ASCO, Author Interviews, Outcomes & Safety, Pharmacology, Prostate Cancer, University of Michigan / 03.03.2017

MedicalResearch.com Interview with: Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan   MedicalResearch.com: What is the background for this study? Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data. (more…)
ASCO, Author Interviews, Prostate Cancer, Radiation Therapy / 01.03.2017

MedicalResearch.com Interview with: Daniel A. Hamstra, MD PhD Radiation Oncologist Beaumont Hospital Dearborn Michigan MedicalResearch.com: What is the background for the The SpaceOAR phase 3 trial study and the hydrogel spacer? Response: External beam radiation therapy is commonly used to treat men with prostate cancer. As part of this treatment, side effects can occur involving bowel, urinary, and sexual symptoms. This study was performed to test if an absorbable hydrogel placed between the prostate and rectum (using a simple outpatient procedure) could move the rectum away from the prostate and thus result in sparing of the rectum and decreased bowel toxicity. The study randomized 222 men and the three-year data were just published (The International Journal of Radiation Oncology Biology and Physics). With three years of follow-up, we saw that the spacer did improve the radiation plans and decreased both rectal toxicity and urinary toxicity. (more…)
ASCO, Author Interviews, Cognitive Issues, Endocrinology, Journal Clinical Oncology, Prostate Cancer, Testosterone / 27.02.2017

MedicalResearch.com Interview with: Farzin Khosrow-Khavar, M.Sc. Ph.D. Candidate Department of Epidemiology, Biostatistics and Occupational Health, McGill University Center for Clinical Epidemiology - Jewish General Hospital Montreal, QC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies have shown an association between androgen deprivation therapy (ADT) and risk of dementia and Alzheimer’s disease. However, these studies had methodological limitations that may account for this positive association. Using appropriate study design and methodology, we found no association between androgen deprivation therapy and risk of dementia (including Alzheimer’s disease) in patients with prostate cancer. These results were consistent by cumulative duration of  androgen deprivation therapy use and by ADT modality. (more…)
ASCO, Author Interviews, Cancer Research, Colon Cancer, Genetic Research, Journal Clinical Oncology / 01.02.2017

MedicalResearch.com Interview with: Matthew B Yurgelun, M.D Instructor in Medicine, Harvard Medical School Dana-Farber Cancer Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: It has long been known that hereditary factors play a key role in colorectal cancer risk. It is currently well-established that approximately 3% of all colorectal cancers arise in the setting of Lynch syndrome, a relatively common inherited syndrome that markedly increases one’s lifetime risk of colorectal cancer, as well as cancers of the uterus, ovaries, stomach, small intestine, urinary tract, pancreas, and other malignancies. Current standard-of-care in the field is to test all colorectal cancer specimens for mismatch repair deficiency, which is a very reliable means of screening for Lynch syndrome. The prevalence of other hereditary syndromes among patients with colorectal cancer has not been known, though other such factors have been presumed to be quite rare. (more…)
ASCO, Author Interviews, Brigham & Women's - Harvard, Colon Cancer, Exercise - Fitness / 21.01.2017

MedicalResearch.com Interview with: Brendan John Guercio, M.D. Clinical Fellow in Medicine (EXT) Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sedentary lifestyle is a known risk factor for the development of colon cancer and has been associated with increased disease recurrence and mortality in patients with early stage colorectal cancer. This is the first study to our knowledge to show an association between increased physical activity (i.e. non-sedentary lifestyle) and improved survival and progression-free survival in patients with metastatic colorectal cancer. (more…)
ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology / 22.09.2016

MedicalResearch.com Interview with: Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease. (more…)
ASCO, Author Interviews, Journal Clinical Oncology, MD Anderson, Ovarian Cancer / 14.09.2016

MedicalResearch.com Interview with: Larissa A. Meyer, MD MPH F.A.C.O.G. Assistant Professor Dept of Gynecologic Oncology and Reproductive Medicine Houston, TX 77030-1362 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite the completion of two randomized controlled trials, controversy regarding the optimal approach for the treatment of advanced ovarian cancer remains. Our observational study highlights the importance of thoughtful selection of individuals for primary cytoreductive surgery for advanced ovarian cancer. Our results suggest that primary cytoreductive surgery may improve survival for patients with stage IIIC ovarian cancer who are likely to achieve an optimal cytoreduction, while neoadjuvant chemotherapy may be the preferred option for many women with stage IV ovarian cancer. (more…)
ASCO, Author Interviews, Cancer Research, End of Life Care / 09.09.2016

