Most Patients Who Carry BRCA1/2 Pathogenic Variants Are Unaware

MedicalResearch.com Interview with:

Michael F. Murray, MD, FACMG, FACP Director for Clinical Operations in the Center for Genomic Health Yale School of Medicine

Dr. Murray

Michael F. Murray, MD, FACMG, FACP
Director for Clinical Operations in the Center for Genomic Health
Yale School of Medicine

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

Response: Population screening for the cancer risk associated with the BRCA1 and BRCA2 genes has been suggested by some.  We screened a cohort of about 50,000 adult patient volunteers at Geisinger Health System in Pennsylvania for this risk.  Continue reading

High-Risk Gleason 5 Prostate Cancers Not Resistant to Androgen Deprivation Therapy

MedicalResearch.com Interview with:

Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles

Dr. Kishan

Amar U. Kishan, MD
Assistant Professor
Department of Radiation Oncology
University of California, Los Angeles

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

Response: Three large randomized trials demonstrated an overall survival (OS) benefit when androgen deprivation therapy (ADT) is combined with radiotherapy (RT) for high-risk prostate cancer (PCa). The duration of ADT in these seminal studies ranged from six months to lifelong. Because ADT has multiple attendant adverse effects–including bone loss, altered metabolism, diminished muscle mass, gynecomastia, hot flashes, and possibly increased cardiovascular events–shortening the duration of ADT without compromising oncologic effectiveness has been an area of active study. Five trials have compared various durations of ADT, reaching conflicting conclusions with respect to overall survival outcomes, with some suggesting an improvement with longer durations of ADT and others failing to show a uniform survival benefit.

Most of these trials have amalgamated Gleason grade group 4 (Gleason score 8) PCa with Gleason grade group (GG) 5 (Gleason score 9-10) PCa. Emerging data indicate that GS 9-10 PCa constitutes a distinct subset of high-risk PCa with inferior outcomes and earlier progression than GS 8 disease. With the knowledge that GS 9-10 PCas constitute a distinct, more aggressive form of PCa, one might hypothesize that longer durations of ADT may be more advantageous in both augmenting local control and controlling potential micrometastatic disease. Alternatively, as GS 9-10 lesions by definition contain highly de-differentiated Gleason pattern 5 disease foci and may proceed to a castrate-resistant state more rapidly, one may also hypothesize that GS 9-10 lesions are less responsive to ADT, and longer durations may be counter-productive.

In order to identify differences in the impact of ADT duration on clinical outcomes of patients with GG 4 and GG 5 PCa, we performed an individual patient-level meta-analysis of six randomized trials. Our working hypothesis was that longer durations of ADT would offer significant survival benefits in both groups.

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Medicare Spends Hundreds of Millions Annually to Treat Precancerous Skin Lesions

MedicalResearch.com Interview with:
“Actinic Keratosis” by Ed Uthman is licensed under CC BY 2.0Howa Yeung, MD
Assistant Professor of Dermatology
Emory University School of Medicine
Atlanta, GA 30322 

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by actinic keratoses?

Response: Actinic keratoses are common precancerous skin lesions caused by sun exposure. Because actinic keratoses may develop into skin cancers such as squamous cell carcinoma and basal cell carcinoma, they are often treated by various destructive methods. We used Medicare Part B billing claims to estimate the number and cost of treated actinic keratoses from 2007 to 2015.

MedicalResearch.com: What are the main findings? 

Response: While the number of Medicare Part B beneficiaries increased only moderately, the number of actinic keratoses treated by destruction rose from 29.7 million in 2007 to 35.6 million in 2015. Medicare paid an average annual amount of $413.1 million for actinic keratosis destruction from 2007 to 2015. Independently billing non-physician clinicians, including advanced practice registered nurses and physician assistants, are treating an increasing proportion of actinic keratosis, peaking at 13.5% in 2015.

MedicalResearch.com: What should readers take away from your report?

Response: Readers should understand that the burden of actinic keratosis treatment is increasing in the Medicare population. There is also an increasing proportion of actinic keratoses being treated by advanced practice registered nurses and physician assistants.  Continue reading

Factor in Quality of Life When Deciding Radiotherapy vs Surgery in Patients With Oropharyngeal Cancer

MedicalResearch.com Interview with:

Dr. David Sher MD MPH Radiation Oncology, Harold C. Simmons Comprehensive Cancer Center UTSouthwestern Medical Center Associate Senior Editor International Journal of Radiation Oncology

Dr. Sher

Dr. David Sher MD MPH
Radiation Oncology,
Harold C. Simmons Comprehensive Cancer Center
UTSouthwestern Medical Center
Associate Senior Editor International Journal of Radiation Oncology

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

Response: The prevalence of oropharyngeal cancer is rising rapidly, and the two primary therapeutic approaches – upfront radiation therapy or surgery resection – have both been improving in terms of acute and late toxicity profiles. There is significant debate as to which therapy is better, and comparative data are necessary to help physicians and patients decide which paradigm is preferred for a given clinical scenario. Although there is a lot of anecdotal experience in comparing the two treatments, there really is a lack of published data on the question, and this is where our study fits in. 

