Category Archives: Cancer Research

Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

Posted on by
Reply

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).

Continue reading →

Fat Distribution Linked to Advanced and Fatal Prostate Cancer

Posted on by
Reply

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.

Continue reading →

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

Posted on by
Reply

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.

Continue reading →

Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

Posted on by
Reply

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.

Continue reading →

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

Posted on by
Reply

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

Posted on by
Reply

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

Posted on by
Reply

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.

Continue reading →

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

Posted on by
Reply

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®)

Posted on by
Reply

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

Posted on by
Reply

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.

Continue reading →

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

Posted on by
Reply

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. 

Continue reading →

Fewer Oncologists Have Financial Ties to Pharmaceutical Companies

Posted on by
Reply

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 

Jun 3, 2019 @ 12:45 am

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.

 

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

Posted on by
Reply

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.

Continue reading →

Circulating DNA Can Indicate Melanoma Treatment Failure

Posted on by
Reply

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.

Continue reading →

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

Posted on by
Reply

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

Posted on by
Reply

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

Posted on by
Reply

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.

Continue reading →

Do Smokers Stick to Cancer Screening Guidelines?

Posted on by
Reply

MedicalResearch.com Interview with:

Nina Niu Sanford, M.D. Assistant ProfessorUT Southwestern Department of Radiation OncologyDallas TX 75390

Dr. Sanford

Nina Niu Sanford, M.D. 
Assistant Professor
UT Southwestern Department of Radiation Oncology
Dallas TX 75390 

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

Response: The background of this study is that smoking is associated with increased risk for multiple cancer types, although the most commonly noted association is between smoking and lung cancer – because of this, lung cancer screening guidelines have been established for current smokers and those who have recently quit.

What is less well known is whether patients who smoke are more or less likely to adhere to screening guidelines for other cancer types.

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

Response: In this study, we found that current smokers were less likely to adhere to national screening guidelines for prostate, breast and colorectal cancer, as compared to never smokers. 

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

Response: That smokers are less likely to undergo age appropriate cancer screening for several major cancer types.  This is important because they are at baseline higher risk for these cancers thus without screening, would be more likely to present at advanced stage.  We know that current smoking is a risk factor for worse cancer-specific outcomes, and delayed diagnosis could be one of the contributing factors.

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

Response: Further research is needed to identify the barriers to cancer screening among individuals who smoke, such that initiatives can be undertaken to increase uptake of cancer screening among this population.

Citation:

Sanford NN, Sher DJ, Butler S, et al. Cancer Screening Patterns Among Current, Former, and Never Smokers in the United States, 2010-2015. JAMA Netw Open. 2019;2(5):e193759. doi:10.1001/jamanetworkopen.2019.3759

 

May 19, 2019 @ 6:32 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.

 

Cancer Survivors: Insurance Patterns Before and After Affordable Care Act

Posted on by
Reply

MedicalResearch.com Interview with:

Nina Niu Sanford, M.D. Assistant ProfessorUT Southwestern Department of Radiation OncologyDallas TX 75390

Dr. Sanford

Nina Niu Sanford, M.D. 
Assistant Professor
UT Southwestern Department of Radiation Oncology
Dallas TX 75390 

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

Response: The background for this study is that we know cancer survivors are at risk for uninsurance or underinsurance and the most commonly cited reason for this is cost of insurance.  However, there have been no prior studies assessing from the patient perspective the reasons for not having insurance.

In addition, there has been further recent controversy over the Affordable Care Act, including threats from the current administration to dismantle it.  Thus assessing the impact of the ACA among at risk populations including cancer survivors is timely.

Continue reading →

HPV6 Serology Associated with Bladder Cancer

Posted on by
Reply

MedicalResearch.com Interview with:

Lael S. Reinstatler, MD, MPH.PGY 4 Urology ResidencyDartmouth Hitchcock

Dr. Reinstatler


Lael S. Reinstatler, MD, MPH.
PGY 4 Urology Residency
Dartmouth Hitchcock

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

Response: Human Papillomavirus is an oncogenic virus associated with other genitourinary cancers including penile cancer.

HPV is detectable in urine and in urethral swabs and it interacts with stratified squamous epithelium which lines the majority of the genitourinary tract. Prior research has identified HPV in bladder tumors but detection methods are inconsistent.

In this study, we looked for an association with HPV serology (indicating prior HPV systemic exposure) and bladder cancer.

Continue reading →

Circulating Tumor DNA Linked to Recurrence After Colon Cancer Surgery

Posted on by
Reply

MedicalResearch.com Interview with:

Louise OlssonSenior researcherDepartment of Molecular Medicine and SurgeryColorectal SurgeryKarolinski InstituteStockholm, Sweden

Dr. Olsson

Louise Olsson MD PhD
Senior researcher
Department of Molecular Medicine and Surgery
Colorectal Surgery
Karolinski Institute
Stockholm, Sweden 

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

Response: I read a very interesting paper back in 2006 “Detection and quantification of mutation in the plasma of patients with colorectal cancer”. Only some 60 % of patients with early colorectal cancer were detectable in this way whereas patients with stage IV disease all had a high concentration of APC mutations in their plasma. So the prospects of using the method for example, screening of primary colorectal cancer seemed limited but I thought wow, this is the test to detect recurrences and generalized disease during follow-up after surgery for colorectal cancer. After some discussion we started to collect plasma samples from patients at the hospital where I worked and that´s how my research began.

