Author Interviews, Biomarkers, Cancer Research, Genetic Research, Lancet / 29.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27431" align="alignleft" width="200"]Dr. Manel Esteller Director of the Epigenetics and Cancer Biology Program (PEBC) Bellvitge Biomedical Research Institute Dr. Manel Esteller[/caption] Dr. Manel Esteller Director of the Epigenetics and Cancer Biology Program (PEBC) Bellvitge Biomedical Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cancer of Unknown Primary (CUP) occurs when the patient is diagnosed with a metastasis but the primary tumor is not found. It accounts for around 5-10% of tumors around the world and the survival is very poor. Until now, only in 25% of cases the primary site was identified after diagnosis pipeline. We are showing herein that the use of epigenetic profiling, based in the determination of the chemical marks occurring in DNA that are tumor-type specific, reaches a diagnoses of 87% of cases.
Author Interviews, Breast Cancer, Chemotherapy, Genetic Research, JAMA, NEJM / 26.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27366" align="alignleft" width="150"]Prof. Laura van ’t Veer, PhD Leader, Breast Oncology Program, and Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center Angela and Shu Kai Chan Endowed Chair in Cancer Research UCSF Helen Diller Family Comprehensive Cancer Center Dr. Laura Van't Leer[/caption] Prof. Laura van ’t Veer, PhD Leader, Breast Oncology Program, and Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center Angela and Shu Kai Chan Endowed Chair in Cancer Research UCSF Helen Diller Family Comprehensive Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: MINDACT was designed to involve only patients with node negative and 1 to 3 positive lymph node breast cancer. Node negative breast cancer is a cancer that has not spread to the surrounding lymph nodes and therefore has a lower risk of recurrence. Scientists have also demonstrated that breast cancer which has spread to 1 to 3 lymph nodes may behave like node negative breast cancer. Patients with either node negative cancer or with a cancer that involves 1-3 lymph nodes are often prescribed chemotherapy, although physicians believe that approximately 15% of them do not require such treatment. MINDACT provides the highest level of evidence to show that using MammaPrint® can substantially reduce the use of chemotherapy in patients with node-negative and 1-to-3 node positive breast cancer – in other words, it can identify patients with these types of breast cancer who can safely be spared a treatment that may cause significant side effects, and will offer no to very little benefit.
Author Interviews, Cancer Research, Immunotherapy / 26.08.2016

MedicalResearch.com Interview with: Dr Charles Akle, Chairman and Linda Summerton, CEO Immodulon Therapeutics Short Hills, NJ 07078 and London, UKDr Charles Akle, Chairman and Dr. Linda Summerton, CEO Immodulon Therapeutics Short Hills, NJ 07078 and London, UK MedicalResearch.com: What is the background for Immodulon? Would you tell us a little about Dr. Charles Akle? Response: Immodulon was established in November 2007. The founder and Chairman, Dr Charles Akle, was a Harley Street surgeon and pioneer of keyhole surgery who established Immodulon with the financial support of a former patient. His interest in immunology led him to the potential of cancer immunotherapy long before the term “immuno-oncology” was coined and when skepticism, rather than optimism was the norm. His ambition from the start was to develop an affordable immunotherapy treatment that would transform the way that cancer is treated in the world today. Since then, Immodulon has become a leading, independent biopharmaceutical company with one of the longest running research projects into how to harness the power of the immune system in treating cancer. It also has its own R&D and manufacturing capability in Lyon, France. The wider Immodulon senior team has extensive experience of bringing drugs to market and includes Dr James Shannon and Dr Jean Pierre Bizzari.
Author Interviews, Cancer Research, Chemotherapy, JAMA / 25.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27352" align="alignleft" width="96"]Leni van Doorn, MSc Department of Medical Oncology Erasmus MC Cancer Institute Rotterdam, the Netherlands Leni van Doorn[/caption] Leni van Doorn, MSc Department of Medical Oncology Erasmus MC Cancer Institute Rotterdam, the Netherlands MedicalResearch.com: What is the background for this study? Response: The common cancer treatment capecitabine, a regular treatment for patients mostly diagnosed with breast-, colon- or gastic cancer, induces hand foot syndrome (HFS). HFS is a cutaneous condition that may lead to red palms and blisters in approximately 50% to 60% of the patients and is believed to result in the loss of fingerprints. This fingerprint loss has been described sporadically in the literature. The main aim of our prospective study was to have a closer look of the association between  hand foot syndrome and the loss of fingerprints.
Author Interviews, Cancer Research, Weight Research / 25.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27327" align="alignleft" width="125"]Beatrice Lauby-Secretan, PhD IARC – Section IMO (International Agency for Research on Cancer) Lyon, France Dr. Beatrice Lauby-Secretan[/caption] Beatrice Lauby-Secretan, PhD IARC – Section IMO (International Agency for Research on Cancer) Lyon, France MedicalResearch.com: What is the background for this study? Response: The IARC Handbook of Cancer Prevention Series perform systematic reviews and evaluations of the cancer-preventive effects of interventions and strategies. The summary article published today presents the conclusions of a Working Group of experts who examined and assessed the currently available literature on the link between overweight/obesity and cancer. Thus this is not a single study, but the report on more than 1000 individual studies.
