Author Interviews, Breast Cancer, Chemotherapy, Immunotherapy / 19.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29794" align="alignleft" width="200"]Edith Perez, MD Vice President and Head of U.S. Medical Affairs Genentech BioOncology Dr. Edith Perez[/caption] Edith Perez, MD Vice President and Head of U.S. Medical Affairs Genentech BioOncology MedicalResearch.com: What is the background for this study? What are the main findings? Response: MARIANNE was designed to evaluate three HER2-targeted regimens in previously untreated (first-line) HER2-positive metastatic breast cancer (Kadcyla alone, Kadcyla plus Perjeta, Herceptin plus chemotherapy). The study met its non-inferiority endpoint, showing similar progression-free survival (PFS) among the three treatment arms. However, neither Kadcyla-containing treatment arm significantly improved PFS compared to Herceptin and chemotherapy.
Author Interviews, Cancer Research, Immunotherapy / 17.11.2016

MEDICALRESEARCH.COM INTERVIEW WITH: [caption id="attachment_29733" align="alignleft" width="160"]THOMAS W. DUBENSKY, JR., PH.D.</strong> CHIEF SCIENTIFIC OFFICER ADURO BIOTECH, INC. DR. THOMAS W. DUBENSKY, Jr.[/caption] THOMAS W. DUBENSKY, JR., PH.D. CHIEF SCIENTIFIC OFFICER ADURO BIOTECH, INC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: This presentation highlights findings from multiple preclinical models evaluating ADU-S100 (also known as MIW815), Aduro Biotech’s investigational STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy. The company is developing ADU-S100 in partnership with Novartis. ADU-S100 is a synthetic ‘off-the-shelf’ small molecule immune modulator that is designed to generate a response against a patient’s own unique set of cancer antigens. It does this through the activation of human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T-cell adaptive immune response. We conducted preclinical studies in a variety of preclinical models to better understand the potential mechanism of action of ADU-S100 and its potential for treating a variety of cancer types, both within the immediate tumor environment, as well as throughout the body. Data from these preclinical studies suggest the following:
  • Intratumoral injection of ADU-S100 activates the STING Pathway and induces both a durable local and systemic anti-tumor immune response as evidenced by induction of type I interferons (IFNs) and a CD8+ T-cell response.
  • ADU-S100 is able to induce tumor-specific memory mediated by immune cells (e.g. T-cells and NK-cells) whereby the immune system is able to eliminate specific cancerous cells upon their reintroduction without further therapy.
  • Combination of STING activation in the tumor microenvironment and an anti-PD-1 checkpoint inhibitor enhances antitumor efficacy activation of the STING pathway, resulting in the complete eradication of local and distal tumors.
Author Interviews, Cancer Research, Immunotherapy, Pediatrics, Rheumatology / 16.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29722" align="alignleft" width="170"]Timothy Beukelman, MD, MSCE Associate Professor of Pediatrics Division of Rheumatology and Division of Clinical Immunology & Rheumatology University of Alabama at Birmingham Dr. Timothy Beukelman[/caption] Timothy Beukelman, MD, MSCE Associate Professor of Pediatrics Division of Rheumatology and Division of Clinical Immunology & Rheumatology University of Alabama at Birmingham MedicalResearch.com: What is the background for this study? Response: In 2009 the US FDA issued a boxed warning about malignancies reported in children treated with TNF inhibitors but their analysis did not account for a possible malignancy risk from other medications of from the Juvenile idiopathic arthritis (JIA) disease process itself.
Author Interviews, Immunotherapy, JAMA, Melanoma / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29273" align="alignleft" width="150"]Feng Xie, Ph.D.</strong> Associate Professor Department of Clinical Epidemiology and Biostatistics Faculty of Health Sciences, McMaster University Dr. Feng Xie[/caption] Feng Xie, Ph.D. Associate Professor Department of Clinical Epidemiology and Biostatistics Faculty of Health Sciences McMaster University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous melanoma, an aggressive and deadly form of skin cancer, in early stages is often cured with surgery alone. Most patients presenting with advanced-stage disease, however, are not candidates for surgery and drug therapy is the main course of treatment. Around 40-60% of melanomas have a mutation in the BRAF protein. Multiple effective first-line treatment options are available for patients with advanced BRAF-mutated melanoma, which fall under two established classes of drug therapies: targeted therapy and immunotherapy. Presently, it remains uncertain which is the optimal first-line treatment. In our network meta-analysis we evaluated 15 randomized controlled trials published between 2011 and 2015 assessing the benefits and harms of targeted or immune checkpoint inhibitors in 6662 treatment naïve patients with lymph node metastasis not amenable to surgery or distant metastatic melanoma. We found that combined BRAF and MEK targeted therapy and PD-1 immunotherapy were both equally effective in improving overall survival. Combined BRAF and MEK inhibition was most effective in improving progression-free survival. PD-1 inhibition was associated with the lowest risk of serious adverse events.