MedicalResearch.com: What is the background for this study? Were there significant quality-of-life differences between the two treatment modalities?

Response: The main findings were comparable outcomes in long-term survival, toxicity and even cost between primary radiation therapy and primary surgery. This equivalence highlights the importance of patient-centered decision-making and engaging patient preferences in their optimal treatment approach. There was clearly an increase in stomach tube use in patients receiving primary chemoradiotherapy, which may be an important consideration in some patients, depending on the expected functional outcome of initial surgery. This difference became non-significant after a short period of time, but it was real and may influence decision-making.

MedicalResearch.com: What should readers take away from your report?

Response: Readers should take away that there are no particularly large differences between these treatments. Survival, toxicity and cost are all comparable in the long-run. It was quite clear, though, that primary surgery was associated with a lower risk of gastrostomy tube use. Although the difference in tube use was negligible within a few months, the use of any feeding tube may be a deciding factor for some patients. We showed here this difference was due to concurrent chemotherapy during radiotherapy. This result echoes our clinical experience, but we were able to show this finding quite clearly. On the other hand, we also found that the increased dependence with radiation therapy was clearly short-lived, so patients should absolutely not consider this difference as a long-term problem preferentially associated with radiotherapy.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: It is critical for future research to consider the functional and quality-of-life outcomes in future comparisons of these different treatment approaches. Claims-based analyses such as this can uniquely show the “big picture” with respect to complications that require a medical treatment. However, more granular and subtle patient-reported outcomes are not included in this study, and they will be essential to help patients and physicians in the decision-making process.   

The study was funded by the Radiation Oncology Institute.

Citation:

Sher DJ, Agiro A, Zhou S, Day AT, DeVries A. Commercial Claims–Based Comparison of Survival and Toxic Effects of Definitive Radiotherapy vs Primary Surgery in Patients With Oropharyngeal Squamous Cell Carcinoma. JAMA Otolaryngol Head Neck Surg. Published online September 20, 2018. doi:10.1001/jamaoto.2018.1929

Sep 21, 2018 @ 3:05 pm 

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Access to Treatment for Head/Neck Cancer Patients Improved with Medicaid Expansion

MedicalResearch.com Interview with:

Richard B. Cannon, MD Division of Otolaryngology–Head and Neck Surgery School of Medicine University of Utah, Salt Lake City 

Dr. Cannon

Richard B. Cannon, MD
Division of Otolaryngology–Head and Neck Surgery
School of Medicine
University of Utah, Salt Lake City 

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

 Response: The Patient Protection and Affordable Care Act (ACA) is a nationwide effort to reduce the number of uninsured individuals in the United States and increase access to health care. This legislation is commonly debated and objective data is needed to evaluate its impact.  As a head and neck cancer surgeon, I sought to evaluate how the ACA had specifically influenced my patients.  Main findings below:    

MedicalResearch.com: What should readers take away from your report?

Response: This population-based study found an increase in the percentage of patients enrolled in Medicaid and private insurance and a large decrease in the rates of uninsured patients after implementation of the Patient Protection and Affordable Care Act (ACA).  This change was only seen in states that adopted the Medicaid expansion in 2014. The decrease in the rate of uninsured patients was significant, 6.2% before versus 3.0% after. Patients who were uninsured prior to the Patient Protection and Affordable Care Act had poorer survival outcomes.

Continue reading

Artificial Intelligence Can Reliably Diagnosis Specific Types of Lung Cancer

MedicalResearch.com Interview with:

Aristotelis Tsirigos, Ph.D. Associate Professor of Pathology Director, Applied Bioinformatics Laboratories New York University School of Medicine

Dr. Tsirigos

Aristotelis Tsirigos, Ph.D.
Associate Professor of Pathology
Director, Applied Bioinformatics Laboratories
New York University School of Medicine

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

Response: Pathologists routinely examine slides made from tumor samples to diagnose cancer types. We studied whether an AI algorithm can achieve the same task with high accuracy. Indeed, we show that such an algorithm can achieve an accuracy of ~97%, slightly better than individual pathologists.

