Author Interviews, Dermatology, JAMA, Melanoma / 10.11.2016

MedicalResearch.com Interview with: 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). (more…)
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. (more…)
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. (more…)
Author Interviews, Cancer Research, Cost of Health Care / 08.11.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, Kaiser Permanente, Mayo Clinic, Prostate Cancer / 03.11.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Breast Cancer, Vaccine Studies / 30.10.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, Biomarkers, Cancer, Cancer Research, University of Pennsylvania / 28.10.2016

MedicalResearch.com Interview with: 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? (more…)
Author Interviews, Cancer Research, JAMA, Smoking / 24.10.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, NEJM, Prostate Cancer / 21.10.2016

MedicalResearch.com Interview with: 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). (more…)
Author Interviews, ESMO, Immunotherapy, Lung Cancer / 21.10.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, ESMO / 18.10.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Breast Cancer, ESMO, Immunotherapy / 17.10.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cancer Research, Pharmacology / 17.10.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cancer Research, ESMO, Immunotherapy, NYU / 16.10.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, ESMO, Immunotherapy, Ovarian Cancer / 14.10.2016

MedicalResearch.com Interview with: 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: (more…)
Author Interviews, Cancer Research, ESMO, Immunotherapy / 13.10.2016

MedicalResearch.com Interview with: Dr. Mathew Galsky MD Associate Professor, Medicine, Hematology and Medical Oncology Assistant Professor, Urology Director, Genitourinary Medical Oncology The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since the development of combination cisplatin-based chemotherapy for the treatment of metastatic bladder (urothelial) cancer several decades ago, there have been few advances in the treatment of this disease. Further, until recently, there had been no global standard treatment options for patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. Several lines of evidence suggest that urothelial cancer may be sensitive to immunotherapeutic treatment strategies. Recently, in a phase I/II study published by Sharma and colleagues in Lancet Oncology, the anti-PD-1 antibody Nivolumab demonstrated a durable objective response rate of 24% in patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. To confirm to antitumor effects of Nivolumab in this patient population, we conducted a large global multicenter single-arm phase II study (more…)
Author Interviews, Cost of Health Care, Journal Clinical Oncology, Melanoma / 13.10.2016

MedicalResearch.com Interview with: Caroline Watts| Research Fellow Cancer Epidemiology and Prevention Research Sydney School of Public Health The University of Sydney  MedicalResearch.com: What is the background for this study? Response: A clinic for people at high risk of melanoma was established at the Royal Prince Alfred Hospital, Sydney in 2006 as part of a research project to look at the impact of surveillance regime which included regular full body skin examination supported by dermoscopy and total body photography at 6 monthly intervals. If a suspicious lesion was identified, the lesion was either removed or an image of the lesion was captured using digital dermoscopy and the patient returned in 3 months for review. This study aimed to estimate the costs and benefits from a health system perspective associated with specialised surveillance compared with current routine care high risk people would receive in the community.  (more…)
Author Interviews, Breast Cancer, Heart Disease, JAMA / 12.10.2016

MedicalResearch.com Interview with: Husam Abdel-Qadir, MD, FRCPC, DABIM (Cardiology and Internal Medicine) Graduate student, Clinical Epidemiology and Health Care Research Elliot Philipson Clinician Scientist Training Program University of Toronto MedicalResearch.com: What is the background for this study? Response: Breast cancer is the most common malignancy among North American women. The successes of screening and treatment have led to a marked increase in the number of breast cancer survivors, whose cardiovascular health is becoming of prime concern. Many recent publications have raised alarm about the incidence of cardiovascular abnormalities after breast cancer treatment. However, there is a paucity of data about the frequency of death from cardiovascular disease rather than breast cancer. Contemporary estimates of the incidence of competing risks like cardiovascular disease are important to guide discussions about prognosis, subsequent follow-up, and survivorship plans. It is important that such incidence estimates are generated using methodology that appropriately accounts for competing risks to avoid providing results that are biased upwards. (more…)
Author Interviews, Cancer Research, ESMO / 12.10.2016

MedicalResearch.com Interview with: Dr. Amanda Bobridge University of South Australia Adelaide MedicalResearch.com: What is the background for this study? Response: Despite cancer screening being demonstrated to reduce cancer morbidity and mortality, current participation in established screening programs is variable. In Australia, the participation rates range from 37% for bowel cancer (FOBT) screening to 57% for cervical cancer screening. This study aimed to determine the barriers to and enablers for cancer screening and whether the target population for screening would support the concept of combined cancer screening (all screening offered at the same time at the same location). (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Dr. Sham Mailankody, MBBS Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? Response: The high price of older drugs has been increasingly criticized in part because of recent dramatic price hikes. There are some well known examples like pyrimethamine and more recently EpiPen. Whether and to what degree examples like pyrimethamine represent a common problem or exceptional cases remains unknown. Using Medicare data available for Part B, we sought to analyze the change in average sales price of cancer drugs between January 2010 and January 2015, and whether older drugs were more likely to undergo price increases than newer drugs. (more…)
Author Interviews, Breast Cancer, ESMO / 12.10.2016

MedicalResearch.com Interview with: Judith Balmaña MD Medical Oncology Hospital Vall d’Hebron and Vall d’Hebron Institute of Oncology Barcelona, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Tumors  with brca1 or brca2 mutations share homologous recombination repair deficiency, which confers sensitivity to different types of dna damaging agents. An understanding of the role of brca1 and brca2 in the repair of double-stranded dna damage opened a window of opportunity for treating brca mutation–associated cancers with targeted therapies. Lurbinectedin is a trabectedin analog that specifically binds to cg-rich motifs with a selective mechanism of action: in living cells, lurbinectedin inhibits active transcription by degradation of elongating rna polymerase ii. This process occurs specifically on activated genes and is associated with the formation of double strand dna breaks and the collapse of replication forks. In addition, lurbinectedin exerts some antitumoral effect in the microenvironment by inhibiting the transcription of selected cytokines by tumor-associated macrophages, abrogating their protumoral properties. Observations that lurbinectedin was active against homologous-recombination-deficient cell lines led us to test it in patients with metastatic breast cancer having deleterious germline brca mutations. (more…)
Author Interviews, Cancer Research, Immunotherapy / 11.10.2016

MedicalResearch.com Interview with: Bernard Vanhove, Chief Operating Officer Director of R&D and International Scientific Collaborations Ose Immunotherapeutics MedicalResearch.com: What is the background for this study? What are the main findings? Response: Myeloid suppressive cells, including tumor associated macrophages (TAM) and myeloid-derived suppressor cells (MDSC), represent an abundant immune cell type in the microenvironment of solid tumors where they promote tumor growth, metastases, angiogenesis, inhibiting anti-tumor immune responses. Myeloid cells selectively express SIRPα, an immune tyrosine associated inhibitory receptor (also named CD172a), which controls myeloid functions. We investigated the role of Effi-DEM, new generation checkpoint inhibitor specifically targeting the SIRP- α receptor on the strategic SIRP-α/CD47 pathway in human macrophages polarization and MDSC differentiation. CD47 the ligand of SIRP alpha is ubiquitously expressed in human cells and has been found to be overexpressed in many different tumor cells with a poor prognosis established. Effi-DEM is a selective antagonist of these myeloid suppressive cells as its target SIRP-α is expressed on these cells. Based on this rationale, the preclinical studies conducted with Effi-DEM have demonstrated its potential to transform suppressor myeloid and tumor associated macrophage cells in non-suppressive cells, thereby inducing a reactivation of the immune response. Effi-DEM has also shown to be effective in various aggressive cancer models with encouraging preclinical results, both in monotherapy and in therapeutic combinations with anti-PD-L1 (checkpoint inhibitors) and anti-CD137 (4-1BB) mAbs, activators of the T-cell response. Significant efficacy and survival increase data were demonstrated in models of hepatocarcinoma, melanoma and triple negative breast cancer. (more…)
Author Interviews, Breast Cancer, ESMO, Immunotherapy / 10.10.2016

MedicalResearch.com Interview with: Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O. Professor of Medicine Nellie B. Connally Chair in Breast Cancer Department of Breast Oncology Co-Director, Multidisciplinary Breast Cancer Research Program University of Texas MD Anderson Cancer Center Houston, Texas MedicalResearch.com: What is the background for this study? What are the main findings? Response: MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer. The primary efficacy results from the pivotal MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (HR= 0.556; 95% CI: 0.429-0.720; p=0.00000329)1. The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone, significantly extending PFS across all patient subgroups. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% during treatment (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)1. (more…)
Author Interviews, ESMO, Pharmacology / 09.10.2016

MedicalResearch.com Interview with: Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs. It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs. However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities. This line of reasoning is particularly true for new or "relatively new" drugs, such as immunotherapy (IT) and targeted agents (TT). So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database. (more…)
Author Interviews, Cancer Research, Cost of Health Care, ESMO, Melanoma / 08.10.2016

MedicalResearch.com Interview with: Prof. dr Lidija Kandolf Sekulovic MD, PhD EADO project access to innovative medicines coordinator Interdisciplinary Melanoma team, Department of Dermatology Medical Faculty, Military Medical Academy Belgrade, Serbia MedicalResearch.com: What made you set out to organize this survey? Response: Before 2011 there were no effective treatment options for metastatic melanoma patients, but that have tremendously changed in the last 5 years. Now we have innovative medicines which are able to prolong overall survival of these patients to more than 18 months, and in some patients, durable responses lasting for up to 10 years are not infrequently reported. However, the access to these medicines is restricted, and patients and physicians are facing more and more difficulties to obtain them. This is especially the case for countries of Eastern and South-Eastern Europe, where majority of patients are still treated with palliative chemotherapy that does not prolong overall survival. We wanted to explore this issue more deeply, to map the access to innovative medicines between 1st May 2015 to 1st May 2016, and particularly the access to first-line treatment recommended by ESMO and EDF/EORTC/EADO guidelines that are based on scientific evidence and which are published in 2015 and 2016. (more…)
Author Interviews, Biomarkers, Cancer, Prostate Cancer, UT Southwestern / 08.10.2016

MedicalResearch.com Interview with: Dr Ryan Hutchinson MD and Yair Lotan MD Department of Urology University of Texas Southwestern Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The United States Preventative Services Task Force recommendation against PSA screening generated significant controversy. Research since then has relied heavily on survey data to examine the impact of the recommendation on PSA screening practices. In a hotly charged issue such as this, such data can carry significant bias. We examined a large, whole-institution data in the years before and after the USPSTF recommendations reflecting actual practice and found that the changes in PSA use at our institution, if any, were small. This is more consistent with behavior seen after the vast majority of practice recommendations. (more…)