Author Interviews, Cancer Research, JAMA, Lung Cancer, Surgical Research / 23.12.2015

MedicalResearch.com Interview with: Dr Najib Rahman D Phil MSc MRCP Consultant and Senior Lecturer Lead for Pleural Diseases Oxford Centre for Respiratory Medicine Clinical Director, Oxford Respiratory Trials Unit Tutor in Clinical Medicine University College, Oxford Medical Research: What is the background for this study? Dr. Rahman : Up to TIME1, the evidence base behind optimal pleurodesis for malignant pleural effusion in terms of tube size and analgesia was poor. Optimal pleurodesis in this context is one which is successful (i.e. the patient needs no further pleural interventions for that malignant effusion), but occurs with the minimum discomfort. This is particularly important as the treatment intent in malignant effusion pleurodesis is palliative. This is the first adequately powered randomized trial to address two important issues in pleurodesis for malignant pleural effusion - that of whether NSAIDs reduce pleurodesis efficacy, and if smaller chest tubes (12F) are "as good as" larger chest tubes (24F) for pleurodesis success and in terms of pain. Medical Research: What are the main findings? Dr. Rahman : The main and somewhat surprising findings are that:
  1. NSAIDs given short term but at high dose do not impair pleurodesis - they are no better than morphine for pain control (in fact, they needed modestly more rescue medication), but can be freely used during malignant effusion pleurodesis with no fear of reducing pleurodesis success.
  1. Smaller tubes were marginally less painful than larger tubes - but this difference was not clinically very relevant
  1. Smaller tubes cannot now be said to be "as good as" larger tubes for malignant effusion pleurodesis. Our data shows that they failed in non-inferiority to larger tubes for pleurodesis success at 3 months. 
  1. Smaller tubes resulted in higher fall our rates, a higher incidence of not being able to administer talc and were associated with more complications during insertion .
(more…)
Author Interviews, Cancer Research, Leukemia / 21.12.2015

MedicalResearch.com Interview with: Renaud Capdeville, MD Global Program Head Oncology Global Development Novartis Medical Research: What is the background for this study? What are the main findings? Dr. Capdeville: RATIFY (Randomized AML Trial in FLT3 in patients <60 Years Old; CALGB 10603) was a Phase III, international, randomized, placebo-controlled, double-blind group trial of newly-diagnosed (Acute myeloid leukemia, acute myelogenous leukemia) AML patients aged 18 to less than 60 who have a FLT3 mutation. In the study, patients who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy experienced a 23% improvement in overall survival (OS) (hazard ratio [HR] = 0.77, P =0.0074) compared with those treated with standard induction and consolidation chemotherapy alone. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group. The data, collected and analyzed in partnership with the Alliance for Clinical Trials in Oncology, are from the largest clinical trial in FLT3-mutated AML to date, with 3,279 patients screened and 717 study participants from around the world. (more…)
Author Interviews, Breast Cancer, Cancer Research, Dental Research, Smoking / 21.12.2015

MedicalResearch.com Interview with: Jo Freudenheim, PhD UB Distinguished Professor and Interim Chair Department of Epidemiology and Environmental Health School of Public Health and Health Professions University at Buffalo Buffalo, NY Medical Research: What is the background for this study? What are the main findings? Dr. Freudenheim: There have been a number of studies that have shown an association between periodontal disease and chronic diseases, particularly stroke and heart attacks. There is also some newer evidence that periodontal disease is associated with cancer, particularly cancers of the gastrointestinal tract. Ours is the first large prospective study of periodontal disease and breast cancer. This was part of a study of more than 70,000 postmenopausal women from throughout the United States, the Women’s Health Initiative. Women provided information about their health and other related factors and then those women were followed to see who developed certain diseases. We found that women who had been told that they had periodontal disease were more likely to develop breast cancer. In particular, women who were former smokers (quit within the last 20 years) and who had periodontal disease were at increased breast cancer risk. There was a similar increase in risk for current smokers with periodontal disease but it was not statistically significant. (There was a relatively small number of current smokers in the WHI study.) (more…)
Author Interviews, Cancer Research / 21.12.2015

MedicalResearch.com Interview with: Amye Tevaarwerk, M.D. Assistant Professor of Medicine Hematology/Oncology Section University of Wisconsin School of Medicine and Public Health Carbone Comprehensive Cancer Center Wisconsin Institute for Medical Research (WIMR) Madison, WI  Medical Research: What is the background for this study? What are the main findings? Dr. Tevaarwerk: These patients were enrolled on a larger clinical trial known as the Symptom Outcomes and Practice Patterns study (SOAPP). SOAPP recruited breast, prostate, colon and lung cancer patients directly during outpatient oncology follow-up visits. All of the patients were recruited between May 2006 and May 2008. The parent study recruited 3123 patients, of these 680 patients had metastatic disease and 668 had employment data. Patients were asked if they were working and if there had been a change due to illness. We were able to compare those stably working with those who had changed to "no longer working" and look at factors that associated with this change (age, gender, cancer type, race/ethnicity, time since diagnosis, location of metastatic disease, type of treatment, performance status, number of metastases, symptom burden.) (more…)
Author Interviews, Dermatology, FDA, Melanoma, NYU / 19.12.2015

