Category Archives: Cancer Research

Voice Changes Common After Thyroid Cancer Surgery

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MedicalResearch.com Interview with:

Megan Rist Haymart MD Associate Professor Metabolism, Endocrinology and Diabetes Clinic Michigan Medicine

Dr. Haymart

Megan Rist Haymart MD
Associate Professor
Metabolism, Endocrinology and Diabetes Clinic
Michigan Medicine

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

Response: Thyroid cancer is a common malignancy with surgery considered one of the primary treatments. Complications from thyroid surgery can lead to long-term voice problems. However, few studies have used validated scales to quantify the impact of thyroid surgery on patient voice. Prior work has largely focused on single institution studies with high volume surgeons or claims data with reports of specific nerve injury.

We surveyed a diverse cohort of patients affiliated with SEER sites Georgia and Los Angeles to identify the prevalence, severity and correlates of poor voice outcomes following surgery for differentiated thyroid cancer.

We found that out of 2,325 patients 25.8% reported voice changes lasting greater than 3 months after surgery, 12.7% had abnormal voice per a validated voice scale (Voice Handicap Index- 10), and 4.7% reported a diagnosis of vocal fold motion impairment. We also identified patient factors associated with abnormal voice 2-4 years post op.

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Prostate Cancer: Effects of Hormone Therapy on Cognitive Function Addressed in Large Study

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MedicalResearch.com Interview with:

Ravi Jayadevappa, PhD, MS Department of Medicine Perelman School of Medicine University of Pennsylvania Philadelphia, PA 19104-2676 

Dr. Jayadevappa

Ravi Jayadevappa, PhD, MS
Department of Medicine
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA 19104-2676 

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

Response: In the US, prostate cancer is the most commonly diagnosed non-skin cancer and the second leading cause of cancer death among men. Research shows that hormone therapy or ADT reduces the levels of male hormones in the body, called androgens, to stop them from stimulating cancer cells to grow., and thus is effective in reducing the spread and progression of prostate cancer.

At the same time, some research has suggested that decreasing androgen levels may increase the risk factors for Alzheimer’s and dementia, including loss of lean body mass, diabetes, cardiovascular disease, and depression. The ADT therapy may lead to impaired neuron growth and the regeneration of axons, thus affecting the cognitive function. Thus there is growing interest in the possible association between exposure to ADT and cognitive dysfunction.

Our study investigates the association between exposure to ADT and subsequent diagnosis of Alzheimer’s or dementia in elderly, fee-for-service Medicare enrollees using SEER-Medicare linked databases.

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Surgical Safety Variations With Affiliation to a Top-Ranked Cancer Hospital

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MedicalResearch.com Interview with:

Daniel Boffa, MD Professor of Surgery Yale School of Medicine

Dr. Boffa

Daniel Boffa, MD
Professor of Surgery
Yale School of Medicine 

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

Response: We have previously demonstrated that top-ranked hospitals are significantly safer than their affiliates for complex cancer surgery (patients 1.4 times more likely to die after cancer surgery at affiliate hospitals).  A logical extension of this work was to compare affiliate hospitals to hospitals that were not affiliated with a top ranked hospital.
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US Cancer Deaths Cost Society Billions in Lost Earnings

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MedicalResearch.com Interview with:

Farhad Islami, MD PhD Scientific Director, Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303

Dr. Islami

Farhad Islami, MD PhD
Scientific Director, Surveillance Research
American Cancer Society, Inc

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

Response: In the United States, cancer is the second leading cause of death, and premature cancer deaths impose significant economic burden. Contemporary information on the economic burden of cancer mortality can inform policies and help prioritize resources for cancer prevention and control, but this information is lacking.

In our study, we provide contemporary estimates for the loss of future earnings (lost earnings) due to cancer death at national and state levels for all cancers combined and for major cancers.

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Atomwise Launches AI-Powered Virtual Drug Screening Program for Pediatric Cancers

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MedicalResearch.com Interview with:
atomwiseAbraham Heifets, PhD
Department of Computer Science
University of Toronto 

MedicalResearch.com: What is the background for this announcement? How many children and adolescents are affected by pediatric cancer?

Response: Cancer is diagnosed in more than 15,000 children and adolescents each year. Many cancers, including pediatric cancer, do not have effective treatments and for those that do, it is estimated that 80% have serious adverse effects that impact long-term health. 