Continue reading →

Proximity to Oil Refineries and Risk of Bladder Cancer

Posted on by
Reply

MedicalResearch.com Interview with:

Stephen B. Williams, MD, FACSChief, Division of UrologyAssociate Professor, Urology and RadiologyRobert Earl Cone ProfessorshipDirector of Urologic OncologyDirector of Urologic ResearchCo-Director Department of Surgery Clinical Outcomes Research ProgramUniversity of Texas Medical Branch at Galveston

Dr. Williams

Stephen B. Williams, MD, FACS
Chief, Division of Urology
Associate Professor, Urology and Radiology
Robert Earl Cone Professorship
Director of Urologic Oncology
Director of Urologic Research
Co-Director Department of Surgery Clinical Outcomes Research Program
University of Texas Medical Branch at Galveston

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

Response: Despite prior studies evaluating cancer in those living near and working in oil refineries, there remains a gap in knowledge regarding proximity to oil refineries and risk of bladder cancer.

Aromatic amines have been associated with increased risk of various cancers including bladder cancer. Texas is a home to the largest numbers of oil refineries in the US. Our goal was to evaluate if there was a link between bladder cancer and living in close proximity to an oil refinery in Texas.

Our data did suggest that living within 10 miles of an oil refinery was associated with a small increase in risk of bladder cancer. These data support further research to validate these findings.

Continue reading →

Could Aspirin Improve Stool Testing for Colon Cancer Screening?

Posted on by
Reply

MedicalResearch.com Interview with:
Prof. Dr. med. Hermann Brenner
Clinical Epidemiology and Aging Research
Division Head
German Cancer Research Center
Foundation under Public Law
Germany 

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

Response: Colorectal cancer is the third most common cancer globally, accounting for almost 900.000 deaths every year. Most of these deaths could be prevented by screening colonoscopy with early detection and removal of precursors of the cancer. However, capacities and use of screening colonoscopy are limited in most parts of the world, and low-cost but reliable noninvasive screening tests are important alternative primary screening tests.

The currently best established noninvasive tests are fecal immunochemical tests for hemoglobin (FITs) which are offered for colorectal cancer screening in an increasing number of countries. Although FITs detect the majority of colorectal cancers they detect approximately one out of four advanced adenomas only, the precursors of most colorectal cancers.

We hypothesized that this proportion could be increased by taking a single pill of aspirin two days prior to collecting the stool sample for FIT, because the well-established antithrombotic effects of aspirin might favor detecting occult bleeding from colorectal cancer or its precursors.

Continue reading →

Machine Learning Can Analyze Entire Transcriptome To Improve Diagnosis of Difficult Cancers

Posted on by
Reply

MedicalResearch.com Interview with:

Steven J.M. Jones, Professor, FRSC, FCAHSCo-Director & Head, BioinformaticsGenome Sciences CentreBritish Columbia Cancer Research CentreVancouver, British Columbia, Canada

Dr. Jones

Steven J.M. Jones, Professor, FRSC, FCAHS
Co-Director & Head, Bioinformatics
Genome Sciences Centre
British Columbia Cancer Research Centre
Vancouver, British Columbia, Canada and

Jasleen Grewal, BSc.Genome Sciences CentreBritish Columbia Cancer Research CentreVancouver, British Columbia, CanadaJasleen Grewal, BSc.
Genome Sciences Centre
British Columbia Cancer Research Centre
Vancouver, British Columbia, Canada

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

Response: Cancer diagnosis requires manual analysis of tissue appearance, histology, and protein expression. However, there are certain types of cancers, known as cancers of unknown primary, that are difficult to diagnose based purely on their appearance and a small set of proteins. In our precision medicine oncogenomics program, we needed an accurate approach to confirm diagnosis of biopsied samples and determine candidate tumour types for where the primary site of the cancer was uncertain.  We developed a machine learning approach, trained on the gene expression data of over 10,688 individual tumours and healthy tissues, that has been able to achieve this task with high accuracy.

Genome sequencing offers a high-resolution view of the biological landscape of cancers. RNA-Seq in particular quantifies how much each gene is expressed in a given sample. In this study, we used the entire transcriptome, spanning 17,688 genes in the human genome, to train a machine learning method for cancer diagnosis. The resultant method, SCOPE, takes in the entire transcriptome and outputs an interpretable confidence score from across a set of 40 different cancer types and 26 healthy tissues.  Continue reading →

Single Higher Dose Radiation Treatment Effective for Metastatic Cancer Pain Relief

Posted on by
Reply

MedicalResearch.com Interview with:

Quynh-Nhu Nguyen, MDDepartment of Radiation OncologyThe University of Texas MD Anderson Cancer CenterHouston

Dr. Quynh-Nhu

Quynh-Nhu Nguyen, MD
Department of Radiation 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: This is the first non-spine bone metastases trial comparing higher dose single fraction radiotherapy vs multifraction standard fractionated radiotherapy for patients with painful bone metastases.