Author Interviews, JAMA, Prostate, Prostate Cancer, Surgical Research, Urology / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29302" align="alignleft" width="134"]Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065 Dr. Jim Hu[/caption] Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The US Preventative Services Task Force (USPSTF) recommended against PSA testing in men older than 75 years in 2008 and more recently in all US men regardless of age in 2012. This was largely based on a faulty study, the prostate, lung, colo-rectal and ovarian screening study. We demonstrated in May 2016 that this randomized trial did not compare screening to no screening or apples to oranges, as it set out to do. It compared screening to screening. Although controversial, the guidelines were well-intentioned, as recognize that there is over-diagnosis and over-treatment of men with prostate cancer. Given this background, the goal of our study was to explore the downstream consequences of the recommendation against PSA screening. As such, we explored 3 separate databases to characterize national procedure volumes for prostate needle biopsy and radical prostatectomy, or surgery to cure prostate cancer. The main finding was that prostate biopsy numbers decreased by 29% and radical prostatectomy surgeries decreased by 16% when comparing before to after USPSTF recommendations against PSA screening. Therefore practice patterns followed policy. Prostate biopsies are usually performed due to an elevated, abnormal screening PSA. However, it is also performed to monitor low-risk, slow growing prostate cancers. We also found that while the overall number of prostate biopsies decreased, there was a 29% increase in the proportion or percentage of biopsies performed due to active surveillance, or monitoring of low risk prostate cancers which should be done periodically. Therefore we provide the first national study to demonstrate that there is less over-diagnosis and over-treatment of prostate cancer. However, the concern is that we also recently demonstrated that there is more aggressive prostate cancer on surgical pathology for men who go on to radical prostatectomy. They have high grade, higher stage cancers, which have a lower chance of cure. The link is: http://www.prostatecancerreports.org/fulltext/2016/_Hu_JC160708.pdf
Author Interviews, Cancer Research, ENT, JAMA, Radiation Therapy, Stanford / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29579" align="alignleft" width="188"]Michelle M. Chen, MD/MHS Department of Otolaryngology- Head and Neck Surgery Stanford University Dr. Michelle Chen[/caption] Michelle M. Chen, MD/MHS Department of Otolaryngology- Head and Neck Surgery Stanford University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The benefit of post-operative radiotherapy (PORT) for patients with T1-T2 N1 oral cavity and oropharyngeal cancer without adverse pathologic features is unclear. Starting in 2014, the national guidelines no longer recommended consideration of post-operative radiotherapy for N1 oropharyngeal cancer patients, but left it as a consideration for N1 oral cavity cancer patients. We found that post-operative radiotherapy was associated with improved survival in both oral cavity and oropharyngeal cancers, particularly in patients younger than 70 years of age and those with T2 disease.
Author Interviews, Dermatology, Melanoma / 15.11.2016

MedicalResearch.com Interview with: Dr. Mario Mandalà, MD Division of Oncology, Department of Oncology and Hematology Papa Giovanni XXIII Hospital Bergamo, Italy.  MedicalResearch.com: What is the background for this study? Response: The 7th edition of the TNM AJCC classification incorporated mitotic rate (MR) only for primary cutaneous melanoma with Breslow thickness ≤1 mm. We investigated whether and to what extent MR is able to predict sentinel lymph node (SLN) status and clinical outcome of  primary cutaneous melanoma (PCM) patients with BT >1 mm.
