Author Interviews, Cancer Research, Dermatology, JAMA, University of Pennsylvania / 06.07.2017

MedicalResearch.com Interview with: Mackenzie R. Wehner, MD, MPhil Department of Dermatology University of Pennsylvania Philadelphia, PA MedicalResearch.com: What is the background for this study? Response: For some diseases, we have national registries, in which information about every person with that disease is entered for research purposes. For other diseases, unfortunately, we do not have such registries. There are growing opportunities to use information like internet searches to better understand behaviors and diseases, however. Our study was a proof-of-concept: we aimed to find out whether internet searches for diseases correlated with known incidence (how many people are diagnosed with the disease) and mortality (how many people die of the disease) rates. E.g. does the number of people who searched 'lung cancer' online correlate with the number of people who we know were diagnosed with or who died of lung cancer during that same time period? This is important to know if researchers in the future want to use internet search data for diseases where we lack registry information. (more…)
Author Interviews, Prostate Cancer, Race/Ethnic Diversity / 06.07.2017

MedicalResearch.com Interview with: Dr. Norman Lee PhD Professor of Pharmacology and Physiology School of Medicine and Health Sciences George Washington University MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are health disparities when it comes to prostate cancer. The African American population, in general, has a higher prostate cancer incidence and mortality rate compared to other racial groups such as European Americans. A major reason for this disparity is due to socioeconomic factors such as access to health care. There are also biological influences for the disparities, such as specific gene mutations and genetic polymorphisms that are found at a higher incidence in the African American population. My lab has been studying other potential contributing biological factors in prostate cancer disparities; namely, RNA splicing. RNA splicing is a cellular program that increases the diversity of expressed proteins by regulating which exons are included in an mRNA transcript, leading to mRNA variants encoding slightly different proteins (or isoforms) in different cells, organs, and individuals. One can think of RNA splicing as a form of genetic diversity. What we have found is that the repertoire of mRNA variants can differ in prostate cancer between African and European Americans. We also find that the mRNA variants in African American prostate cancer encode signal transduction proteins that are more oncogenic and resistant to targeted therapies, compared to the variants found in European American prostate cancer. (more…)
Author Interviews, Cancer Research, Melatonin, Occupational Health / 28.06.2017

MedicalResearch.com Interview with: Parveen Bhatti, PhD Associate Member Fred Hutchinson Cancer Research Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Evidence in humans for an association between shift work and cancer has been mixed. This may be due to difficulties in accurately assessing long-term exposures to shift work in studies of cancer risk. We took a different approach that circumvented these difficulties. Rather than look at cancer risk directly, we measured, among actively employed shift workers, a marker of DNA damage that has been linked to cancer. When repaired by cellular machinery, this particular marker is excreted in urine where it can be measured. We found that, compared to sleeping at night during their night off, shift workers had lower urinary levels of the DNA damage marker during their night work. This effect appears to be driven by reductions in circulating melatonin levels among shift workers during night work relative to night sleep. Given that melatonin has been shown to enhance repair of DNA damage, our results suggest that, during night work, shift workers have reduced ability to repair DNA damage resulting in lower levels being excreted in their urine. Because of this, shift workers likely have higher levels of DNA damage remaining in their cells, which can lead to mutations and cause cancer. (more…)
Author Interviews, Cancer Research / 24.06.2017

MedicalResearch.com Interview with: Dr. Ajai Chari, MD Associate Professor of Medicine Multiple Myeloma Program and Associate Director of Clinical Research Mount Sinai Hospital, New York MedicalResearch.com: What is the background for this study? Would you briefly explain multiple myeloma (How common is it, whom does it chiefly affect, etc.)? Response: Multiple myeloma is a rare form of blood cancer that occurs when plasma cells grow uncontrollably in the bone marrow. It is estimated that approximately 30,280 people will be diagnosed and 12,590 will die from the disease in the United States in 2017. While some patients with multiple myeloma have no symptoms at all, symptoms can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections. Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as proteasome inhibitors (PIs) and immunomodulatory agents. Therefore, these patients continue to need new options. The MMY1001 (EQUULEUS) study is a Phase 1b, open-label study assessing daratumumab in combination with multiple backbone regimens for multiple myeloma. In one arm of the study, supporting the recent approval of DARZALEX (daratumumab), the treatment was assessed in combination with pomalidomide and dexamethasone in patients with multiple myeloma who had received a prior PI and an immunomodulatory agent. Data from the study showed that the addition of daratumumab resulted in an overall response rate (ORR) of 59.2 percent (95 percent CI: 49.1 percent, 68.8 percent), with very good partial response (VGPR) achieved in 28.2 percent of patients. Complete response (CR) was achieved in 5.8 percent of patients and stringent CR (sCR) was achieved in 7.8 percent of patients. (more…)
Author Interviews, Cancer Research, Genetic Research / 22.06.2017

