Category Archives: Breast Cancer

Everolimus Plus Exemestane vs Monotherapy for ER+ HER2- Advanced Breast Cancer

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MedicalResearch.com Interview with:

Guy Jerusalem, MD, PhD CHU Sart Tilman Liege and Liege University Liege, Belgium

Dr. Jerusalem

Dr. Guy Jerusalem, MD, PhD
CHU Sart Tilman Liege and Liege University
Liege, Belgium

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

Response: BOLERO-6 was conducted to fulfill postapproval regulatory commitments to the FDA and EMA to estimate treatment benefit with EVE + EXE vs EVE alone or CAP for ER+, HER2− ABC that had progressed on an NSAI. Everolimus plus exemestane has not previously been compared with everolimus alone or capecitabine in a randomized setting.Data describing everolimus alone are limited to a single phase 2 study of just 19 patients. Thus, the FDA deemed it important to ascertain the efficacy of everolimus alone for ER+ breast cancer, and to determine the contribution of exemestane to combination therapy with everolimus. Capecitabine is often the first chemotherapeutic agent given for ER+ breast cancer that has progressed on anti-estrogen therapy. It has a reported PFS of 4.1–7.9 months among patients with HER2-negative advanced breast cancer. However, it has a different safety profile to everolimus or exemestane, and a comparison of endocrine-based combination therapy with single-agent chemotherapy was yet to be conducted.

The median PFS with EVE + EXE (8.4 months) was consistent with BOLERO-2 (7.8 months), and compared to EVE alone here (6.8 months) corresponded to an estimated 26% reduction of risk of disease progression or death (HR 0.74).

A numerical median PFS difference was observed for CAP over EVE + EXE (9.6 vs 8.4 months), which may be attributed to various baseline characteristics favoring CAP and potential informative censoring. The median PFS with capacitabine was longer than expected based on previous trials. Interpretation of the results of BOLERO-6 must consider the limited sample size and open-label design.  Continue reading →

Can a Pill Plus Infrared Light Replace Mammograms?

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MedicalResearch.com Interview with:

Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan 

Dr. Thurber

Greg Thurber, PhD
Assistant Professor
Department of Chemical Engineering
Assistant Professor
Department of Biomedical Engineering
University of Michigan 

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

Response: Most current disease screening strategies rely on either blood tests, where the physician can obtain information on specific disease molecules but has no idea where they originated in the body, or anatomical imaging, where the physician can see changes in the structure of tissues but doesn’t have any molecular information. We wanted to develop a method that could provide both molecular information and an image of where these molecules were located. We know from decades of research in cancer that this is a molecular disease, so providing molecular information to the physician will help improve detection and diagnosis. Breast cancer screening provides an excellent opportunity to apply this approach to improve detection. Currently, estimates indicate that we are overspending $4 billion per year on the overdiagnosis and overtreatment of breast cancer because we cannot accurately determine which patients need treatment and which can be safely monitored with no intervention. Despite this problem with overdiagnosis, however, screening saves lives…we simply need a better way.

Molecular imaging has the capability of providing both molecular information and the location within the body. However, most of these techniques are expensive and use ionizing radiation, meaning there is a small risk of actually causing cancer. This is not acceptable for screening large numbers of otherwise healthy patients. To avoid this risk and provide a safe, inexpensive, and relatively easy method for patients to undergo screening, we decided to develop near-infrared fluorescent imaging agents that can be taken as a pill. The goal is for the patient to simply take a pill a day or two before their visit, and then the physician shines near-infrared light on the breast tissue to detect tumors where they ‘light up’ by giving off a different color of light.

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Osteoporosis Drug Has Potential To Fight Triple Negative Breast Cancer

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MedicalResearch.com Interview with:
Chenfang Dong, Ph.D & M.D.
Professor
Department of Pathology and Pathophysiology
Zhejiang University School of Medicine, 

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

Response: Basal-like breast cancer (BLBC), which generally falls into the triple-negative breast cancer subtype, is associated with a poor clinical outcome due to few treatment options and poor therapeutic response; thus there is a pressing need to elucidate the determinants of aggressiveness in BLBC and identify potential therapeutic targets for this challenging disease.