Author Interviews, Cancer Research, JAMA / 25.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27281" align="alignleft" width="160"]Dr. Aaron Mitchell MD Hematology/Oncology Fellow University North Carolina Dr. Aaron Mitchell[/caption] Dr. Aaron Mitchell MD Hematology/Oncology Fellow University North Carolina MedicalResearch.com: What is the background for this study? Response: It is well known that many physicians work with the pharmaceutical industry. In some cases, this can create conflicts of interest with physicians' other responsibilities. The Open Payments law, passed as part of the Affordable Care Act, recently made these relationships public, which now allows us to study them more systematically.
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Chemotherapy, Nature / 25.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27306" align="alignleft" width="125"]Shyamala Maheswaran, PhD Associate Professor of Surgery Harvard Medical School Assistant Molecular Biologist Center for Cancer Research Dr. Shyamala Maheswaran[/caption] Shyamala Maheswaran, PhD Associate Professor of Surgery Harvard Medical School Assistant Molecular Biologist Center for Cancer Research MedicalResearch.com: What is the background for this study? What are the main findings? Response: About 85% hormone receptor positive HER2 negative metastatic breast cancer patients show that cancer cells acquire HER2 expression during disease progression. These HER2 positive cells coexist with HER2 negative cancer cells, and these two populations are able to spontaneously oscillate between these two states; in culture and in cancers established in mice. Both HER2 positive and HER2 negative cells form tumors when injected into mice, but HER2 positive cancer cells form tumors more rapidly than HER2 negative tumors. At a molecular level, several growth factor pathways are activated in HER2 positive cancer cells, while activation of the Notch pathway, an embryonic signaling event, is observed in HER2 negative cells. Thus the HER2 positive and HER2 negative cancer cells exhibit differential sensitive to drugs: the HER2 positive cells, which are more proliferative and non-responsive to HER2-targeting agents, are responsive to chemotherapy drugs whereas the HER2 negative tumor cells are sensitive to Notch inhibitors. A combination of chemotherapeutic drugs and notch inhibitors effectively eliminate tumors formed by a mixture of these two population of cancer cells compared to either drug alone. These findings highlight the importance of tumor heterogeneity in cancer progression and drug responses and suggest that targeting all the different populations within cancers is necessary to effectively manage cancer progression.
Author Interviews, Leukemia, Race/Ethnic Diversity, Social Issues / 22.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27119" align="alignleft" width="132"]Luciano J. Costa, MD, PhD Associate Professor Department of Medicine and UAB-CCC Bone Marrow Transplantation and Cell Therapy Program Birmingham, AL 35294 Dr. Luciano Costa[/caption] Luciano J. Costa, MD, PhD Associate Professor Department of Medicine and UAB-CCC Bone Marrow Transplantation and Cell Therapy Program Birmingham, AL 35294 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Even though expected survival for multiple myeloma patients has increased over the last two decades, that improvement has not been much more pronounced among White than among patients of racial/ethnic minorities. It is possible that such discrepancy results from unequal access to care, particularly as treatment becomes more complex and expensive. We used a large dataset of patients with  multiple myeloma to explore how socioeconomic factors, specifically marital status, income and insurance affect outcome and how these factors relate to race/ethnicity.
Author Interviews, Dermatology, JAMA, Melanoma, Stanford / 22.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27029" align="alignleft" width="200"]Susan M. Swetter, MD Professor of Dermatology Director, Pigmented Lesion & Melanoma Program Physician Leader, Cancer Care Program in Cutaneous Oncology Stanford University Medical Center and Cancer Institute Dr. Susan Swetter[/caption] Susan M. Swetter, MD Professor of Dermatology Director, Pigmented Lesion & Melanoma Program Physician Leader, Cancer Care Program in Cutaneous Oncology Stanford University Medical Center and Cancer Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dysplastic nevi (DN) are frequently re-excised following initial biopsy due to concerns for malignant transformation; however, the long-term risk of melanoma developing in mildly or moderately dysplastic nevi with positive histologic margins is unknown. In this cohort study of 590 histologic DN that were followed over 20 years, 6 cases of melanoma (5 in situ) arose in the 304 DN with positive margins that were clinically observed, only 1 of which developed from an excisionally-biopsied dysplastic nevus. One melanoma in situ arose in the 170 cases that underwent complete excision at the outset. The risk of new primary melanoma at other sites of the body was over 9% in both groups.