Author Interviews, Dermatology, Melanoma, Surgical Research / 14.11.2016

MedicalResearch.com Interview with: Timothy Patton, DO Department of Dermatology Falk Medical Center University of Pittsburgh Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: As dermatologists we are confronted daily with how to manage lesions that are biopsied and diagnosed as dysplastic nevi. These lesions are considered by some to be potential melanoma precursors and by others as benign lesions with little to no malignant potential. Often, particularly for lesions with severe atypia these lesions are re excised. There are no prospective studies or consistent guidelines as to how to manage these lesions. We decided to retrospectively look at the outcome of 451 patients with dysplastic nevi with severe atypia, many of whom had not had their lesions re-excised, who had at least 5 years of follow up to determine if any developed melanoma at the site of the biopsied dysplastic nevus or distantly. We found no cases of metastatic melanoma in patients who did not already have a diagnosis of melanoma. We found two cases of thin melanoma in patients who had their lesions re-excised. Both of those patients were treated with reexcision and did not develop subsequent melanoma metastasis or recurrence.
Author Interviews, BMJ, Cancer Research, Cost of Health Care, Imperial College / 11.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29575" align="alignleft" width="200"]Peter Wise MD Charing Cross Hospital and Imperial College School of Medicine London, UK Dr. Peter Wise[/caption] Peter Wise MD Charing Cross Hospital and Imperial College School of Medicine London, UK MedicalResearch.com: What is the background for this analysis? Response: As a medical ethicist, I wished to know how much patients with advanced – metastatic – cancer knew about the drugs that were being used to treat it. What were their perceptions of likely treatment success and how did that tally with our knowledge of what drugs could actually achieve – and at what cost to the body and to the pocket. Did patients actually have a choice – and how did the drugs get approved for use in the first place?
Author Interviews, Cancer Research, Immunotherapy / 11.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29564" align="alignleft" width="75"]Dr. Michael Lotze, MD Chief Scientific Officer, Lion Biotechnologies San Carlos, CA 94070 Dr. Lotze[/caption] Dr. Michael Lotze, MD Chief Scientific Officer, Lion Biotechnologies San Carlos, CA 94070 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adoptive cell therapy (ACT) with Tumor-infiltrating Lymphocytes (TIL) has shown promise in mediating cancer regression which rely on activation in vivo compared to other immunotherapies that utilize genetically modified T-cells. In TIL therapy, autologous administration of TIL expanded outside the body elicits a highly individualized, specific and potent attack against the tumor. Clinical trials conducted at the National Cancer Institute evaluating TIL therapy for the treatment of metastatic melanoma reported overall response rates of up to 56%. The durable responses observed in these metastatic melanoma patients as well as other patients with cervical cancer, cholangiocarcinoma, and head and neck cancer signal the potential for broader application of TIL therapy to treat patients with other solid tumors, currently an area of substantial unmet clinical need. Lion’s study, recently presented at the Society for Immunotherapy of Cancer, sought to demonstrate the feasibility of culturing and expanding TIL isolated from non-melanoma tumors. We were successful in culturing TIL from tumors obtained from bladder, cervical, head and neck, lung and triple negative breast cancer.
Author Interviews, Dermatology, JAMA, Melanoma / 10.11.2016

MedicalResearch.com Interview with: [caption id="attachment_28969" align="alignleft" width="133"]Caroline Watts| Research Fellow Dr. Caroline Watts[/caption] Caroline Watts | Research Fellow Cancer Epidemiology and Prevention Research Sydney School of Public Health Melanoma Institute Australia (MIA) investigator The University of Sydney MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Melanoma Patterns of Care study was a population-based observational study of physicians’ reported clinical management of 2727 patients diagnosed with an in situ or invasive primary melanoma over a 12-month period from October 2006 to 2007 in New South Wales, Australia. This paper investigated the differences between 1052 (39%) patients who were defined as higher risk owing to a family history of melanoma, multiple primary melanomas, or many nevi (moles) compared to patients who did not have any risk factors. We found that the higher-risk group had a younger mean age at diagnosis compared to those without risk factors, (62 vs 65 years, P < .001) which varied by type of risk factor (56 years for patients with a family history, 59 years for those with many nevi, and 69 years for those with a previous melanoma). These age differences were consistent across all body sites. Among higher-risk patients, those with many nevi were more likely to have melanoma on the trunk (41% vs 29%, P < .001), those with a family history of melanoma were more likely to have melanomas on the limbs (57%vs 42%, P < .001), and those with a personal history were more likely to have melanoma on the head and neck (21% vs 15%, P < .001).