MedicalResearch.com Interview with: Antonis Antoniou PhD Reader in Cancer Risk Prediction Academic Course Director MPhil in Epidemiology Centre for Cancer Genetic Epidemiology Department of Public Health and Primary Care Strangeways Research Laboratory Cambridge University of Cambridge MedicalResearch.com: What is the background for this study? What are the main findings? Response: Several studies demonstrated that women with genetic faults in the BRCA1 and BRCA2 genes are at increased risk of developing breast and ovarian cancer. Having accurate age-specific cancer risk estimates for women with mutations is essential for their optimal clinical management. Most studies to date that estimated cancer risks for BRCA1 and BRCA2 mutation carriers have been "retrospective", in other words they look at what happened in the past. Estimates from such studies are prone to biases because they rely on the experience of women who have already developed cancer and on self-reported cancer family history information on relatives - which may have inaccuracies. The ideal epidemiological study design for estimating cancer risks are prospective studies.  In prospective studies, healthy women with genetic faults are followed over time and overcome these potential biases. However, to date, published  prospective studies have been very small. In the present study we used data from a prospective cohort of women with BRCA1 and BRCA2 mutations who were recruited from 1997 to 2011 and were followed over time. The study included almost 10,000 women who were included in the analyses, and was made possible through collaborations between scientists from Europe, North America and Australia.  The prospective study design explains why it has taken 20 years of hard work to get these results. Most importantly, it took an enormous long-term contribution and commitment from the women themselves to allow the scientists to be able to assemble this dataset. Here, we were able to estimate more precisely the breast and ovarian cancer risks for women with faults in BRCA1 and BRCA2.  These risk estimates will provide more confidence in the counseling and clinical management of women with faults in the BRCA1 and BRCA2  genes. A novel finding in this study is that breast cancer risk for women with faults in BRCA1 and BRCA2  increases rapidly at a young age then remains at a constant high level for the rest of their lives. It peaks in the 40’s for BRCA1 mutation carriers and in the 50’s for BRCA2 carriers, but  carriers of mutations in both genes  are at about the same high risk in later life. This is important information to inform the clinical management of older mutation carriers. This study also shows clearly that for women with a mutation, there are other factors that are important in modifying the breast cancer risk. The study has demonstrated that the extent of the woman’ family history of cancer and the exact place on the gene where her mutation is located are very important in determining the actual risk. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, Melanoma / 22.06.2017

MedicalResearch.com Interview with: David E. Fisher MD, PhD Edward Wigglesworth Professor & Chairman Dept of Dermatology Director, Melanoma Program MGH Cancer Center Director, Cutaneous Biology Research Center Massachusetts General Hospital Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study grew from an interest to mimic the dark pigmentation patterns in human skin which are known from epidemiology to be associated with low skin cancer risk. In the current work, a molecular inhibitor of the SIK enzyme was used to block the inhibitory action of SIK relative to melanin synthesis. The result was stimulation of dark pigmentation within human skin. (more…)
Author Interviews, Biomarkers, Colon Cancer, JAMA / 19.06.2017

MedicalResearch.com Interview with: Anastasia Katsoula, MD MSc Aristotle University of Thessaloniki Greece  MedicalResearch.com: What is the background for this study? Response: Early detection of colorectal cancer (CRC) has proven to be effective in reduction of cancer-related mortality. Fecal immunochemical testing (FIT) has been recently advocated for population-based screening for CRC in average-risk individuals due to its high accuracy and potential for adherence, based on results from previous systematic reviews and meta-analyses in average-risk populations. However, the potential role of FIT for screening of subjects at increased risk for CRC has not yet been elucidated, hence colonoscopy is currently the only recommended screening option for subjects at increased risk of CRC. We performed a systematic review and meta-analysis to explore the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in patientswith personal or familial history of CRC, using colonoscopy as the reference standard. (more…)
Author Interviews, Medical Imaging, Prostate Cancer / 19.06.2017