By analyzing gene expression profiles of breast cancer in multiple publicly available datasets that contain over 5000 cases, we have identified that UDP-galactose ceramide galactosyltransferase (UGT8), a key enzyme in the sulfatide biosynthetic pathway, promotes BLBC progression by activating sulfatide-αVβ5 axis.

Importantly, we identify that zoledronic acid (ZA), a marketed drug for treating osteoporosis and bone metastasis, is a direct inhibitor of UGT8, which has the potential to become a valuable targeted drug for treating Basal-like breast cancer.  Continue reading →

Liquid Biopsy Can Guide Radiation Therapy in Early Stage Breast Cancer

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MedicalResearch.com Interview with:

Chelain Goodman, MD PhD PGY-3, Radiation Oncology Northwestern University Chicago, IL 60611

Dr. Goodman

Chelain Goodman, MD PhD
PGY-3, Radiation Oncology
Northwestern University
Chicago, IL 60611

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

Response: Circulating tumor cells are cancer cells that are shed from the primary tumor into the peripheral blood stream and are hypothesized to be one of the first steps in the initiation of metastatic progression. Prospective studies have demonstrated that approximately 15-25% of patients with early-stage breast cancer can be found to have at least one circulating tumor cell in a small sample of their blood. Currently, all patients with early-stage invasive breast cancer who undergo breast conserving surgery receive adjuvant radiation therapy. In these analyses, we wanted to determine whether presence of circulating tumor cells may be predictive of benefit of radiation therapy following surgery.

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What’s the Prognosis If You Get Breast Cancer After a Negative Mammogram?

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MedicalResearch.com Interview with:

Anne Marie McCarthy, PhD Department of Medicine Massachusetts General Hospital and Harvard Medical School Boston

Dr. McCarthy

Anne Marie McCarthy, PhD
Department of Medicine
Massachusetts General Hospital and Harvard Medical School
Boston

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

Response: Mammography is effective in reducing breast cancer mortality. However, it is not perfect, and approximately 15% of breast cancers are diagnosed despite a negative mammogram before the next recommended screening.

MedicalResearch.com: What should clinicians and patients take away from your report?

Response: Using data from the NCI funded PROSPR (Population-Based Research Optimizing Screening through Personalized Regimens) Consortium, we determined the rates of cancer diagnosis within one year following a negative or positive screening mammogram. The rate of cancer diagnosis within one year of a negative mammogram was small (5.9 per 10,000 screenings), but those cancers were more likely to have poor prognosis than cancers diagnosed after a positive mammogram (43.8% vs. 26.9%). As expected, women with dense breasts were more likely to have cancer diagnosed within 1 year of a negative mammogram. However, breast density was not a good predictor of poor prognosis among women diagnosed with cancer after a negative mammogram. Younger women were more likely to be diagnosed with poor prognosis breast cancer after a negative screening mammogram.

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Which Cancers Cost The Most To Treat?

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MedicalResearch.com Interview with:

Matthew P. Banegas, PhD, MPH Center for Health Research Kaiser Permanente

Dr. Banegas

Matthew P. Banegas, PhD, MPH
Center for Health Research
Kaiser Permanente

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

Response: Despite a large body of research on cancer care costs, we observed a significant evidence gap. Namely, while about one-half of cancer diagnoses in the U.S. occur among people under age 65, it can be difficult to find good data on the costs of care for this population. That’s because most of the current literature on cancer care costs is based on SEER Medicare data, which are limited to Medicare fee-for-service beneficiaries.

At a time of rising costs and an ever-increasing number of new therapies, we felt it was important to improve our understanding of cancer costs for U.S. adults of all ages. We examined medical care costs for the four most common types of cancer in the United States: breast, colorectal, lung, and prostate cancer.