Author Interviews, Breast Cancer, Chemotherapy, JAMA, Karolinski Institute / 09.11.2016

MedicalResearch.com Interview with: Jonas Bergh M.D, Ph.D. F.R.C.P. (London, UK) Professor of Oncology (Mimi Althainz´donation) Director Strategic Research Program in Cancer Karolinska Institutet Radiumhemmet, Karolinska University Hospital Stockholm, Swede MedicalResearch.com: What is the background for this study? Response: Present standard dosing of chemotherapy is aiming at a similar dose for each individual (similar effects and side-effects) , by calculating the dose per mg/m2 based on a formula originally established by du Bois (1916), based on body surface calculations by measuring height and weight. As I recall it, this was done on nine individuals… However, the body surface has very little to do with how you cytotoxic drugs are metabolized and excreted… in practice this means that chemotherapy dosing based on body surface area will result in under- or overdosing of quite a proposition of the patients… Please Google/run a PubMed research on H. Gurney in Australia, he and other have really expressed their concerns with our present chemotherapy dosing strategies. In our prospective adjuvant chemotherapy study of high risk breast cancer patients we tested a very well established standard chemotherapy regimen given every third week (FEC100 mg/m2 x 3+ docetaxel 100 mg/m2 x3) vs. our experimental arm given very second week in a dose dense fashion. We also tried to optimize the dosing, aiming at avoiding overdosing some patients at the first course and increase the dose for those without predefined toxicities. Therapy duration was similar in both groups, 15 weeks. Please see the end of the discussion in JAMA for the shortcomings with our study.
Author Interviews, Cancer Research, Immunotherapy, Vaccine Studies / 09.11.2016

MedicalResearch.com Interview with: Leslie Chong Imugene Chief Operating Officer Armadale, Australia Leslie Chong Imugene Chief Operating Officer Armadale, Australia   MedicalResearch.com: What is the background for this study? How does HER-Vaxx work? • The technology originates from the Medical University of Vienna, one of Europe’s leading cancer institutes and was identified in 2012 by Dr Axel Hoos (Currently Sr. Vice President of Oncology R&D at GlaxoSmithKline, previous Clinical Lead on Ipilumimab at Bristol-Myers Squibb, a director at Imugene; his only Board seat worldwide) • HER-Vaxx is a peptide vaccine designed to treat tumours that over-express the HER2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The vaccine is constructed from various B Cell epitopes of HER2/neu. It has been shown in pre-clinical work and in a Phase 1 study to stimulate a potent polyclonal antibody response to HER2/neu, a commercially and clinically validated cancer target. HER-Vaxx’s successful Phase 1 study was in patients with metastatic breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer initiating in 2016.
Author Interviews, Cancer Research, Cost of Health Care / 08.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29479" align="alignleft" width="200"]Carolyn R. Aldigé Carolyn R. Aldigé[/caption] Carolyn R. Aldigé President of the Prevent Cancer Foundation MedicalResearch.com: What is the background for this tool? What types of cancers are covered under this comparison tool? Response: The coverage tool compares screening coverage by the 30 largest health insurers in the U.S. Consumers can use the tool to see their insurance plans' policies on coverage of screening tests for breast, cervical, colorectal, lung and prostate cancers. MedicalResearch.com: What are some of the differences in insurance coverage of screening tests? Response: There is a sizable variation in what insurance plans cover, partly a result of differing screening guidelines from three leading organizations. Though insurance plans are required to cover screenings recommended by the United States Preventive Services Task Force (USPSTF) without a co-pay, many will choose to cover other screening tests as well—but which guidelines do they follow? This is confusing to both patients and providers. Breast cancer screening is an area where we see big differences in insurance coverage. All 30 plans cover 2D mammography, but only 13 plans cover 3D mammography (tomosynthesis). Colorectal cancer screening coverage also differs. While almost all plans cover colonoscopy, CT colonography, flexible sigmoidoscopy, and FIT and FOBT screening tests, there are differences in coverage of stool-based DNA tests.
Author Interviews, Cancer Research, JAMA / 04.11.2016

MedicalResearch.com Interview with: Ayako Okuyama, RN, PHN, MW, PhD Center for Cancer Control and Information Services National Cancer Center, Japan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chemotherapy-induced nausea and vomiting (CINV) is a major concern for chemotherapy patients. Despite widespread concern, not all chemotherapeutic drugs cause severe CINV. Our study illustrated that the potential for overuse of prophylactic antiemetics for chemotherapy with minimal and low emetic risks according to the antiemetic guidelines.