In addition, we demonstrated that AI can be used to predict genes that are mutated in these tumors, a task that pathologists cannot do. Although the accuracy for some genes is as high as 86%, there is still room for improvement. This will come from collecting more training data and also from improvement in the annotations of the slides by expert pathologists.  

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Patients Most Often Receive Breast Cancer Diagnosis By Phone

MedicalResearch.com Interview with:

Dr. Emily Albright, MD Surgical Oncology Missouri University Health Care

Dr. Albright

Dr. Emily Albright, MD
Surgical Oncology
Missouri University Health Care

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

Response: Traditional medicine had a paternalistic approach but more recent changes have transitioned into shared decision making and a patient centered approach. However, current research has not addressed the mode of communicating bad news to patients.

This study was designed to look at trends in modes of communication of a breast cancer diagnosis. This study identified a trend for patients to receive a diagnosis of breast cancer over the telephone in more recent years. Also noted was that of those receiving the diagnosis in person 40% were alone.

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Clothing Patterns of Boys Compared to Girls May Explain Differences in Patterns of Mole Development

MedicalResearch.com Interview with:

Lori A. Crane, PhD Department of Community and Behavioral Health Colorado School of Public Health University of Colorado Anschutz Medical Campus, Aurora CO

Dr. Crane

Lori A. Crane, PhD
Department of Community and Behavioral Health
Colorado School of Public Health
University of Colorado Anschutz Medical Campus,
Aurora CO 

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

Response: Nevi, which are commonly called “moles”, are brown or black spots on the skin that are usually raised.  Moles are the number one risk factor for malignant melanoma, the most dangerous kind of skin cancer.  About 9,000 people die of melanoma each year in the U.S. The more moles a person has, the higher their risk for melanoma.  Sun exposure is a major factor in the development of moles, and in order to prevent melanoma, it is important to better understand how moles are formed on the skin.

Most moles are formed during childhood and adolescence.  We studied non-Hispanic and Hispanic white children age 3-16 and found that non-Hispanic children developed many more moles than Hispanic children.  Overall, boys developed more moles than girls, but there were some important differences.  For parts of the skin that are often covered by clothing but sometimes exposed to the sun, such as the chest and back, upper arms and upper legs, girls developed more moles than boys, especially among Hispanic children.  In contrast, for parts of the skin that are usually exposed to the sun, such as the face, boys developed many more moles than girls.  The development of moles leveled off by age 16 for parts of the skin usually exposed to the sun, while for the less often exposed skin, children continued to develop moles to age 16.

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Disease-Free and Overall Survival Among Patients With Operable HER2-Positive Breast Cancer Treated With Sequential vs Concurrent Chemotherapy

MedicalResearch.com Interview with:

Kelly K. Hunt, MD Department of Breast Surgical Oncology The University of Texas MD Anderson Cancer Center Houston

Dr. Hunt

Kelly K. Hunt, MD
Department of Breast Surgical Oncology
The University of Texas MD Anderson Cancer Center
Houston

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

Response: We completed a neoadjuvant trial at MD Anderson Cancer Center and published the results in 2005 demonstrating that trastuzumab delivered in combination with anthracycline and taxane based chemotherapy resulted in pathologic complete response rates of up to 60% in patients with HER-2 positive breast cancer. This was a single institutions study and there was concern about cardiac toxicity when using anthracyclines and trastuzumab concurrently.

We therefore worked with the NCI cooperative groups, the American College of surgeons oncology group (ACOSOG), to design the ACOSOG Z1041 trial. This trial compared to different regimens in the neoadjuvant setting, one regimen utilizing concurrent anthracycline and taxanes based chemotherapy with trastuzumab and the other regimen utilizing concurrent taxanes with trastuzumab but the anthracycline was delivered in a sequential fashion.

The primary end point of the trial was pathologic complete response rates in the breast.

The results from this primary end point were published in the Lancet Oncology in 2013 and showed that the pathologic complete response rates were the same with the 2 different regimens. This was important since patients could be assured of similar efficacy without the potential added toxicity of delivering anthracyclines and trastuzumab together.

The current publication is a report of the disease-free and overall survival rates from the Z1041 trial. Several studies have shown an association between pathologic complete response rates and survival. The current study shows that there is no difference in survival rates between the 2 different regimens. So once again there is an association between pathologic complete response and survival and it is not important that the anthracycline and trastuzumab are given concurrently in order to achieve these high pathologic complete response rates and improve survival rates. Continue reading

H. pylori Link to Stomach Cancer Strengthened

MedicalResearch.com Interview with:

Nina R. Salama. PhD Member Human Biology Division Member Public Health Sciences Division Affiliate Member Basic Sciences Division Dr. Penny E. Petersen Memorial Chair for Lymphoma Research  Director of Molecular and Cellular Biology (MCB) Graduate Program Fred Hutchinson Cancer Research Center

Dr. Salama

Nina R. Salama. PhD
Member Human Biology Division
Member Public Health Sciences Division
Affiliate Member Basic Sciences Division
Dr. Penny E. Petersen Memorial Chair for Lymphoma Research
Director of Molecular and Cellular Biology (MCB) Graduate Program
Fred Hutchinson Cancer Research Center 

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

Response: We wanted to better understand why certain patients infected with H. pylori developed stomach cancer and how we could better identify them. H. pylori is one of the strongest risk factors for stomach cancer, but how much it predisposes individuals to gastric cancer varies around the world.

Working closely with colleagues from Zhengzhou University, we ran tests on 49 samples from China and found that 91 percent of patients infected with the EPIYA D gene variant of H. pylori also had stomach cancer. Continue reading

Fatal Toxicities Rare With Checkpoint Inhibitors

MedicalResearch.com Interview with:

Douglas B. Johnson, M.D. Assistant Professor of Medicine Clinical Director, Melanoma Research Program Melanoma, clinical and translational studies Vanderbilt University Medical Center

Dr. Johnson

Douglas B. Johnson, M.D.
Assistant Professor of Medicine
Clinical Director, Melanoma Research Program
Melanoma, clinical and translational studies
Vanderbilt University Medical Center

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

Response: Immune checkpoint inhibitors produce long-lasting responses in patients with many different types of cancer. However, they may cause serious autoimmune-like side effects that may affect any organ. We used several large databases to determine how often these side effects were fatal, when they occurred, and which types of side effects were responsible.

We found that overall, fatal side effects were uncommon, ranging from 0.3 – 1.3%. However, they tended to occur early on treatment (on average within the first 6 weeks), and affected a variety of organs, including the heart, lungs, colon, liver, and brain. There was a dramatic increase in reporting of fatal toxicities since 2017, likely reflecting the increased use of immune checkpoint inhibitors.  Continue reading

IMPRES Score Predicts Melanoma Response to Immunotherapy

MedicalResearch.com Interview with:

Melanoma CDC/ Carl Washington, M.D., Emory Univ. School of Medicine; Mona Saraiya, MD, MPH

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM).  Reminder: Melanoma can take many forms. Not all look like this. Have your skin examined for skin cancer.

Dr. Noam Auslander PhD
National Cancer institute and the Center for Bioinformatics and Computational Biology University of Maryland, College Park

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

Response: Immunotherapy – specifically immune checkpoint blockage (ICB) therapy – has been shown to be very effective in treating melanoma. However, only some patients with advanced tumors currently benefit from ICB therapies, while others are completely resistant and hence can be spared from the associated side effects and costs. Hence, predicting which patients are most likely to respond is an important challenge that can have great clinical benefits.   Continue reading

Humanized Antibody To Attack Resistant Multiple Myeloma Cells in Bone Marrow

MedicalResearch.com Interview with:

Hans van Eenennaam, Ph.D. Executive vice president antibody research and site head Aduro Biotech Europe

Dr. van Eenennaam

Hans van Eenennaam, Ph.D.
Executive vice president antibody research and site head
Aduro Biotech Europe

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

Response: A PRoliferation Inducing Ligand (APRIL) is a member of the tumor necrosis factor superfamily and has been shown to stimulate the proliferation and survival of healthy B-lymphocytes. Malignant B-lymphocytes, such as multiple myeloma, use APRIL primarily in the bone marrow to support its proliferation and survival. Studies have shown that APRIL is overproduced in patients with multiple myeloma and mediates primarily via binding to B-cell maturation antigen (BCMA) to stimulate a wide variety of responses that promote multiple myeloma growth and survival, as well as suppressing the immune system so that the tumor cells are protected and sustained in the bone marrow and can escape current available treatments.

Continue reading

Can the HPV Vaccine Be Used To Treat Some Skin Cancers?

MedicalResearch.com Interview with:

Jeffrey Rapaport

Dr. Rapaport

Dr. Jeffrey Rapaport MD, PA
Emeritus head of Dermatology
Teaneck’s Holy Name Hospital.

