Author Interviews, Cancer Research, Genetic Research, Weight Research / 24.01.2019

MedicalResearch.com Interview with: Brian R. Lane MD PhD Division of Urology Spectrum Health Grand Rapids, Michigan MedicalResearch.com: Can you explain how you conducted your study, and what the main findings were? Response:  We used large-scale genome-wide association studies (GWAS) to identify genetic variants associated with obesity measures, blood pressure, lipids, type 2 diabetes, insulin, and glucose. these genetic variants were used as proxies for the above-mentioned risk factors and evaluated in relation to renal cell carcinoma risk (kidney cancer) using GWAS data from 10,000 RCC patients and 20,000 control participants. -          Based on these genetic data, we found that multiple measures of obesity, as well as diastolic blood pressure (DBP) and fasting insulin, are associated with renal cell carcinoma risk. In contrast, we found little evidence for an association with RCC risk for systolic blood pressure (SBP), circulating lipids, overall diabetes, or fasting glucose.  (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Leukemia / 21.01.2019

MedicalResearch.com Interview with: medicalresearch.comDr. Marie Joelle Jabagi, PharmD, MPH University of Paris Sud, Paris-Saclay University, Paris Health Product Epidemiology Department French National Agency for Medicines and Health Products Safety Saint-Denis, France MedicalResearch.com: What is the background for this study? Response: Secondary hematologic malignant neoplasms that develop months or years after the diagnosis of breast cancer may be a consequence of genetic predisposition, environmental factors, previous cancer treatments or a combination of all those factors. These secondary malignant neoplasms are increasingly becoming a concern given that the population of breast cancer survivors is growing substantially. However, their frequency in real life has been poorly investigated to date. The aims of our research were to estimate the frequency of various types of hematologic malignant neoplasm following a diagnosis of primary breast cancer among women aged 20 to 85 years in France during the past decade, and to compare it to the corresponding frequency in women of the French general population. (more…)
Author Interviews, Cancer Research, Cost of Health Care / 21.01.2019

MedicalResearch.com Interview with: Zhiyuan "Jason" Zheng PhD Director, Economics and Healthcare Delivery Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Historically, the cost of healthcare can be a substantial burden for cancer survivors and their families in the US. Even with health insurance, a cancer diagnosis can impose significant out-of-pocket costs for medical care.  These are partially due to the rising costs of cancer treatments in recent years, moreover, the increasing levels of coinsurance, copayments, and deductibles also shift a significant portion of the burden to cancer patients. We found that younger cancer survivors, those aged 18-49 years, bear a higher burden than their older counterparts. We also found that two-thirds of cancer survivors enrolled in high-deductible health plans did not have health savings accounts, and they are more vulnerable to financial hardship than those in high-deductible health plans with health savings accounts and those covered by low-deductible plans. These findings are important to patients because although cancer patents have benefited from newer and more advanced treatments, financial hardship may lead to emotional distress, cause changes in health behaviors, and jeopardize treatment adherence and health outcomes.  (more…)
Author Interviews, Chemotherapy, Colon Cancer / 12.01.2019

MedicalResearch.com interview with: Anders Rabbe CEO of Isofol Medical MedicalResearch.com: What is the background for this study? How common is colorectal cancer?  Response: Colorectal cancer (CRC) is one of the most common forms of cancer with more than 1.8 million new cases identified globally every year. Due to a lack of new therapeutic options and a high mortality rate, colorectal cancer is a disease with a significant unmet need for effective new treatments. Isofol is developing arfolitixorin (Modufolin®) to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer. Arfolitixorin is the company’s proprietary drug candidate currently being studied in a global Phase 3 AGENT study (ISO-CC-007) as a first-line treatment for patients with metastatic colorectal cancer (mCRC), which just enrolled its first patient in December of 2018. (more…)
Author Interviews, Cancer Research, Esophageal, NEJM, Surgical Research / 11.01.2019

MedicalResearch.com Interview with: Guillaume Piessen, MD, PhD University Hospital Centre Lille, Franc MedicalResearch.com: What is the background for this study? Response: Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIE) with a combined laparoscopy+thoracotomy procedure compared to an open esophagectomy (OE), according to results of the MIRO trial published in the last issue of the New England Journal Of Medicine (link article). This French prospective multi-center randomized controlled study was funded by the French National Cancer Institute (Grant n° 1907). The study was conducted by Pr Mariette who sadely passed away in 2017 and Pr Piessen (Department of Digestive and Oncological Surgery, CHU Lille), under the hauspice of FRENCH (Fédération de Recherche EN Chirurgie) and FREGAT (French Eso-Gastric Tumors) working group (https://www.fregat-database.org/fr/). Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 08.01.2019