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Protein Associated with Metastatic Breast Cancer

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MedicalResearch.com Interview with:
Yingfei Wang, Ph.D. and Weibo Luo, Ph.D.
Department of Pathology
UT Southwestern Medical Center
Dallas TX 75390

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

Response: Breast cancer is the most commonly diagnosed cancer in women. Tumor metastasis is frequently found in breast cancer patients and causes more than 90% of cancer death. There is currently no cure for this deadly disease. We have known that breast tumor is not supplied with sufficient oxygen (a phenomenon known as hypoxia), which makes breast cancer cells more aggressive and may be responsible for tumor recurrence, metastasis, and therapy resistance. Hypoxia-inducible factor (HIF) is a master regulator frequently detected in the hypoxic regions and switches on many oncogenes needed for breast cancer cells to grow and spread around the body. The role of HIF in gene regulation is precisely controlled and shutting down of HIF’s activity would be a promising strategy for the treatment of metastatic breast cancer.

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Everolimus plus Endocrine Therapy: Effective 1st Line Option for Postmenopausal Women with HR+/HER2- Advanced Breast Cancer

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MedicalResearch.com Interview with:

Melanie E. Royce, MD, PhD Division of Hematology/Oncology University of New Mexico Comprehensive Cancer Center Albuquerque

Dr. Royce

Melanie E. Royce, MD, PhD
Division of Hematology/Oncology
University of New Mexico Comprehensive Cancer Center
Albuquerque

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

Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/human epidermal growth factor receptor (HER2)-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression. Results of the BOLERO-4 trial published in JAMA Oncology showed that everolimus in combination with endocrine therapy is an effective first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer.

A total of 202 patients received everolimus in combination with letrozole as first-line treatment between March 7, 2013 and December 17, 2014. Median progression-free survival (PFS) in the first-line setting was 22.0 months (95% CI 18.1-25.1) with an overall response rate of 45% (95% CI 38.1-52.2) and clinical benefit rate of 74% (95% CI 67.7-80.1). A total of 152 (75%) discontinued treatment, primarily due to disease progression (51%) or adverse events (16%).

Data from a smaller number of patients in BOLERO-4 also show limited efficacy with continued everolimus, combined with exemestane, following disease progression.
Second-line treatment was ongoing in 16 (32%) patients, while 34 (68%) had discontinued. The most frequent reason for second-line treatment discontinuation was disease progression (56%). In the second-line setting, median PFS was 3.7 months (95% CI 1.9-7.4) with an overall response of 6% (95% CI 1.3-16.5) and clinical benefit rate of 28% (95% CI 16.2-42.5).

Safety findings from BOLERO-4 are consistent with previous studies of Afinitor in advanced breast cancer. The most common (≥ 20% incidence) first-line all-grade adverse events were stomatitis (69%), weight loss (44%), nausea (37%) and anemia (35%). Most were ‘low grade’ in severity (grade 1 or 2) and generally well managed. Safety findings show the most common (≥ 10% incidence) second-line adverse events were stomatitis (20%) and weight loss (20%). Lower rates of stomatitis in second-line were noted.  Continue reading →

Obesity Fuels Resistance To Anti-VEGF Therapy in Breast Cancer Patients

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MedicalResearch.com Interview with:

Dr. Fukumura

Dr. Fukumura

Dai Fukumura, M.D., Ph.D
Associate Professor, Radiation Oncology
Harvard Medical School
Deputy Director, Edwin L. Steele Laboratory,
Radiation Oncology, Massachusetts General Hospital
Boston, MA 

 

 

Joao Incio

Dr. Incio

Dr. Joao Incio PhD
Post-Doc, Edwin L. Steele Laboratory

 

 

 

 

 

Dr. Rakesh K. Jain PhD

Dr. Jain

Dr. Rakesh K. Jain PhD
Andrew Werk Cook Professor of Tumor Biology and director of the Edwin L. Steele Laboratories for Tumor Biology
Rradiation oncology department
Massachusetts General Hospital and Harvard Medical School.