The results of this trial demonstrated more durable pain relief and superior local control for patients treated in the higher dose(12 Gy-16 Gy)  single fraction RT compared to standard 30 Gy/10 fractions multifractionated regimen.  This trial supports the previous multiple randomized trials which recommend single fraction should be standard palliative radiotherapy regimen for bone metastases.  This trial is unique in that it addressed previous criticism that single fraction does not provide durable palliation with lower 8 gy single fraction and result in higher re-irradiation rates.  This trial on the contrary with the utilization of modern radiotherapy techniques, demonstrated we can safely and more effectively deliver a higher single fraction radiotherapy regimen for improvement in the quality of life for patients.  This higher dose should be the new standard single fraction regimen for patients who are functional and have a longer life expectancy.  Continue reading →

Cancer Patients May Receive Better Emergency Care at Hospital Where They Receive Cancer Treatments

Posted on by
Reply

MedicalResearch.com Interview with:

Keerat Grewal, MD, MSc, FRCPC Schwartz/Reisman Emergency Medicine Institute Mount Sinai Hospital Toronto, ON

Dr. Grewal

Keerat Grewal, MD, MSc, FRCPC
Schwartz/Reisman Emergency Medicine Institute
Mount Sinai Hospital
Toronto, ON 

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

Response: Patients with cancer have complex care requirements and often use the emergency department. The purpose of our study was to determine whether continuity of care, cancer expertise, or both, impact outcomes among cancer patients in the emergency setting. Using administrative data we looked at adult patients with cancer who received chemotherapy or radiation therapy in the 30 days prior to an emergency department visit.  Continue reading →

Occupational Exposure to Pesticides: Poor Prognosis for Diffuse Large B-Cell Lymphoma Patients

Posted on by
Reply

MedicalResearch.com interview with:
Sylvain Lamure, MD, Hematologist, Principal Investigator
Pascale Fabbro-Peray, MD, PhD , Epidemiologist, Senior Investigator
University of Montpellier, France

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

Response: Occupational exposure to pesticides is a well-documented associated factor for non-Hodgkin lymphoma. The main biological mechanisms of both pesticides and chemotherapy are genotoxicity and reactive oxygen species generation. Cellular adaptation among patients exposed to low doses of genotoxic and oxidative compounds might hinder chemotherapy efficiency in lymphoma patients. T

hus, we have investigated the association of occupational exposure with response to immunochemotherapy and survival in the subgroup of diffuse large B cell lymphoma, whose treatment is standardized.

Continue reading →

Medicaid Payments For Breast Cancer Radiation Vary Widely

Posted on by
Reply

MedicalResearch.com Interview with:

Ankit Agarwal, MD, MBAPGY-3, Radiation Oncology ResidentUNC Health Care

Dr. Agarwal

Ankit Agarwal, MD, MBA
PGY-3, Radiation Oncology Resident
UNC Health Care

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

Response: Medicaid provides vital health insurance for millions of mostly low income Americans throughout the United States. However, it is well known that patients with Medicaid have worse clinical outcomes than patients with private insurance or Medicare insurance. Part of the reason for this may be due to difficulties with access to care, in part due to the traditionally very low payments in the Medicaid system.

We found that Medicaid payment rates for a standard course of breast cancer radiation treatment can vary over fivefold (ranging from $2,945 to $15,218)  Continue reading →

Gene Linked to Colon Cancer in Younger Patients Identified

Posted on by
Reply

MedicalResearch.com Interview with:

Valentine N. Nfonsam, MD, MS, FACSAssociate Professor of SurgeryProgram Director, General Surgery ResidencyColon and Rectal SurgeryDivision of Surgical OncologyUniversity of Arizona, Tucson

Dr. Nfonsam

Valentine N. Nfonsam, MD, MS, FACS
Associate Professor of Surgery
Program Director, General Surgery Residency
Colon and Rectal Surgery
Division of Surgical Oncology
University of Arizona, Tucson 

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

Response: The overall incidence of colon cancer in the United states has gone down in the last few decades. However, there has been a significant increase in the incidence of sporadic colon cancer is young patients (<50 years old). The etiology of this phenomenon is likely multi-factorial.

These young patients do present with more advanced disease and with aggressive features. We demonstrated in our study that the colon cancer tumor biology was different between young and older patients. We also singled out a particular gene, Cartilage oligomeric Matrix Protein (COMP) which was significantly over-expressed in young patients and demonstrated its role in cancer proliferation and metastasis and also its potential as a prognostic biomarker since we were able to detect it in plasma.

Continue reading →

AI Poised to Revolutionize Radiation Therapy for Cancer

Posted on by
Reply

MedicalResearch.com Interview with:

Raymond H Mak, MDRadiation OncologyBrigham and Women's Hospital

Dr. Mak

Raymond H Mak, MD
Radiation Oncology
Brigham and Women’s Hospital

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

  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be

Continue reading →