MedicalResearch.com Interview with: Kiu Tay-Teo, PhD World Health Organization Geneva, Switzerland MedicalResearch.com: What are the main findings? Response: High costs and high risks of R&D for drugs have been presented to justify high drug prices, especially for cancer drugs. However, it is unclear whether prices are in fact justifiable compared to the overall return on R&D investment. In this paper, we systematically compared incomes from the sales of cancer drugs with the R&D costs. We quantified the incomes generated from the sales of 99 cancer drugs approved by FDA from 1989–2017. This was based on sales figures reported in the originator companies’ annual financial reports, and where necessary, estimates deduced from the reported figures. The sales incomes were net of rebates and discounts, but without accounting for expenses and taxes. For the R&D costs of bringing one new cancer drug to the market, the literature reported a typical costs of between $219 million and $2.9 billion, after accounting for the costs of failed products that were investigated but not marketed and the opportunity costs. For the main analysis, we used a median cost of $794 million, as reported in the literature. To be clear, this analysis did not estimate profit return because we do not have information about the costs and year-to-year variations in costs (i.e. expenses and taxes) specific to cancer drugs. (more…)
Author Interviews, Cancer Research, Chemotherapy, Menopause, Mental Health Research / 02.01.2019

MedicalResearch.com Interview with: Nicole J. Gervais, Ph.D. Postdoctoral fellow | Einstein lab University of Toronto, Department of Psychology Toronto, ON  MedicalResearch.com: What is the background for this study?   Response: Aromatase inhibitors (AIs) including letrozole are given as an adjuvant therapy for postmenopausal women with hormone receptor positive breast cancer. Women taking this drug have reported a number of symptoms including hot flashes, memory complaints and mood changes. However, not all studies report memory issues. This might be due to the fact that studies in this population are hampered by confounds, such as chemotherapy/radiotherapy, stress and disease stage, all of which can also adversely impact memory. These confounds make it challenging to observe the independent effects of AIs on memory. By using a non-human primate model, we were able to examine the effects of aromatase inhibition on these symptoms as well as brain function without these confounding effects. (more…)
Author Interviews, Cancer Research, JAMA, Weight Research / 28.12.2018

MedicalResearch.com Interview with: Farhad Islami, MD PhD Scientific Director, Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study?
Response: Despite variations in excess body weight (EBW) prevalence among states in the United States, there was little information on the proportion of incident cancers attributable to EBW (or population attributable fraction, PAF) by state. This information would be useful to help states set priorities for cancer control initiatives. In this paper, we estimated the PAF and number of incident cancer cases attributable to EBW by sex in all 50 states and the District of Columbia using representative exposure and cancer occurrence data. To provide more accurate estimates, we adjusted state-level data on body mass index (BMI) based on self-reported weight and height from the Behavioral Risk Factor Surveillance System by sex, age group, race/ethnicity, and education level (162 strata) using BMI values from the National Health and Nutrition Examination Survey, a nationally representative survey with objectively-measured height and weight.
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Author Interviews, Breast Cancer, NIH, OBGYNE / 27.12.2018

MedicalResearch.com Interview with: Dale P. Sandler, Ph.D. Chief, Epidemiology Branch National Institute of Environmental Health Sciences NIH MedicalResearch.com: What is the background for this study? Response: Not having children is a well-established risk factor for breast cancer, but most of this evidence comes from studies of postmenopausal women since breast cancer before menopause is relatively uncommon. There is growing evidence that some risk factors differ for premenopausal and postmenopausal breast cancer – for example obesity which increases risk for breast cancer after menopause but appears to be protective before menopause. There was some evidence that breast cancer risk increased shortly after pregnancy. It was thought that this risk lasted for 5 to ten years. Studies were unable to fully characterize the duration of this increase in risk or evaluate factors such as breast feeding, age at birth, or family history of breast cancer that could modify the relationship between recent pregnancy and breast cancer risk. Breast cancer before menopause or age 55 is relatively rare, and few individual studies are large enough to answer these questions. To answer these questions, we formed the Breast Cancer Collaborative Group, a pooling project involving 20 prospective cohort studies. We included 890,000 women from 15 of these long-term studies across three continents, including over 18,000 incident breast cancer cases.  (more…)
Author Interviews, Cancer Research, NEJM, Pancreatic / 21.12.2018