MedicalResearch.com Interview with: Dr. Jennifer Stein MD Associate Professor Department of Ronald O. Perelman Department of Dermatology NYU Langone Medical Center Medical Research: What is the background for this FDA decision? What is the issue surrounding tanning beds? Dr. Stein:  This is an important proposal from the FDA because it restricts minors from tanning and requires adults to sign an acknowledgement stating they have been informed about the risks of tanning. There is clear evidence that indoor tanning significantly increases a person’s risk for skin cancer, including melanoma, a potentially deadly form of skin cancer. It is important to protect young people from the dangers of tanning beds, especially because many patients report that they started indoor tanning as teens. There are 1.6 million minors using tanning beds every year. MedicalResearch: What is the problem with tanning?  Isn't a tan better than a sunburn? Dr. Stein: Tanning beds deliver intense amounts of UVA. We know that UVA penetrates deep into the skin and causes mutations that lead to skin cancers, including melanoma. Tanning is a sign that skin cells have been damaged by UV light. (more…)
Author Interviews, Cancer Research, CDC / 18.12.2015

MedicalResearch.com Interview with: S. Jane Henley, MSPH Division of Cancer Prevention and Control National Center for Chronic Disease Prevention and Health Promotion CDC Medical Research: What is the background for this study? What are the main findings? Response: Many factors contribute to changes in cancer incidence, including changes in risk exposures or changes in the use of cancer screening tests. To monitor changes in cancer incidence and assess progress toward achieving Healthy People 2020 objectives, we analyzed data from U.S. Cancer Statistics (USCS) which includes high quality incidence data from CDC’s National Program of Cancer Registries (NPCR) and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program and survival data from NPCR. This study updates a previous study, using the latest available data on population-based cancer incidence and survival. We found that about 1.5 million new cancer cases were reported in the US in 2012, and rates of prostate, lung, and colorectal cancer were lower than in 2011. The rates of getting cancer were higher among men than women, highest among black people, and varied by state from 371 to 515 per 100,000 people. The most common kinds of cancer were prostate, female breast, lung, and colorectal. About two of every three people who were diagnosed with cancer lived five years or more after diagnosis. (more…)
Author Interviews, Cancer Research, Genetic Research, Nature / 17.12.2015

MedicalResearch.com Interview with: Dr. Li Ding PhD Director, Medical Genomics group McDonnell Genome Institute Department of Medicine Washington University in St. Louis St. Louis, Missouri Medical Research: What is the background for this study? What are the main findings? Dr. Li Ding:  Next-generation sequencing technologies have provided unprecedented opportunities for building a comprehensive catalog of point mutations, simple insertion and deletion mutations (indels) and structural variants in human cancers. Although significant progress has been made for documenting these common events through studies from individual research labs and large consortiums, there has been little progress in the discovery of complex indels after the transition from Sanger sequencing to NGS technologies.  It is well known in the scientific community that indel detection using short next generation sequencing reads is a challenging problem. Our study, for the first time, directly addresses complex indel detection that has been barely touched in the cancer field. More importantly, our analysis discovered 285 complex indels in cancer genes such as PIK3R1GATA3, and TP53, revealing an unexpected high prevalence of these events in human cancers. (more…)
Author Interviews, Breast Cancer, Cancer Research, Depression / 17.12.2015

MedicalResearch.com Interview with: Ruhi Kanani  Cancer Epidemiology and Population Health Research Oncology King's College London London, UK  MedicalResearch.com: What is the background of this study? What are the main findings? Response: There is a long history of research investigating the possible association between psychological and physical health. This study is the first to analyse cancer registration information and hospital records of depression for a large group of women with breast cancer in South East England. 77, 173 women diagnosed with breast cancer between 2000 and 2009 were included and followed until the end of 2010. 955 women had a record of depression, 422 before, and 533 in the year after their cancer diagnosis. The results showed that women with a record of depression had a worse overall survival. This was particularly so for those with a  new record of depression after the cancer diagnosis, who had a 45% higher risk of death from all causes compared to those who didn’t develop depression after their cancer diagnosis. (more…)
Author Interviews, Cancer Research, Clots - Coagulation, Sloan Kettering / 16.12.2015