Author Interviews, CT Scanning, Lung Cancer, PLoS, Radiology / 19.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27200" align="alignleft" width="150"]Matthew B. Schabath PhD Department of Cancer Epidemiology H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida Dr. Matthew Schabath[/caption] Matthew B. Schabath PhD Department of Cancer Epidemiology H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study is a post-hoc analysis of data from a large randomized clinical trial (RCT) called the National Lung Screening Trial (NLST). The NLST found that lung cancer screening with low-dose helical computed tomography (LDCT) significantly reduced lung cancer deaths by 20 percent compared to screening with standard chest radiography (i.e., X-Ray). In our publication, we performed a very detailed analysis comparing outcomes of lung cancer patients screened by LDCT according to their initial (i.e., baseline), 12 month, and 24 month screening results. We found that patients who had a negative baseline screening but tested positive for lung cancer at the 12- or 24-month screen had lower survival and higher mortality rates than patients who had a positive initial screen that was a non-cancerous abnormality but developed lung cancer in subsequent screens.
Author Interviews, Cancer Research, Esophageal, Genetic Research / 19.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27129" align="alignleft" width="138"]Prof. Trevor A Graham, MSc, MRes, PhD Lead, Evolution and Cancer Laboratory Centre for Tumour Biology Barts Cancer Institute, Queen Mary University of London John Vane Science Centre London Prof. Trevor Graham[/caption] Prof. Trevor A Graham, MSc, MRes, PhD Lead, Evolution and Cancer Laboratory Centre for Tumour Biology Barts Cancer Institute, Queen Mary University of London John Vane Science Centre London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Barrett’s Oesophagus is a common condition that affects an estimated 1.5 million people in the UK alone, although many are undiagnosed . This condition involves normal cells in the oesophagus (food pipe) being replaced by a different, unusual cell type called Barrett’s Oesophagus, and the replacement of the cells is thought to be a consequence of chronic reflux (heartburn). People with Barrett’s have an increased risk of developing oesophageal cancer - a cancer that sadly still has a five year survival of 15% . But although the overall lifetime risk of developing oesophageal cancer in people with Barrett’s is significant (some estimates suggest the risk is comparable to that associated with smoking and lung cancer), the risk for each patient per year is very low. This presents a big problem - most Barrett’s patients will never develop cancer in their lifetime, but the unfortunate few develop an aggressive cancer. Doctors urgently need better tools to distinguish which people with Barrett’s are actually at risk of developing cancer, so that they can receive the best treatment, and everyone else at low risk of cancer can be reassured and not need to endure unnecessary treatment. But because good a way to distinguish high-risk people doesn’t exist, all people with Barrett's have regular (every 3 years or thereabouts) endoscopy; a camera pushed into the oesophagus to look for early signs of cancer. Together with Prof Sheila Krishnadath  and her colleagues at the Amsterdam Medical Centre, Holland, we confirmed that we can identify people at high risk of developing cancer from pre-cancerous condition Barrett’s oesophagus by measuring the genetic diversity of Barrett’s cells. Importantly, we also showed level of genetic diversity amongst a person’s Barrett’s cells essentially being fixed over time – no significant changes in genetic diversity were found during the ~4 years that the patients were followed. This means that whenever someone’s Barrett’s is tested, it looks like their future risk of developing cancer can be predicted regardless of how long it’s been since the abnormal Barrett’s cells began to appear.
Author Interviews, JAMA, Prostate Cancer / 18.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27166" align="alignleft" width="138"]Dr. Ahmedin Jemal, DVM, PhD Vice President, Surveillance and Health Services Research American Cancer Societ Dr. Ahmedin Jemal[/caption] Dr. Ahmedin Jemal, DVM, PhD Vice President, Surveillance and Health Services Research American Cancer Society MedicalResearch.com: What is the background for this study? What are the main findings? Response: We previously showed large decrease in early stage prostate cancer incidence rates from 2011 to 2012 in men 50 years and older following the US Preventive services Task Force recommendation against routine prostate-specific antigen testing in 2011. In this paper, we examined whether the decrease in early stage incidence persisted through 2013. We found that early stage prostate cancer incidence rates in men age 50 and older decreased from 2012 to 2013, although the decrease (6%) was lower compared to the decrease from 2011-2012 (19%). In contrast, rates for distant stage disease between 2012 and 2013 remained unchanged.