MedicalResearch.com Interview with: Prof. Thierry Conroy MD, Director Department of Medical Oncology Institut de Cancérologie de Lorraine Vandoeuvre-lès-Nancy CEDEX MedicalResearch.com: What is the background for this study? Response:  Surgery of pancreatic cancer offers the only chance of cure. Despite the low response rate (5% - 9%) of gemcitabine in metastatic disease, a 6-month regimen of adjuvant therapy with gemcitabine increases 5-year survival from 10% to 20% and is recognized as standard of care. However, recurrence rate remain high despite adjuvant treatment with 69-75% of patients relapsing within 2 years. -       The combination of bolus and continuous infusion Fluorouracil, Folinic Acid, Irinotecan and Oxaliplatin (Folfirinox) was shown to increase response rate (31.6% versus 9.4%) in metastatic disease as compared to Gemcitabine and increase survival (11.1 versus 6.8 months). -       Deletion of bolus Fluorouracil in the Folfirinox regimen (mFOLFIRINOX) decreased toxicity and do not reduce efficacy in advanced disease. -       We performed a randomized trial in patients with good performance status, ECOG 0-1 CA 19.9 ≤ 180 U/L and no cardiac contraindication to fluorouracil. (more…)
Author Interviews, Cancer Research, Herpes Viruses / 18.12.2018

MedicalResearch.com Interview with: Jiahui Qian, MPH School of Public Health and Community Medicine University of New South Wales Sydney Australia     MedicalResearch.com: What is the background for this study? Response: Herpes zoster is a neurocutaneous disease caused by the reactivation of latent varicella zoster virus and its risk is related to the cell-mediated immunity. Previous studies have reported a higher zoster risk among patients with haematological cancer and cancer patients receiving chemotherapy. However, the role of the cancer itself and the receipt of cancer treatment is not clearly separated, we therefore started this study and tried to separate the risk of zoster associated with the cancer itself from cancer treatment.  (more…)
Author Interviews, Cancer Research, Dermatology / 15.12.2018

MedicalResearch.com Interview with: Dr. Kristine A. Romine MD CEO and Founder of Camelback Dermatology & Skin Surgery Phoenix, AZ MedicalResearch.com: Would you give a brief overview of the different types of skin cancer? Response: There are multiple types of skin cancer, including: melanoma, basal cell carcinoma, squamous cell carcinoma, and actinic keratosis. Known as the deadliest form of skin cancer, melanoma develops when irreparable DNA damage results in malignant transformation of melanocytes. This type of skin cancer is most commonly caused by intense UV exposure from the sun or tanning beds, which activate mutations that lead skin cells to rapidly multiply and form malignant tumors. Melanoma can range in color from dark brown to black and are rarely red or even skin colored. They are usually irregular and asymmetrical. In 2018, there were an estimated 91,270 new cases of melanoma (American Cancer Society, 2018). Basal cell carcinoma (BCC) is the most common type of skin cancer and cancer diagnosed. BCCs arise in the skins’ outermost layers. BCCs resemble open sores, red or pink plaques, pearly nodules with telangiectasia, or scars. It is estimated that 4.3 million BCCs are diagnosed in the U.S. every year (Skin Cancer Foundation, 2018). Squamous cell carcinoma (SCC), the second most common type of skin cancer, arises from the squamous cells in the skin that have been exposed to UV over long periods of time. SCCs appear as scaly red or pink macules, papules, or plaques. They can be crusted and appear eroded and can commonly arise within a solar keratosis. More than 1 million cases of SCC are diagnosed in the U.S. every year (Skin Cancer Foundation, 2018). Lastly, actinic keratoses (AKs) are the most common pre-cancerous skin growth that can develop into a SCC if left untreated. Similar to all other types, AKs are caused by exposure to UV light and, in rare cases, high exposures to x-rays. AKs can appear on sun-exposed areas, including the face, scalp, ears, shoulders, and legs. They resemble pink, scaly rough patches on the skin. (more…)
Author Interviews, Cancer Research / 12.12.2018

MedicalResearch.comInterview with:
Alexandra Avgustinova PhD
Postdoctoral fellow at the Institute for Research in Biomedicine (IRBBarcelona)

Dr. Avgustinova
Dr. Avgustinova

MedicalResearch.com:  What is the background for this study?