 

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

Response: Based on promising data from preclinical studies and subsequent increase in progression-free survival in patients, anti-vascular endothelial growth factor (VEGF) therapy received accelerated approval for metastatic breast cancer. However, this approval was withdrawn in the United States based on the lack of overall survival benefit in several subsequent phase III studies in metastatic and adjuvant settings. Potential mechanisms of resistance to anti-VEGF therapy include the upregulation of alternative angiogenic and pro-inflammatory factors. Production of some of these factors has been shown to increase in obesity specifically in hypoxic adipose tissues including the breast. Given that up to 70% of breast cancer (BC) patients in the United States are overweight or obese, we addressed one simple but important question in this study: Is obesity contributing to anti-VEGF treatment resistance in breast cancer?

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Greater Risk of Breast Cancer in Women With Schizophrenia

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MedicalResearch.com Interview with:
Chuanjun Zhuo, MD, PhD
Department of Psychiatric Laboratory
Department of Psychiatric Neuroimaging Faculty
Tianjin Mental Health Center
Tianjin, China 

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

Response: According to previous epidemiological studies, women with schizophrenia may be associated with significantly increased risk of breast cancer. However, the results of these studies were not always consistent. In view of the fact that medical care for patients with schizophrenia is becoming multidisciplinary, we aimed to evaluate the risk of breast cancer in women with schizophrenia via a meta-analysis of relevant cohort studies. We included twelve cohorts and adopted the recently proposed prediction interval to evaluate the heterogeneity among the included studies.

We found that schizophrenia was associated with about 30% increased risk of breast cancer incidence in women. However, significant heterogeneity existed of the included studies, which indicates that more extensive researches into the potential mechanisms underlying the associations between schizophrenia and breast cancer risk are needed.

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Genetic Variant of p53 Associated With Poor Breast Cancer Survival

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MedicalResearch.com Interview with:
Maureen E. Murphy, Ph.D.
Program Leader and Professor
Molecular and Cellular Oncogenesis and
Subhasree Basu PhD
Postdoctoral researcher
The Wistar Institute
Philadelphia, PA 19104

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

Response: Unlike most other genes that are intimately involved in the cause of cancer, the p53 gene displays considerable genetic variation; in other words, p53 is unusual among cancer genes in that the amino acids in p53 protein can frequently differ amongst different populations and ethnic groups. Additionally, unlike most other tumor suppressor genes, when p53 is mutated in a tumor, as it is in 50% of human cancers, that mutant protein now has a positive function in cancer progression, changing tumor metabolism and promoting tumor metastasis.

In this study, the authors analyze for the first time the impact of a common genetic variant in p53 (single nucleotide polymorphism, or SNP) in the ability of mutant p53 to promote tumor metabolism and metastasis, and they find significant differences.  Continue reading →

Mammograms Reduce Mortality From Higher Grade Breast Cancers

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MedicalResearch.com Interview with:

Prof-Stephen-Duffy.jpg

Prof. Duffy

Stephen W. Duffy
Professor of Cancer Screening
Wolfson Institute of Preventive Medicine,
Barts and The London School of Medicine and Dentistry
Queen Mary University of London

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

Response: The phenomenon of length bias, whereby screening has more chance of detecting slow growing tumours, has been known about for some years. This has led some colleagues to speculate that breast cancer screening only benefits those with slow-growing, less aggressive cancers, and does not reduce deaths from more aggressive, rapidly progressing cancers.

In this study, we addressed this question directly using data from a randomised trial of mammographic screening. We calculated the reduction in mortality from grade 1 (less aggressive), grade 2 (intermediate) and grade 3 (most aggressive) cancers, as a result of screening. We found that the greatest reduction in breast cancer mortality was from the aggressive, fast-growing grade 3 cancers, contrary to what had been suspected.  Continue reading →

BRCA1/BRCA2 Testing Varies Widely Worldwide

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MedicalResearch.com Interview with:

Amanda Toland, PhD, Cancer biology and genetics researcher of The Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 

Dr. Toland

Amanda Toland, PhD,
Cancer biology and genetics researcher of
The Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

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

Response: The Breast Information Core (or BIC) is a database that catalogs BRCA1 and BRCA2 sequenced variants.  The BIC is hosted by the National Human Genome Research Institute at NIH and has a steering committee that oversees the BIC and has members from Europe, the middle East, Australia and the US.  In BIC SC discussions, we learned that there are differences in how BRCA1/2 clinical is testing between countries.