MedicalResearch.com Interview with: Luke V. Selby, MD Research Fellow, Department of Surgery Vivian E. Strong, MD FACS Associate Attending Surgeon, Department of Surgery Memorial Sloan Kettering Cancer Center Medical Research: What is the background for this study? What are the main findings? Response: There was strong concern at our institution about the safety of providing pre-operative Venous Thromboembolism (VTE) chemoprophylaxis (in addition to our standard peri and post-operative prophylaxis) was unsafe.  To answer this question we administered a single dose of either low molecular weight heparin or unfractionated heparin to all eligible surgical patients at our institution over a six month period. When compared to identically selected patients operated on during the preceding 18 months, patients who received the pre-operative VTE chemoprophylaxis did not have higher rates of bleeding complications and had lower rates of DVT and pulmonary embolism (PE). (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, JAMA / 16.12.2015

MedicalResearch.com Interview with: Roger Stupp, MD Professor & Chairman Department of Oncology & Cancer Center University of Zurich & University Hospital Zurich (USZ) Zürich / Switzerland Medical Research: What is the background for this study? Dr. Stupp: Tumor Treating Fields are an entirely novel modality in cancer treatment. Over 10 years ago researchers demonstrated that alternating electrical fields will block cell growth, interfere with organelle assembly, in particular perturb the spindle apparatus and cell division, all leading to mitotic arrest and ultimately apoptosis. This was shown in vitro, but importantly also in vivo animal models including not only mice and rats, but also hamsters and rabbits with deep seated solid tumours. So the question was whether we can demonstrate such an effect also in the clinic. Glioblastoma are locally invasive and aggressive tumours in the brain. They usually do not metastasise however they grow diffusely within the CNS and despite the best possible surgery, radiation and chemotherapy virtually always recur. We thus applied alternating electrical fields therapy, so called Tumor Treating Fields to the scalp of patients with newly diagnosed glioblastoma. After the end of standard chemoradiotherapy (TMZ/RT), patients were randomized to receive either standard maintenance TMZ-chemotherapy alone or in combination with TTFields. Almost 700 patients were randomized, here we report on a preplanned interim analysis looking at the first 315 patients included once they were followed for at least 18 months. The data on the first 315 patients are mature and allowed the IDMC to conclude that the trial should be stopped and the results made available. Medical Research: What are the main findings? Dr. Stupp: The study demonstrated a consistent prolongation of both progression-free and also of overall survival for patients who have been treated with TTFields in addition to standard therapy. The median progression-free survival and overall survival were prolonged by 3 months, translating to an absolute increase in overall survival at 2 years of 14%, from 29% to 43%. Or a hazard ratio of 0.74 for overall survival and of 0.62 for progression-free survival. (more…)
Aging, Author Interviews, Breast Cancer / 16.12.2015

MedicalResearch.com Interview with: Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003  Medical Research: What is the background for this study? What are the main findings? Dr.Boolbol:  The background for this study is predicated on the USPSTF's recommendations that there is insufficient evidence to continue the use of screening mammography in women over the age of 75. According to the American College of Radiology, cancer detection rates via screening mammography should be at least 2.5 per 1000 mammograms at an institution, with reported rates as high as 4.7 cases per 1000. We reviewed 2057 screening mammograms in women aged 75 and older. We found 10 cases of breast cancer in this group. Of these cancers, 60% were invasive breast cancer. The breast cancer detection rate in this cohort was 4.9 per 1000 screening mammograms. (more…)
Author Interviews, Brigham & Women's - Harvard, JCEM, Thyroid, Thyroid Disease / 14.12.2015

MedicalResearch.com Interview with: Dr. Erik K. Alexander, MD FACP Chief, Thyroid Section, Division of Endocrinology Brigham & Women's Hospital Associate Professor of Medicine, Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Alexander: Thyroid nodular disease has become an increasingly common medical illness, with prevalence reported to range between 26-67% in the adult.  Though advancing age is known to influence the formation of thyroid nodules, their precise relationship remains unclear.  Furthermore, it is uncertain whether age influences the risk that any thyroid nodule may prove cancerous.  Thus we conducted a study to determine the impact of patient age on nodule formation, the number of thyroid nodules, and risk of thyroid malignancy. Medical Research:  What are the main findings? Dr. Alexander: Our study is a prospective cohort analysis of consecutive adults who presented for evaluation of nodular disease from 1995-2011 at Brigham and Women’s Hospital, Boston, MA.  6,391 patients underwent thyroid ultrasound and fine needle aspiration that resulted in 12,115 thyroid nodules ≥1 cm.  Patients were stratified into six age groups and compared using sonographic, cytologic, and histologic endpoints. We found that the prevalence of thyroid nodular disease increases with advancing age.  The mean number of nodules at presentation increased from 1.5 in the youngest cohort (ages 20–30) to 2.2 in the oldest cohort (>70 years).  In contrast, the risk for malignancy in a newly identified nodule declined with advancing age.  Thyroid cancer incidence per patient was 22.9% in the youngest cohort, but 12.6% in the oldest cohort.  Despite a lower likelihood of malignancy, identified cancers in older patients demonstrated a more aggressive cancer subtype.  While nearly all malignancies in younger patients were well-differentiated, older patients were more likely to have higher risk papillary thyroid cancer variants, poorly differentiated cancer, or anaplastic carcinoma. (more…)
Author Interviews, Cancer Research / 14.12.2015