Response: The basis of this study was the strong association between closed chromatin and high mutation rate reported several years ago. We were surprised to see this observation being widely interpreted as a causal association, as it was largely based on correlative studies without experimental backing. Therefore we decided to experimentally test for the first time whether indeed altering chromatin opening would affect mutation rate or distribution within tumours.

MedicalResearch.com: What are the main findings?

Response: We found that, despite significantly increasing chromatin opening, loss of the histone methyltransferase G9a did not have any major influence on the mutation rate or distribution within cutaneous squamous cell carcinomas. These results demonstrate that chromatin opening does not play a major role in determining the mutation rate within tumours, and we speculate that other, confounded factors (e.g. replication timing or H3K36me3 levels) are likely causal for the observed association. This, however, remains to be proven experimentally.

Another major conclusion of our study was that although tumour initiation was delayed and tumour burden decreased in the absence of G9a, the tumours that did develop were highly aggressive due to selection for more aggressive tumour clones. This finding was contrary to many published reports suggesting G9a as a good candidate for clinical targeting, highlighting the need for long-term follow-up in pre-clinical studies.

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Author Interviews, Cancer Research / 12.12.2018

MedicalResearch.comInterview with:

Zhen Gu, Ph.D. Professor, Department of Bioengineering University of California, Los Angeles (UCLA)
Dr. Zhen Gu

Zhen Gu, Ph.D.
Professor, Department of Bioengineering
University of California, Los Angeles (UCLA)

MedicalResearch.com:  What is the background for this study?  What are the main findings?

Response: Despite improvements in surgical techniques, local residual tumor micro infiltration and circulating tumor cells continue causing tumor recurrence after resection. 

Calcium carbonate nanoparticles could scavenge H+ in the surgical wound, reserving the immunosuppressive tumor microenvironment and promoting the antitumor immuneresponses. 

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Author Interviews, Breast Cancer, JAMA, Weight Research / 06.12.2018

MedicalResearch.com Interview with: Neil M. Iyengar, MD Breast Medicine Service Department of Medicine Memorial Sloan Kettering Cancer Center Evelyn H. Lauder Breast And Imaging Center New York, NY  MedicalResearch.com: What is the background for this study? Response: Obesity is one of the leading modifiable risk factors for the development of hormone receptor positive breast cancer in postmenopausal women. Traditionally, physicians use a person's body mass index (weight in kilograms divided by height in squared meters, kg/m2) to estimate body fat levels. A BMI of 30 or greater is considered to be obese, and this level of BMI increases the risk of at least 13 different cancers. However, BMI is a crude measure of body fat and can be inaccurate. For example, some normal weight individuals (BMI less than 25) have obesity-related problems like diabetes and high blood pressure. Before our study, it was unknown whether high body fat levels in normal weight women contributes to obesity-related cancers such as breast cancer. (more…)
Author Interviews, Hematology, Leukemia, Pediatrics / 05.12.2018

MedicalResearch.com Interview with: Charles G. Mullighan, MBBS (Hons), MSc, MD Member, St. Jude Faculty Co-Leader, Hematological Malignancies Program Medical Director, St. Jude Biorepository William E. Evans Endowed Chair St. Judes Children’s Research Hospital Memphis, TN MedicalResearch.com: What is the background for this study?   Response: B-lineage acute lymphoblastic leukemia (B-ALL) is the commonest form of ALL, and the commonest childhood tumor. It is a leading cause of childhood cancer death. It consists of multiple subtypes defined by genetic alterations. These are often chromosomal translocations that deregulate oncogenes or form fusion proteins. These alterations are disease initiating events and are associated with distinct patterns of leukemic cell gene expression. Most subtypes also have additional mutations that are important for cells to become fully leukemic. Identifying these initiating genetic changes is very important to identify patients that are likely to respond or do poorly with conventional therapy (multiagent chemotherapy). Also, some identify new opportunities for targeted therapy. However, using standard genetic testing approaches such as chromosomal cytogenetics, about 30% of B-ALL patients don’t have a subtype classifying alteration. (more…)
Author Interviews, Cancer Research, Hematology, J&J-Janssen / 04.12.2018