To characterize this variation, we performed an international survey of 86 genetic testing labs from around the world.

Our main findings are that there were many variations between testing laboratories.  These include: technologies differed for finding “large” genetic sequence variants, what parts of the genes were assessed, how genetic variants were classified as disease associated or not being associated with diseases, if genetic sequencing information was shared in public databases and testing volume.

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With or Without Reconstruction, Hard To Predict How You Will Feel After Mastectomy

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MedicalResearch.com Interview with:
Dr. Clara Nan-hi Lee, MD Comprehensive Cancer Center The Ohio State UniversityDr. Clara Nan-hi Lee, MD
Comprehensive Cancer Center
The Ohio State University 

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

Response: The decision about breast reconstruction is very challenging because it’s unfamiliar, involves complex risk information, affects very personal concerns, and happens at a stressful time. One of the challenges is to predict how one will feel after the surgery. We know from psychology research that people often mis-predict their future emotions. So we were interested to see how well women predict their future well being after surgery.

The main findings are that patients having mastectomy without reconstruction believed they would be less satisfied than they turned out to be. And patients having mastectomy with reconstruction believed they would be more satisfied than they turned out to be. Continue reading →

Improving Adjuvant Clinical Trials By Including Only Patients For Whom Current Therapies Do Not Work Well

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MedicalResearch.com Interview with:

Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director of Breast Cancer Translational Research Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program Yale School of Medicine New Haven, CT  06511

Dr. Pusztai

Lajos Pusztai, M.D, D.Phil.
Professor of Medicine
Director of Breast Cancer Translational Research
Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program
Yale School of Medicine
New Haven, CT  06511

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

Response: Overall, about 85% of newly diagnosed stage I-III breast cancer patients will not die of their disease, and this roughly equates to an 85% cure rate. Of course cure rates are higher for stage I cancers and lower for stage III cancers. An 85% overall cure rate is good but not good enough, we continuously try to develop new therapies hoping to push these rates to 90%…,95%…etc. However, it is not possible to cure a patient twice over. For example, if surgery plus endocrine therapy cures all patients, the addition of chemotherapy cannot improve on it no matter how effective it is. If surgery plus endocrine therapy cures 95%, adding the perfect chemo to this treatment can only bring about a 5% improvement, and very good chemo that would push cure from 95% to 97%, would require a very large trial including many thousands of patients.

This is an increasingly common scenario in modern breast cancer adjuvant trials (where the goal is to improve survival and cure); the control arm that receives the current standard of care invariably does better than expected and the experimental arm only improves outcome by 1-3% that does not reach statistical significance.  The painful conclusion from these trials is that we do not know if the new drug actually works or not because there were not enough events to demonstrate an effect.

Of course, a lot of patients in the study were also exposed to a new drug with all of its associated toxicities who could not possibly benefit from it.

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Relative Risk of Breast-Anaplastic Large Cell Lymphoma With Implants is Low But Still Elevated

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MedicalResearch.com Interview with:

Dr. Mintsje de Boer, MD Resident plastic surgery
Department of Plastic, Reconstructive and Hand-Surgery
Maastricht University Medical Centre+, Maastricht the Netherland

On behalf of the Netherlands BIA-ALCL Consortium: Daphne de Jong (Hematopathologist, VU university medical Center, Amsterdam, the Netherlands), Hinne Rakhorst (Plastic Surgeon, MST/ZGT, Enschede, the Netherlands) René van der Hulst (Plastic surgeon, MUMC+ Maastricht, the Netherlands) Flora van Leeuwen (Epidemiologist, Netherlands Cancer Institute, Amsterdam, the Netherlands), Jan Paul de Boer (Hemato-oncologist, Netherlands Cancer Institute, Amsterdam, the Netherlands) Lucy Overbeek (Database expert PALGA, Houten, the Netherlands), 

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

Response: Breast implants are one of the most commonly used medical devices worldwide. Associations with breast cancer, connective tissue diseases and auto-immune diseases have never been unequivocally supported. For lymphoma risk, this is different and several reports have suggested an association between breast implants and risk of anaplastic large cell lymphoma in the breast (breast-ALCL).