MedicalResearch.com Interview with: Lindsey Torre, MSPH  Epidemiologist, Surveillance Research Surveillance Research group at the American Cancer Society Medical Research: What is the background for this study? What are the main findings? Response: This study updates a previous study published in 2010 using the latest available data on cancer incidence and mortality from cancer and vital registration around the world. We found that while high-income countries still have the highest cancer rates in the world, some low- and middle-income countries now also have elevated cancer rates. Also, mortality rates for common cancers such as lung, breast, and colorectum are declining in high-income countries, while they are increasing in low-income countries. At the same time, low-income countries still have a disproportionate burden of infection-related cancers, such as stomach, liver, and cervix. (more…)
Author Interviews, Leukemia, Race/Ethnic Diversity, Stanford / 14.12.2015

MedicalResearch.com Interview with: Manali Patel, MD, MPH Instructor in the Division of Oncology Department of Medicine Stanford University School of Medicine Researcher at the Clinical Excellence Research Center and the Primary Care and Outcomes Research Group at Stanford Staff oncologist at the Veterans Administration and a researcher in the Palo Alto Veterans Administration Health Services & Research Development group.  Medical Research: What is the background for this study? Dr. Patel: Racial and ethnic disparities in Acute Leukemia are well documented in the literature but the reasons underlying the disparities remain largely unknown. In our previous work, we demonstrated mortality disparities for minorities with Acute Myeloid Leukemia despite favorable prognostic demographic and molecular factors. We have also shown that differences in receipt of treatment may partially explain a large component of these disparities. The purpose of this study is to determine how socioeconomic status factors influence  mortality from Acute Leukemia using a population-based novel linked dataset of the Surveillance Epidemiology and End Results Database and the National Longitudinal Mortality Study. Medical Research: What are the main findings? Dr. Patel:  We found a total of 121 patients with Acute Lymphoid Leukemia and 438 patients with Acute Myeloid Leukemia in the linked dataset.  After adjusting for socioeconomic status factors, there were increased risk of mortality among Hispanic and decreased risk of mortality among Asian Pacific Islander patients as compared with non-Hispanic white patients in Acute Lymphocytic Leukemia.  Among patients with Acute Myeloid Leukemia, we found no associations of mortality by race/ethnicity and socioeconomic status. (more…)
Author Interviews, Cancer Research, Cost of Health Care, Medicare / 14.12.2015

MedicalResearch.com Interview with: Dr. Stacie B. Dusetzina, PhD Assistant professor in the Division of Pharmaceutical Outcomes and Policy Eshelman School of Pharmacy University of North Carolina  Medical Research: What is the background for this study? What are the main findings? Dr. Dusetzina: As part of the Affordable Care Act the Medicare Part D “doughnut hole” is closing – reducing Medicare beneficiaries out-of-pocket expenses during this phase of coverage from 100% of drug costs to 25% between 2010 and 2020.  In this study we analyzed 3,344 Medicare formularies that spell out how insurers cover prescription drugs. We found that in 2010, a typical course of oral chemotherapy drugs costs patients on average up to $8,100 per year. When the doughnut hole closes in 2020, patients will still have to pay on average $5,600 out of pocket per year, more than what the average Medicare beneficiary’s household spends on food each year. Even after the doughnut hold is closed oral chemotherapy drugs will still be out of reach for millions of Americans. (more…)
Author Interviews, Breast Cancer, Chemotherapy, University Texas / 14.12.2015