MedicalResearch.com Interview with: Caroline McKay, PhD Real World Value & Evidence, Oncology Janssen Scientific Affairs MedicalResearch.com: What is the background for this study? What are the main findings? Response: Considering patient preferences in treatment decision-making in oncology is growing in importance. While recent introduction of new treatments for multiple myeloma have improved survival and the possibility of sustaining longer remission periods, regimen options still vary with respect to efficacy, safety, and dosing. Therefore, patients and providers must consider tradeoffs inherent in making treatment decisions that are growing in complexity. Despite this, there is a lack of research describing patient preferences within the context of currently available treatment regimens. To address this gap, this study examined how multiple myeloma patients evaluate, or weigh, treatment options. Key findings from the research are that treatment preferences do not appear to be static, but instead suggest that the relative importance of treatment attributes may change over time and treatment history. Further, patients place higher importance on overall survival and progression-free survival than other treatment attributes, and may be willing to accept an increase in the risk of serious side effects and reduced convenience in exchange for greater efficacy; however, when efficacy is comparable, patients appear to place greater weight on dosing frequency than on the duration of treatment administration, i.e., more frequent dosing appears to be less preferable to patients than longer administration/infusion time.  (more…)
Author Interviews, Breast Cancer, Mammograms / 03.12.2018

MedicalResearch.com Interview with: Stamatia Destounis MD, FACR, FSBI, FAIUM Elizabeth Wende Breast Care Clinical Professor University of Rochester Imaging Sciences Rochester, NY 14620  MedicalResearch.com: What is the background for this study? What are the main findings? Response:  The current breast cancer screening recommendations in the United States are unclear regarding when to stop screening. Several societies with published recommendations conflict in regard to when to discontinue screeningmammography. There is little evidence studying the benefit of annual mammography in the population of women 75 and older. Due to this, we felt that it was a very important and timely topic to investigate, with the goal of providing further guidance on why screening mammography may be beneficial in this older population. (more…)
Anemia, Author Interviews, Cancer Research, Hematology, Leukemia / 03.12.2018

MedicalResearch.com Interview with: Dr. Alan List MD President and Chief Executive Officer Moffitt Cancer Center Tampa, FL MedicalResearch.com: What is the background for this study?   Response: In patients with lower risk Myelodysplastic Syndromes (MDS), which accounts for the vast majority of patients with MDS overall, the most common symptomatic cytopenia is anemia. These patients, overtime, become dependent upon red blood cell transfusions and with that, they face a risk of iron loading as well as complications that occur with it. The standard first line therapy that we consider for these patients is erythropoietin-stimulating agents (ESAs). Patients who are transfusion dependent have a low response rate to ESAs, and responses are of short duration. There limited effective limited treatment options for those patients unresponsive or lose response to ESAs. For years, we’ve known that the transforming growth factor (TGF)-β pathway play an important pathogenetic role in suppressing red cell maturation and cell survival. Luspatercept is an agent that acts as an erythroid maturation agent by inhibiting the TGF-β signaling pathway by neutralizing a select group of TGF-β superfamily ligands.  (more…)
Author Interviews, Cancer Research, Hematology / 03.12.2018

MedicalResearch.com Interview with: Maria-Victoria Mateos, MD, PhD Associate Professor of Medicine University of Salamanca Salamanca, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alcyone trial is a phase 3 trial in which Daratumumab, the CD38 mAb has been added to a standard of care for elderly newly diagnosed myeloma patients, VMP, and compared with VMP. The main finding is that the addition of dara to VMP resulted into a significant benefit in PFS with a 57% reduction in the risk of progression and/or death. In addition, the benefit was also reported in terms of ORR and CR rate and 45% of patients receiving Dara VMP achieved CR. Minimal residual disease was evaluated and was undetectable in 27% of the patients what it is relevant because a 5% increase was observed in comparison with the publication one year ago. This means that Daratumumab as maintenance after the first 9 cycles daraVMP was able to upgrade the quality of response. Toxicity profile was acceptable and no new safety signals were reported. (more…)
Author Interviews, Cancer Research, JAMA, OBGYNE / 02.12.2018

