Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50871" align="alignleft" width="150"]Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author) Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)[/caption] Dr. Graca Dores MD MPH US Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Epidemiology Silver Spring, Maryland Oklahoma City, OK MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for?  Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses. Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database.
Author Interviews, Cancer Research, Outcomes & Safety, Surgical Research, Yale / 12.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50208" align="alignleft" width="160"]Daniel Boffa, MD Professor of Surgery Yale School of Medicine Dr. Boffa[/caption] Daniel Boffa, MD Professor of Surgery Yale School of Medicine  MedicalResearch.com: What is the background for this study? Response: We have previously demonstrated that top-ranked hospitals are significantly safer than their affiliates for complex cancer surgery (patients 1.4 times more likely to die after cancer surgery at affiliate hospitals).  A logical extension of this work was to compare affiliate hospitals to hospitals that were not affiliated with a top ranked hospital.
ASCO, Author Interviews, Education, Gender Differences, Surgical Research / 04.06.2019

MedicalResearch.com – Responses [caption id="attachment_49547" align="alignleft" width="200"]Marina Stasenko, MD Memorial Sloan Kettering Cancer Center Dr. Stasenko
Photo: MSKCC[/caption] Marina Stasenko, MD Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians. Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology.
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 19.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49162" align="alignleft" width="191"]Nina Niu Sanford, M.D. Assistant ProfessorUT Southwestern Department of Radiation OncologyDallas TX 75390 Dr. Sanford[/caption] Nina Niu Sanford, M.D.  Assistant Professor UT Southwestern Department of Radiation Oncology Dallas TX 75390  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that we know cancer survivors are at risk for uninsurance or underinsurance and the most commonly cited reason for this is cost of insurance.  However, there have been no prior studies assessing from the patient perspective the reasons for not having insurance. In addition, there has been further recent controversy over the Affordable Care Act, including threats from the current administration to dismantle it.  Thus assessing the impact of the ACA among at risk populations including cancer survivors is timely.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA, Radiation Therapy, Technology / 19.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48660" align="alignleft" width="200"]Raymond H Mak, MDRadiation OncologyBrigham and Women's Hospital Dr. Mak[/caption] Raymond H Mak, MD Radiation Oncology Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? 
  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be
Author Interviews, Brain Cancer - Brain Tumors, Radiation Therapy, Surgical Research / 12.11.2018

MedicalResearch.com Interview with: [caption id="attachment_45901" align="alignleft" width="148"]Dr. Stephanie E. Weiss MD FASTRO Chief, Division of Neurologic Oncology Associate Professor, Department of Radiation Oncology Director, Radiation Oncology Residency and Fellowship Training Program Fox Chase Cancer Center Philadelphia, Pennsylvania Dr. Weiss[/caption] Dr. Stephanie E. Weiss MD FASTRO Chief, Division of Neurologic Oncology Associate Professor, Department of Radiation Oncology Director, Radiation Oncology Residency and Fellowship Training Program Fox Chase Cancer Center Philadelphia, Pennsylvania MedicalResearch.com: What is the background for this study? Response: Brain metastasis are the most common form of brain tumor. Historically all patients received whole brain radiation as the primary therapy. Patients required neurosurgery to remove lesions if there was a question of diagnosis, what the diagnosis is and if there was a mass effect not relieved with steroids. Surgery was also indicated for patients with a single brain lesion because this offers a survival benefit over just receiving whole brain radiotherapy. In 2003 a randomized trial proved that radiosurgery offers a similar benefit. So the question taxing patients and doctors at tumor boards since has been: which is better? If neurosurgery is superior, we are under-treating a lot of patients with radiosurgery. If radiosurgery is superior, we are subjecting a lot of patients to unnecessary brain surgery. Attempts to study this in a head-to-head randomized trial have failed. Patient and physician preference for one treatment or the other has proven to be a barrier to randomization and accrual. The EORTC 22952-2600 trial was originally designed to compare outcomes with and without whole brain radiation for patients receiving surgery or radiosurgery for brain metastasis. We used this as the highest-quality source data available to compare local control of brain metastasis after surgery or radiosurgery, adjusted for by receipt or not of whole brain radiation.  
ASCO, ASCO18, Author Interviews, Dermatology, Melanoma, Merck, University of Pittsburgh / 05.06.2018

MedicalResearch.com Interview with: [caption id="attachment_40044" align="alignleft" width="200"]This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification. This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.
CDC Image[/caption] Dr. Diwakar Davar, MD Assistant Professor of Medicine Division of Hematology/Oncology University of Pittsburgh  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The optimal surveillance strategy to detect recurrence in cutaneous melanoma remains elusive. Risk of recurrence increases with higher stage, and is especially high for patients with stage IIIC disease. Although consensus guidelines agree on surveillance imaging for high-risk (stage IIB-IIIC) MEL, there is no consensus regarding optimal frequency/modality in these patients. NCCN guidelines suggest chest radiography (CXR) at 6- to 12-month intervals for stage IA-IIA melanoma  patients; although this is controversial. There exists a great deal of practice variation in the surveillance of these patients.
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmaceutical Companies / 09.04.2018