MedicalResearch.com Interview with: Dr. Susanne Lütje Ärztlicher Dienst Universitätsklinikum Essen (AöR) Klinik für Nuklearmedizin Essen Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer (PCa) is the most common cancer in men and accounts for a significant amount of morbidity and mortality. At present, the curative treatment option of choice for localized stages of PCa is radical prostatectomy, which may include extended lymph node dissection. Unfortunately, surgical procedures can be accompanied by complications such as urinary incontinence. Most importantly, small tumor deposits may not be seen by the surgeon during surgery and could ultimately lead to disease recurrence. To overcome these issues, new and innovative treatments are needed. The prostate-specific membrane antigen (PSMA) is a surface protein that is overexpressed in prostate cancer and can be used as a target to guide new therapies. Photodynamic therapy (PDT) is an ablative procedure in which tumor cells can be destroyed effectively by irradiation of light of a specific wavelength, which activates previously administered photosensitizers. The photosensitizers can respond by emitting fluorescence or emitting oxygen radicals which can cause cellular damage. Coupling the photosensitizer to an agent that targets PSMA on the tumor surface offers the possibility to selectively and effectively destroy prostate tumor remnants and micrometastases, while surrounding healthy tissues remain unaffected. In our study, the PSMA targeting antibody D2B was coupled to the photosensitizer IRDye700DX and radiolabeled with 111In. In a mouse model, this multi-modality agent was used to preoperatively visualize tumor lesions with SPECT/CT to allow rough localization of the tumors. During surgery, the fluorescent signal originating from the photosensitizer facilitates visualization of tumors and residual tumor tissue, so the surgeon can be guided towards accurate resection of the entire tumors and metastases. In addition, the PSMA-targeted PDT can be applied to destroy small tumor deposits in cases where close proximity of the tumors. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Prostate Cancer / 15.06.2017

MedicalResearch.com Interview with: Dr. Yong-Jie Lu MBBS, MD, PhD Reader in Medical Oncology Centre for Molecular Oncology Barts Cancer Institute - a CR-UK Centre of Excellence Queen Mary University of London John Vane Science Centre, Charterhouse Square London MedicalResearch.com: What is the background for this study? Response: Identifying/monitoring the occurrence of metastasis and the prediction of the length that a patient may survive with a prostate cancer is critical for doctors to select the proper treatment, aiming to achieve the best control of the cancer with a balance of quality of life. Currently this is achieved mainly by analysing the cancer tissues acquired through very invasive procedures or by expensive imaging techniques, most of which expose the patient to toxic radioactive materials. Circulating tumour cells (CTCs), which play a key role in the metastasis process, have been shown for their potential to be used for cancer prognosis by a simple blood sample analysis. However, previous CTC studies mainly detect the epithelial type of CTCs. Using the ParsortixTM (ANGLE plc) cell-size and deformability based CTC isolation system, we analysed not only epithelial CTCs, but also CTCs with epithelial-mesenchymal transition (EMT), a cellular process associated with cancer invasion and metastasis. (more…)
ASCO, Author Interviews, Breast Cancer / 14.06.2017

MedicalResearch.com Interview with: Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX MedicalResearch.com: What is the background for this study? Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease. MedicalResearch.com: What are the main findings? o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer: • After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone. • The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone. • In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo. • Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo. o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis. • The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%). (more…)
Author Interviews, Biomarkers, Pancreatic / 13.06.2017

MedicalResearch.com Interview with: 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 Germantown, MD MedicalResearch.com: What is the background for this study? Response: Pancreatic ductal adenocarcinoma (a.k.a. pancreatic cancer) is one of the most deadly of all types of cancer and currently the third leading cause of cancer-related death in United States. Current therapeutic options for pancreatic cancer involve combination cytotoxic chemotherapy, which yield only minimal survival benefit. A multitude of Phase III clinical trials have failed to demonstrate efficacy, largely due to the aggressive growth of pancreatic tumors. Metabolic reprogramming is a hallmark of cancer cells, including pancreatic cancer. Altered metabolism is central to the pathogenesis of pancreatic cancer and contributes to promotion of proliferation, survival, invasiveness and chemo-resistance of cancer cells. Pharmacologic strategies targeting cancer metabolism might therefore represent a promising approach towards the development of effective drugs against pancreatic cancer. We utilized a clinically relevant and genetically characterized platform of patient-derived pancreatic cancer xenografts, which we originally created from the freshly resected pancreatic cancer tissues of patients, to explore the in vivo anti-tumor efficacy of a panel metabolic inhibitors and investigated whether mutational status, gene expression and metabolite profile of tumors correlate with the sensitivity to metabolic inhibitors. To our knowledge, this is the largest preclinical trial which enrolled a large number of animals (over 500 mice) with established human pancreatic tumors for the comprehensive evaluation of key metabolic inhibitors in pancreatic cancer.  (more…)
Author Interviews, Cancer, Cancer Research, Hepatitis - Liver Disease, Race/Ethnic Diversity / 12.06.2017