MedicalResearch.com Interview with: Dr. Weimin Ye, MD MSC, PhD Department of Medical Epidemiology and Biostatistics Karolinska Institue MedicalResearch.com: What is the background for this study? What are the main findings? Response: Polycystic ovary syndrome (PCOS) is the most common endocrine    disorder affecting 5-10% of women of reproductive age. Characterized by hyperandrogenism and metabolic abnormalities, PCOS is known to be related to various long-term health consequences, including diabetes, cardiovascular disease and endometrial cancer. Besides, inconsistent results have been reported for the associations between PCOS and the risk of ovarian and breast cancer. Studies addressing the risks of other cancers are scarce. Thus, we conducted a large, population-based cohort study with a long follow-up and rather sufficient confounding adjustment to explore the full picture of associations between PCOS and the risks of various cancer types. We found that PCOS is a risk factor for certain types of cancer, including cancers of the endometrium, ovary, endocrine gland, pancreas, kidney and skeletal & hematopoietic system. (more…)
Author Interviews, Cancer Research, Hematology, J&J-Janssen / 02.12.2018

MedicalResearch.com Interview with: Peter Voorhees, MD Plasma Cell Disorders Program Department of Hematologic Oncology and Blood Disorders Levine Cancer Institute Atrium Health MedicalResearch.com: What is the background for this study? Response: All multiple myeloma arises from its precursor conditions, monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Although the rate of progression to multiple myeloma for patients with MGUS is low (~5% over 5 years), patients with SMM have a ~50% likelihood of requiring therapy for their multiple myeloma within the first 5 years of diagnosis. For those at intermediate to high risk of disease progression, early intervention to delay progression of disease, thereby averting disease-related morbidities related and potentially changing the natural course of the disease, is highly desirable. On the other hand, given the fact that these patients are by definition asymptomatic and would otherwise be monitored off treatment, it is critical that any intervention applied in this group of patients is well tolerated. Daratumumab is a highly attractive candidate in this particular space, because it has single agent activity in heavily-pretreated relapsed/refractory multiple myeloma and a favorable side effect profile relative to many other myeloma therapeutics. Additionally, given the importance of impaired immune surveillance in multiple myeloma, the immuno-stimulatory effects of daratumumab in the bone marrow microenvironment could potentially reawaken robust T cell responses to the disease. (more…)
Author Interviews, Cost of Health Care, Hematology, J&J-Janssen, Lymphoma / 02.12.2018

MedicalResearch.com Interview with: Murali Sundaram, MBA, Ph.D. Director of Real World Value and Evidence Oncology, Janssen MedicalResearch.com: What is the background for this study? Response: Ibrutinib is a novel Bruton's tyrosine kinase (BTK) inhibitor approved for the treatment of patients with newly diagnosed chronic lymphocytic leukemia (CLL). Ibrutinib is administered orally while standard of care (CD20 monoclonal antibody-based chemoimmunotherapy [CIT]) is administered intravenously. This difference in route of administration impacts what type of benefit covers these treatments (i.e., pharmacy benefit for oral ibrutinib and medical benefit for intravenous CIT). Previous studies evaluating the costs burden of patients treated with ibrutinib versus CIT did not include the full spectrum of real-world healthcare costs. (more…)
Author Interviews, Biomarkers, Cancer Research / 28.11.2018

MedicalResearch.com Interview with: Ricardo Alvarez MD MSc Medical Director of the Breast Cancer Center Director of Cancer Research Cancer Treatment Centers of America, CTCA Atlanta MedicalResearch.com: What is the background for this study? What are the main findings? Response: “The background of this study comes from five years of experience in one of our precision medicine programs that was launched in 2013 and this is the experience of a group of personnel from a hospital that helps physicians in five different hospitals that are a part of the CTCA network and for physicians who order a next generation sequencing test. In this particular report, we have only one vendor, and that is Foundation Medicine and we analyze three different genomic platforms, Foundation One test, Foundation Act and Foundation One Hem. In total, approximately 8,800 tests have been analyzed and that was the presentation at ESMO 2018. It’s important that the Precision Medicine Program (PMed) helps physicians to identify actionable and potentially actionable targets for the result of this test so patients can be treated with targeted therapy, and this can be done by selecting clinical trials or recommending patients to be treated off-label agents. When we say off label, meaning that they are not specifically FDA-approved drugs for this indication that we are treating.” (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 26.11.2018