Over the past few years, the number of women with breast implants reported with breast-ALCL has strongly increased. This has resulted in significant attention amongst medical professionals and women alike with publications in medical journals and lay press. In part due to the rarity of the disease and due to the lack of breast implant prevalence data in the population, the absolute risks of breast-ALCL are largely unknown, precluding evidence-based counseling about implants. In the Netherlands, we are in the unique position to be able to retrieve all diagnosed breastALCL since 1990 as well as appropriate population-based control groups from the Nationwide Network and Registry of Histo- and Cytopathology in the Netherlands (PALGA). This has allowed a formal epidemiological risk assessment study based on sufficient numbers. Moreover, using combined and complementary sources of information, we have been able to determine age- and calendar year-specific implant prevalence rates to determine reliable absolute risks.

This study could be successfully performed thanks to a multidisciplinary taskforce consisting of plastic surgeons, hematopathologists, epidemiologists, hemato-oncologists and radiologists from the several large institutions in the Netherlands  Continue reading →

Deep Learning Algorithms Can Detect Spread of Breast Cancer To Lymph Nodes As Well or Better Than Pathologists

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MedicalResearch.com Interview with:
Babak Ehteshami Bejnordi Department of Radiology and Nuclear Medicine Radboud University medical center, NijmegenBabak Ehteshami Bejnordi
Department of Radiology and Nuclear Medicine
Radboud University medical center, Nijmegen

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

Response: Artificial intelligence (AI) will play a crucial role in health care. Advances in a family of AI popularly known as deep learning have ignited a new wave of algorithms and tools that read medical images for diagnosis. Analysis of digital pathology images is an important application of deep learning but requires evaluation for diagnostic performance.

Accurate breast cancer staging is an essential task performed by the pathologists worldwide to inform clinical management. Assessing the extent of cancer spread by histopathological analysis of sentinel lymph nodes (SLN) is an important part of breast cancer staging. Traditionally, pathologists endure time and labor-intensive processes to assess tissues by reviewing thousands to millions of cells under a microscope. Using computer algorithms to analyze digital pathology images could potentially improve the accuracy and efficiency of pathologists.

In our study, we evaluated the performance of deep learning algorithms at detecting metastases in lymph nodes of patients with breast cancer and compared it to pathologist’s diagnoses in a diagnostic setting.

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Breast Cancer Survival Remains Lower For Black Women

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MedicalResearch.com Interview with:
“Family Weekend 2014-Breast Cancer Walk” by Nazareth College is licensed under CC BY 2.0Dr. Jacqueline Miller, MD
Division of Cancer Prevention and Control
CDC 

MedicalResearch.com: What efforts have proven successful in reducing racial disparities like these?

Response: While some racial disparities will exist due to differences in tumor types, improving early diagnosis and providing specific treatment based on tumor characteristics in a timely fashion would result in reducing breast cancer disparities.

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About 20% Increased Risk of Breast Cancer in Women On Oral Contraceptives

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MedicalResearch.com Interview with:
“Birth control pills” by lookcatalog is licensed under CC BY 2.0Lina Mørch PhD, MSc
Senior Researcher
Rigshospitalet

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

Response: There was a lack of evidence on contemporary hormonal contraception and risk of breast cancer. In particular the knowledge of risk with newer progestins was sparse.

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PTK6 Inhibitors May Target Endocrine Therapy-Resistant ER+ Breast Cancer

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MedicalResearch.com Interview with:

Hanna Irie MD PhD Assistant Professor Oncology Mount Sinai Health System 

Dr. Irie

Hanna Irie MD PhD, senior author
Assistant Professor of Medicine
(Hematology and Medical Oncology) and Oncological Sciences at The Tisch Cancer Institute,
Icahn School of Medicine at Mount Sinai

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

Response: Our study identified PTK6 as a critical gene regulating survival of ER+ breast cancer cells.