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Risk Prediction Nodule Helps Determine Cancer Risk of Pulmonary Nodule Found on CT Scan

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MedicalResearch.com Interview with:

Barbara Nemesure, PhD  Professor, Department of Family, Population and Preventive Medicine Division Head, Epidemiology and Biostatistics Director, Cancer Prevention and Control Program Director, Lung Cancer Program, Stony Brook Cancer Center Renaissance School of Medicine Stony Brook University  

Dr. Nemesure

Barbara Nemesure, PhD
Professor, Department of Family, Population and Preventive Medicine
Division Head, Epidemiology and Biostatistics
Director, Cancer Prevention and Control Program
Director, Lung Cancer Program, Stony Brook Cancer Center
Renaissance School of Medicine
Stony Brook University   

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

Response: Lung cancer is the most common cause of cancer death, claiming the lives of more than 150,000 people in the United States each year. While lung nodules are not uncommon, it has remained a challenge to differentiate those that will progress to cancer and those that will remain benign. Although numerous risk prediction models for lung cancer have been developed over the past 2 decades, the majority have been based on retrospective analyses or high risk groups with a strong history of tobacco use. To date, there have been a limited number of large-scale, prospective studies evaluating risk that a nodule will convert to cancer in the general population.

This investigation aimed to construct a population-based risk prediction model of incident lung cancer for patients found to have a lung nodule on initial CT scan. The derived model was determined to have high accuracy for predicting nodule progression to cancer and identified a combination of clinical and radiologic predictors including age, smoking history (pack-years), a personal history of cancer, the presence of chronic obstructive pulmonary disease (COPD), and nodule features such as size, presence of spiculation and ground glass opacity type.

When compared to patients in the low risk category, those defined as high risk had more than 14 times the risk of developing lung cancer. Quantification of reliable risk scores has high clinical utility, enabling physicians to better stratify treatment plans for their patients.      Continue reading →

Do Decision Aids Make a Difference in Prostate Cancer Screening?

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MedicalResearch.com Interview with:

Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland

Dr. Tikkinen

Kari Tikkinen, MD, PhD, Adjunct Professor
Departments of Urology and Public Health
University of Helsinki and Helsinki University Hospital
Helsinki, Finland

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

Response: Men’s choice of whether to undergo screening is value and preference sensitive: fully informed men will make different choices depending on their experience and perspective. For such decisions, shared decision-making represents an ideal approach to decision making. In shared decision-making both the patient and health care provider contribute to the medical decision-making process. The health care provider explains alternatives to patients, informs them of the best evidence regarding the anticipated consequences of a decision for or against the intervention, and helps them choose the option that best aligns with their preferences. All major guidelines of prostate cancer screening acknowledge the importance of informing men about risks and benefits of PSA screening.

Shared decision-making is challenging because it requires time, knowledge, and specific skills. Prostate cancer screening decisions aids may, by summarizing the current best evidence and by supporting conversations that address what matters most to men, address these challenges. The impact of decision aids on the decision-making process is, however, uncertain. We therefore undertook a systematic review and meta-analysis of the randomized trials that have addressed the impact of decision aids in the context of prostate cancer screening.  Continue reading →

COLVERA™ Blood Test Provides Improved Effectiveness Detecting Recurrence of Colorectal Cancer

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MedicalResearch.com Interview with:

Lawrence LaPointe, Ph.D. Chief Innovation Officer Clinical Genomics Bridgewater, New Jersey 

Dr. LaPointe

Lawrence LaPointe, Ph.D.
Chief Innovation Officer
Clinical Genomics
Bridgewater, New Jersey 

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

Response: Colorectal cancer is a cancer of the colon and the rectum. The American Cancer Society estimates that about 1 in 21 men and 1 in 23 women in the United States will develop colorectal cancer during their lifetime.

This disease is the second leading cause of cancer death in women, and the third for men. Colorectal cancer has a high 5-year recurrence rate and most likely is spread to the liver and lungs.

Clinical Genomics has two decades of experience striving to save lives and reduce costs by developing easy-to-use tests for the detection of colorectal cancer. With breakthrough diagnostic tools, the company aims to offer affordable and accurate tests, supporting physicians and patients with potential life-saving knowledge about colorectal cancer.

On June 3, 2019, Clinical Genomics presented research detailing breakthrough methods of colorectal cancer recurrence monitoring at the American Society of Clinical Oncology (ASCO) annual meeting in the McCormick Place Convention Center, Chicago. 