MedicalResearch.com Interview with: Erin Kent, PhD, MS Program Director Outcomes Research Branch of the Healthcare Delivery Research Program National Cancer Institute MedicalResearch.com: What is the background for this study? Response: Informal or family caregivers assist loved ones by providing care which is typically uncompensated, takes place typically at home, and often involves significant efforts for an extended period of time. Caregiving can require the performance of demanding tasks, which include managing symptom burden, monitoring for side effects from treatment, coordinating care, administering medication, and managing a care recipient’s financial and social obligations. In addition, there are many unique aspects of cancer that can place unique demands on caregivers, including sometimes a rapid deterioration of health, the receipt of multi-modal therapy (eg. surgery, chemotherapy, and radiation), and the possibility of cancer recurrence. (more…)
ASCO, Author Interviews, Outcomes & Safety / 22.07.2016

MedicalResearch.com Interview with: Claire O’Hanlon, MPP Pardee RAND Graduate School and Courtney Gidengil, MD, MPH RAND Corporation MedicalResearch.com: What is the background for this study? Response: Providing high-quality health care is central to our nation’s commitment to veterans, but the quality of care provided in Veterans Affairs health care system (VA) is a longstanding area of concern. Part of the 2014 Veterans Access, Choice and Accountability Act (VACAA) mandated an independent assessment of VA’s health care capabilities and resources of the Veterans Health Administration, including a comprehensive evaluation of health care quality. As part of this evaluation we conducted this systematic review of journal articles that compare quality of care at the VA to other settings as an update to a 2009 review on this subject. (more…)
ASCO, Author Interviews, Cancer Research, Chemotherapy, Lung Cancer / 22.06.2016

MedicalResearch.com Interview with: Dr. Lan Huang PhD Co-founder, Chairman and CEO BeyondSpring Pharmaceuticals, Inc MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is the toxicity of Docetaxel chemotherapy causes inadequate dosing with Docetaxel due to dose delay, reduction or discontinuation, thus leaving the patient with inadequate chemotherapy treatment. A main finding is a statistically significant p value of 0.002 in lower rates of grade 3 and 4 Neutropenia for patients dosed with a combination of BeyondSpring’s Plinabulin and Docetaxel compared to those patients dosed with Docetaxel alone. As a result, approximately 14 percent more patients stayed on the adequate (dense) dose of Docetaxel in the Docetaxel + Plinabulin arm as compared to Docetaxel alone. (more…)
ASCO, Author Interviews, Breast Cancer, Genetic Research, Journal Clinical Oncology, NIH / 14.06.2016

MedicalResearch.com Interview with: Valentina Petkov, MD, MPH Health Scientist/Program Officer NIH/NCI/DCCPS/Surveillance Research Program MedicalResearch.com: What is the background for this study? Dr. Petkov: The number of breast cancer diagnoses is increasing in older patients because of increasing life expectancy and changing population demographics. Despite high incidence, little is known about breast cancer biology and outcomes in patients older than 70, which are often under-represented in clinical trials. The 21-gene Oncotype DX Breast Recurrence Score assay has been used in clinical practice to predict distant recurrence risk and chemotherapy benefit in lymph node negative, hormonal receptor positive (estrogen and/or progesterone receptor positive) invasive breast cancer since 2004. The goal of our study was to evaluate the role of the 21 gene assay in older patients at population level. We used Surveillance Epidemiology and End Results (SEER) data. We included in the analysis 40,134 patients who were diagnosed with invasive breast cancer between 2004 and 2011, had negative nodes and their tumors were hormonal receptor positive and HER2 negative. Breast Cancer Specific Mortality (BCSM) was assessed at 5 years after diagnosis in patients with low risk (Recurrence Score <18), intermediate risk (Recurrence Score 18-30) and high risk (Recurrence Score >30). (more…)
ASCO, Author Interviews, Cancer Research, Immunotherapy / 08.06.2016