Author Interviews, Kaiser Permanente, Mayo Clinic, Prostate Cancer / 03.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29357" align="alignleft" width="150"]Lauren P. Wallner, PhD, MPH Assistant Professor, Departments of Medicine and Epidemiology, University of Michigan Adjunct Investigator, Kaiser Permanente Southern California North Campus Research Complex Ann Arbor, MI Dr. Lauren P. Wallner[/caption] Lauren P. Wallner, PhD, MPH Assistant Professor, Departments of Medicine and Epidemiology, University of Michigan Adjunct Investigator Kaiser Permanente Southern California North Campus Research Complex Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: 5 alpha-reductase inhibitors (5ARIs) are often used for the management of lower urinary tract symptoms in men. Two prior clinical trials found 5ARIs also reduced the risk of prostate cancer, but there was an increase in more aggressive (Gleason 7-10) cancers among the men who were diagnosed. Thus, concerns over whether 5ARIs may increase the risk of prostate cancer death have limited their use in the prevention of prostate cancer, which remains controversial. To address the safety of 5ARIs for the primary prevention of prostate cancer, we conducted a large population-based study of over 200,000 men in community practice settings of over a 19 year observation period to assess whether 5ARI use (as compared to alpha-blocker use) was associated with prostate cancer mortality. Our results suggest that 5ARI use was not associated with an increased risk of prostate cancer mortality when compared to alpha-blocker use.
Author Interviews, Breast Cancer, Vaccine Studies / 30.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29263" align="alignleft" width="140"]Josef Singer MD, PhD Comparative Medicine Messerli Research Institute of the University of Veterinary Medicine Medical University Vienna University Vienna, Austria & Department for Comparative Immunology and Oncology Institute of Pathophysiology and Allergy Research Medical University Department of Internal Medicine II University Hospital Krems Karl Landsteiner University of Health Sciences Krems, Austria Dr. Josef Singer[/caption] Josef Singer MD, PhD Comparative Medicine Messerli Research Institute of the University of Veterinary Medicine Medical University Vienna University Vienna, Austria & Department for Comparative Immunology and Oncology Institute of Pathophysiology and Allergy Research Medical University Department of Internal Medicine II University Hospital Krems Karl Landsteiner University of Health Sciences Krems, Austria  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Immunotherapy of cancer has gained increasing interest in treatment of oncologic patients. Especially passive immunotherapy with monoclonal antibodies against tumor-associated antigens has been very successful due to good response rates with relatively moderate side effects compared to conventional chemotherapy. Trastuzumab, an antibody against the human epidermal growth-factor receptor-2 (HER-2), is widely applied for the treatment of metastatic breast cancer. Trastuzumab leads to longer progression-free and overall survival in patients with HER-2 positive disease. However, monoclonal antibody therapies have to be repetitively applied, which represents a risk for infusion-related side effects and, due to the high costs, a massive burden for social security systems. Our aim was to replace the passive immunotherapy by a vaccine actively inducing patients´ own antibodies with the same specificity as trastuzumab. A novel mimotope library platform enabled the development of a HER2-specific cancer vaccine: Mimotopes are small peptides that are able to mimic antibody epitopes on tumor-associated antigens, in our case the trastuzumab antigen on HER-2. We use Adeno-associated-viruses (AAV) as carriers for our HER2 vaccine as they are highly immunogenic and safe. We could demonstrate that this HER-2 mimotope AAV-vaccine induced antibodies against human HER- 2 similar to the clinically used trastuzumab. In a mouse tumor model the HER-2 mimotope AAV vaccine was able to delay the growth of tumors significantly.