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Children with Birth and Chromosomal Defects More Likely to Develop Cancer

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MedicalResearch.com Interview with:

Philip J. Lupo, PhD, MPH Co-Director, Childhood Cancer Epidemiology and Prevention Program, Texas Children's Cancer Center Associate Professor, Department of Pediatrics Section of Hematology-Oncology, Member, Dan L. Duncan Comprehensive Cancer Center Baylor College of Medicine Adjunct Associate Professor, Human Genetics Center, Division of Epidemiology, Human Genetics and Environmental Sciences University of Texas School of Public Health

Dr. Lupo

Philip J. Lupo, PhD, MPH
Co-Director, Childhood Cancer Epidemiology and Prevention Program, Texas Children’s Cancer Center
Associate Professor, Department of Pediatrics
Section of Hematology-Oncology,
Member, Dan L. Duncan Comprehensive Cancer Center
Baylor College of Medicine
Adjunct Associate Professor, Human Genetics Center, Division of Epidemiology, Human Genetics and Environmental Sciences
University of Texas School of Public Health
 

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

Response: While cancer risk in children with certain chromosomal defects like Down syndrome is well established, much less is known for children with birth defects where there is no known genetic cause, sometimes called non-chromosomal defects. Non-chromosomal defects, as a group, affect more children, but one of the primary challenges of understanding risk among these children is that limited sample sizes make studying specific defects, like spina bifida, more difficult.

Because of that, we gathered data from birth, birth defect, and cancer registries across Texas, Arkansas, Michigan, and North Carolina to generate a birth cohort of more than 10 million children born between 1992 and 2013. We looked at diagnoses of cancer until 18 years of age to determine differences in cancer risk between those with and without birth defects.

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Chronic Pain in Cancer Patients Varies by Income and Insurance Status

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MedicalResearch.com Interview with:

Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program, Class of 2020 Ichan School of Medicine at Mount Sinai

Dr. Jiang

Changchuan (Charles) Jiang MD, MPH
MSSLW Internal Medicine Residency Program
Class of 2020
Ichan School of Medicine at Mount Sinai

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

Response: Chronic pain is one of the common side effects of cancer treatments and it has been linked to low life quality, lower adherence to treatment, higher medical cost. As the population of cancer survivors grows rapidly, chronic pain will be a major public health issue in this population. We know from previous studies that chronic pain is common in certain cancers such as breast cancer. However, little was known about the epidemiology of chronic pain in the cancer survivors until our study.

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World Trade Center 9/11 Dust: Altered Gene Expression Links Exposure to Prostate Cancer Risk

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MedicalResearch.com Interview with:

Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology Icahn School of Medicine at Mount Sinai Asociate director for Population Science Tisch Cancer Institute

Dr. Taioli

Emanuela Taioli, MD, PhD,
Director of the Institute for Translational Epidemiology
Icahn School of Medicine at Mount Sinai
Asociate director for Population Science
Tisch Cancer Institute 

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

Response: An excess incidence of prostate cancer has been identified among World Trade Center responders. We wanted to study if this excess was associated with exposure to WTC dust
The results suggest that respiratory exposure to WTC dust can induce inflammatory and immune responses in prostate tissue. Chronic inflammation could facilitate prostate cancer development

Taken together, our results suggest that World Trade Center prostate cancer cases have a distinct gene expression pattern that may be the result of exposure to specific carcinogens during the WTC attacks. WTC dust-exposed rat prostate displayed unique changes in gene expression and immune cell infiltrates after acute dust exposure, suggesting that the effect of exposure may be measured locally in target organs such as prostate. In addition, some of the genes overexpressed in rat normal prostates as a consequence of exposure are also overexpressed in human prostate cancer tissues, suggesting a link between exposure, local immune dysregulation, and prostate cancer development Continue reading →

Highly Trained Beagles Can Smell Lung Cancer in Serum

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MedicalResearch.com Interview with:

Thomas A. Quinn, DO, FAOCOPM Clinical Professor Lake Erie College of Osteopathic Medicine Bradenton

Dr. Quinn

Thomas A. Quinn, DO, FAOCOPM
Clinical Professor
Lake Erie College of Osteopathic Medicine
Bradenton 

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

Response: Canine scent detection of lung cancer is showing evidence of being an effective, safe and cost effective method of early detection of lung as well as other types of cancer.