MedicalResearch.com Interview with: [caption id="attachment_41105" align="alignleft" width="133"]Aaron Mitchell, MD Division of Hematology/Oncology, Department of Medicine,  Lineberger Comprehensive Cancer Center The Cecil G. Sheps Center for Health Services Research The University of North Carolina at Chapel Hil Dr. Mitchell[/caption] Aaron Mitchell, MD Division of Hematology/Oncology, Department of Medicine, Lineberger Comprehensive Cancer Center The Cecil G. Sheps Center for Health Services Research The University of North Carolina at Chapel Hill MedicalResearch.com: What is the background for this study? What are the main findings? Response: Financial relationships between physicians and the pharmaceutical industry are very common. However, we are just beginning to figure out whether these relationships may lead to potentially concerning changes in physician behavior - whether physicians tend to prescribe more of the drugs made by a company that has given them money. We decided to ask whether oncologists who receive money from drugmakers are more likely to use the cancer drugs made by companies that have given them money in the past. In studying two specific groups of cancer drugs, one for kidney cancer and one for chronic myeloid leukemia (CML), we found that oncologists who had received payments such as meals, consulting fees, travel & lodging expenses from the manufacturer of one of these drugs tended to use that drug more. When looking at oncologists who received payments for research, we found increased prescribing among the kidney cancer drugs but not the CML drugs.
Author Interviews, Breast Cancer, Cancer Research, Education / 30.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28448" align="alignleft" width="120"]Adam Brufsky, MD, PhD, FACP Medical Director of the Women's Cancer Center University of Pittsburgh Medical Center Dr. Adam Brufsky[/caption] Adam Brufsky, MD, PhD, FACP Medical Director of the Women's Cancer Center University of Pittsburgh Medical Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • The Make Your Dialogue Count survey was conducted by Harris Poll on behalf of Novartis between June 20 and August 22, 2014. A total of 359 surveys were collected among women 21 years+ living with advanced breast cancer in addition to 234 caregivers of women with advanced breast cancer and 252 licensed oncologists who treat at least five advanced breast cancer patients per month within the United States. Novartis conducted the survey with guidance from oncologists, patient advocacy experts and a psychologist to better understand the dialogue around treatment goals and decisions that takes place among advanced breast cancer patients, caregivers and oncologists.
  • Main survey findings show communication gaps exist in discussions between patients and oncologists, particularly around treatment plans and goals.
  • 89% of patients and 76% of oncologists said that it’s important or very important to discuss long-term treatment plans beyond the current recommended treatment at their initial advanced breast cancer diagnosis. Yet, 43% of patients reported that this did not take place.
  • 70% of patients and 65% of oncologists said that it’s important or very important to refer patients to support services at their initial advanced breast cancer diagnosis. Yet, only 36% of patients reported that this was something their doctor did.
  • 23% of oncologists said that at times their emotions have kept them from sharing certain information with their advanced breast cancer patients, and 27% of oncologists said that, in certain situations, they do not discuss with patients the fact that advanced breast cancer is incurable.
Author Interviews, Cancer Research, JAMA / 25.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27281" align="alignleft" width="160"]Dr. Aaron Mitchell MD Hematology/Oncology Fellow University North Carolina Dr. Aaron Mitchell[/caption] Dr. Aaron Mitchell MD Hematology/Oncology Fellow University North Carolina MedicalResearch.com: What is the background for this study? Response: It is well known that many physicians work with the pharmaceutical industry. In some cases, this can create conflicts of interest with physicians' other responsibilities. The Open Payments law, passed as part of the Affordable Care Act, recently made these relationships public, which now allows us to study them more systematically.
Author Interviews, CT Scanning, Lancet, Medical Imaging, MRI, Pediatrics, Stanford / 20.02.2014

Dr Heike Daldrup-Link Associate Professor of Radiology Stanford University School of Medicine, Palo AltoMedicalResearch.com: Interview with: Dr Heike Daldrup-Link Associate Professor of Radiology Stanford University School of Medicine, Palo Alto   MedicalResearch.com: What are the main findings of the study? Answer: We use magnetic resonance imaging, a technology based on magnetic fields rather than radiotracers or x-rays. The underlying technology is not new – it has been used for tumor staging for many years. This is an advantage as MR scanners are available in nearly every major Children’s Hospital where children with cancer are treated. What is new about our approach is that we combined anatomical and functional images, similar to current approaches that use radiotracers and CT (PET/CT):  We first acquired scans that showed the anatomy of the patient very well and we then acquired scans that depict tumors as bright spots with little or no background information. We did that by using an iron supplement as a contrast agent: The iron supplement can be detected by the MRI magnet and improved tumor detection and vessel delineation MR scans. We then fused the anatomical scans with the tumor scans.