MedicalResearch.com Interview with: Dr. Arjun Balar MD Assistant Professor, Department of Medicine Co-Leader Genitourinary Cancers Program NYU Langone Medical Center Laura and Isaac Perlmutter Cancer Center MedicalResearch.com: What is the background for this study? Dr. Balar: Standard treatment for advanced urothelial cancer includes cisplatin chemotherapy. But more than half of patients are not expected to tolerate it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative to cisplatin. Atezolizumab is a PD-L1 blocking antibody that reactivates the body¹s immune system to fight bladder cancer and has been recently FDA approved in the management of advanced urothelial cancer in the second-line setting after failure of platinum-based chemotherapy. (more…)
ASCO, Author Interviews, Cancer Research, Immunotherapy, University of Pittsburgh / 07.06.2016

MedicalResearch.com Interview with: Robert L. Ferris, M.D., Ph.D. Robert L. Ferris, M.D., Ph.D. UPMC Endowed Professor and Vice-Chair Associate Director for Translational Research Co-Leader, Cancer Immunology Program MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Ferris: Investigators at the University of Pittsburgh Cancer Institute<http://upci.upmc.edu/> (UPCI) co-led CheckMate-141<https://clinicaltrials.gov/ct2/show/NCT02105636> a large, randomized international phase III clinical trial that enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed. Nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer. The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group. Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group. In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline. The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug. (more…)
ASCO, Author Interviews, Dermatology, Journal Clinical Oncology, Melanoma, Primary Care, University of Pittsburgh / 07.06.2016

MedicalResearch.com Interview with: Laura Ferris, M.D., Ph.D. Associate professor, Department of Dermatology University of Pittsburgh School of Medicine and Member of the Melanoma Program University of Pittsburgh Cancer Institute MedicalResearch.com: What is the background for this study? Dr. Ferris: Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment. Typically, patients receive skin checks by setting up an appointment with a dermatologist. UPMC instituted a new screening initiative, which was modeled after a promising German program, the goal being to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their primary care physicians (PCPs). PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion. (more…)
ASCO, Author Interviews, Cancer Research, Geriatrics, Lymphoma, NYU, Pharmacology / 07.06.2016

MedicalResearch.com Interview with: Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Cancer Center New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Diefenbach: It is well known that age is important prognostic factor in non-Hodgkin’s lymphoma (NHL). Multiple studies have illustrated that elderly lymphoma patients have inferior survival outcomes as compared to their younger counterpart. While the tumor biology is often different in these two groups, and may play a role in this discordancy, elderly patients are often frail or have multiple medical comorbidities. These include geriatric syndromes, such as: cognitive impairment, falls, polypharmacy, and potentially inappropriate medication (PIM) use. All of these may contribute to poor outcomes for elderly patients. In addition, elderly patients are often under-treated for their aggressive lymphoma out of concern for toxicity or side effects, even though the data clearly demonstrates that elderly patients can still benefit from curative intent chemotherapy. (more…)
ASCO, Author Interviews, Biomarkers, Cancer Research, Cost of Health Care, Immunotherapy / 07.06.2016

MedicalResearch.com Interview with: Neil T. Mason, MBA Personalized Medicine Strategist Personalized Cancer Medicine Division of Population Science Moffitt Cancer Center MedicalResearch: What is the background for this study? What are the main findings? Response: Immune checkpoint inhibitors targeting PD-1 (nivolumab and pembrolizumab) and CTLA-4 (ipilimumab) have revolutionized the treatment of metastatic disease in melanoma and non-small cell lung cancer with additional indications showing positive results. These drugs have elicited profound and durable responses in a significant number of patients, but have been criticized for their high cost. Though the price of the drugs themselves can reach over $100,000 per year, they can also cause severe, life threatening toxicities that are difficult and expensive manage. This model utilizes patient data from a large, NCI-designated cancer center to estimate the average cost of treatment with immune checkpoint inhibitors based on average duration of treatment and reported incidence of major toxicities. Based on the model, PD-1 inhibitor therapies are less costly than ipilimumab due to the significantly higher cost per dose of ipilimumab and average treatment duration of less than a year for PD-1 inhibitors. Managing drug-related toxicities were estimated to contribute between $8,200 and $9,600 to the cost of therapy with nivolumab adding the most cost. (more…)
ASCO, Author Interviews, Biomarkers, Personalized Medicine, UCSD / 07.06.2016

