the levels of male hormones in the body, called androgens, to stop them from stimulating cancer cells to grow., and thus is effective in reducing the spread and progression of prostate cancer. At the same time, some research has suggested that decreasing androgen levels may increase the risk factors for Alzheimer’s and dementia, including loss of lean body mass, diabetes, cardiovascular disease, and depression. The ADT therapy may lead to impaired neuron growth and the regeneration of axons, thus affecting the cognitive function. Thus there is growing interest in the possible association between exposure to ADT and cognitive dysfunction. Our study investigates the association between exposure to ADT and subsequent diagnosis of Alzheimer’s or dementia in elderly, fee-for-service Medicare enrollees using SEER-Medicare linked databases. (more…)
Author Interviews, Cancer Research, Outcomes & Safety, Surgical Research, Yale / 12.07.2019

MedicalResearch.com Interview with: Daniel Boffa, MD Professor of Surgery Yale School of Medicine  MedicalResearch.com: What is the background for this study? Response: We have previously demonstrated that top-ranked hospitals are significantly safer than their affiliates for complex cancer surgery (patients 1.4 times more likely to die after cancer surgery at affiliate hospitals).  A logical extension of this work was to compare affiliate hospitals to hospitals that were not affiliated with a top ranked hospital. (more…)
Author Interviews, Cancer Research, JAMA / 03.07.2019

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: In the United States, cancer is the second leading cause of death, and premature cancer deaths impose significant economic burden. Contemporary information on the economic burden of cancer mortality can inform policies and help prioritize resources for cancer prevention and control, but this information is lacking. In our study, we provide contemporary estimates for the loss of future earnings (lost earnings) due to cancer death at national and state levels for all cancers combined and for major cancers. (more…)
Author Interviews, Cancer Research, Pediatrics, Technology / 02.07.2019

MedicalResearch.com Interview with: atomwiseAbraham Heifets, PhD Department of Computer Science University of Toronto  MedicalResearch.com: What is the background for this announcement? How many children and adolescents are affected by pediatric cancer? Response: Cancer is diagnosed in more than 15,000 children and adolescents each year. Many cancers, including pediatric cancer, do not have effective treatments and for those that do, it is estimated that 80% have serious adverse effects that impact long-term health.  (more…)
AACR, Author Interviews, CT Scanning, Lung Cancer / 28.06.2019

MedicalResearch.com Interview with: Barbara Nemesure, PhD Professor, Department of Family, Population and Preventive Medicine Division Head, Epidemiology and Biostatistics Director, Cancer Prevention and Control Program Director, Lung Cancer Program, Stony Brook Cancer Center Renaissance School of Medicine Stony Brook University    MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lung cancer is the most common cause of cancer death, claiming the lives of more than 150,000 people in the United States each year. While lung nodules are not uncommon, it has remained a challenge to differentiate those that will progress to cancer and those that will remain benign. Although numerous risk prediction models for lung cancer have been developed over the past 2 decades, the majority have been based on retrospective analyses or high risk groups with a strong history of tobacco use. To date, there have been a limited number of large-scale, prospective studies evaluating risk that a nodule will convert to cancer in the general population. This investigation aimed to construct a population-based risk prediction model of incident lung cancer for patients found to have a lung nodule on initial CT scan. The derived model was determined to have high accuracy for predicting nodule progression to cancer and identified a combination of clinical and radiologic predictors including age, smoking history (pack-years), a personal history of cancer, the presence of chronic obstructive pulmonary disease (COPD), and nodule features such as size, presence of spiculation and ground glass opacity type. When compared to patients in the low risk category, those defined as high risk had more than 14 times the risk of developing lung cancer. Quantification of reliable risk scores has high clinical utility, enabling physicians to better stratify treatment plans for their patients.      (more…)
Author Interviews, JAMA, Prostate, Prostate Cancer, Urology / 25.06.2019