PTK6 inhibition also suppresses growth and survival of ER+ breast cancer cells that are resistant to the effects of therapies commonly used to treat patient ER+ breast cancers, making PTK6 an attractive candidate therapeutic target for these resistant cancers.

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Should Hormonal Therapy Be Extended Past Five Years After Estrogen+ Breast Cancer?

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MedicalResearch.com Interview with:

Dr Hongchao Pan PhD Medical Research Council Population Health Research Unit Clinical Trial Service Unit & Epidemiological Studies Unit Nuffield Department of Population Health Oxford 

Dr Hongchao Pan

Dr Hongchao Pan PhD
Medical Research Council Population Health Research Unit
Clinical Trial Service Unit & Epidemiological Studies Unit
Nuffield Department of Population Health
Oxford

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

Response: We’ve known for a long time that recurrences can occur late in women with oestrogen receptor positive breast cancers. Our study aimed to assess how big the risk was for women who had taken endocrine treatment (tamoxifen or an aromatase inhibitor) for 5 years, which greatly reduces the risk of recurrence (by about a half during treatment and one third for the 5 years after stopping). We also wanted to find out what factors influenced the risk of recurrence, and whether some women had such a low risk that they could safely stop hormonal treatment after 5 years or, conversely, whether other women had a particularly high risk so it would make sense for them to keep on taking hormonal treatment.

What we found by following the progress of over 60,000 women who had stopped hormonal treatment at 5 years is that the risk of the cancer spreading stays about the same for the next 15 years. This risk is much higher for women whose breast cancer had spread to the nodes when first diagnosed but even for those with the best outlook (no spread to the lymph nodes and small tumours), there was a 10% chance of cancer spread over 15 years.

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Study Finds No Increased Recurrence Risk in Breast Cancer Survivors Who Become Pregnant

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MedicalResearch.com Interview with:

Hatem A. Azim Jr, MD, PhD Adjunct Assistant Professor, American University of Beirut (AUB) Beirut, Lebanon 

Dr. Azim

Hatem A. Azim Jr, MD, PhD
Adjunct Assistant Professor, American University of Beirut (AUB)
Beirut, Lebanon 

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

Response: This study aimed at evaluating the safety of pregnancy after breast cancer particularly in patient with history of ER+ breast cancer; a subset in which safety of future pregnancy is always put into question by oncologists and obstetricians.

This study included more than 300 pregnant women and 800 non-pregnant breast cancer patients who acted as a comparator group The results show that after more than 7 years after pregnancy, women who became pregnant did not have an increased risk of recurrence compared to those who did not become pregnant irrespective of ER status. There was no impact of breastfeeding, abortion or time of pregnancy on patient outcome.

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Recurrent Metastatic Breast Cancer Remains a Clinical Challenge With Poor Prognosis

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MedicalResearch.com Interview with:

Judith A. Malmgren, PhD President, HealthStat Consulting, Inc Epidemiology Department University of Washingto

Dr. Malmgren

Judith A. Malmgren, PhD
President, HealthStat Consulting, Inc
Epidemiology Department
University of Washington

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

Response: Metastatic breast cancer (MBC) has two types, de novo stage IV MBC discovered to be metastatic at initial diagnosis as advanced disease and recurrent MBC found on follow up after diagnosis and treatment for initial invasive breast cancer. Our institutional breast cancer registry tracks both de novo metastatic breast cancer and invasive breast cancer for distant metastases. With this information we were able to compare the presentation, treatment and outcomes of both types, something that is not possible in national SEER data as recurrent MBC is not tracked.

We found a remarkable improvement in 5-year survival from 28% to 55% over time among the de novo metastatic breast cancer patients.  Recurrent MBC 5-year survival did not improve in the same time period (23% to 13%) although incidence of recurrent MBC fell from 18% to 7% from 1990 to 2010. Incidence of recurrent metastatic breast cancer hormone receptor and HER2 positive breast cancer declined the most, leaving a large number of triple-negative recurrent metastatic breast cancer cases in the most recent time period.

Worse metastatic breast cancer survival was associated with recurrent vs. de novo MBC, hormone receptor negative disease, older age (70+) and visceral dominant disease. HER2 positive disease was associated with better outcomes.