MedicalResearch.com Interview with: Maria Schwaederle PharmD Clinical Research Scientist Center for Personalized Cancer Therapy UCSD Moores Cancer Center La Jolla, CA 92093 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Schwaederle: We performed this analysis with experts in the field, including but not limited to Drs Schilsky, Lee, Mendelsohn and Kurzrock, all known for their experience in the area of precision/personalized medicine. Historically, phase I trials (which are often first in human or highly experimental in other ways) were believed to be examining only toxicity. Our meta-analysis of 13,203 patients shows that in the era of precision medicine, this historical belief needs to be discarded. Second, it is the use of precision medicine that makes this belief outdated. Indeed, Phase I trials that utilized a biomarker-driven approach that is the essence of precision medicine had a median response rate of about 31%, which is higher than many FDA approved drugs, and this is in spite of the fact that phase I patients are a highly refractory group having failed multiple lines of conventional therapy. Importantly, however, it was not the use of targeted agents alone that was important. It was the biomarker-based approach where patients are matched to drugs. Without matching, response rates were dismal—about 5%. (more…)
ASCO, Author Interviews, Cancer Research, Chemotherapy / 06.06.2016

MedicalResearch.com Interview with: Dawn L. Hershman, MD MS Professor of Medicine and Epidemiology Leader, Breast Cancer Program Herbert Irving Comprehensive Cancer Center Columbia University NY NY MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Hershman: Chemotherapy induced peripheral neuropathy is a common side effect of anti cancer therapy and there are currently no ways to prevent it. We used a large clinical trials database, SWOG, and linked it to Medicare claims for patients over the age of 65. We found that age and type of taxane were associated with the development of CIPN. We also found a significant increase when a taxane was given along with a platinum agent. We found a doubling of risk among patients with a prior history of diabetes. No other chronic condition was associated with an increased risk of CIPN. We found a suggestion of a decreased risk among patients with a prior history of auto-immune disease. (more…)
ASCO, Author Interviews, Brigham & Women's - Harvard, Cancer Research, Pediatrics / 06.06.2016

MedicalResearch.com Interview with: Katie Greenzang, MD Dana-Farber/Boston Children’s Cancer and Blood Disorders Center MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Greenzang: Advances made over the last several decades mean that more than 80 percent of children diagnosed with cancer will become long-term survivors. However, many of these survivors experience physical and cognitive late effects of the treatment that cured them. We surveyed 352 parents of children recently diagnosed with cancer to assess how well they understood their children’s risk of future limitations in physical abilities, intelligence, and quality of life. We found that an overwhelming majority of parents (92 percent) are very interested in learning about possible late effects, and most (86 percent) seek detailed information. Yet, parent and physician predictions of a child’s risk of experiencing late effects of treatment often don’t match. Among children identified by their oncologists as being at high risk for such challenges, only 38 percent of parents recognized this risk in physical abilities, 21 percent in intelligence, and 5 percent in quality of life. (more…)
ASCO, Author Interviews, Cancer Research, Genetic Research / 06.06.2016

MedicalResearch.com Interview with: Gregory Idos MD Division of Gastroenterology and Hepatology Keck School of Medicine University of Southern California Los Angeles, CA 90033 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Idos: Identifying individuals at increased risk for hereditary cancer prompts enhanced cancer surveillance as early detection mitigates disease specific morbidity and mortality. This justifies germ line genetic testing for specific cancer risk alleles. In recent years, the field of cancer genetics has moved from a gene by gene sequencing approach to now having the ability to examine multiple genes concurrently. Multiplex gene panel (MGP) testing allows simultaneous analysis of multiple high- and moderate- penetrance genes. As a result, more pathogenic mutations and variants of uncertain significance (VUS) are discovered. MGP tests are increasingly being used by cancer genetic clinics, but questions remain about the clinical utility and complexities of these tests. We are conducting a multi center prospective trial to measure the added yield of detecting pathogenic mutations using the MGP approach. In our interim analysis of the first 1000 participants, we found that multiplex gene panel testing increased the yield of detection of pathogenic mutations by 26%. In some cases, we found patient’s who had a mutation in the BRCA gene, but their family history did not indicate a history of breast or ovarian cancer. (more…)
ASCO, Author Interviews, Cost of Health Care, Prostate Cancer, Surgical Research / 06.06.2016