Author Interviews, Colon Cancer, JAMA / 30.10.2016

MedicalResearch.com Interview with: Fausto Petrelli, MD Oncology Unit, Oncology Department Treviglio ,Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: This meta-analysis evaluated if side (excluding rectum site) represents an independent prognostic factor for survival in patients with stages 1-4 colon cancer. This variable is in fact associated with an adverse outcome with a reduced risk of death by 20% if patients are affected by a left colon cancer compared to those with right colon cancers. Implications are enormous: for prognosis first but also for follow-up, stratification into clinical trials and treatment (for both medical and surgical therapies). The power of the study is relevant: it enclosed 66 studies with more than 1 million of patients retrospectively or prospectively analyzed for survival according to common variables known to be prognostic in colorectal cancer (age, sex, stage, race, adjuvant CT..etc) in multivariate analysis. Side is significantly associated with survival independent of other covariates analyzed. The question of the side is old and partially known, but no study systematically explored the published literature to confirm this suggestion. Recent large randomized trials in metastatic disease showed different results according to the site of disease with right colon cancers usually less responsive to anti-EGFR treatment due to a different molecular behavior and conversely left colon cancers which attained the greater benefit from cetuximab and panitumumab due to less BRAF mutations in their tissue. Also, a less extensive and radical lymphadenectomy in right-sided cancers, without a complete mesocolon excision during surgery, could hamper their cure rate, as our colorectal surgeon's team lead by Prof. Giovanni Sgroi and Luca Turati MD, suggested in the discussion. It is also well known the leads term bias with a later diagnosis of right cancers due to clinical and anatomic reasons.
Author Interviews, Biomarkers, Cancer, Cancer Research, University of Pennsylvania / 28.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29147" align="alignleft" width="112"]Eric Ojerholm, MD Resident, Radiation Oncology Hospital of the University of Pennsylvania Dr. Eric Ojerholm[/caption] Eric Ojerholm, MD Resident, Radiation Oncology Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: Multiple studies reported that a blood test —the neutrophil-to-lymphocyte ratio (NLR)—might be a helpful biomarker for bladder cancer patients. If this were true, NLR would be very appealing because it is inexpensive and readily available. However, previous studies had several methodological limitations. MedicalResearch.com: What did you do in this study Response: We therefore put NLR to the test by performing a rigorous “category B” biomarker study—this is a study that uses prospectively collected biomarker data from a clinical trial. We used data from SWOG 8710, which was a phase III randomized trial that assessed surgery with or without chemotherapy for patients with muscle-invasive bladder cancer. We tested two questions. First, could NLR tell us how long a bladder cancer patient would live after curative treatment? Second, could NLR predict which patients would benefit from chemotherapy before surgery?
Author Interviews, Cancer Research, JAMA, Smoking / 24.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29105" align="alignleft" width="133"]Joannie Lortet-Tieulent MSc Senior Epidemiologist American Cancer Society, Inc. Joannie Lortet-Tieulent[/caption] Joannie Lortet-Tieulent MSc Senior Epidemiologist American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? Response: Many tobacco control policies are decided at state level. We have known for some times that some states have pioneered tobacco control, or have implemented strong tobacco control or programs. Meanwhile, in other states, tobacco control and programs can be weaker. Also, some states have large populations with low socioeconomic status, among which smoking prevalence is higher. We were interested in how those state-level differences impact people’s health.
Author Interviews, NEJM, Prostate Cancer / 21.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29065" align="alignleft" width="151"]Professor Jenny Donovan OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Lewins Mead, Bristol Professor of Social Medicine School of Social and Community Medicine University of Bristol Prof. Jenny Donovan[/caption] Professor Jenny Donovan OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Lewins Mead, Bristol Professor of Social Medicine School of Social and Community Medicine University of Bristol  MedicalResearch.com: What is the background for this study? What are the main findings? Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years. The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).
Author Interviews, ESMO, Immunotherapy, Lung Cancer / 21.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29030" align="alignleft" width="133"]Shirish Gadgeel, MD Leader of the Thoracic Oncology Multidisciplinary team Professor at Karmanos Cancer Institute Detroit Dr. Shirish Gadgeel[/caption] Shirish Gadgeel, MD Leader of the Thoracic Oncology Multidisciplinary team Professor at Karmanos Cancer Institute Detroit MedicalResearch.com: What is the background for this study? What are the main findings? Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial's co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety.