Lung cancer is the leading cause of cancer deaths and early detection has proven to be one of the most effective ways to reduce the mortality and morbidity of this deadly disease.  In a collaborative study conducted by the Lake Erie College of Osteopathic Medicine (LECOM) and BioScentDX, a canine training and research facility, we were able to show that highly trained dogs can detect non-small cell cancer of the lung by scent alone.  For this study we chose to use Beagles because of their superior scent capability as well as their temperament, sociability and easy trainability.  The dogs proved to be able, in this double blind study, to detect lung cancer in blood serum with a 96.7% sensitivity and a 97.5% specificity. The dogs underwent an eight-week training program using the clicker/treat training method.  We trained four Beagles for this study but one of the dogs did not respond well to the training methods and had to be removed from the program. That dog was retrained as a service dog for a handicapped child.

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Acute Myeloid Leukemia: LSD1 Inhibition In Combination With Azacitidine in the Elderly

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MedicalResearch.com Interview with:

Dr Carlos Buesa

Dr Buesa

Dr. Carlos Buesa PhD
Chief Executive Officer
Oryzon Genomics 

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

Response: Lysine specific demethylase 1 (LSD1, also known as KDM1A) is a histone modifying enzyme that removes methyl groups, thereby regulates the expression of many genes important in cancer progression and cell proliferation.

Aberrant expression of LSD1 has been shown in many types of cancers. In particular, LSD1 expression is upregulated in bladder, small cell lung (SCLC), and colorectal clinical cancer tissues when compared with the corresponding nonneoplastic tissues. LSD1 has also been shown to be overexpressed in some breast cancers and may function as a biomarker of the aggressiveness of the disease.

However, the function of LSD1 is most understood in acute leukemia, particularly Acute Myeloid Leukemia and Acute Lymphoblastic leukemia. LSD1 is crucial for the function and maintenance of the leukemic stem cells, a subset of malignant cells that is believed to be the ultimate reason for relapse in these patients. LSD1 inhibition might be a therapeutic solution to avoid those relapses.

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Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

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MedicalResearch.com Interview with:

Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School

Dr. Mak

 

Raymond H Mak, MD
Assistant Professor of Radiation Oncology
Harvard Medical School
Radiation Oncology
Brigham and Women’s Hospital

 

 

Dr-Katelyn M. Atkins

Dr. Atkins

 

Katelyn M. Atkins MD PhD
Harvard Radiation Oncology Program
Dana-Farber Cancer Institute
Brigham and Women’s Hospital
Boston, Massachusetts

 

 

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

  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).

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Fat Distribution Linked to Advanced and Fatal Prostate Cancer

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MedicalResearch.com Interview with:

Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA

Dr. Dickerman

Barbra Dickerman, PhD
Research Fellow
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Boston, MA

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

Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.

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Some Patients Can Be Rechallenged After Immune Adverse Events from Checkpoint Inhibitors

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MedicalResearch.com Interview with:
Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. Olivier Lambotte, MD, PHD
Professor of Internal Medicine
Paris XI University Medical School
Research Director
Control of Chronic Viral Infections Department

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

Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited  on the safety of resuming treatment after such an event.

We  studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with  irAE grade 2 or higher for whom the  rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.

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Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

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MedicalResearch.com Interview with:

Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health

Dr. Adamson

Blythe J.S. Adamson, PhD, MPH
Senior Quantitative Scientist
Flatiron Health

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

Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees.

Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis.

This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.

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Accumulation of Metabolite M-2 Predicts Overall Survival of Chemorefractory Metastatic Colorectal Cancer Patients Treated with Regorafenib (Stivarga®)

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MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981

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

Response: Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R).

This prospective pharmacokinetic (PK) ancillary study is part of a prospective phase II study evaluating treatment response with regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) called TEXAN, which aimed to investigate correlations between overall survival (OS) and regorafenib, or its enterohepatic cycle-dependent active metabolites M-2 and M-5 concentrations.

As measured by LC-MS/MS, the main findings showed that regorafenib, M-2 and M-5 were respectively 1.99 (1.03-2.73), 1.44 (0.89-2.49) and 1.61 (0.79-2.37) mg/L during the first cycle at day 15 (C1D15) and 1.90 (1.10-2.76), 1.29 (0.77-2.24) and 1.17 (0.45-2.42) mg/L at during the second cycle at day 15 (C2D15).  Continue reading →

Children with High Risk AML: Intensification of Induction II Chemotherapy and Liberalization of Stem Cell Donor Source does not Improve Outcomes

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MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981

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

Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI).

The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML).

At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.  Continue reading →

Despite Large Numbers of Female Gynecologic Surgeons, Gender Disparities and Harassment Persist

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MedicalResearch.com – Responses

Marina Stasenko, MD Memorial Sloan Kettering Cancer Center

Dr. Stasenko
Photo: MSKCC

Marina Stasenko, MD
Memorial Sloan Kettering Cancer Center

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

Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine.

Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women.

Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians.

Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology.

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Larotrectinib (VITRAKVI® ): Efficacy and Safety in Pediatric TRK Fusion Cancer Patients

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MedicalResearch.com Interview with:

Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine

Dr. Hawkins

Douglas S. Hawkins, M.D.
Hematology/Oncology Division Chief and Professor
Pediatrics at Seattle Children’s Hospital
University of Washington School of Medicine

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

Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway.

At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting.  Continue reading →

SPARTAN Study: Older Castration-Resistant Prostate Cancer Patients Can Tolerate and Benefit from Apalutamide (ERLEADA®)

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Dr. Julie Graff

MedicalResearch.com Interview with:
Julie N. Graff, MD
Associate Professor of Medicine
Knight Cancer Institute
Chief of Hematology/Oncology
VA Portland Health Care System

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

Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival.

The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint.  Continue reading →

CLL: Ibrutinib (IMBRUVICA®) Demonstrated Durable Responses for High Risk Patients

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MedicalResearch.com Interview with:

Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute

Dr. Barr

Paul M. Barr, M.D.
Associate Professor of Medicine and Director of the Clinical Trials Office
Director of the Clinical Trials Office
Wilmot Cancer Institute 

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

Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies.

Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results.

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Novartis Piqray® Approved for Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer

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MedicalResearch.com Interview with:

Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator.

Dr. Fabrice André

Fabrice André, MD, PhD
Research director and head of INSERM Unit U981
Professor in the Department of Medical Oncology
Institut Gustave Roussy in Villejuif, France
Global SOLAR-1 Principal Investigator.

MedicalResearch.com: What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 

  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. 

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Fewer Oncologists Have Financial Ties to Pharmaceutical Companies

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MedicalResearch.com Interview with:
Deborah C. Marshall, MD
Icahn School of Medicine at Mount Sinai

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

Response: Open Payments has brought sweeping change to medicine by introducing transparency to physician relationships with industry. We have seen its impact on oncology through the recent media attention to high-profile physicians in oncology scrutinized for their failure to disclose industry relationships and through the resulting changes to conflict of interest policies of clinical, professional and research organizations in recent months.

We wanted to better understand the impact of Open Payments on individual physician behavior due to the important ethical and policy implications.  We have a cohort of oncology physicians that we followed from the inception of Open Payments to see whether the implementation and increasing awareness of Open Payments have resulted in fewer physicians engaging with industry and has shifted payments towards those considered more appropriate.

The study is important because we evaluate trends at the physician-level to explore the impact of Open Payments on how physicians interact with industry, which is difficult to measure. 

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

Response: The most important finding is that oncology physician interactions with industry are decreasing, which we interpret as being due to the effect of Open Payments.  Notably, we do not see large shifts in the types of payments yet, which suggests that transparency alone may not be enough to significantly alter behavior.  Moreover, while there has been a decrease in oncology physicians interacting with industry, the number and value of these interactions has not shifted greatly, which should reassure those who were concerned that this type of transparency program would have a negative impact on beneficial industry interactions.

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

Response: We are likely going to see the continued impact of Open Payments over time as the downstream effects of transparency become apparent, which warrants ongoing attention to help guide future policy-making.  Engaging stakeholders in these discussions, as well as investigating the impact of industry relationships on how physicians are providing care, conducting and reporting research, and educating future doctors are relevant areas of further research.  Also, there is increasing financial interest in oncology so addressing the risk associated with financial interactions with industry and conflicts of interest are more important than ever. 

Citation: 2019 ASCO Annual Meeting  June 1 2019

Trends in financial relationships between industry and individual medical oncologists in the United States from 2014 to 2017: A cohort study.