MedicalResearch.com Interview with: Farhad Islami, MD PhD Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liver cancer is one of the leading causes of cancer death in the United States, accounting for nearly 29,000 deaths per year, with variations in occurrence by race/ethnicity and state. We examined trends in liver cancer incidence, survival, and mortality in the United States and provided liver cancer mortality rates by race/ethnicity at the national and state level. State-level statistics are particularly important as they can inform state cancer control and prevention planning. We also provided detailed information on prevalence and trends in major risk factors for liver cancer and interventions to prevent or reduce their burden, to make our article a comprehensive yet concise source of information on liver cancer statistics, risk factors, and interventions in the United States. (more…)
Author Interviews, Breast Cancer / 12.06.2017

MedicalResearch.com Interview with: Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA   MedicalResearch.com: What is the background for this study? Response: Public health depends on coordinated actions between patients, payors and providers. Important preventative care and evidence-based screenings need to be understood and sought out by patients, need to be reimbursed by or subsidized by insurance plans, and offered and recommended by physicians and care team members. Women’s breast health is a good example of how – in theory – all these come together and allow women to obtain regular screenings for breast cancer through mammograms. Yet it is commonly accepted that perhaps as many as 1 in 3 women are not adequately screened or are not screened at all. In this study we hypothesized that a prominent global celebrity, Ms Angelina Jolie’s, highly public announcement of her own risk-reducing surgery to prevent breast cancer and her recommendation to women to understand whether they were at high risk might spur uptake of breast screenings at our institution. (more…)
Author Interviews, Cancer Research, Geriatrics, JAMA, Johns Hopkins / 12.06.2017

MedicalResearch.com Interview with: Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine MedicalResearch.com: What are the main findings? Response: A lot of cancer screenings are not expected to save lives until up to 10 years later; however, the side effects of the test happen right away. Because of this, clinical guidelines have recommended against routine screening for those patients who will not live long enough to benefit but may experience the potential harm of the test in the short term. However, many patients with limited life expectancy still receive screening and clinicians are worried about how patients would react if they recommended that patients stop screening. This research is important because it is the first study that explores how patients think about the decision of stopping cancer screening and how patients want to talk to their doctors about this issue. Understanding patient perspectives would help improve screening practices and better align recommendations and patient preference. (more…)
ASCO, Author Interviews, Cancer Research, Vaccine Studies / 12.06.2017

MedicalResearch.com Interview with: Chrisann Kyi, MD Fellow, Division of Hematology and Medical Oncology Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, Box 1079 New York, NY 10029 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein. At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors. In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY (more…)
ASCO, Author Interviews, Breast Cancer, Merck, NYU / 10.06.2017

MedicalResearch.com Interview with: Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016   MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings? Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A). The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy. (more…)
Author Interviews, Breast Cancer, JAMA, Surgical Research / 10.06.2017

MedicalResearch.com Interview with: Monica Morrow, MD, FACS Chief, Breast Service Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering MedicalResearch.com: What is the background for this study? Response: Although we know that bigger surgery does not result in better patient outcomes in breast cancer, since 2005 rates of lumpectomy have been decreasing accompanied by an increase in bilateral mastectomy for unilateral cancer. High rates of second surgery after initial lumpectomy are one deterrent for patients. In 2013 the SSO and ASTRO developed an evidence based consensus guideline endorsing no ink on tumor as the standard negative margin width for women with stage 1 and 2 cancer having breast conserving surgery with whole breast irradiation. The purpose of our study was to examine time trends in the use of additional surgery after lumpectomy before and after guideline dissemination and to determine the impact of these trends on final rates of breast conservation. (more…)
ASCO, Author Interviews, Colon Cancer, Exercise - Fitness, Nutrition, UCSF / 06.06.2017

MedicalResearch.com Interview with: Dr. Erin Van Blarigan, ScD Assistant Professor, Department of Epidemiology and Biostatistics UC San Francisco MedicalResearch.com: What is the background for this study? Response: There are over 1.3 million colorectal cancer survivors in the United States. Cancer survivors often seek guidance on what they can do to lower their risk of cancer recurrence and death. In response to patient interest and the need for improved survivorship care, the American Cancer Society (ACS) published guidelines on nutrition and physical activity for cancer survivors. The guidelines are to: 1) achieve and maintain a healthy body weight; 2) engage in regular physical activity; and 3) achieve a dietary pattern that is high in vegetables, fruits, and whole grains. (more…)
ASCO, Author Interviews, Cancer Research / 05.06.2017

MedicalResearch.com Interview with: Dr. Kelly Garneski Paulson, MD, PHD Fred Hutchinson Cancer Research Center Seattle, WA   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Merkel cell carcinoma (MCC) is an aggressive skin cancer with increasing impact. Currently, there are more than 2000 new cases of MCC diagnosed each year in the US. Over one third of patients will develop metastatic disease. Most cases of Merkel cell carcinoma are caused by a virus (Merkel cell polyomavirus). In these cancers, the viral oncoproteins (cancer causing proteins) are highly expressed (exclusively on tumor tissue), immunogenic and are necessary for cancer growth.  These oncoproteins are thus ideal targets for cancer immunotherapy, making MCC a great cancer in which to study and develop immunotherapy.  Indeed, immunotherapies are effective in MCC, with observed response to checkpoint inhibitor mono therapy on the order of 35-55%, although complete responses remain rare. In our first trial, we treated four patients with metastatic Merkel cell carcinoma with endogenous T cell therapy (ex vivo expanded polyclonal T cells recognizing Merkel cell polyomavirus). One patient developed a complete response, but three patients rapidly progressed. Interestingly, we observed that the patient with the complete response had low levels of PD-1 expression on the virus specific transferred T cells. We thus hypothesized adding adding an immune checkpoint inhibitor (avelumab, anti-PD-L1) to the transferred T cells would be acceptably safe and potentially improve clinical effectiveness. (more…)
ASCO, Author Interviews, Cancer Research, NYU / 05.06.2017

MedicalResearch.com Interview with: Prof Francisco J Esteva MD PhD Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer. In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial. We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar. (more…)
Author Interviews, Breast Cancer, Race/Ethnic Diversity, Surgical Research, University of Michigan / 01.06.2017

MedicalResearch.com Interview with: Elham Mahmoudi, PhD, MS Section of Plastic Surgery, University of Michigan Medical School Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups. In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR. Our results did not show any effect on the overall rate of immediate  post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication. (more…)
Author Interviews, Brain Cancer - Brain Tumors, JAMA, Radiation Therapy / 01.06.2017

MedicalResearch.com Interview with: Professor Rakesh Jalali, MD Professor of Radiation Oncology President, Indian Society of Neuro-Oncology Tata Memorial Parel, Mumbai India  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Randomized controlled trials to test the efficacy of radiotherapy techniques are challenging to perform. High-precision conformal techniques such as stereotactic radiosurgery/radiotherapy, intensity modulated radiotherapy (IMRT) and particle therapy, etc have been incorporated into routine clinical practice including for brain tumors without always being supported by level-1 evidence. We therefore conducted a prospective, randomized, controlled trial of stereotactic conformal radiotherapy compared to conventional radiotherapy in young patients with residual/progressive bening and low grade brain tumors requiring radiotherapy for optimal disease control. (more…)
Annals Internal Medicine, Author Interviews, Cancer Research, Colon Cancer, Race/Ethnic Diversity / 24.05.2017

MedicalResearch.com Interview with: Stacey Fedewa PhD Strategic Director, Risk Factors & Screening Surveillance American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Screening for colorectal cancer is effective in reducing incidence and mortality by detecting precancerous lesions or cancer at more curable stages. But colorectal cancers can still develop in screened populations, some are missed at the time of screening; others can develop between recommended screenings. Patterns of risk for interval colorectal cancer, defined as cancers that develop after a negative result on colonoscopy, by race/ethnicity are not well known. The risk for blacks was of interest to us because colorectal incidence and mortality rates in blacks are the highest among any race or ethnicity in the United States. We were also interested to see if quality of colonoscopy, measured by physician’s polyp detection rate, could account for differences. (more…)
Author Interviews, JNCI, Lung Cancer, Smoking, Tobacco, Tobacco Research / 22.05.2017

MedicalResearch.com Interview with: Peter G. Shields, M.D. Deputy Director, Comprehensive Cancer Center James Cancer Hospital Professor, College of Medicine Julius F. Stone Chair in Cancer Research The Ohio State University Columbus, OH MedicalResearch.com: What do we know about the health effects of cigarette filters?  Response:  The issue is that the design of the filters makes a cigarette even more dangerous, which can be regulated by the FDA. The issue is not about having a filter, but how they are made. And now we are changing the dialogue to the design of virtually all cigarettes. The holes on the filter are likely one reason the cigarettes of today are more dangerous. (more…)
Author Interviews, Cost of Health Care, MRI, Prostate, Prostate Cancer / 21.05.2017

MedicalResearch.com Interview with: Vikas Gulani, MD, PhD Director, MRI, UH Cleveland Medical Center Associate Professor, Radiology, CWRU School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to learn if performing MR before prostate biopsy, followed by MR guided strategies for biopsy, are cost effective for the diagnosis of prostate cancer in men who have not previously undergone a biopsy and who have a suspicion of prostate cancer. The most significant findings are as follows: We found that all three MR guided strategies for lesion targeting (cognitive targeting, MR-ultrasound fusion targeting, and in-gantry targeting) are cost effective, as the increase in net health benefits as measured by addition of quality adjusted life years (QALY), outweigh the additional costs according to commonly accepted willingness to pay thresholds in the United States. Cognitive targeting was the most cost effective. In-gantry biopsy added the most health benefit, and this additional benefit was cost-effective as well. (more…)
Author Interviews, Biomarkers, Genetic Research, Prostate Cancer / 19.05.2017

MedicalResearch.com Interview with: Bela S. Denes, MD, FACS Senior Director Medical Affairs UROLOGY Genomic Health Inc. Redwood City, CA. 94063 MedicalResearch.com: What is the background for this study? Response: This is a prospective community based non-interventional study designed to provide information on the utility of Oncotype GPS in the management of men presenting with a new diagnosis of clinically localized low risk prostate cancer. We sought to understand the impact of incorporating a molecular marker into the shared treatment decision in practices already well versed in Active Surveillance (AS) as measured by persistence on surveillance at 2 years as well as a number of patient reported outcomes. The current publication reports on the results of a one year pre-specified interim analysis. (more…)
Author Interviews, JCEM, Surgical Research, Thyroid, University of Michigan / 18.05.2017

MedicalResearch.com Interview with: Megan Rist Haymart MD Assistant Professor University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is typically treated with thyroid surgery. It is common practice for physicians to inform patients that the risk of vocal cord paralysis or hypoparathyroidism with thyroid surgery is 1-3%. However, most of these estimates are based on single institution studies with high volume surgeons. In our study we evaluated surgical risks in a population-based cohort. Using the Surveillance, Epidemiology, and End Results-Medicare database, we found that 6.5% of thyroid cancer patients developed general post-operative complications (fever, infection, hematoma, cardiopulmonary and thromboembolic events) and 12.3% developed thyroid surgery specific complications (hypoparathyroidism/hypocalcemia, vocal cord/fold paralysis). Older patient age, presence of comorbidities, and advanced stage disease were associated with the greatest risks of surgical complications. (more…)
ASCO, Author Interviews, Cancer Research, Genetic Research / 18.05.2017

MedicalResearch.com Interview with: Roy Mano, MD and David Margel, MD, PhD Department of Urology, Rabin Medical Center Petach Tikva, Israel MedicalResearch.com: What is the background for this study? Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies. (more…)
Author Interviews, Cancer Research, NYU, Smoking / 17.05.2017

MedicalResearch.com Interview with: Moon-shong Tang, PhD Professor of Environmental Medicine, Pathology and Medicine New York University Langone School of Medicine Tuxedo Park, New York 10987 MedicalResearch.com: What is the background for this study? Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny. (more…)
Author Interviews, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MIT MedicalResearch.com: What is the background for this study? Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer. To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer. (more…)