Author Interviews, Biomarkers, Immunotherapy, Pancreatic / 21.10.2016

MedicalResearch.com Interview with Dr. Ashton A. Connor, MD PanCuRx Translational Research Initiative, Ontario Institute for Cancer Research Dr. Steven Gallinger MD, MSC Division of General Surgery Toronto General Hospital Toronto, ON MedicalResearch.com: What is the background for this study? What are the main findings? Response: The etiology of pancreatic ductal adenocarcinoma (i.e. "pancreatic cancer") and the relationship between the tumour and its characteristic dense, encroaching stroma are still poorly understood. Using whole genome sequencing in two large cohorts, we show that there are four fundamental mutational processes that give rise to pancreatic cancer. With expression data, we also show that the interaction between the tumour and the surrounding stroma varies with the type of mutational process found in the tumour. Specifically, tumours with defective DNA repair, either homologous recombination or mismatch repair deficiency, elicited strong anti-tumour immune responses, likely due to the relatively high numbers of neoantigens in these tumours. Individually, these concepts have been studied in other cancer types, but we are first to apply either of these to pancreatic cancer, and we also the first to integrate these two aspects of cancer biology for any tumour, to our knowledge.
Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, ESMO / 18.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28991" align="alignleft" width="200"]Corey Pelletier PhD Director, Health Economics & Outcomes Research at Celgene Celgene Corporation Summit, NJ Dr. Corey Pelletier[/caption] Corey Pelletier PhD Director, Health Economics & Outcomes Research Celgene Corporation Summit, NJ MedicalResearch.com: What is the background for this study? What are the main findings? Response: In a phase III clinical trial, ABRAXANE demonstrated significant improvement in ORR vs paclitaxel in patients with metastatic breast cancer. Celgene initiated this study because limited data exist on the comparative effectiveness of ABRAXANE vs paclitaxel for patients with metastatic breast cancer, including HR+/HER2- and triple negative (TN) metastatic breast cancer (MBC), in a real-world setting. This study used a U.S. based electronic medical record (EMR) dataset to evaluate the real-world comparative effectiveness of second-line ABRAXANE vs paclitaxel in patients with MBC and included patients with HR+/HER2- or TN MBC. This study also assessed adverse events and use of supportive care in this patient population. The median time to treatment discontinuation (TTD) for ABRAXANE vs paclitaxel was 4.50 vs 2.83 months (adjusted P<0.0001*) in all patients. Patients with HR+/HER2- or TN MBC had similar TTD. The median time to next treatment (TTNT) in all patients was 5.9 vs 4.2 months (adjusted P=0.2140*) for ABRAXANE vs paclitaxel, respectively. Patients receiving ABRAXANE had less fatigue, neuropathy, and anemia compared to patients receiving paclitaxel. Patients treated with ABRAXANE also used less antiemetics, and had fewer treatments for hydration or allergic reaction compared to those treated with paclitaxel. Patients treated with paclitaxel used less GCSF and had fewer treatments for bone loss compared to those treated with ABRAXANE. *TTD and TTNT were adjusted for age, number of metastases, targeted agent use, adjunctive chemotherapy, HER2 status, TN status, and CCI score without age.
Author Interviews, Breast Cancer, ESMO, Immunotherapy / 17.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28949" align="alignleft" width="150"]Melanie Royce, MD, PhD Professor of Medicine University of New Mexico School of Medicine Director of the Breast Multidisciplinary Clinic and Program UNM Cancer Center. Albuquerque, NM Dr. Melanie Royce[/caption] Melanie Royce, MD, PhD Professor of Medicine University of New Mexico School of Medicine Director of the Breast Multidisciplinary Clinic and Program UNM Cancer Center. Albuquerque, NM MedicalResearch.com: What is the background for this study? What are the main findings? Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/HER2-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression. Results of the Phase II BOLERO-4 clinical trial, presented as an oral presentation at the 2016 European Society for Medical Oncology (ESMO) annual meeting, show preliminary evidence that everolimus in combination with letrozole is effective in treating women with HR-positive/HER2-negative advanced breast cancer in the first-line setting. With follow up of 17.5 months, the median progression-free survival (PFS) is not yet reached. At six months, 83.6% (95% CI: 77.3-88.2%) of women taking everolimus plus letrozole in the first-line setting were without disease progression, and 71.4% (95% CI: 64.0%-77.5%) did not have disease progression at twelve months. Safety findings from BOLERO-4 are consistent with previous studies of everolimus in advanced breast cancer, with the most common adverse events being stomatitis (67.8%), weight loss (42.6%) and diarrhea (36.1%). These adverse events were mostly grade 1 or 2 in severity1.