MedicalResearch.com Interview with: Abiy Agiro, PHD HealthCore Inc Wilmington, Delaware  MedicalResearch.com: What is the background for this study? Response: Biosimilar approval pathway, authorized in 2010 by the Biologics Price Competition and Innovation Act as part of the Affordable Care Act, aims to increase adoption of biosimilar products and generate significant cost savings to payers and patients alike. Biosimilar filgrastim, used to prevent febrile neutropenia, is one of the first biosimilars to be approved in the United States. A large scale, post-approval real-world analysis was needed that compares biosimilar filgrastim to the original drug for safety and efficacy. (more…)
Author Interviews, Cancer Research, JAMA / 26.11.2018

MedicalResearch.com Interview with: Ola Landgren, MD, PhD Professor of Medicine Chief, Myeloma Service Department of Medicine Memorial Sloan Kettering Cancer Center New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Meta-analysis show that minimal residual disease (MRD) negativity is a strong predictor of longer progression-free survival (PFS). Emerging data show that an increasing proportion of newly diagnosed multiple myeloma patients obtain MRD negativity after modern combination therapy, even in the absence of bone marrow transplant. The first generation of 3-drug combination therapy (RVd) was associated with quite high rates of peripheral neuropathy which may be life-long. The current study was designed to define the rates of peripheral neuropathy in newly diagnosed multiple myeloma treated with the second generation of 3-drug combination therapy (KRd), and per default delayed transplant (i.e. collection of stem cells which were stored for potential future use). This single arm, phase 2 study found no cases of grade 3 peripheral neuropathy. The rates of MRD negativity wereunprecedented; 28 of 45 patients achieved MRD-negative CR (62%). The durability of MRD-negative CR has been observed up to 70 months (median duration 52.4 months). Patients who achieved MRD negativity by the end of cycle 8 had a 78% reduced risk of progression. The results were regardless of age or cytogenetic risk category. The results from this second generation of 3-drug combination therapy (KRd) without transplant,  compare favorably to first generation of 3-drug combination therapy (RVd) followed by stem cell transplant. (more…)
Author Interviews, Environmental Risks, JAMA, Melanoma / 24.11.2018

MedicalResearch.com Interview with: Reza Ghiasvand, PhD Oslo Centre for Biostatistics and Epidemiology Faculty of Medicne University of Oslo Oslo, Norway  MedicalResearch.com: What is the background for this study? Response: Melanoma is the most dangerous type of skin cancer. It is estimated that about 288,000 individuals will be diagnosed and about 61,000 will die from it in 2018, with the majority of patients in Australia, New Zealand, Europe and North America. Ultraviolet (UV) exposure (from both the sun and tanning beds) is the most important preventable risk factor for melanoma. However, the association between UV exposure and melanoma is complex and does not accord with a simple model in which risk increases directly with exposure. An individual risk of melanoma also depends on personal characteristics such as skin color and skin sensitivity to the UV exposure, hair color, number of moles, and age. It has been hypothesized that the pattern of UV exposure may play a role in melanoma development in different body sites. For example, melanoma on the trunk (chest and back) has been linked to the recreational UV exposure such as sunbathing and frequent sunburns in people with high number of moles on their body. In contrast, melanomas on the head and neck have been linked to constant sun exposure such as occupational UV exposure, mainly in older people. Epidemiologic and molecular evidence in support of this hypothesis has been published based on analyses of small datasets. Also, melanoma on legs and arms is less studied under this hypothesis. In our study, we examined UV exposure (sunbathing, sunburn and sunbed use) and pigmentary factors (skin, eye, and hair color, freckling, and number of moles), and risk of melanoma on different body sites. We used information from the Norwegian Women and Cancer Study, a population-based cohort study that started in 1991, and includes more than 161,000 Norwegian women followed for an average of 18 years. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Radiation Therapy, Surgical Research / 16.11.2018

MedicalResearch.com Interview with: Anthony Victor D'Amico, MD, PhD Professor and Chief, Genitourinary Radiation Oncology Harvard Medical School MedicalResearch.com: What is the background for this study? Response: This study investigated whether surgery followed by the use of adjuvant low dose radiation and short course hormonal therapy as compared to high dose radiation and hormonal therapy could provide an equivalent low risk of death from prostate cancer amongst men presenting with aggressive and not infrequently fatal Gleason score 9 or 10 prostate cancer. It has been shown previously (https://jamanetwork.com/journals/jama/fullarticle/2673969) and validated in the current study that surgery alone in such cases leads to a more then 2.5-fold increase in the risk of death from prostate cancer as compared to high dose radiation and hormonal therapy.  (more…)