Author Interviews, Breast Cancer, Cancer Research, Depression / 17.12.2015 Interview with: Ruhi Kanani  Cancer Epidemiology and Population Health Research Oncology King's College London London, UK 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 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 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 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 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 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 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 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 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 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 Interview with Dr. Ajay Bhatnagar MD Radiation Oncologist Medical director of 21st Century Oncology of Arizona 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 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 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 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 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 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 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 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 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 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 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 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 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…)
Author Interviews, Breast Cancer, Cancer, Genetic Research / 07.12.2015 Interview with: Dr. Jane E. Churpek, MD Assistant Professor of Medicine Co-Director, Comprehensive Cancer Risk and Prevention Program The University of Chicago Medicine Chicago, IL 6063 Medical Research: What is the background for this study? What are the main findings? Dr. Churpek:   We designed this study to try to understand whether damaging, inherited changes in genes known to cause an increased risk of breast cancer are common in those who develop leukemia after getting chemotherapy and/or radiation for treatment of breast cancer. Leukemias that occur in this setting are called “therapy-related.” This means that chemotherapy or radiation, or both, may have been involved in causing the leukemia.  This is an uncommon but serious complication of cancer treatment, and the factors that put women at risk for this complication are not well understood. We looked at the clinical histories of 88 such women. We found that most of them have relatives who also had cancer, suggesting they may be cancer-prone to begin with. Because we did not have a group of women who had similar breast cancer treatment and who did not get a therapy-related leukemia, we cannot definitively prove that more women with therapy-related leukemia than expected had these mutations. However, this study gives us reason to further study the role of these genes in therapy-related leukemia. (more…)
Author Interviews, Colon Cancer, Cost of Health Care, Health Care Systems, Outcomes & Safety, Surgical Research / 06.12.2015 Interview with: Johannes Govaert MD Department of Surgery Leiden University Medical Center Leiden, The Netherlands Medical Research: What is the background for this study? Dr. Govaert: The Value Based Health Care agenda ofPprof. Porter (Harvard Business School) suggests that focus in healthcare should shift from reducing costs to improving quality: where quality of healthcare improves, cost reduction will follow. One of the cornerstones of potential cost reduction, as mentioned by Porter, could be availability of key clinical data on processes and outcomes of care. Despite the important societal and economical role the healthcare system fulfils, it still lags behind when it comes to standardised reporting processes. With the introduction of the Dutch Surgical Colorectal Audit (DSCA) in 2009, robust quality information became available enabling monitoring, evaluation and improvement of surgical colorectal cancer care in the Netherlands. Since the introduction of the DSCA postoperative morbidity and mortality declined. Primary aim of this study was to investigate whether improving quality of surgical colorectal cancer care, by using a national quality improvement initiative, leads to a reduction of hospital costs. Detailed clinical data was obtained from the 2010-2012 population-based Dutch Surgical Colorectal Audit. Costs at patient-level were measured uniformly in all 29 participating hospitals and based on Time-Driven Activity-Based Costing. Medical Research: What are the main findings? Dr. Govaert: Over three consecutive years (2010-2012) severe complications and mortality after colorectal cancer surgery respectively declined with 20% and 29%. Simultaneously, costs during primary admission decreased with 9% without increase in costs within the first 90 days after discharge. Moreover, an inverse relationship (at hospital level) between severe complication rate and hospital costs was identified among the 29 participating hospitals. Hospitals with increasing severe complication rates (between 2010 and 2012) were associated with increasing costs whereas hospitals with declining severe complication rates were associated with cost reduction. (more…)
Author Interviews, Cancer Research, Cleveland Clinic, Heart Disease / 05.12.2015 Interview with: Sadeer G Al-Kindi, MD Fellow, Harrington Heart and Vascular Institute Onco-Cardiology Program, Advanced Heart Failure and Transplant Center, Harrington Heart and Vascular Institute, University Hospitals Case Medical Center Cleveland, OH Medical Research: What is the background for this study? Dr. Al-Kindi: Cardiovascular disease and cancer are the most common causes of death in the United States. They often have the same risk factors (for example, smoking, advancing age, obesity). Many cancers are treated with drugs that can have detrimental effect on the heart thus limiting their use. Some studies have suggested that cardiovascular diseases can worsen outcomes in patients with cancer. The emergence of onco-cardiology programs led to multidisciplinary care of patients with cancer and heart disease. Given this tight relationship between cancers and cardiovascular disease, we hypothesized that heart disease and its risk factors are very common in patients diagnosed with cancer. Medical Research: What are the main findings? Dr. Al-Kindi: Using a very large clinical database of 1/8th of the US population, we identified patients with most common cancers that are treated with cardiotoxic medications and identified the prevalence of cardiovascular diseases. Overall, prevalence was 33% for hematologic malignancies (leukemia and lymphoma), 43% for lung cancers, 17% for breast cancers, 26% for colon cancers, 35% for renal cancers, and 26% for head and neck cancers. Peripheral artery disease, coronary artery disease and cerebrovascular diseases were the most common, followed by heart failure, and carotid artery disease. Despite the high prevalence, only about a half of these patients were on the cardiovascular medicines and half were referred to cardiologists. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Mental Health Research / 05.12.2015 Interview with: Dr. Jamie Stagl, PhD Was a Ph.D. student in Psychology at University of Miami during the research period Currently, a post-doctoral fellow in Psychiatric Oncology Massachusetts General Hospital Cancer Center in Boston Medical Research: What is the background for this study? What are the main findings? Dr. Stagl: This is a newly published finding from a randomized trial funded by the National Cancer Institute that showed that women with breast cancer who received stress management skills early on in their treatment had longer survival and longer time without breast cancer recurrence at eight to 15 years after their initial diagnosis. This secondary analysis is published online and in the November 2015 issue of Breast Cancer Research and Treatment. The study was conducted by senior investigator, Michael Antoni, Ph.D., Survivorship Theme Leader of the Cancer Control research program at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and Professor of Psychology and Psychiatry and Behavioral Sciences, and his research team, including lead author Jamie Stagl, Ph.D., currently a postdoctoral fellow at Massachusetts General Hospital Cancer Center in Psychiatric Oncology and Behavioral Sciences. In this trial, women received an intervention called Cognitive-Behavioral Stress Management, which was created by Dr. Michael Antoni at the University of Miami. After surgery for breast cancer, women received 10 weekly, group-based sessions of skills to manage stress based in cognitive-behavioral strategies and relaxation training. Women learned muscle relaxation, mindfulness meditation, and breathing exercises to promote relaxation. Women also learned strategies for altering negative thoughts, worries, and improve coping. Previous studies by Dr. Antoni and his research team have shown that women who received these stress management skills had better psychological adjustment, less distress, and less anxiety through treatment. Dr. Stagl recently published findings showing that these women had less depressive symptoms and better quality of life during survivorship. The current study shows that these women may also benefit from stress management in terms of risk of disease progression and mortality. (more…)
Author Interviews, Breast Cancer, Lancet, Mammograms, Radiology / 05.12.2015 Interview with: Prof Stephen Duffy BSc MSc CStat Professor Of Cancer Screening Wolfson Institute Of Preventive Medicine Queen Mary University of London Medical Research: What is the background for this study? What are the main findings? Prof. Duffy: There is debate on the value of diagnosing and treating ductal carcinoma in situ (DCIS) of the breast, depending mainly on different theories about the risk of progression to invasive breast cancer if DCIS were untreated. No-one asserts that no DCIS is progressive and no-one asserts that all DCIS is progressive. There is, however, a range of opinions on the proportion of progressive disease. We found that those mammography screening units in the UK with higher detection rates of DCIS had lower subsequent rates of invasive cancers in the three years after screening. (more…)
Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, CT Scanning, Gender Differences, Lung Cancer / 04.12.2015 Interview with: Phillip Boiselle, M.D. Staff, Cardiothoracic Imaging Beth Israel Deaconess Medical Center Associate Dean for Academic and Clinical Affairs Professor of Radiology, Harvard Medical School Boston, Mass Medical Research: What is the background for this study? What are the main findings? Dr. Boiselle: Previous studies have shown that women have a greater mortality benefit from lung cancer screening then men, and that this test (CT screening) is more cost-effective for women than men. Our purpose was to determine whether the relative risk of lung cancer for women and men differed depending on the specific type of lung nodule that was discovered at screening. Such differences could potentially help to influence a more personalized approach to patient management in lung cancer screening. (more…)
Author Interviews, Breast Cancer, Depression, JNCI, Kaiser Permanente / 03.12.2015 Interview with: Reina Haque, PhD, MPH Research scientist Department of Research & Evaluation Kaiser Permanente Southern California Pasadena Calif Medical Research: What is the background for this study? What are the main findings? Dr. Haque: Tamoxifen is a commonly prescribed generic drug taken by women with breast cancer to reduce their chances of developing a recurrence. Tamoxifen is recommended for five years, but has notable side effects, including hot flashes, night sweats and depression. Since hormone replacement therapy is not recommended to alleviate these symptoms in breast-cancer survivors, antidepressants have been increasingly prescribed for relief. Almost half of the 2.4 million breast-cancer survivors in the U.S. take antidepressants. However, previous studies have suggested that antidepressants reduce tamoxifen's effectiveness in lowering subsequent breast-cancer risk. This study was conducted to determine whether taking tamoxifen and antidepressants (in particular, paroxetine) concomitantly is associated with an increased risk of recurrence or contralateral breast cancer. (more…)