Author Interviews, Cancer Research, Pharmacology / 17.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28926" align="alignleft" width="150"]Dr Pan Pantziarka, PhD Scientist: Anticancer Fund (www.anticancerfund.org) Coordinator: Repurposing Drugs in Oncology (www.redo-project.org) Dr Pan Pantziarka[/caption] Dr Pan Pantziarka, PhD Scientist: Anticancer Fund (www.anticancerfund.org) Coordinator: Repurposing Drugs in Oncology (www.redo-project.org) MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is part of the Repurposing Drugs in Oncology (ReDO) project to look at a series of non-cancer drugs which have strong evidence of anti-cancer effects. Other drugs have included the antacid cimetidine, the antibiotic clarithromycin and the NSAID diclofenac. The data for propranolol comes from multiple sources: epidemiological data and retrospective data from cancer patients who have also been treated concurrently with propranolol, pre-clinical work in vitro and in animal models and from case series reports in which cancer patients have had propranolol added to their existing treatments. The main findings are that propranolol has multiple mechanisms of action, including anti-proliferative and immunomodulation. There is particularly strong evidence that shows that propranolol has potent effects in the treatment of the rare soft-tissue sarcoma angiosarcoma. It is also suggested that when used at the time of surgery, propranolol in combination with a COX-2 inhibitor, can reduce the risk of metastatic spread.
Author Interviews, Cancer Research, ESMO, Immunotherapy, NYU/NYMC / 16.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28911" align="alignleft" width="200"]Arjun Balar, M.D. Assistant Professor of Medicine Director - Genitourinary Medical Oncology Program NYU Perlmutter Cancer Center New York, NY 10016 Dr. Arjun Balar[/caption] Arjun Balar, M.D. Assistant Professor of Medicine Director - Genitourinary Medical Oncology Program NYU Perlmutter Cancer Center New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Standard treatment for advanced urothelial cancer includes cisplatin-based chemotherapy which has been shown to improve survival. But more than half of patients are not expected tolerate it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative to cisplatin. Pembrolizumab is a PD-1 blocking antibody that reactivates the body’s cancer-fighting T-cells (part of the immune system) to fight urothelial cancer. The trial overall enrolled 374 patients who had not yet received any treatment for advanced urothelial cancer, but were considered ineligible for cisplatin chemotherapy.
Alzheimer's - Dementia, Author Interviews, Hormone Therapy, JAMA, Prostate Cancer, University of Pennsylvania / 15.10.2016

MedicalResearch.com Interview with: Kevin T. Nead, MD, MPhil Resident, Radiation Oncology Perelman School of Medicine Hospital of the University of Pennsylvania. MedicalResearch.com: What is the background for this study? Response: Androgen deprivation therapy is a primary treatment for prostate cancer and works by lowering testosterone levels. There is a strong body of research suggesting that low testosterone can negatively impact neurovascular health and function. We were therefore interested in whether androgen deprivation therapy is associated with dementia through an adverse impact on underlying neurovascular function.
Author Interviews, ESMO, Immunotherapy, Ovarian Cancer / 14.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28888" align="alignleft" width="120"]Mansoor Raza Mirza, MD Medical Director: Nordic Society of Gynecologic Oncology (NSGO) Board of Directors: Gynecologic Cancer Inter-Group (GCIG) Faculty: European Society of Medical Oncology (ESMO) Faculty: International Gynecologic Cancer Society (IGCS) Chief Oncologist, Rigshospitalet Copenhagen University Hospital Copenhagen, Denmark Dr. Mansoor Raza Mirza[/caption] Dr. Mansoor Raza Mirza, MD Medical Director: Nordic Society of Gynecologic Oncology Board of Directors: Gynecologic Cancer Inter-Group (GCIG) Faculty: European Society of Medical Oncology (ESMO) Faculty: International Gynecologic Cancer Society (IGCS) Chief Oncologist, Rigshospitalet Copenhagen University Hospital Copenhagen, Denmark MedicalResearch.com: What is the background for this study? Response: Recurrent ovarian cancer is an area of significant unmet medical need, and there have been few therapeutic advances for these patients in the past few decades. Niraparib was studied to provide patients with recurrent ovarian cancer an option other than “watchful waiting,” potentially redefining the standard of care for the disease. The ENGOT-OV16/NOVA trial was a Phase 3 double-blind, randomized, placebo-controlled international study of maintenance treatment with niraparib compared with placebo. Niraparib successfully achieved the primary endpoint of prolonging progression-free survival versus placebo in all three prospectively defined primary efficacy populations: