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.

Continue reading

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.

Continue reading

FDA Approves Poteligeo® (mogamulizumab-kpkc) for T-Cell Lymphoma of the Skin

MedicalResearch.com Interview with:

Jeffrey S. Humphrey, MD President of Kyowa Kirin Pharmaceutical Development, Inc

Dr. Humphrey

Jeffrey S. Humphrey, MD
President of Kyowa Kirin Pharmaceutical Development, Inc

MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by Mycosis Fungoides and Sézary Syndrome?

Response: Kyowya Kirin has received FDA approval for Poteligeo (mogamulizumab), based on findings from the MAVORIC trial. Mogamulizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4), for the treatment of the most common subtypes of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) and Sézary syndrome (SS).

MF and SS may have a profound and severe impact on quality of life, including a patient’s functional, emotional and social well-being, as symptoms may include a scaly red rash or light or dark patches in areas of the body that are not usually exposed to the sun; thin, reddened, eczema-like rash; thickened scaly, red skin (or plaques) or psoriasis-like rash; more advanced disease can include tumors (with significant thickness) on the skin, which may develop ulcers and become infected. Because CTCL manifests in skin lesions, it is often mistaken for other skin conditions (early stage MF and SS can be diagnosed as other skin conditions), which can delay conclusive diagnosis and treatment options.

MF is the most common subtype of CTCL, affecting 50-70% of individuals. In most patients diagnosed with early stage MF, the skin involvement does not progress, but in some patients, it will slowly progress. SS accounts for approximately 3% of CTCL cases and is a more aggressive, leukemic form of CTCL, affecting the blood, skin, lymph nodes and visceral organs

Continue reading

Kidney Cancer: Biomarker Linked to Detection and Progression

MedicalResearch.com Interview with:

Dr. David Muller, PhD  Faculty of Medicine, School of Public Health Research Fellow in Epidemiology and Biostatistics Imperial College London

Dr. Muller

Dr. David C. Muller PhD
Faculty of Medicine, School of Public Health
Research Fellow in Epidemiology and Biostatistics
Imperial College, London

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

Response: Our colleagues in the U.S. have been working on KIM-1 for years, particularly in the context of chronic kidney disease. Recently they found that KIM-1 is also elevated at the time of diagnosis of kidney cancer.

We wanted to see if KIM-1 concentrations could predict the chances of a future diagnosis of kidney cancer. We found that KIM-1 was a strong predictor of being diagnosis with kidney cancer in the next 5 years. We also found that higher pre-diagnostic KIM-1 was associated with worse survival after diagnosis.  Continue reading

How Common is Overdiagnosis of Lung Cancer with Low Dose CT Screening?

MedicalResearch.com Interview with:
“CT Scan” by frankieleon is licensed under CC BY 2.0Dr. Bruno Heleno MD PhD

Assistant Professor | Professor Auxiliar
NOVA Medical School | Faculdade de Ciências Médicas
Universidade Nova da Lisboa 

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

Response: The Danish Lung Cancer Screening Trial (DLCST) is a randomized controlled trial which enrolled 4104 participants (aged 50-70 years; current or former smokers; ≥20 pack years; former smokers must have quit <10 years before enrollment) to either 5 rounds of screening for lung cancer with low-dose CT-scans or to no screening.

After 10 years of follow-up, there was a 2.10 percentage points lung cancer absolute risk increase with low-dose CT-screening. Overdiagnosis, i.e. the detection of cancer that would not progress to symptoms or death, was estimated at 67.2% of the screen-detected cancers.

Continue reading

Patients with CLL Should Be Monitored for Skin Cancer, Including Melanoma

MedicalResearch.com Interview with:

Clive S. Zent MD Professor of Medicine Director of Lymphoma/CLL Program Wilmot Cancer Institute University of Rochester Medical Center Rochester NY

Dr. Zent


Clive S. Zent MD

Professor of Medicine
Director of Lymphoma/CLL Program
Wilmot Cancer Institute
University of Rochester Medical Center
Rochester NY

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

Response: Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) have an increased risk of all skin cancers including malignant melanoma.

This study in a stable population of CLL patients managed by a regional referral center confirmed that melanoma was over 6 times more common in than in an age and sexed matched general population. Because of the proactive skin screening program at the University of Rochester Medical Center’s Wilmot Cancer Center, most melanomas (77%) were detected at earlier stages and were treated surgically with curative intent. One patient with CLL and metastatic melanoma had a sustained remission of both diseases on treatment with ibrutinib and pembrolizumab. Continue reading

DCIS is a Bona Fide Breast Cancer, Not a Cancer Precursor

MedicalResearch.com Interview with:

Steven Narod, MD, FRCPC, FRSC Senior Scientist, Women’s College Research Institute Director, Familial Breast Cancer Research Unit, Women's College Research Institute Professor, Dalla Lana School of Public Health, University of Toronto Professor, Department of Medicine Tier 1 Canada Research Chair in Breast Cancer University of Toronto

Dr. Narod

Steven Narod, MD, FRCPC, FRSC
Senior Scientist, Women’s College Research Institute
Director, Familial Breast Cancer Research Unit, Women’s College Research Institute
Professor, Dalla Lana School of Public Health, University of Toronto
Professor, Department of Medicine
Tier 1 Canada Research Chair in Breast Cancer
University of Toronto

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

Response: In the past we have shown that about 3 percent of women with ductal carcinoma in situ (DCIS) will die of breast cancer within 20  years of diagnosis.   In the current study, we took a very close look at how the different treatments impact on the risk of dying of breast cancer.

Women with DCIS are at risk for  both a new cancer within the breast and dying of breast cancer from cells that spread beyond the breast (lung, liver, brain and bone).   About 20% of DCIS patients will get a new breast cancer within the breast at 20 years.

  • We show here that it is not necessary to develop a new cancer within the breast to die of breast cancer,  in some cases the DCIS spreads directly in the absence of local recurrence.
  • We show that radiotherapy can prevent 25% of the deaths from breast cancer after DCIS. And this has nothing to do with local recurrence.
  • We show that mastectomy reduces the chance of a getting a new cancer (local recurrence) but  doesn’t reduce the chance of dying of breast cancer.

So, if the goal is to prevent new cancers in the breast –   then mastectomy is the best treatment

If the goal is to prevent the woman from dying of breast cancer – then radiotherapy is the best treatment.  Continue reading

Gastric Cancer: Gene Mutation Predictive of Response to Immunotherapy

MedicalResearch.com Interview with:

Wei Zhang, Ph.D. Hanes and Willis Family Professor in Cancer Director Cancer Genomics and Precision Oncology Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, NC  27157-1082

Prof. Zhang

Wei Zhang, Ph.D.
Hanes and Willis Family Professor in Cancer
Director
Cancer Genomics and Precision Oncology
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, NC  27157-1082

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

Response: Gastric cancer is a leading cause of cancer-related death worldwide. Infection by the Helicobacter pylori is the major cause of gastric cancer, which accounts for more than 60% of cases. Despite progress in helicobacter pylori eradication and early cancer diagnosis, the five-year survival rate of gastric cancer remains less than 30%. Gastric cancer is one of the most common cancer types in Asia but the incidence for gastric cancer has seen a steadily increase in the United States in recent years.

Immunotherapy treatment has shown remarkable benefit for some cancer patients whereas others experience toxicities. It is important to identify markers that help oncologists decide which patient would benefit from this promising new treatment strategy. It has been suggested that gastric cancer that is positive for Epstein-Barr Virus is likely more responsive to immunotherapy but only about 10% of gastric cancer patients belong to this category. More potential markers are urgently needed for clinical practice.

There is accumulating evidence that high tumor mutation load, which means there are high numbers of gene mutations in the tumor, can provide a signal to activate immune response systems thus rendering tumors more sensitive to immunotherapy.

Continue reading

HPV Status Influences Survival in Esophageal Cancer

MedicalResearch.com Interview with:

Barrett's Esophagus -wikipedia

Barrett’s Esophagus -wikipedia

Shan Rajendra MBBCh, MSc , MD, FRCP, FRACP
Professor of Medicine
University of New South Wales
Director of Medicine & Clinical Executive Director
Bankstown-Lidcombe Hospital
Director Gastro-Intestinal Viral Oncology Group
Ingham Institute for Applied Medical Research
Sydney 

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

Response: High-risk human papillomavirus(HPV)  infection has been strongly associated with a subset of Barrett’s dysplasia and oesophageal adenocarcinoma.

The research question was; Does HPV status of Barrett’s high-grade dysplasia and esophageal adenocarcinoma influence survival as in viral positive head and neck cancers?

We therefore sought to determine the prognostic significance of esophageal tumor HPV status and associated viral transcriptional markers (E6/E7 mRNA and p16INK4A) and TP53.