MedicalResearch.com Interview with: Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Men’s choice of whether to undergo screening is value and preference sensitive: fully informed men will make different choices depending on their experience and perspective. For such decisions, shared decision-making represents an ideal approach to decision making. In shared decision-making both the patient and health care provider contribute to the medical decision-making process. The health care provider explains alternatives to patients, informs them of the best evidence regarding the anticipated consequences of a decision for or against the intervention, and helps them choose the option that best aligns with their preferences. All major guidelines of prostate cancer screening acknowledge the importance of informing men about risks and benefits of PSA screening. Shared decision-making is challenging because it requires time, knowledge, and specific skills. Prostate cancer screening decisions aids may, by summarizing the current best evidence and by supporting conversations that address what matters most to men, address these challenges. The impact of decision aids on the decision-making process is, however, uncertain. We therefore undertook a systematic review and meta-analysis of the randomized trials that have addressed the impact of decision aids in the context of prostate cancer screening.  (more…)
ASCO, Author Interviews, Biomarkers, Colon Cancer / 24.06.2019

MedicalResearch.com Interview with: Lawrence LaPointe, Ph.D. Chief Innovation Officer Clinical Genomics Bridgewater, New Jersey  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Colorectal cancer is a cancer of the colon and the rectum. The American Cancer Society estimates that about 1 in 21 men and 1 in 23 women in the United States will develop colorectal cancer during their lifetime. This disease is the second leading cause of cancer death in women, and the third for men. Colorectal cancer has a high 5-year recurrence rate and most likely is spread to the liver and lungs. Clinical Genomics has two decades of experience striving to save lives and reduce costs by developing easy-to-use tests for the detection of colorectal cancer. With breakthrough diagnostic tools, the company aims to offer affordable and accurate tests, supporting physicians and patients with potential life-saving knowledge about colorectal cancer. On June 3, 2019, Clinical Genomics presented research detailing breakthrough methods of colorectal cancer recurrence monitoring at the American Society of Clinical Oncology (ASCO) annual meeting in the McCormick Place Convention Center, Chicago.  (more…)
Author Interviews, Cancer Research, Genetic Research, Pediatrics / 24.06.2019

MedicalResearch.com Interview with: Philip J. Lupo, PhD, MPH Co-Director, Childhood Cancer Epidemiology and Prevention Program, Texas Children's Cancer Center Associate Professor, Department of Pediatrics Section of Hematology-Oncology, Member, Dan L. Duncan Comprehensive Cancer Center Baylor College of Medicine Adjunct Associate Professor, Human Genetics Center, Division of Epidemiology, Human Genetics and Environmental Sciences University of Texas School of Public Health   MedicalResearch.com: What is the background for this study?   Response: While cancer risk in children with certain chromosomal defects like Down syndrome is well established, much less is known for children with birth defects where there is no known genetic cause, sometimes called non-chromosomal defects. Non-chromosomal defects, as a group, affect more children, but one of the primary challenges of understanding risk among these children is that limited sample sizes make studying specific defects, like spina bifida, more difficult. Because of that, we gathered data from birth, birth defect, and cancer registries across Texas, Arkansas, Michigan, and North Carolina to generate a birth cohort of more than 10 million children born between 1992 and 2013. We looked at diagnoses of cancer until 18 years of age to determine differences in cancer risk between those with and without birth defects. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pain Research / 21.06.2019

MedicalResearch.com Interview with: Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program Class of 2020 Ichan School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Chronic pain is one of the common side effects of cancer treatments and it has been linked to low life quality, lower adherence to treatment, higher medical cost. As the population of cancer survivors grows rapidly, chronic pain will be a major public health issue in this population. We know from previous studies that chronic pain is common in certain cancers such as breast cancer. However, little was known about the epidemiology of chronic pain in the cancer survivors until our study. (more…)
Author Interviews, Environmental Risks, Genetic Research, Prostate Cancer / 20.06.2019