Dr. Rapaport discusess a case recently reported in JAMA: In 2016:

A 97-year-old female patient was suffering from multiple squamous cell carcinomas varying from small to incredibly large in size on both of her legs. She was injected with the HPV vaccine commonly known as Gardasil, which is also used to treat warts and oral papilloma. She was first injected in her arm, and then after a period of six weeks, the vaccine was directly injected into her tumors. It was observed that this treatment eventually killed off almost all the tumors on her legs. According to recent press coverage, she is now looking forward to celebrating her 100th birthday in fall 2018.

MedicalResearch.com: What is the background for this study?Is HPV thought be a trigger for some cutaneous squamous cell carcinomas?

Response: The link between skin cancers and HPV vaccinations has normally been investigated in patients who have received organ transplants. Due to the immune-suppressant drugs these patients must take, it is incredibly common to find cases of skin cancer in patients who have undergone transplants. The relaxed immune system, which would normally eliminate cancers caused by the HPV virus, would open the floodgates for multiple skin tumors to emerge. In this case of the 97 year old, I would assume her immune system was healthy. There is, however, growing evidence that receiving multiple vaccines for the HPV virus is necessary even in patients with healthy immune systems. So, regardless of immune health, I believe we need to expand the frequency of the HPV vaccine, even beyond the current three-tiered system for women below 26 and men below 21.

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Serial Liquid Biopsies May Predict Response to Colon Cancer Tretment

MedicalResearch.com Interview with:

Andrea Sottoriva, PhD, MSc Reader in Cancer Evolutionary Dynamics | Evolutionary Genomics & Modelling Lab Centre for Evolution and Cancer | The Institute of Cancer Research London

Dr. Sottoriva

Dr. Andrea Sottoriva, PhD
Centre for Evolution and Cancer, The Institute of Cancer Research, London, United Kingdom


MedicalResearch.com: What is the background for this study?
Would you briefly explain what is meant by a liquid biopsy?


Response:
Cetuximab is a targeted treatment available for metastatic colorectal cancer patients. Unfortunately, although many patients benefit from Cetuximab, after an initial response to the treatment many patients relapse and become resistant to the drug.

We know that this resistance is due to the tumour evolving and adapting to therapy. Liquid biopsies allow to look for residual cancer DNA in the blood of a patient and hence monitor the emergence of resistance over time. We used blood samples take every 4 weeks (quite frequently for this type of study) to monitor the evolution of the cancers under treatment and see if there were some measurements that would predict if and when patients will relapse.

Continue reading

Genetics of Aggressive Skin Cancers in Patients with ‘Butterfly’ Skin Identified

MedicalResearch.com Interview with:

Dr Andrew South, PhD, Associate Professor in the department of Dermatology and Cutaneous Biology at Jefferson (Philadelphia University + Thomas Jefferson University) 

Dr. South

Dr Andrew South, PhD,
Associate Professor in the department of Dermatology and Cutaneous Biology at Jefferson (Philadelphia University + Thomas Jefferson University) 

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Butterfly Syndrome or recessive dystrophic epidermolysis bullosa?

Response: Epidermolysis Bullosa, or EB, is a group of genetic diseases caused by mutations in genes which play a role in maintaining skin integrity. An EB patients’ skin can be very fragile which has been likened to butterfly wings, which are also very fragile. Skin blisters are common in EB patients and in some cases large wounds can result from the slightest mechanical trauma, hence the term Butterfly Syndrome.

Skin cancer is a major complication of patients with the recessive dystrophic subtype of EB, known as recessive dystrophic epidermolysis bullosa or RDEB, and these cancers, called squamous cell carcinoma (SCC), are very aggressive. SCC is the leading cause of death in patients with RDEB. SCC also arise very early, affecting RDEB patients in their 20’s and 30’s. Our study used genetic analysis of cancers collected from patients to try and determine what causes the cancer at such an early age and what causes these cancers to be so fatal. Skin SCC arising in the general population as a result of sun exposure are generally benign and occur much later in life, regular skin SCC patients are predominantly over the age of 60, therefore something must be different about RDEB SCC.  Continue reading

Oncologist-Authors Often Do Not Fully Disclose Financial Relationships with Pharmaceutical Companies