Author Interviews, Colon Cancer, Genetic Research, Journal Clinical Oncology, MD Anderson / 18.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27163" align="alignleft" width="114"]Y. Nancy You, MD, MHSc Associate Professor Section of Colorectal Surgery Department of Surgical Oncology Medical Director Familial High-risk Gastrointestinal Cancer Clinic University of Texas MD Anderson Cancer Center Dr. Y. Nancy You[/caption] Y. Nancy You, MD, MHSc Associate Professor Section of Colorectal Surgery Department of Surgical Oncology Medical Director Familial High-risk Gastrointestinal Cancer Clinic University of Texas MD Anderson Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite the progress in the treatment of many cancers, colorectal cancer (CRC) remains the third most common and lethal cancer in the US. Over 130,000 people are expected to be diagnosed and over 50,000 patients will die from CRC this year. In the recent years, the most exciting development has been our understanding of the molecular complexity of CRC. Currently, four major molecular subtypes of colorectal cancer are recognized. Our study focuses on the Consensus Molecular Subtype 1, which accounts for up to 15% of CRCs, and is characterized by a deficiency in DNA mismatch repair (dMMR), a high level of mutations (i.e. hypermutated), by instability in parts of the genome called microsatellites, and by strong immune activation. Prior to our study, patients with rectal cancer that belong to this molecular subtype have represented an unknown, in terms of their prognosis, and how the tumors respond to current treatments. More importantly, this molecular subtype harbor a genetic condition that can be transmitted within the family called “Lynch Syndrome”. So we designed our study to fill these gaps in our understanding that exist in this subtype of CRCs and to highlight key clinical care issues related to the caring for patients with a genetic syndrome. The main findings are that rectal cancers belonging to this molecular subtype have favorable prognosis, respond well to standard chemoradiation, and are linked to Lynch Syndrome and should be treated at centers with expertise in hereditary cancer syndromes.
Author Interviews, Breast Cancer, Cancer Research, Cost of Health Care, Sloan Kettering, Surgical Research / 18.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27055" align="alignleft" width="275"]Monica Morrow, MD, FACS Chief, Breast Service, Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Dr. Monica Morrow[/caption] Monica Morrow, MD, FACS Chief, Breast Service Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan-Kettering Cancer Center MedicalResearch.com: What is the background for this study? Response: DCIS, ductal carcinoma in situ, intraductal cancer or Stage 0 cancer refers to what some people call the earliest form of cancer we can find and others term “precancerous”. This difference in terms is due to the fact that DCIS lacks the ability to spread to other parts of the body, a fundamental characteristic of cancer. The goal of treatment in DCIS is to prevent progression to invasive cancer which has the ability to spread. DCIS accounted for only 2-3 % of breast cancers seen in the pre-screening mammography era, but it comprises 25-30% of the malignancies detected in screening mammography programs. For this reason it is uncommon in women under age 40, and more commonly seen in women over 50 years of age. Approximately 70% of the women in the US diagnosed with DCIS are treated with lumpectomy (removal of the DCIS and a margin of surrounding normal breast tissue), and additional surgeries to obtain clear, or more widely clear, margins are done in approximately 30% of women. For this reason, the Society of Surgical Oncology, the American Society for Therapeutic Radiation Oncology, and the American Society of Clinical Oncology undertook the development of an evidence based guideline to determine the optimal clear margin for women with DCIS treated with lumpectomy and whole breast radiotherapy.
Author Interviews, Environmental Risks, NIH, OBGYNE, Ovarian Cancer / 18.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27098" align="alignleft" width="133"]Clarice Weinberg, Ph.D. Deputy Branch Chief Biostatistics and Computational Biology Branch National Institute of Environmental Health Sciences National Institutes of Health Research Triangle Park, NC 27709 Dr. Clarice Weinberg[/caption] Clarice Weinberg, Ph.D. Deputy Branch Chief Biostatistics and Computational Biology Branch National Institute of Environmental Health Sciences National Institutes of Health Research Triangle Park, NC 27709 MedicalResearch.com: What is the background for this study? What are the main findings? Response: A number of studies have reported a link between genital use of talc powders and ovarian cancer. We wondered whether the practice of douching could contribute to that risk by moving fibers and chemicals into and up the reproductive tract. We are carrying out the Sister Study, a large cohort study that enrolled more than 50,000 women who each had a sister diagnosed with breast cancer and who are consequently at increased risk of ovarian cancer. During the Sister Study enrollment interview, we asked each of them about their douching and use of talc in the previous 12 months. During approximately 6 years of follow up, 154 participants developed ovarian cancer. Our statistical analyses did not show any relationship between talc use and risk of ovarian cancer, but we estimated that women who had said they douched had almost double the risk for ovarian cancer compared to women who did not douche.
Author Interviews, Prostate Cancer, Urology / 17.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27048" align="alignleft" width="135"]Jennifer Cullen Meyer, PhD, MPH Director of Epidemiologic Research, Center for Prostate Disease Research Assistant Professor, Norman M. Rich Dept. of Surgery, Uniformed Services University Rockville, MD 20852 Dr. Jennifer Cullen Meyer[/caption] Jennifer Cullen Meyer, PhD, MPH Director of Epidemiologic Research, Center for Prostate Disease Research Assistant Professor, Norman M. Rich Dept. of Surgery, Uniformed Services University Rockville, MD 20852 MedicalResearch.com: What is the background for this study? Response: Men diagnosed with prostate cancer who are at low risk for cancer progression may choose to defer immediate treatment with curative intent and, instead, monitor their cancer. This strategy is referred to as “active surveillance.” The primary benefit of active surveillance is that it allows men to temporarily defer definitive cancer treatments that are known to cause decrements in health-related quality of life (HRQoL). Studies have shown that HRQoL is better in men choosing active surveillance as compared to other treatment modalities. However, prior to our study, it was not known whether men on active surveillance experience worse HRQoL than men without prostate cancer.
Author Interviews, Immunotherapy, Lymphoma, Pharmacology / 14.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26974" align="alignleft" width="200"]Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company Dr. Dirk Huebner[/caption] Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy. The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm.
Author Interviews, Immunotherapy, Leukemia, Stem Cells, Transplantation / 12.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26960" align="alignleft" width="200"]Felix Garzon, MD, PhD Senior Vice President Head of Clinical Development Actinium Pharmaceuticals, Inc. New York, NY 10016 Felix Garzon[/caption] Felix Garzon, MD, PhD Senior Vice President Head of Clinical Development Actinium Pharmaceuticals, Inc. New York, NY 10016 MedicalResearch.com: What is the background for this study? What is goal of this Study? Response: Iomab-B (“Iomab”) was developed at the Fred Hutchinson Cancer Research Center (“the Hutch”) in Seattle, Washington. The Hutch is a pioneer in the field of bone marrow transplantation (BMT) having 3 Nobel Prizes and doctors there performed some of the first transplants for leukemia patients. Iomab-B is intended to be an induction and conditioning agent prior to a BMT for patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. BMT is the only potentially curative option for AML i.e. for this patient population that currently has a survival prognosis of 2-6 months which means that if Iomab-B is successful it would create a new market segment and offer patients a great clinical benefit and a hope for a cure. Actinium Pharmaceuticals licensed Iomab from the Hutch in 2012 and prior to us licensing Iomab, it had been studied in almost 300 patients in several phase 1 and phase 2 clinical trials in an array of blood cancers, both leukemias and lymphomas. Actinium is now the sponsor of a pivotal phase 3 trial for Iomab-B to study its use as an induction and conditioning agent prior to a bone marrow transplantation in patients with relapsed or refractory AML who are over the age of 55. This trial, which we have named the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial, started at the end of June 2016 and we expect to enroll 150 patients by the end of 2017. The primary endpoint of the SIERRA trial is durable complete remissions (dCR) of 6 months. The study arm will consist of Iomab-B administration followed by a  bone marrow transplantation, patients will be evaluated for dCR at 6 months after engraftment, which will be assessed at day 28 or day 56. The control arm of the study will be physician’s choice of chemotherapy and if the patient is able to achieve a complete remission (CR) they may receive a BMT or some other form of treatment with curative intent. The study is designed to evaluate if the study arm of Iomab-B and a BMT can double the dCR rate of the control arm, which is designed to replicate the current treatment regimen prior to a bone marrow transplantation .
Author Interviews, Brain Cancer - Brain Tumors, Cancer, Cost of Health Care / 12.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26739" align="alignleft" width="180"]Wuyang Yang, M.D., M.S. Research Fellow Department of Neurosurgery Johns Hopkins Hospital Baltimore, MD 21287 Dr. Wuyang Yang[/caption] Wuyang Yang, M.D., M.S. Research Fellow Department of Neurosurgery Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The treatment for glioblastoma (GBM) patients involves a combined approach of surgery, radiation therapy and chemotherapy. Despite advancement in the therapeutic approaches for GBM, differing socioeconomic status result in disparities in health-care access, and may superimpose a significant impact on survival of glioblastoma patients. Insurance status is an indirect indicator of overall socioeconomic status of a patient, and has been shown to correlate with survival of patients with malignant tumor in other parts of the body. We conducted the first study to determine a relationship between different types of insurance and survival of GBM patients. In our study of 13,665 cases of GBM patients, we found that non-Medicaid insured patients have a significant survival benefit over uninsured and even Medicaid insured patients. This is the first time a study describes this relationship in glioblastoma patients, and also the first to compare and quantify the likelihood of poor prognosis between different insurance categories. A difference in insurance coverage was also uncovered, and patients with insurance were more likely to be older, female, white, and married. In addition, we found that younger, female, married patients with smaller tumor size survive longer than other patients, which confirmed findings in existing literature.
Author Interviews, Breast Cancer, Cost of Health Care, Johns Hopkins / 11.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26928" align="alignleft" width="170"]Pedram Argani, M.D. Professor of Pathology and Principal consultant of the Breast Pathology Service Johns Hopkins Medicine Dr. Pedram Argani[/caption] Pedram Argani, M.D. Professor of Pathology and Principal consultant of the Breast Pathology Service Johns Hopkins Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most pathology laboratories, at the request if clinicians, automatically (reflexively) test needle core biopsies containing ductal carcinoma in situ (DCIS) for estrogen receptor (ER) and progesterone receptor (PR). The logic for testing DCIS for these hormone receptors is that, for patients who have pure DCIS that is ER positive after surgical excision, treatment with estrogen blockers like Tamoxifen can decrease the recurrence of DCIS by a small amount, though overall survival (which is excellent) is not impacted. However, there are several factors which suggest that this reflex testing unnecessarily increases costs. • First, the ER/PR results on core needle biopsy do not impact the next step in therapy; namely, surgical excision. • Second, a subset of excisions performed for DCIS diagnosed on core needle biopsy will harbor invasive breast carcinoma, which would than need to be retested for ER/PR. • Third, because ER and PR labeling is often variable in DCIS, negative results for ER/PR in a small core biopsy specimen should logically be repeated in a surgical excision specimen with larger amounts of DICS to be sure that the result is truly negative. • Fourth, many patients with pure DCIS which is ER/PR positive after surgical excision will decline hormone therapy, so any ER/PR testing of their DCIS is unnecessary. • Fifth, PR status in DCIS has no independent value. We reviewed the Johns Hopkins experience with reflex ER/PR testing of DCIS on core needle biopsies over 2 years. We found that reflex core needle biopsy specimen testing unnecessarily increased costs by approximately $140.00 per patient. We found that ER/PR testing in the excision impacted management in only approximately one third of cases, creating an unnecessary increased cost of approximately $440.00 per patient. Extrapolating the increased cost of reflex ER/PR testing of DCIS to the 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increased costs by approximately 35 million dollars.
Author Interviews, Cancer Research, Chemotherapy, Johns Hopkins, Pancreatic / 11.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26931" align="alignleft" width="200"]Rajesh Kumar NV, Ph.D. Instructor of Oncology and Pathology Johns Hopkins University School of Medicine Baltimore, MD, USA Current Affiliation: Senior Manager, Human Therapeutics Division, Intrexon Corporation, 20358 Seneca Meadows Parkway, Germantown, MD, USA Dr. Rajesh Kumar NV[/caption] Rajesh Kumar NV, Ph.D. Instructor of Oncology and Pathology Johns Hopkins University School of Medicine Baltimore, MD, USA Current Affiliation: Senior Manager, Human Therapeutics Division, Intrexon Corporation, 20358 Seneca Meadows Parkway, Germantown, MD, USA MedicalResearch.com: What is the background for this study? Response: Pancreatic cancer remains as one of the most deadly malignancies in the world. Recently, a cremophor-free and albumin-bound formulation of paclitaxel (nab-PTX, Abraxane) in combination with gemcitabine (GEM, Gemzar) is recently approved as a standard of care treatment option for patients with metastatic pancreatic cancer. Majority of the newly diagnosed pancreatic cancer patients use the nab-PTX plus GEM regimen. Currently there are over 100 clinical trials at various stages with this regimen as a backbone to approved medicines or investigational agents. Since widely available cremophor-based paclitaxel (PTX, Taxol) is a key chemotherapy component for the treatment of several human malignancies and the treatment cost of nab-PTX is relatively higher than PTX, patients, clinicians, third party payers and regulatory agencies have a substantial interest in understanding whether these two drugs provide a similar level of therapeutic efficacy in pancreatic cancer. We utilized orthotopic models of human pancreatic cancer, which were shown to better recapitulate the histologic and metastatic characteristics of disease, and compared the anticancer efficacy, effect on tumor stroma modulation, metastatic spreading to distant organs and survival following GEM, PTX, nab-PTX and combinations of GEM plus PTX or nab-PTX. The preclinical trial used a total of 300 mice with established orthotopic pancreatic tumors. The tumors used for implantation were originally resected from the primary tumors of patients with moderately differentiated and poorly differentiated pancreatic cancer.
Author Interviews, Genetic Research, JAMA, Melanoma / 11.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26912" align="alignleft" width="150"]Ulrich Pfeffer, PhD Laboratory of Molecular Pathology Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliera Universitaria San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy Dr. Ulrich Pfeffer[/caption] Ulrich Pfeffer, PhD Laboratory of Molecular Pathology Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliera Universitaria San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: The melanoma of the eye or uveal melanoma is well controlled by radiotherapy or surgery but very aggressively growing metastases often develop and therapy has only marginally improved in decades. On the other hand, uveal melanoma is probably the best studied cancer in absolute: we know its development in great detail and we can make very precise prognosis. An important piece of information that is lacking is the effect of a chromosomal alteration, amplification of a part of chromosome 6, that is often encountered in a subset of uveal melanomas that show features of bad prognosis but actually perform better. Many have guessed that the immune system or more generally, inflammation might protect uveal melanomas with this alteration from progression to metastasis. Therefore we have set out to analyze a candidate gene, the putative immunomodulatory BTNL2, that is located on chromosome 6. We found highly variable expression of this gene in uveal melanoma samples where it is expressed by tumor cells and by infiltrating immune cells. The type of infiltrate is strongly associated with the risk to develop metastases. We also analyzed genetic variants of BTNL2 in 209 patients but we could not find a significant association with uveal melanoma risk.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Cost of Health Care / 08.08.2016

MedicalResearch.com Interview with: Sarah C. Markt, ScD, MPH Research Associate Harvard T.H. Chan School of Public Health | Department of Epidemiology Boston, MA 02115 MedicalResearch.com: What is the background for this study? Response: Age is associated with insurance status, with the greatest proportion of uninsured between the ages of 20 to 34 years. For testicular cancer this is important because the median age of diagnosis is 33 years and the majority of the cases are diagnosed between then ages of 20 and 44 years. Previous studies have shown that people with cancer who are uninsured are more likely to present with worse disease, less likely to receive treatment, and are more likely to die of their disease, compared with those who have private insurance. Furthermore, the associations between Medicaid coverage and cancer outcomes have been conflicting.
Abuse and Neglect, Author Interviews, Brain Cancer - Brain Tumors / 06.08.2016

Novocure is the developer of Optune, which uses Tumor Treating Fields to treat cancer. Tumor Treating Fields, or TTFields, are low intensity, alternating electric fields within the intermediate frequency range. TTFields disrupt cell division through physical interactions with key molecules during mitosis. This non-invasive treatment targets solid tumors. MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Comprehensive Cancer Network (NCCN) has recommended Optune as a standard treatment option for newly diagnosed glioblastoma (GBM) in its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. NCCN panel members designated Optune together with temozolomide as a category 2A treatment for newly diagnosed GBM for patients with good performance status, indicating uniform consensus among panel members to add Optune to the guidelines for newly diagnosed GBM. Optune has been included in the NCCN Guidelines as a category 2B treatment option for recurrent GBM since 2015. The recommendation follows the publication of Novocure’s EF-14 phase 3 pivotal trial data in The Journal of the American Medical Association (JAMA) in December, 2015. The EF-14 phase 3 pivotal trial demonstrated that adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival in newly diagnosed GBM. Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. Approximately 12,500 GBM tumors, or tumors that may transform into GBM, are diagnosed in the U.S. each year. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in older adults and to affect men than women. GBM is one of the deadliest forms of cancer, with patients typically not surviving beyond 15 months after diagnosis.
Author Interviews, Beth Israel Deaconess, Biomarkers, Lung Cancer, Science / 05.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26759" align="alignleft" width="200"]Dr. Elena Levantini, PhD Beth Israel Deaconess Medical Center Instructor, Medicine, Harvard Medical School Research Associate, Hematology-Oncology Beth Israel Deaconess Medical Center Dr. Elena Levantini[/caption] Dr. Elena Levantini, PhD Beth Israel Deaconess Medical Center Instructor, Medicine, Harvard Medical School Research Associate, Hematology-Oncology Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lung cancer is one of the deadliest cancers in the world, accounting for 30% of tumor-related deaths. Like many solid tumours, lung cancer is very heterogeneous (consisting of cancer cells which behave and respond differently) and hence there is currently no single efficient drug which is able to treat all patients. Levantini and colleagues previously showed that non-small cell lung cancer (NSCLC) tumor cells frequently express too little or none of a transcription factor called C/EBPα, a protein that regulates gene expression and cell proliferation in lung tissues. It’s also known to play a role in a form of leukemia, as well as liver cancer, squamous cell skin carcinomas, squamous cell cancers of the head and neck and other cancers. In their previous work, the scientists suspected that C/EBPα may act as a tumor suppressant in normal cells, but the mechanism by which its absence promoted lung cancer tumors remained unclear. Dr. Levantini went on to develop a mouse model in which deleting C/EBPα resulted in NSCLC. Analysis of this model led to the discovery that C/EBPα suppressed lung tumor formation by inhibiting the expression of BMI1. Dr Levantini then demonstrated that reducing the levels of BMI1 in her mouse model by genetic means, or by using a drug reducing expression of BMI1, led to inhibition of tumor formation. This study has established an important link between C/EBPα and BMI1 for the first time.
Author Interviews, Erectile Dysfunction, Prostate Cancer, Urology / 05.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26742" align="alignleft" width="143"]Juzar Jamnagerwalla, MD Division of Urology, Department of Surgery Cedars-Sinai Medical Center Los Angeles, California Dr. Juzar Jamnagerwalla[/caption] Juzar Jamnagerwalla, MD Division of Urology, Department of Surgery Cedars-Sinai Medical Center Los Angeles, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: In mouse models phosphodiesterase type-5 inhibitors (PDE-5i) have been shown to have anti-neoplastic activity, and given the routine use of PDE-5i for treatment of erectile dysfunction after prostatectomy several studies have examined the association between PDE-5i use and biochemical recurrence after treatment for prostate cancer with mixed findings. Only one previous study has explored the association between risk of prostate cancer, finding that men on PDE-5i had a lower chance of being diagnosed with prostate cancer. Given this, we tested the relationship between PDE-5i use and risk of prostate cancer in 6,501 men in the REDUCE study finding that PDE-5i use was not associated with prostate cancer diagnosis. On secondary analysis, among North American men who had a much higher baseline use of PDE-5i use, there was an inverse association between PDE-5i use and prostate cancer diagnosis, which approached, but did not reach statistical significance.
Author Interviews, Biomarkers, Genetic Research, Leukemia, Personalized Medicine / 05.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26730" align="alignleft" width="200"]Dr Laura Eadie PhD Post Doctoral Researcher Affiliate Lecturer Discipline of Medicine University of Adelaide Dr. Laura Eadie[/caption] Dr Laura Eadie PhD Post Doctoral Researcher Affiliate Lecturer Discipline of Medicine University of Adelaide Summary: Researchers based at SAHMRI (South Australian Health and Medical Research Institute) in Adelaide, South Australia have recently demonstrated the significance of early increases in the expression of ABCB1 in predicting long-term response to imatinib therapy. Lead researcher, Dr Laura Eadie, has recently had these findings published in the journal Leukemia and says that she hopes “the evidence provided by the study could be used to inform better patient treatment in the future”. MedicalResearch.com: What is the background for this study? What are the main findings? Response: ABCB1 (p-glycoprotein) is a membrane transporter known to be involved in the efflux of the tyrosine kinase inhibitors (TKIs) that are used to treat chronic myeloid leukaemia (CML). Overexpression of ABCB1 has also been demonstrated to cause resistance to the TKIs imatinib, nilotinib and dasatinib in vitro. Although studied previously in CML patients, the predictive value of ABCB1 in determining a patient’s long-term response to imatinib had not been realized ... until now. Previous studies investigating ABCB1 as a predictive biomarker focused on expression levels of ABCB1 at one time point in isolation. For our study, we have measured the levels of ABCB1 at two separate time points specified in the TIDEL II trial protocol: day 1 (prior to the start of imatinib therapy) and day 22 (three weeks on imatinib). We then calculated the fold rise in ABCB1 expression levels at day 22 compared with day 1 and grouped patients about the median into high and low fold rise. When we compared molecular outcomes for patients within these two ABCB1 expression groups we noticed a striking difference in outcome to imatinib therapy.
Author Interviews, BMJ, Environmental Risks, Lung Cancer / 05.08.2016

[caption id="attachment_26722" align="alignleft" width="150"]Sandrah P. Eckel PhD Assistant Professor of Preventive Medicine USC Division of Biostatistics Dr. Sandrah Eckel[/caption] MedicalResearch.com Interview with: Sandrah P. Eckel PhD Assistant Professor of Preventive Medicine USC Division of Biostatistics MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lung cancer is the most common cancer and it is responsible for 1 in 5 cancer deaths. There is a growing body of evidence that ambient air pollution exposures are linked to lung cancer incidence and mortality, but the effect on survival of exposures after diagnosis are unclear. The International Agency for Research on Cancer recently classified ambient air pollution as carcinogenic. We reasoned that if air pollution drives lung cancer development, it could impact lung cancer progression—and shorten survival—through the same biological pathways. We used 20 years of data on more than 300,000 newly diagnosed lung cancer cases from the California Cancer Registry and calculated average air pollution exposures at each patient’s residence from the date of diagnosis through the end of follow-up. We found that patients living in areas with higher pollution levels had shorter survival, particularly for patients who were diagnosed at an early stage and for those diagnosed at an early stage with adenocarcinoma histology. Interestingly, adenocarcinoma is the most common histological subtype of lung cancer in non-smokers.
Author Interviews, Genetic Research, Prostate Cancer, Race/Ethnic Diversity, Vitamin D / 02.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26679" align="alignleft" width="142"]Gerard (Gary) Hardiman, Ph.D Professor, Department of Medicine Professor Department of Public Health Sciences Bioinformatics Director Center for Genomic Medicine Medical University of South Carolina Charleston, SC 29425 Dr. Gerard Hardiman[/caption] Gerard (Gary) Hardiman, Ph.D Professor, Department of Medicine Professor Department of Public Health Sciences Bioinformatics Director Center for Genomic Medicine Medical University of South Carolina Charleston, SC 29425 MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are significant racial disparities in prostate cancer outcomes. The disease disproportionately affects African American men in terms of incidence, morbidity, and mortality, even after adjustment for stage. African American men have a 2- to 3-times increased risk of developing prostate cancer and have a greater mortality rate compared to European American men. We carried out a prospective clinical study aimed at examining the effects of vitamin D3 supplementation at 4,000 IU per day for two months in male subjects who selected surgical removal of the prostate (prostatectomy) as a definitive treatment for their prostate cancer. The primary goal of this study was to examine molecular differences in gene expression patterns relevant to prostate cancer disparities between African American and European American men, and investigate the global effects of vitamin D3 supplementation on the prostate transcriptome. We carried out genome wide expression profiling experiments using high throughput (HT) RNA sequencing. Transcriptional profiles of each of the patient’s tissue samples were generated and systems level analyses were performed.