MedicalResearch.com Interview with: Sarmad Sadeghi MD, MS, PhD Assistant Professor of Medicine Norris Comprehensive Cancer Center University of Southern California MedicalResearch.com: What is the background for this study? Dr. Sadeghi: Several years ago analyses of outcomes for radical prostatectomy highlighted the significant impact of surgical experience on the oncological outcome for the patients. In this case experience was measured by the number of radical prostatectomies performed by the surgeon, and oncological outcome was measured by treatment failure rates (rising PSA). Despite this data, the move for redirecting patients to “high volume centers” where more experienced surgeons perform the operation has been sluggish. There was insufficient data on what is involved in referring patients to high volume centers and whether or not such action is cost effective. In a previous study we demonstrated that for every referral to a high volume center, there would be an average of $1,800 over a follow-up period of 20 years in societal cost savings. The main source of these savings is fewer treatment failures. The next question was who is a good candidate for referral and whether these savings can offset the referral costs. (more…)
ASCO, Author Interviews, Cancer Research, Stem Cells / 05.06.2016

MedicalResearch.com Interview with: Philip McCarthy, BA, MD Professor of Oncology Director, Blood and Marrow Transplant Program Roswell Park Cancer Institute Associate Professor of Medicine Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo Buffalo, NY 14263 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. McCarthy: There have been three Phase III studies that examined the role of maintenance lenalidomide after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma patients. IFM 2005-02 (France), CALGB 100104 (Alliance, USA), GIMEMA-RVMM-PI-209 (Italy). All three studies had progression free survival (PFS) as their primary endpoint and all demonstrated a superior PFS when compared to placebo or no therapy after ASCT. However only the CALGB 100104 study demonstrated a statistically superior overall survival (OS). Thus, a meta-analysis was necessary to assess the effect of post-ASCT lenalidomide maintenance on overall survival. This study utilized a pooled analysis of updated primary-source patient data from all three studies after the primary efficacy analyses had been conducted. The meta-analysis demonstrated that there is a statistically superior OS (P value=0.001, HR=0.74 (0.62-0.89)), Median OS for no maintenance or placebo was 86 months and the median OS for lenalidomide had not been reached. The median OS for lenalidomide treatment arm was extrapolated to be 116 months based on median of the control arm and HR (median, 86 months; HR = 0.74). Thus, there is a 26% reduction in the risk of death which is an estimated 2.5 year increase in median OS. There is an increased incidence of second primary malignancies with lenalidomide maintenance when compared to placebo but this risk is less than the risk of dying when not receiving lenalidomide. (more…)
ASCO, Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Immunotherapy / 04.06.2016

MedicalResearch.com Interview with: Wayne L. Furman, MD Department of Oncology Jude Children's Research Hospital Memphis, TN 38105-3678 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Furman: Despite improvement in 2-yr EFS from 46% to 66% with the inclusion of dinutuximab, a monoclonal antibody that recognizes a glycoprotein on neuroblasts called ‘GD2’ (disialoganglioside), more than one-third of children with high-risk neuroblastoma still are not cured. Therefore novel therapeutic approaches are needed for this subset of patients. The clinical evaluation of various anti-GD 2 monoclonal antibodies in children with neuroblastoma has been exclusively focused on treatment of patients after recovery from consolidation, in a state of ‘minimal residual disease’. This is because traditionally chemotherapy has been thought to be too immunosuppressive to combine with monoclonal antibodies. However recent studies suggest, even in the setting of “bulky” solid tumors, the combination of chemotherapy with monoclonal antibodies can enhance the effectiveness of the antibodies. First, chemotherapy can increase the efficacy of antibodies by depleting cells of the immune system that suppress immune function. Also chemotherapy-induced tumor cell death can trigger tumor antigen release, uptake by antigen processing cells and an enhanced antitumor immune response. There is also data that anti-GD2 monoclonal antibodies can suppress tumor cell growth independent of immune system involvement. Furthermore anti-GD2 monoclonal antibodies and chemotherapy have non-overlapping toxicities. All of these reasons were good reasons to evaluate the addition of a novel anti-GD2 monoclonal antibody, called hu14.18K322A, to chemotherapy, outside the setting of minimal residual disease, in children with newly diagnosed children with high-risk neuroblastoma. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer, Chemotherapy, Genetic Research, Journal Clinical Oncology / 03.03.2016

MedicalResearch.com Interview with: Oleg Gluz, MD West German Study Group Breast Center Niederrhein Evangelical Hospital Bethesda Moenchengladbach, Germany MedicalResearch.com: What is the background for this study? Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients. For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk. MedicalResearch.com: What are the main findings? Dr. Gluz: The study has two major findings: We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67). Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up. (more…)
ASCO, Author Interviews, Breast Cancer, Cancer Research, University of Michigan / 28.02.2016

MedicalResearch.com Interview with: Sarah T. Hawley PhD MPH Professor of Medicine University of Michigan Medical Research: What is the background for this study? What are the main findings? Dr. Hawley: Research has shown that breast cancer patients do not have a good understanding of their risk of distant recurrence, and and that the fear of cancer spreading is one of the biggest concerns that patients have. The research that has been done shows that most patients over-esimate this risk, and think they have a bigger chance of the cancer coming back than they actually have. There has been relatively little done to investigate the association between patient over-estimation of risk and patient reported outcomes, specifically their quality of life. We therefore conducted our study to understand the extent of overestimation of risk in a population-based sample of breast cancer patients with very favorable prognosis (DCIS, low risk invasive breast cancer) using a numeric (number based) and descriptive (general understanding) measure, and to understand the association between over-estimation and quality of life. The main findings are that almost 40% of our sample of patients over-estimated their risk; 33% using a numeric measure and 15% using a descriptive measure. There was no clear “type” of patient who overestimated her risk of distant recurrence, though women with lower education more over overestimated numerically than those with higher education. Both numeric and descriptive over-estimation was associated with reduced quality of life outcomes, especially with frequency of worry about recurrence, however over estimating descriptively mattered the most. Women who overestimated their risk both numerically and descriptively had a nearly 10 fold odds of frequent worry compared to women who understood their risk. (more…)
ASCO, Author Interviews, Cancer Research, Lymphoma / 18.01.2016

More Cancer Research on MedicalResearch.com MedicalResearch.com Interview with: Erin E. Hahn, PhD, MPH Research Scientist Southern California Permanente Medical Group Kaiser Permanente Research Department of Research & Evaluation Pasadena, CA 91101 Medical Research: What is the background for this study? Dr. Hahn:  Adolescent and young adults, or AYAs, who are diagnosed and treated for Hodgkin lymphoma have very high overall survival rates. However, these patients are at high risk for short and long term health issues related to their cancer treatment, including cancer recurrence, cardiac and pulmonary problems, and developing new primary cancers. Some of these issues arise during treatment and persist over time, called long-term effects, and some develop years later, called late effects. Evidence and consensus based guidelines are available from organizations like the National Comprehensive Cancer Network and the Children’s Oncology Group to help manage the post treatment care of  Adolescent and young adults Hodgkin lymphoma survivors. Examining adherence to guidelines is an important part of high quality care, and can help us find and address gaps in care. Guideline recommended care for these patients includes: oncology visits, imaging and labs, preventive care, counseling and education, risk based screening for late effects. Risk-based screening is based on a patient’s treatment. The type of health screening a patient needs is determined by the treatment exposure they had, such as certain types of chemotherapy or high-dose radiation that have known late effects  Medical Research: What are the main findings? Dr. Hahn: For this pilot study, I was interested to see if post-treatment  Adolescent and young adults Hodgkin lymphoma patients in an integrated health care system received recommended short and long term care. The study setting is Kaiser Permanente Southern California (KPSC). KPSC provides care for almost 4 million members with 14 medical centers, and they have a long-standing electronic medical record. For our population, we included AYA patients diagnosed with classical Hodgkin lymphoma between 15 and 39 years of age, diagnosed between 2000 and 2010. We wanted to find patients who were diagnosed, treated, and followed for at least 2 years within this single system. We have a sample of 354 patients, which is great. It has been traditionally difficult to find and follow these patients/obtain accurate medical information that isn’t only self-report data. We were able to extract chemotherapy, radiation, and other care details from the electronic medical record. We first looked at receipt of short term recommended care, within the first year after treatment had ended. We looked specifically at oncology visits, use of recommended CT scan and lab tests, and preventive care, such as the flu vaccine. The great majority of patients had the recommended oncology visits, CT scan, and lab tests. However, receipt of the flu vaccine was lower, at 20%. When we looked at a composite measure of all 4 recommended services, only about half of the patients received all four recommended services within the first year after treatment. We also looked at use of a longer term recommended service for cardiac issues. Cardiac screening is recommended for patients who are 10 years out from their treatment and who received high-dose anthracyclines, plus radiation to the chest. This is the highest risk group for cardiac damage. Almost everyone received annual blood pressure screening, but only about 30% received screening with an electrocardiogram, echocardiogram, or MUGA scan. (more…)
ASCO, Author Interviews, Immunotherapy, Ovarian Cancer / 02.12.2015

MedicalResearch.com Interview with: Junzo Hamanishi  M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan Medical Research: What is the background for this study? Dr. Hamanishi: More than 70% of patients with advanced ovarian cancer who achieve remission ultimately relapse and there are few effective treatments for these patients. Because the development of new treatment strategies for these patients is urgently required, we have focused on and studied the potential of cancer cells to escape from host immunity with PD-1/PD-L1 immunosuppressive signal in the tumor microenvironment to find new treatment strategies to overcome this phenomenon, collaborating with Professor Honjo who discovered PD-1 since 2006. Therefore, we conducted a phase II clinical trial in 20 platinum-resistant, recurrent ovarian cancer patients to evaluate the safety and anti-tumor efficacy of anti-PD-1 antibody (nivolumab) with 2 cohort at a dose of 1 or 3 mg/kg (constituting two 10-patient cohorts). Medical Research: What are the main findings? Dr. Hamanishi: This study is the first investigator-initiated phase II clinical trial testing the safety and efficacy of nivolumab against platinum-resistant ovarian cancer. In the 20 patients in whom responses could be evaluated, the best overall response was 15%, including two patients with a durable complete response (3mg/kg cohort). The disease control rate in all 20 patients was 45%. The median progression-free survival was 3.5 months, with a median overall survival of 20.0 months. Especially in the 3 mg/kg cohort, two patients achieved a complete response, and disease stabilized in another two patients. The objective response rate in 3mg/kg cohort cohort was 20% and disease was controlled in 40% of the higher-dose group. In the four patients who demonstrated an antitumor response, responses were durable and evident. Grade 3 or 4 treatment-related adverse events (AE) occurred in eight out of 20 patients or 40% overall. However, the frequency of AEs were not different in 2 cohorts. (more…)
ASCO, Author Interviews, Biomarkers, Cancer Research / 06.06.2015

MedicalResearch.com Interview with: Dr. Kirsten Timms, PhD Program Director VP Biomarker Discovery at Myriad Genetics Inc Medical Research: What is the background for this study? What are the main findings? Dr. Timms: The Homologous Recombination Deficiency (HRD) score is a tumor biomarker which quantitates genomic rearrangements associated with defects in DNA damage repair. It has been shown in multiple studies that HRD score can identify tumors sensitive to DNA damaging agents such as platinum salts or PARP inhibitors. Many tumors are spatially heterogeneous: different parts of a tumor show variation at both the genomic level, and in their appearance. This tumor heterogeneity has the potential to negatively impact the accuracy of biomarker tests. This study assessed the consistency of the HRD score in multiple biopsies obtained from the same cancer to understand the impact of tumor heterogeneity on the HRD score. The main finding of this study is that the HRD score is highly conserved between different biopsies of the same tumor. (more…)
ASCO, Author Interviews, Chemotherapy / 03.06.2015

Professor Patrick Schöffski Head, Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospital Leuven, KU Leuven, BelgiumMedicalResearch.com Interview with: Professor Patrick Schöffski Head, Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospital Leuven, KU Leuven, Belgium MedicalResearch: What are the key points of the study? Professor Schöffski: This is the first and only randomised controlled trial of a single agent systemic therapy to demonstrate an improvement in overall survival in people previously treated for advanced soft tissue sarcomas. The study met its primary objective for overall survival benefit (OS) for investigational use in patients treated with eribulin compared to dacarbazine. Median OS for eribulin was 13.5 months versus 11.5 months for dacarbazine representing a significant benefit, meaning that patients treated with eribulin may have a 23% reduction in the risk of death. Furthermore, an additional study endpoint included progression-free survival (PFS) at 12 weeks.  While there was a numerical difference between arms favouring eribulin versus dacarbazine (33% vs 29%) this was not statistically significant. Median PFS was 2.6 months in both arms. (more…)