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Cole Wayant Oklahoma State University Center for Health Sciences ‐ Analytical and Institutional Research Tulsa, OK MedicalResearch.com: What is the background for this study? What are the main findings? Response: New FDA-approved oncology drugs are essential to oncology practice. These drugs may immediately change clinical care by offering better treatments for common, lethal forms of cancer. But, new FDA-approved oncology drugs are expensive and have been shown to have variable efficacy. Given the importance of new FDA-approved oncology drugs to patients and physicians, the trials that underpin the FDA-approval of these drugs must be free from bias and transparent. Therefore, we investigated the financial relationships between oncologist-authors of clinical trials that underpin FDA-approvals. MedicalResearch.com: What should readers take away from your report? Response: The key takeaway from our study is that oncologist-authors often do not fully disclose their financial relationships with pharmaceutical companies. Financial disclosures are important for the reasons of transparency and trust between physicians and other stakeholders, such as patients. Disclosing conflicts of interest helps readers interpret the findings of a research study, especially given the fact that drug companies finance their own drug trials. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: In the future, beyond recommending that authors fully disclose all financial relationships with the sponsor of the trial, I recommend that journals use the Open Payments Database to verify the accuracy and completeness of author disclosure statements. Doing so is a small first step toward mitigating the potential for financial bias in the oncology literature.” Disclosures: I do not have anything else to add. None of the authors have conflicts of interest - financial or otherwise. Citation: Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials  <span class="last-modified-timestamp">Aug 30, 2018 @ 5:06 pm</span> The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Cole Wayant

Cole Wayant BS
Oklahoma State University Center for Health Sciences ‐ Analytical and Institutional Research
Tulsa, OK

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

Response: New FDA-approved oncology drugs are essential to oncology practice. These drugs may immediately change clinical care by offering better treatments for common, lethal forms of cancer.

But, new FDA-approved oncology drugs are expensive and have been shown to have variable efficacy. Given the importance of new FDA-approved oncology drugs to patients and physicians, the trials that underpin the FDA-approval of these drugs must be free from bias and transparent. Therefore, we investigated the financial relationships between oncologist-authors of clinical trials that underpin FDA-approvals. 

MedicalResearch.com: What should readers take away from your report?

Response: The key takeaway from our study is that oncologist-authors often do not fully disclose their financial relationships with pharmaceutical companies. Financial disclosures are important for the reasons of transparency and trust between physicians and other stakeholders, such as patients. Disclosing conflicts of interest helps readers interpret the findings of a research study, especially given the fact that drug companies finance their own drug trials.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: In the future, beyond recommending that authors fully disclose all financial relationships with the sponsor of the trial, I recommend that journals use the Open Payments Database to verify the accuracy and completeness of author disclosure statements. Doing so is a small first step toward mitigating the potential for financial bias in the oncology literature.” 

Disclosures: I do not have anything else to add. None of the authors have conflicts of interest – financial or otherwise.

Citation:

Wayant C, Turner E, Meyer C, Sinnett P, Vassar M. Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials. JAMA Oncol. Published online August 30, 2018. doi:10.1001/jamaoncol.2018.3738

Aug 30, 2018 @ 5:06 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Cervical Cancer: Women Should Discuss PAP Smear, HPV Testing or Both With Their Health Care Provider

MedicalResearch.com Interview with:

Dr. Carol Mangione. M.D., M.S.P.H., F.A.C.P. Division Chief of General Internal Medicine and Health Services Research Professor of Medicine Barbara A. Levey, MD, and Gerald S. Levey, MD, endowed chair in Medicine David Geffen School of Medicine University of California, Los Angeles (UCLA) professor of public health at the UCLA Fielding School of Public Health.

Dr. Mangione

Dr. Carol Mangione, M.D., M.S.P.H., F.A.C.P.
Division Chief of General Internal Medicine and Health Services Research
Professor of Medicine
Barbara A. Levey, MD, and Gerald S. Levey, MD, endowed chair in Medicine David Geffen School of Medicine University of California, Los Angeles (UCLA)
professor of public health at the UCLA Fielding School of Public Health.

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

Response: Screening for cervical cancer saves lives by identifying cervical cancer early when it is treatable. Most cases of cervical cancer occur in women who have not been regularly screened or treated, which is why it’s important for women to get screened regularly throughout their lifetime with one of several effective options.

Women ages 21 to 29 should get a Pap test every three years.