Continue reading

Type of Oral Contraceptive Can Influence Effect of Medications on EKG Change

MedicalResearch.com Interview with:

Joe-Elie SALEM, MD-PhD Chef de Clinique Assistant, Médecin délégué du Centre d'Investigation Clinique Paris-Est Institut CardioMétabolisme et Nutrition INSERM

Dr. Salem

Joe-Elie SALEM, MD-PhD
Chef de Clinique Assistant, Médecin délégué du Centre d’Investigation Clinique
Paris-Est
Institut CardioMétabolisme et Nutrition
INSERM

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

Response: The drug-induced long QT syndrome (diLQTS) is a problem for clinicians balancing risk and benefits across multiple therapeutic areas, and for pharmaceutical scientists and regulators evaluating new drug candidates. The prevalent view is that block of a specific ion current, the rapid component of the cardiac delayed rectifier (IKr), is the common mechanism predisposing to diLQTS across drug classes and that patients with mutations in ion channel genes are at especially increased risk. In the very extreme form of diLQTS, a specific form of ventricular arrhythmia potentially lethal, called Torsade de Pointes, can occur. All IKr blocking drugs do not confer the same Torsade de Pointes risk; the risk with antiarrhythmics such as sotalol or dofetilide can be 1-2%, while the risk with IKr-blocking antibiotics such as moxifloxacin is much lower, <1/20,000.

Women are at higher risk of diLQTS than men. Androgens are protective. Influence of hormonal contraception on diTdP and QT prolongation is controversial

MedicalResearch.com: Were you surprised by the study findings, why or why not? 

Response: We were not really surprised because the influence of testosterone (the main androgenic hormone) to shorten the duration of cardiac repolarization was already known. We wanted to see if this effect was also present with contraceptive pills with various androgenic-like activities.

MedicalResearch.com: Can you explain what exactly is “sotalol-induced QTc prolongation”? 

Response: After each heartbeat, the heart recovers to normal. This phenomenon is called ventricular repolarization and can be assessed on the electrocardiogram by measuring the duration of a parameter called QT interval. This QT interval is influenced by many factors one of them being heart rate. QT interval is therefore corrected for the heart rate observed at the time of its measurement (QTc). Sotalol is one of several drugs given to prolong ventricular repolarization, and hence QTc, as a mean to prevent the recurrence of some disturbances of heart beats. These disturbances are called arrhythmias. However, drugs which prolong QTc can also provoke a very rare arrhythmia which can cause cardiac arrest or the heart to stops. Only rare susceptible patients are at risk of having this drug-induced arrhythmia and most patients who receive sotalol and have prolonged QTc are doing well. 

MedicalResearch.com: What were the drug-induced alterations in “ventricular repolarization” seen among the women? 

Response: The alterations of ventricular repolarization were those expected with sotalol: prolongation of QTc interval and changes is the morphology of the T-wave which is part of the QT interval. What we found is that the extent of QTc prolongation and T-wave morphological changes caused by sotalol was greater in women who were receiving the anti-androgenic contraceptive pill drospirenone compared with levonorgestrel. This is in line with the known effect of androgens to shorten ventricular repolarization in men but it was not known to be influenced by the progestin androgenic activity of oral contraceptives in women. 

MedicalResearch.com: What new information does this study provide to the scientific literature on oral contraceptives? 

Response: We did not show that oral contraceptives influence ventricular repolarization. This was not the purpose of the study. Our study, with its limitations, suggests that the type of oral contraceptive can influence the effects of drugs such as sotalol which prolong QTc. Drospirenone, an oral contraceptive with antiandrogenic properties, was associated with greater drug-induced QTc prolongation than levonorgestrel, an oral contraceptive with androgenic activity. Whether this is associated with a greater risk of provoking arrhythmias with antiandrogenic pills is not proven although there are indirect indications from an analysis of the European pharmacovigilance database, that this might be the case. Additional studies need to be performed to better assess this risk.

MedicalResearch.com: What were some limitations of the study? 

Response: The type of oral contraceptive taken by women participating in the study was prescribed by their physician and women receiving different oral contraceptives may have differed in their response to sotalol for other reasons. In other words, oral contraceptives were not administered by chance to the women (the study was not randomized but observational) and this is not the most robust method to examine the influence drugs in general. Also, the level of the natural sex hormones in the blood of the study participants was not measured and it may have influenced QTc interval  

MedicalResearch.com: Why is this study important? 

Response: In spite of its limitations, our study prompts for a more thorough assessment of the influence of progestin androgenic activity of oral contraceptives on drug-induced QTc interval prolongation and the risk of associated arrhythmias. It also emphasizes the importance of androgens as a factor limiting the risk of QTc prolongation in patients receiving drugs which prolong ventricular repolarization.

Citation: 

Salem J, Dureau P, Bachelot A, et al. Association of Oral Contraceptives With Drug-Induced QT Interval Prolongation in Healthy Nonmenopausal Women. JAMA Cardiol. Published online August 01, 2018. doi:10.1001/jamacardio.2018.2251

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