MedicalResearch.com Interview with: Mariana Chavez Mac Gregor, MD, MSC Assistant Professor Breast Medical Oncology Department Health Services Research Department The University of Texas MD Anderson Cancer Center Medical Research: What is the background for this study? What are the main findings? Dr. Chavez Mac Gregor: Adjuvant chemotherapy has proven to significantly decrease the risk of recurrence among breast cancer patients, however the optimal time to start adjuvant chemotherpay remains unknown. There are biological resasons to believe that a delay in the initiation of systemic therapy can be associated with adverse outcomes. In this large study we evaluated the impact of a delay in the initiation of time to chemotherapy (TTC).  We analyzed data from 24,843 patients with invasive breast cancer (stages I to III) from the California Cancer Registry and observed that compared with patients who received chemotherapy within 31 days of surgery,  no adverse outcomes were associated with time to chemotherapy of 31 to 90 days of surgery. However, there was  a 34 % increase in the risk of death and a 27% increase in the risk of breast cancer specific death  among patients who started  chemotherapy 91 or more days after surgery. In a stratified analysis according to breast cancer subtype, patients with triple-negative breast cancer, a TTC greater than 91 days  was  significantly  associated with worse overall and breast cancer-specific survival. In addition we evaluated factors associated with delays in  time to chemotherapy (defined as > or = 91 days) and observed that many of the factors are sociodemographic in nature including low socioeconomic status, non-private insurance, and being Hispanic or African American. (more…)
Author Interviews, BMJ, Colon Cancer, Gastrointestinal Disease / 13.12.2015

MedicalResearch.com Interview with: Dr Franco Radaelli Division of Digestive Endoscopy and Gastroenterology Valduce Hospital Como, Italy  Medical Research: What is the background for this study? Dr. Radaelli: Split regimens of bowel preparation are strongly recommended by European and American Guidelines as they have been associated with a higher level of colon cleansing. However, there is still uncertainty on whether the higher level of cleansing associated with a split regimen also results in a higher proportion of subjects with at least one adenoma (adenoma detection rate, ADR), that represents by far a more relevant quality indicator than the level of cleansing itself. On this background, we designed a randomized investigator-blinded controlled trial to evaluate whether a “split regimen” of low-volume 2-L PEG-ascorbate solution was superior to the traditional “full dose, the day before regimen” in terms of ADR. Differently from other studies on bowel preparation, we considered adenoma detection rate  instead of the level of colon cleansing, the primary study end-point, and we designed the sample size accordingly. A precise estimation of the sample size was facilitated by including an homogeneous population of asymptomatic subjects undergoing first colonoscopy after positive-FIT within CRC organized screening program. Besides, ADR represents a very solid end-point due to the very low inter-pathology variability in the differential diagnosis between neoplastic and non-neoplastic lesions, while the assessment of the level of cleansing is hampered by unavoidable degree of subjectivity and higher degree of inter-operator variability. (more…)
Author Interviews, Cancer Research, Radiation Therapy / 12.12.2015

MedicalResearch.com Interview with Dr. Ajay Bhatnagar MD Radiation Oncologist Medical director of 21st Century Oncology of Arizona MedicalResearch.com: What is the background for this report? What are the main findings? Dr. Bhatnagar: I recently presented updated data regarding my research at the American Society for Radiation Oncology (ASTRO) annual meeting in a poster titled “Electronic brachytherapy for the treatment of Non-Melanoma Skin Cancer: Results up to 5 years.” For this clinical study, I have been using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® which is FDA cleared, CE marked and licensed in Canada for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers, and nonmelanoma skin cancer (NMSC) including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). For the treatment of nonmelanoma skin cancer, the Xoft System uses a proprietary, miniaturized x-ray source to deliver a precise dose of targeted radiation directly to the surface lesion. This treatment uses electronic brachytherapy (eBx) to target cancerous cells while sparing healthy tissue. It is painless, non-invasive and offers a number of patient benefits, including fewer treatments than traditional radiation therapy. According to my findings, the Xoft System is safe and effective for the treatment of nonmelanoma skin cancer, with low rates of recurrence and excellent clinical outcomes. (more…)
Author Interviews, Lancet, Leukemia / 12.12.2015

MedicalResearch.com Interview with: Dr. Christoph Röllig Medizinische Klinik und Poliklinik I Universitätsklinikum der Technischen Universitä Dresden, Germany Medical Research: What is the background for this study? What are the main findings? Dr. Röllig: When this trial began in 2009, standard treatment for Acute Myelogenous Leukemia (AML) consisted of a combination of cytarabine plus anthracyclin/anthracendion and the need for improvement was obvious in the light of only around 50% long-term survivors even amongst younger patients. Although a promising approach, the use of kinase inhibitors in AML had not been shown to be beneficial and was not widely used. Sorafenib had been shown to be tolerable as single agent and in combination with commonly used chemotherapeutic agents. The results of the trial show that the addition of sorafenib to standard chemotherapy for newly diagnosed AML patients up to the age of 60 years is associated with significant prolongation of event-free survival and relapse-free survival compared to placebo plus standard chemotherapy. That means that patient who took sorafenib had less AML relapses. To our knowledge, this is the first randomized-controlled showing that integrating a kinase inhibitor into standard intensive chemotherapy of younger patients with AML is associated with significant improvement of relapse-free survival, with no increase in treatment-related mortality. After a decade of evaluating the potential of kinase inhibitors in AML, their use in combination with standard treatment is becoming an important option for newly diagnosed younger patients. (more…)
Author Interviews, Immunotherapy, Lymphoma, NYU / 11.12.2015

MedicalResearch.com Interview with: Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Langone Laura and Isaac Perlmutter Cancer Center New York, NY 10016  Medical Research: What is the background for this study? What are the main findings? Dr. Diefenbach: The background of the study is that through an understanding of the unique immunobiology of Hodgkin lymphoma we can derive rational treatment strategies which may heighten the efficacy of existing therapies, and improve the outcomes for patients with relapsed disease.  In E4412 which is a national study sponsored by the Eastern Cooperative Oncology Group (ECOG-ACRIN) we explore the safety and efficacy of combination of the antibody drug conjugate brentuximab vedotin which targets CD30 on the surface of the Hodgkin lymphoma tumor cells, and immune stimulation of the T cells in the tumor microenvironment using checkpoint inhibitors.  We reported the data from the first arm of the study Brentuximab Vedotin and Ipilimumab.  To date 23 patients with relapsed Hodgkin lymphoma have been treated; the combination of brentuximab and ipilimumab was safe and well tolerated with primarily grade 1 and 2 toxicities.  In 18 patients evaluable for response the ORR was 72% with a complete response rate of 50%. (more…)
Author Interviews, Cancer Research, Depression, MD Anderson, Tobacco / 11.12.2015

MedicalResearch.com Interview with: Dr. Eileen H. Shinn PhD Assistant Professor, Department of Behavioral Science Cancer Prevention and Population Sciences MD Anderson Cancer Center The University of Texas Houston, TX  Medical Research: What is the background for this study? What are the main findings? Dr. Shinn: Recent studies with leukemia, breast, lung, renal and liver cancer patients have shown that patients with depression have worsened survival.  These effect sizes are small, but independent of any of the traditional factors that are known to impact survival, such as extent of cancer, types of treatment administered and baseline health and age of the patient.  The current thinking is that cancer patients who are depressed have chronically heightened responses to stress; the constant release of stress hormones trigger changes in the tumor itself (such as noradrenergically-driven tumor angiogenesis) or may weakens the body’s immune function and ability to resist tumor growth. When we measured depression in newly diagnosed patients with oropharyngeal cancer (cancer of the base of tongue and tonsil), we found that those patients who scored as depressed were 3.5 times more likely to have died within the five year period after their diagnosis, compared to nondepressed patients.  We also found that patients who were depressed were also 3.8 times more likely to have their cancer recur within the first five years after diagnosis.  We also found that patients who continued to smoke after diagnosis were more likely to recur within the first five years. These effect sizes were larger than those typically found in recent studies.  We believe that the larger effect size may be due to the tight eligibility criteria ( e.g., we did not include patients who already had recurrent disease, we only included patients with one specific type of head and neck cancer, oropharyngeal) and also due to controlling other known factors (all patients completed individualized treatment regimens of radiation/ chemoradiation at a comprehensive cancer center and patients with more advanced disease stage were more likely to have received treatment intensification compared to patients with early stage disease).  In all, we had 130 patients, one of the largest prospective studies with oropharyngeal cancer to examine the effect of depression on cancer outcome. (more…)
Author Interviews, Breast Cancer, Surgical Research, Yale / 11.12.2015

MedicalResearch.com Interview with: Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS Associate Professor, Department of Surgery Director, The Breast Center Smilow Cancer Hospital at Yale-New Haven Assistant Director -- Global Oncology Yale Comprehensive Cancer Center Yale University School of Medicine Medical Research: What is the background for this study? Dr. Chagpar: Up to 40% of women undergoing breast conserving surgery for breast cancer will have to return to the operating room due to positive margins (or cancer cells being found at the edge of what was removed at the initial surgery).  We recently reported the results of a randomized controlled trial, published in the New England Journal of Medicine, in which we found that taking a little more tissue circumferentially around the cavity (called shave margins) at the time of the initial surgery could cut the need for re-excisions (or return trips to the operating room) in half.  In this analysis, we evaluate the implications of this technique on costs. Medical Research: What are the main findings? Dr. Chagpar: We found that taking additional tissue added 10 minutes to the initial operative time.  While taking cavity shave margins resulted in higher costs associated with the initial surgery due to increased OR time and additional tissue requiring pathologic evaluation, this is offset by the significant reduction in the need for re-excisions.  From a payer perspective, costs including facility and provider fees for the index surgery as well as any breast surgery care in the ensuing 90 days was roughly $750 less for patients who had shave margins taken than for those who did not, although this did not reach statistical significance. (more…)
Author Interviews, Cancer Research, Chemotherapy, Dermatology, JAMA / 11.12.2015

MedicalResearch.com Interview with: Chia-Yu Chu, MD, PhD Associate Professor, Department of Dermatology National Taiwan University Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Chia-Yu Chu: It has been well known that EGFR TKIs could cause skin toxicities (acneiform eruptions, pruritus, xerosis and paronychia). However, incidences of these skin toxicities have varied according to the different clinical trials, some of which even simply use “skin rash” instead of specific cutaneous findings in the reports. Afatinib, in contrast to first generation EGFR TKIs like gefitinib and erlotinib, is a second generation EGFR TKI with irreversible inhibition to not only EGFR, but also HER2 and ErbB4. Whether afatinib cause more skin toxicities remained unknown. Many of our patients received 2 or even 3 different EGFR TKIs with adequate drug exposure and washout period. Therefore, we had an opportunity to compare skin toxicities in “same patients” receiving different EGFR TKIs, and we found that around 30% of patients receiving afatinib developed paronychia whereas only 10% in gefetinib or erlotinib. This was the only significant difference between the 3 drugs. We also found afatinib treated patients needed significantly more dermatologic visits within 180 days of treatments and the reason was due to higher incidence of afatinib-related paronychia. Interestingly, regardless of causative agents, once skin toxicities developed they could be managed effectively in the same manners. (more…)
Author Interviews, Breast Cancer, Chemotherapy / 10.12.2015

MedicalResearch.com Interview with: Sam Smith, PhD CPsychol Cancer Research UK Postdoctoral Fellow Centre for Cancer Prevention Queen Mary University of London Wolfson Institute of Preventive Medicine London Medical Research: What is the background for this study? What are the main findings? Dr. Smith:  Several trials have demonstrated that agents (e.g. tamoxifen) can be used to prevent breast cancer among women at increased risk. However, their effectiveness is dependent upon their appropriate use by this patient group. Several studies have suggested that uptake is low, and that women are not taking the medications for the full 5 year course. We attempted to synthesize the evidence investigating these topics, as well as identify the factors affecting these behaviours. The main findings are that only 1 in 6 women (16.3%) were willing to start taking oral medications to prevent breast cancer. Furthermore, uptake rates were lower in routine clinical practice (9%) compared with trial enrollment rates (25%), suggesting that there may be problems with implementing chemoprevention within routine clinical care. We noted that day to day adherence and persistence over a short period (e.g. 1 year) was adequate, but when looking at the longer term studies only 1 in 10 reported that >80% of women were still taking their medications at the 5 year end point. Women may not be experiencing the full preventive effect of these medications. (more…)
Alzheimer's - Dementia, Author Interviews, Journal Clinical Oncology, Prostate Cancer, Testosterone, University of Pennsylvania / 10.12.2015

MedicalResearch.com Interview with: Kevin T. Nead, MD, MPhil Dept. of Radiation Oncology Perelman School of Medicine University of Pennsylvania MedicalResearch: What is the background for this study? What are the main findings? Dr. Nead: There are a growing number of studies suggesting that the use of  Androgen Deprivation Therapy (ADT)  may be associated with cognitive changes and some of these changes overlap with characteristic features of Alzheimer’s disease. In addition, low testosterone levels have been associated with Alzheimer’s disease risk and ADT lowers testosterone levels. Despite these findings, we could not identify any studies examining the association between ADT and Alzheimer’s disease risk. We therefore felt this study could make an important contribution in guiding future research to fully understand the relative risks and benefits of ADT. We examined electronic medical record data from Stanford University and Mt. Sinai hospitals to identify a cohort of 16,888 patients with prostate cancer. We found that men with prostate cancer who received Androgen Deprivation Therapy were more likely to develop Alzheimer’s disease than men who did not receive  Androgen Deprivation Therapy. We also found that this risk increased with a longer duration of ADT. These results were consistent using multiple statistical approaches and separately at both Stanford and Mr. Sinai. (more…)
Author Interviews, Dermatology, Genetic Research, JAMA, Melanoma / 10.12.2015

MedicalResearch.com Interview with: Susana Puig MD PhD Chief Dermatology Service Research Director "Melanoma: Imaging, genetics and immunology" at IDIBAPS Consultant & Assistant Professor Melanoma Unit, Dermatology Department Hospital Clinic, University of Barcelona Barcelona Spain  Medical Research: What is the background for this study? What are the main findings? Dr. Puig: CDKN2A is the main high-penetrance melanoma susceptibility gene. A rare functional variant in MITF, p.E318K (rs149617956), has been identified as a moderate risk allele in melanoma susceptibility and also predisposes to renal cell carcinoma. In this study MITF p.E318K was associated with an increased melanoma risk (OR=3.3, p<0.01), especially in patients with multiple primary melanoma (OR=4.5, p<0.01) and high nevi count (>200 nevi) (OR=8.4, p<0.01). Interestingly, two fast growing melanomas were detected among two MITF p.E318K carriers during dermatologic digital follow-up. Furthermore, we have detected a similar prevalence of MITF p.E318K in CDKN2A wild-type and mutated individuals. (more…)
Author Interviews, Breast Cancer, Chemotherapy, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Professor Michael Gnant, M.D., FASC Director and Chairman Department of Surgery President, Austrian Breast&Colorectal Cancer Study Group Head, Breast Health Center Vienna Comprehensive Cancer Center Vienna Medical University of Vienna - Department of Surgery Austria Medical Research: What is the background for this study? What are the main findings? Response: The background of this presentation is as follows: For many years, we have seen intriguing - but also sometimes conflicting - results of trials using adjuvant bone-targeted therapy. ABCSG-18 is a placebo-controlled trial of adjuvant denosumab 60mg twice yearly, and I have been able to present to you at this year’s ASCO meeting the dramatic reduction in clinical fractures which was the primary end point of the trial. We have also showed that twice yearly denosumab can be administered without added toxicity in this double-blind placebo-controlled trial. These results were as well published in the Lancet earlier this year. The obvious question remaining now is whether adjuvant treatment with the anti-RANK ligand antibody also improves outcomes in a way similar to what bisphosphonates do. Main findings of ABCSG-18: disease-free survival results of the intention-to-treat analysis: In the placebo group, we observed 203 DFS events. In the denosumab group, there were 167 DFS events, resulting in a hazard ratio of 0.816, indicating an 18% relative DFS improvement by denosumab. In terms of absolute differences, the benefit was 1.2% at 3 years, 2.1% at 5 years, and 3.1% at 7 years. (more…)
Author Interviews, Cancer Research, Chemotherapy, Hematology, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Dr. Ajai Chari MD Associate Professor Medicine, Hematology and Medical Oncology Tisch Cancer Institute Mount Sinai School of Medicine New York, NY Medical Research: What is the background for this study? Dr. Chari: This is a heavily pretreated population where the median progression free survival (PFS) of the pomalidomide dexamethasone is only 4 months and ORR is only 31%. While the anti CD38 monoclonal antibody daratumumab has single agent has activity in this setting, patients with rapidly progressive disease need combination therapy to achieve rapid and deep responses. Pomalidomide also upregulates CD38 on MM cells and like daratumumab, increases the effector cell activity against myeloma. Thus, there is a strong preclinical and clinical rationale for combining daratumumab with pomalidomide and dexamethasone. (more…)
Author Interviews, Chemotherapy, Leukemia / 08.12.2015

MedicalResearch.com Interview with: Jeffrey Tyner, Ph.D. Assistant Professor in Cell, Developmental and Cancer Biology at the Oregon Health & Science University School of Medicine and researcher and OHSU Knight Cancer Institute Stephen Kurtz, Ph.D. Research Assistant Professor at the Oregon Health & Science University School of Medicine Leukemia Center and researcher OHSU Knight Cancer Institute What is the background for this study? What are the main findings?  Dr. Tyner: This study was one of many resulting from the ‘Beat AML’ initiative. Acute myeloid leukemia (AML) is a complex form of leukemia; less than 25 percent of newly diagnosed AML patients survive beyond five years. Led by the Knight Cancer Institute at Oregon Health & Science University and The Leukemia & Lymphoma Society (LLS), Beat AML brings together academic health centers and biopharmaceutical companies to accelerate discoveries to improve outcomes for patients with acute myeloid leukemia. In this study, by using a unique method to test drugs used together, we identified drug combinations that are active against leukemia cells in a patient-specific manner. (more…)
Author Interviews, Melanoma, Pharmacology / 07.12.2015

MedicalResearch.com Interview with: Jeff Legos Senior Vice President Global Program Head Novartis Oncology Medical Research: What is the background for this study? What are the main findings? Response: Melanoma is the most serious form of skin cancer, and in recent years, research has discovered that melanoma is a diverse disease. In metastatic melanoma, approximately half of all patients have a mutation in the BRAF gene, and genetic testing can identify whether BRAF mutations are present in a tumor. Identifying a mutation can help doctors determine the appropriate treatment to treat BRAF-positive melanoma. Since January 2014, the combination of Tafinlar + Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was initially approved based on Phase II data through the FDA’s Accelerated Approval program and reviewed under a priority review designation. The approval was contingent on the results of the Phase III COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation. The regular approval is based on survival data from two Phase III studies: COMBI-d and COMBI-v. These studies showed that Tafinlar + Mekinist demonstrated statistically significant overall survival (OS) and progression-free survival (PFS) compared with dabrafenib or vemurafenib, in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma. In addition, combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the EU, Australia, Canada and additional countries. (more…)