Women ages 30-65 can choose between three approaches, depending on their preferences: a Pap test every three years, an HPV test every five years, or a combination of a Pap test and an HPV test every five years. There are some women who don’t need to be screened for cervical cancer including women younger than 21, women older than 65 who have been adequately screened in the past and are not at high risk, and women who have had a hysterectomy.  Continue reading

Routine Mammography Screening Recommendations Do Not Apply To Women With History of Breast Cancer

MedicalResearch.com Interview with:

Lisa A Newman, MD Director of the Breast Oncology Program for the multi-hospital  Henry Ford  Health System

Dr. Newman

Lisa A Newman, MD
Director of the Breast Oncology Program for the multi-hospital
Henry Ford  Health System

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

Response: In 2009 the United States Preventive Services Task Force published a guideline recommending that American women at average risk for breast cancer defer undergoing screening mammography until they reach the age of 50 years. Prior to this publication, women were widely-encouraged to initiate annual mammography at age 40 years. Women that have a history of breast cancer are automatically considered to be at increased risk for developing a new breast cancer, and so routine screening mammography guidelines do not apply to them. These women require annual mammography regardless of age, unless they have undergone a bilateral mastectomy.

We utilized data from Michigan Blue Cross/Blue Shield to evaluate patterns of mammography utilization among women age 40-49 years, comparing rates before versus after 2009, when the USPSTF guideline was published. We analyzed women that had a prior history of breast cancer separately from those that had no history of breast cancer, and we excluded women that underwent bilateral mastectomy.

Disturbingly, we found that mammography utilization rates declined among women with a history of breast cancer as well as among those with no history of breast cancer in the post-2009 timeline.

This suggested to us that changes in screening recommendations may have had the unintended consequence of generating confusion and misunderstandings regarding the value of mammography among women that undeniably benefit from this imaging, such as those with a history of breast cancer.  Continue reading

Heavy Alcohol Use Early in Life Linked to Aggressive Prostate Cancer

MedicalResearch.com Interview with:

Emma H. Allott, PhD Research Assistant Professor of Nutrition UNC GILLINGS SCHOOL OF GLOBAL PUBLIC HEALTH  University of North Carolina, Chapel Hill 

Dr. Emma Allott

Emma H. Allott, PhD
Research Assistant Professor of Nutrition
UNC GILLINGS SCHOOL OF GLOBAL PUBLIC HEALTH
University of North Carolina, Chapel Hill 

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

Response: Prostate cancer development may span decades. In addition, the prostate grows rapidly during puberty and therefore may be particularly susceptible to dietary or lifestyle factors during this time.

Our study found that heavier alcohol intake earlier in life, as well as higher cumulative alcohol intake across the lifespan, was associated with an increased odds of being diagnosed with an aggressive (clinically significant) prostate cancer in later life. However, current alcohol intake at the time of prostate cancer diagnosis was unrelated to tumor aggressiveness.

Continue reading

Liquid Biopsy Using Circulating Tumor DNA Can Predict Treatment Response in Large B-Cell Lymphoma

MedicalResearch.com Interview with:
Dr. David Kurtz, MD/PhD, Instructor and
Dr. Ash Alizadeh MD/PhD, Associate Professor
Division of Oncology, Department of Medicine
Stanford University Medical Center 

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

Response: This work investigates the utility of circulating tumor DNA – a type of liquid biopsy – in diffuse large B-cell lymphoma, the most common blood cancer in adults.

Liquid biopsies are an emerging technology to track cancers from a simple blood draw. Here, using a cohort of over 200 patients from 6 centers across North America and Europe, we asked if circulating tumor DNA could be used to detect lymphoma in patients, and more importantly, could it be used to identify responders and non-responders.  Continue reading

Continued Aggressive Treatment Indicated For Younger Women with Breast Cancer Who Have Incomplete Response to Chemo

MedicalResearch.com Interview with:

Kathleen Horst, MD Associate Professor of Radiation Oncology (Radiation Therapy)  Stanford University Medical Center

Dr. Kathleen Horst

Kathleen Horst, MD
Associate Professor of Radiation Oncology (Radiation Therapy)
Stanford University Medical Center

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

Response: We were interested in focusing on young women with breast cancer as this is a high-risk patient population that is not studied on its own in clinical trials. Furthermore, the available data on treating breast cancer with neoadjuvant chemotherapy (NAC) does not include detailed outcomes for women under the age of 40 years.

Because most women who are diagnosed with breast cancer in this age group will have aggressive disease, most of them will be treated with NAC followed by surgery. From prospective randomized trials we know that women with breast cancer who attain a pathologic complete response (PCR) to neoadjuvant chemotherapy fare significantly better than those who do not. In addition, existing data suggest that a complete response in the lymph nodes also portends a better prognosis. This is the foundation for the currently ongoing NSABP B-51/RTOG 1304 trial, which is evaluating the role of nodal irradiation in those women who attain a pathologic complete response in the lymph nodes after NAC. We wanted to know whether differences in pathologic response in the breast versus lymph nodes led to different clinical outcomes in this patient group.