MedicalResearch.com Interview with: Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology Icahn School of Medicine at Mount Sinai Asociate director for Population Science Tisch Cancer Institute  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: An excess incidence of prostate cancer has been identified among World Trade Center responders. We wanted to study if this excess was associated with exposure to WTC dust The results suggest that respiratory exposure to WTC dust can induce inflammatory and immune responses in prostate tissue. Chronic inflammation could facilitate prostate cancer development Taken together, our results suggest that World Trade Center prostate cancer cases have a distinct gene expression pattern that may be the result of exposure to specific carcinogens during the WTC attacks. WTC dust-exposed rat prostate displayed unique changes in gene expression and immune cell infiltrates after acute dust exposure, suggesting that the effect of exposure may be measured locally in target organs such as prostate. In addition, some of the genes overexpressed in rat normal prostates as a consequence of exposure are also overexpressed in human prostate cancer tissues, suggesting a link between exposure, local immune dysregulation, and prostate cancer development (more…)
Author Interviews, Cancer Research, Lung Cancer / 19.06.2019

MedicalResearch.com Interview with: Thomas A. Quinn, DO, FAOCOPM Clinical Professor Lake Erie College of Osteopathic Medicine Bradenton  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Canine scent detection of lung cancer is showing evidence of being an effective, safe and cost effective method of early detection of lung as well as other types of cancer. Lung cancer is the leading cause of cancer deaths and early detection has proven to be one of the most effective ways to reduce the mortality and morbidity of this deadly disease.  In a collaborative study conducted by the Lake Erie College of Osteopathic Medicine (LECOM) and BioScentDX, a canine training and research facility, we were able to show that highly trained dogs can detect non-small cell cancer of the lung by scent alone.  For this study we chose to use Beagles because of their superior scent capability as well as their temperament, sociability and easy trainability.  The dogs proved to be able, in this double blind study, to detect lung cancer in blood serum with a 96.7% sensitivity and a 97.5% specificity. The dogs underwent an eight-week training program using the clicker/treat training method.  We trained four Beagles for this study but one of the dogs did not respond well to the training methods and had to be removed from the program. That dog was retrained as a service dog for a handicapped child. (more…)
Author Interviews, Chemotherapy, Leukemia / 18.06.2019

MedicalResearch.com Interview with: Dr. Carlos Buesa PhD Chief Executive Officer Oryzon Genomics  MedicalResearch.com: What is the background for this study? Response: Lysine specific demethylase 1 (LSD1, also known as KDM1A) is a histone modifying enzyme that removes methyl groups, thereby regulates the expression of many genes important in cancer progression and cell proliferation. Aberrant expression of LSD1 has been shown in many types of cancers. In particular, LSD1 expression is upregulated in bladder, small cell lung (SCLC), and colorectal clinical cancer tissues when compared with the corresponding nonneoplastic tissues. LSD1 has also been shown to be overexpressed in some breast cancers and may function as a biomarker of the aggressiveness of the disease. However, the function of LSD1 is most understood in acute leukemia, particularly Acute Myeloid Leukemia and Acute Lymphoblastic leukemia. LSD1 is crucial for the function and maintenance of the leukemic stem cells, a subset of malignant cells that is believed to be the ultimate reason for relapse in these patients. LSD1 inhibition might be a therapeutic solution to avoid those relapses. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lung Cancer, Radiation Therapy / 10.06.2019

MedicalResearch.com Interview with:   Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Radiation Oncology Brigham and Women's Hospital       Katelyn M. Atkins MD PhD Harvard Radiation Oncology Program Dana-Farber Cancer Institute Brigham and Women’s Hospital Boston, Massachusetts     MedicalResearch.com: What is the background for this study? What are the main findings? 
  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).
(more…)
Author Interviews, Brigham & Women's - Harvard, Prostate Cancer, Weight Research / 10.06.2019

MedicalResearch.com Interview with: Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study. (more…)
Allergies, Author Interviews, Cancer Research, Immunotherapy / 07.06.2019

MedicalResearch.com Interview with: Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections Department MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited  on the safety of resuming treatment after such an event. We  studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with  irAE grade 2 or higher for whom the  rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence. (more…)
ASCO, Author Interviews, Cancer Research, Cost of Health Care, Race/Ethnic Diversity / 06.06.2019