Author(s): Deborah Catherine Marshall, Elizabeth Stieglitz Tarras, Kenneth Rosenzweig, Deborah Korenstein, Susan Chimonas; Icahn School of Medicine at Mount Sinai, New York, NY; New York University School of Medicine, New York, NY; Memorial Sloan Kettering Cancer Center, New York, NY

https://abstracts.asco.org/239/AbstView_239_258191.html 

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Older Women With Early Breast Cancer May Have A Choice of Radiation Therapy Alone

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MedicalResearch.com Interview with:

Manjeet Chadha, MD, MHA, FACR, FASTRO Prof. Radiation Oncology Director of the Department of Radiation Oncology Mount Sinai Downtown 

Prof. Chadha

Manjeet Chadha, MD, MHA, FACR, FASTRO
Prof. Radiation Oncology
Director of the Department of Radiation Oncology
Mount Sinai Downtown 

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

Response: Largely, the goal of cancer care among the elderly is to de-escalate therapy searching for a modality that is both an effective treatment and also associated with minimal toxicity.

Approximately, 30% of new breast cancers diagnosed annually are among women older than 70 years of age. Age-adjusted trends note a relatively higher incidence of stage I breast cancer in women between the ages of 70-74 years. For this group of patients, it is imperative that we take a closer look at the evidence-base for our current practice standards, and evaluate opportunities to improve cancer care delivery in the elderly.

Randomized trials have helped arrive at an acceptance of adjuvant endocrine monotherapy in older patients with ER positive, node negative breast cancer. However, in the older patients high rates of non-compliance to tamoxifen secondary to poor tolerance is widely recognized. Emerging data also detail the side effect profile of aromatase inhibitors. Most commonly observed symptoms of arthralgia, reduced bone mineral density, and increased risk of fractures throughout the duration of treatment are important considerations for an older population. At least a quarter of patients on aromatase inhibitors discontinue therapy specifically due to skeletal events and musculoskeletal symptoms. Overall, the side effects of ET contribute to a high rate of non-compliance and negative impact on patients’ quality of life.

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Circulating DNA Can Indicate Melanoma Treatment Failure

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MedicalResearch.com Interview with:

David Polsky, MD, PhDDermatologist and Director of the Digmented Lesion Service

Dr. Polsky

David Polsky, MD, PhD
Dermatologist and Director of the Digmented Lesion Service

Mahrukh M. Syeda, MS
Research Associate

Ronald O. Perelman Department of Dermatology
NYU Langone Health

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

Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any.

In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma.

Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial.

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TItan Study: Apalutamide (ERLEADA®) plus Androgen Deprivation Therapy Improved Survival in Some Metastatic Prostate Cancer Patients

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MedicalResearch.com Interview with:

Dr. Kim Chi. MDProfessor of MedicineMedical Oncologist and Medical Director at BC Cancer – VancouverUniversity of British Columbia,Principal Investigator of the TITAN Study.

Dr. Kim Chi

Dr. Kim Chi. MD
Professor of Medicine
Medical Oncologist and Medical Director at BC Cancer – Vancouver
University of British Columbia,
Principal Investigator of the TITAN Study.

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

Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history.

Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS).  Continue reading →

Only 1 in 5 Cancer Drugs Receiving FDA Accelerated Approval Have Proven Benefits in Confirmatory Trials

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MedicalResearch.com Interview with:

Bishal Gyawali  MD PhD Med Onc. Asst. Professor 

Dr. Gyawali

Bishal Gyawali  MD PhD

  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada

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

Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists.

Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review.

Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  Continue reading →

More Younger People Getting Later Stage Colon Cancer

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MedicalResearch.com Interview with:

Dr. Reinier G. S. Meester, PhDPostdoctoral scholar in the Department of MedicineDivision of Gastroenterology and HepatologyStanford

Dr. Meester

Dr. Reinier G. S. Meester, PhD
Postdoctoral scholar in the Department of Medicine
Division of Gastroenterology and Hepatology
Stanford

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

Response: Incidence of colorectal cancer has increased for decades in adults under age 50 years in the United States. However, there is still uncertainty regarding the underlying causes of this increase.

We studied the patterns in the stage at diagnosis from cancer registry data to assess whether the increases may be due more common use of colonoscopy in the ages 40-49 years, which account for nearly 3 out of 4 young-onset cases. If the increase in incidence were the result of earlier detection from increased colonoscopy use, earlier stage at diagnosis would be expected, whereas if the increased incidence were the result of true rises in risk, relatively later stage at diagnosis would be expected.

Our results suggest that the incidence of late-stage (metastatic) colorectal cancer increased at almost twice the relative rate since 1995 (2.9% per year) compared to earlier stages (1.3-1.4% per year). Over 1 in 4 young-onset cases are now diagnosed at a late stage vs. approximately 1 in 5 cases in the 1990s.

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