We evaluated outcomes following neoadjuvant chemotherapy for breast cancer in 155 women age 40 and younger. We focused on pathologic response in the breast and lymph nodes as predictors of disease recurrence and survival. We found that any residual disease in either the breast or lymph nodes lessened the chance of cure significantly.

Importantly, women who attained a complete response in the lymph nodes but continued to have residual disease in the breast fared just as poorly as those who remained lymph node positive following neoadjuvant chemotherapy.  Continue reading

Low Risk Prostate Cancer Imaging More Common Outside of VA Hospitals

MedicalResearch.com Interview with:

Danil V. Makarov, MD, MHS Department of Urology and Department of Population Health New York University Langone School of Medicine VA New York Harbor Healthcare System, Robert F. Wagner Graduate School of Public Service Cancer Institute, New York University School of Medicine, New York

Dr. Makarov

Danil V. Makarov, MD, MHS
Department of Urology and
Department of Population Health
New York University Langone School of Medicine
VA New York Harbor Healthcare System,
Robert F. Wagner Graduate School of Public Service
Cancer Institute, New York University School of Medicine, New York

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

Response: Reducing prostate cancer staging imaging for men with low-risk disease is an important national priority to improve widespread guideline-concordant practice, as determined by the National Comprehensive Cancer Network guidelines. It appears that prostate cancer imaging rates vary by several factors, including health care setting. Within Veterans Health Administration (VHA), physicians receive no financial incentive to provide more services. Outside VHA, the fee-for-service model used in Medicare may encourage provision of more healthcare services due to direct physician reimbursement.

In our study, we compared these health systems by investigating the association between prostate cancer imaging rates and a VA vs fee-for-service health care setting. We used novel methods to directly compare Veterans, Medicare Recipients, and Veterans that chose to receive care from both the VA at private facilities using Medicare insurance through the Choice Act with regard to rates of guideline-discordant imaging for prostate cancer.

We found that Medicare beneficiaries were significantly more likely to receive guideline-discordant prostate cancer imaging than men treated only in VA.

Moreover, we found that men with low-risk prostate cancer patients in the VA-only group had the lowest likelihood of guideline-discordant imaging, those in the VA and Medicare group had the next highest likelihood of guideline-discordant imaging (in the middle), and those in the Medicare-only group had the highest likelihood of guideline-discordant imaging.  Continue reading

Breast and Ovarian Cancers: More Genes Than BRCA1 and BRCA2

MedicalResearch.com Interview with:
Ambry GeneticsShuwei Li, PhD
Principal Statistical Geneticist
Ambry Genetics

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

Response: Breast cancer is the most commonly diagnosed cancer, while ovarian cancer is the fifth leading cause of death due to cancer, in US women. Since the discovery of BRCA1 and BRCA2, multiple genes have been reported as risk factors; however, it is still unclear whether the known findings represent the complete genetic landscape of breast and ovarian cancers.

Our team performed exome sequencing on more than 10,000 breast and/or ovarian cancer patients and nearly 4,000 controls. We observed increased risk of breast cancer associated with PALB2, ATM, CHEK2 and MSH6 genes, and increased risk of ovarian cancer associated with MSH6, RAD51C, TP53 and ATM genes.   Continue reading

Complex Racial and Ethnic Disparities in Childhood Cancer Survival

MedicalResearch.com Interview with:
Rebecca D. Kehm, PhD
Division of Epidemiology and Community Health
University of Minnesota School of Public Health
Minneapolis, MN  

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

Response: Racial and ethnic differences in childhood cancer survival have long been known, and there has been some research indicating that SES could explain disparities. However, our study is the first to use statistical methods that put numbers to the relative contribution of SES to survival disparities for different types of childhood cancer. We set out to investigate whether racial and ethnic disparities in childhood cancer survival are attributed to underlying differences in socioeconomic status, defined as one’s social and economic position in relation to others based on income, education, and occupation, which scientists abbreviate as SES. Our findings provide evidence that SES does in fact contribute to racial and ethnic disparities in survival for some types of childhood cancer. Specifically, we found that SES accounted for 28-73% of the racial and ethnic survival disparity for acute lymphoblastic leukemia, acute myeloid leukemia, neuroblastoma, and non-Hodgkin lymphoma. However, SES did not significantly contribute to racial and ethnic disparities in survival for other types of childhood cancer including central nervous system tumors, soft tissue sarcomas, Hodgkin lymphoma, Wilms tumor, and germ cell tumors. These tumor-specific results help inform where to place resources to best reduce racial and ethnic survival disparities for each of the major types of childhood cancer.

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