MedicalResearch.com Interview with: Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health MedicalResearch.com: What is the background for this study? Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees. Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis. This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates. (more…)
Author Interviews, Bayer, Biomarkers, Colon Cancer / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). This prospective pharmacokinetic (PK) ancillary study is part of a prospective phase II study evaluating treatment response with regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) called TEXAN, which aimed to investigate correlations between overall survival (OS) and regorafenib, or its enterohepatic cycle-dependent active metabolites M-2 and M-5 concentrations. As measured by LC-MS/MS, the main findings showed that regorafenib, M-2 and M-5 were respectively 1.99 (1.03-2.73), 1.44 (0.89-2.49) and 1.61 (0.79-2.37) mg/L during the first cycle at day 15 (C1D15) and 1.90 (1.10-2.76), 1.29 (0.77-2.24) and 1.17 (0.45-2.42) mg/L at during the second cycle at day 15 (C2D15).  (more…)
ASCO, Author Interviews, Bayer, Leukemia, Pediatrics / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI). The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML). At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.  (more…)
ASCO, Author Interviews, Education, Gender Differences, Surgical Research / 04.06.2019

MedicalResearch.com – Responses Marina Stasenko, MD Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians. Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology. (more…)
ASCO, Author Interviews, Bayer, Cancer Research, Pediatrics / 03.06.2019

MedicalResearch.com Interview with: Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine MedicalResearch.com: What is the background for this study? Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway. At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting.  (more…)
Author Interviews, Cancer Research, Prostate Cancer / 03.06.2019

MedicalResearch.com Interview with: Julie N. Graff, MD Associate Professor of Medicine Knight Cancer Institute Chief of Hematology/Oncology VA Portland Health Care System MedicalResearch.com: What is the background for this study? Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival. The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint.  (more…)
ASCO, Author Interviews, Cancer Research, J&J-Janssen, Leukemia / 03.06.2019

MedicalResearch.com Interview with: Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute  MedicalResearch.com: What is the background for this study?   Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies. Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results. (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Novartis / 03.06.2019

MedicalResearch.com Interview with: Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. MedicalResearch.com: What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 
  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. 
(more…)
ASCO, Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, Radiation Therapy / 03.06.2019

MedicalResearch.com Interview with: Manjeet Chadha, MD, MHA, FACR, FASTRO Prof. Radiation Oncology Director of the Department of Radiation Oncology Mount Sinai Downtown  MedicalResearch.com: What is the background for this study? Response: Largely, the goal of cancer care among the elderly is to de-escalate therapy searching for a modality that is both an effective treatment and also associated with minimal toxicity. Approximately, 30% of new breast cancers diagnosed annually are among women older than 70 years of age. Age-adjusted trends note a relatively higher incidence of stage I breast cancer in women between the ages of 70-74 years. For this group of patients, it is imperative that we take a closer look at the evidence-base for our current practice standards, and evaluate opportunities to improve cancer care delivery in the elderly. Randomized trials have helped arrive at an acceptance of adjuvant endocrine monotherapy in older patients with ER positive, node negative breast cancer. However, in the older patients high rates of non-compliance to tamoxifen secondary to poor tolerance is widely recognized. Emerging data also detail the side effect profile of aromatase inhibitors. Most commonly observed symptoms of arthralgia, reduced bone mineral density, and increased risk of fractures throughout the duration of treatment are important considerations for an older population. At least a quarter of patients on aromatase inhibitors discontinue therapy specifically due to skeletal events and musculoskeletal symptoms. Overall, the side effects of ET contribute to a high rate of non-compliance and negative impact on patients’ quality of life. (more…)
ASCO, Author Interviews, Biomarkers, Melanoma, NYU / 02.06.2019

MedicalResearch.com Interview with: David Polsky, MD, PhD Dermatologist and Director of the Digmented Lesion Service Mahrukh M. Syeda, MS Research Associate Ronald O. Perelman Department of Dermatology NYU Langone Health MedicalResearch.com: What is the background for this study? Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any. In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma. Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial. (more…)
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…)