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Machine Learning Applied To Predicting High-Risk Breast Lesions May Reduce Unnecessary Surgeries

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MedicalResearch.com Interview with:

Manisha Bahl, MD, MPH Director, Breast Imaging Fellowship Program, Massachusetts General Hospital Assistant Professor of Radiology, Harvard Medical School

Dr. Bahl

Manisha Bahl, MD, MPH
Director, Breast Imaging Fellowship Program,
Massachusetts General Hospital
Assistant Professor of Radiology,
Harvard Medical School

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

Response: Image-guided biopsies that we perform based on suspicious findings on mammography can yield one of three pathology results: cancer, high-risk, or benign. Most high-risk breast lesions are noncancerous, but surgical excision is typically recommended because some high-risk lesions can be upgraded to cancer at surgery. Currently, there are no imaging or other features that reliably allow us to distinguish between high-risk lesions that warrant surgery from those that can be safely followed, which has led to unnecessary surgery of high-risk lesions that are not associated with cancer.

We decided to apply machine learning algorithms to help us with this challenging clinical scenario: to distinguish between high-risk lesions that warrant surgery from those that can be safely followed. Machine learning allows us to incorporate the full spectrum of diverse and complex data that we have available, such as patient risk factors and imaging features, in order to predict which high-risk lesions are likely to be upgraded to cancer and, ultimately, to help our patients make more informed decisions about surgery versus surveillance.

We developed the machine learning model with almost 700 high-risk lesions, then tested it with more than 300 high-risk lesions. Instead of surgical excision of all high-risk lesions, if those categorized with the model to be at low risk for upgrade were surveilled and the remainder were excised, then 97.4% malignancies would have been diagnosed at surgery, and 30.6% of surgeries of benign lesions could have been avoided.

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Most Women Unaware of Breast Cancer Overdiagnosis and Overtreatment

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MedicalResearch.com Interview with:

Rebekah Nagler PhD Assistant professor Hubbard School of Journalism and Mass Communication University of Minnesota

Dr. Nagler

Rebekah Nagler PhD Assistant professor
Hubbard School of Journalism and Mass Communication
University of Minnesota 

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

Response: Both the American Cancer Society (ACS) and the U.S. Preventive Services Task Force (USPSTF) have stated that women in their 40s–or, in the case of ACS, women ages 40-44–should have the choice to decide when they want to start screening for breast cancer. These organizations recommend that women in this age group weigh the benefits and risks of mammography screening, with the goal of making an informed decision about when to start screening. Yet recent research has shown that women are more aware of the benefits of mammography screening than the harms, including overdiagnosis and overtreatment (doi:10.1001/jamainternmed.2017.2247). We therefore wondered whether women actually have the information they need to make informed screening decisions.

In a population-based sample of 429 U.S. women ages 35-55, we found that awareness of breast cancer overdiagnosis (16.5%) and overtreatment (18.0%) was low. Moreover, we found that most women did not find statements about these harms to be believable and persuasive.

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Kisqali (ribociclib) Plus Aromatase Inhibitor Receives EU Approval For Advanced Breast Cancer

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MedicalResearch.com Interview with:

Wolfgang Janni, MD, PhD University of Ulm MONALEESA-2 investigator

Dr. Janni

Wolfgang Janni, MD, PhD
University of Ulm
MONALEESA-2 investigator

MedicalResearch.com: What is the background for the MONALEESA-2 trial? What are the main findings?

Response: The Phase III MONALEESA-2 trial was the primary study that supported the recent European approval of Kisqali (ribociclib). Findings from the study showed superior efficacy and demonstrated safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who received no prior therapy for their advanced breast cancer.

The trial showed Kisqali plus letrozole reduced the risk of progression or death by 43% versus letrozole alone. At a pre-planned analysis, Kisqali plus letrozole demonstrated a median progression-free survival (PFS) of 25.3 months compared to 16.0 months for letrozole alone (HR=0.568 (95% CI: 0.457-0.704; p<0.0001)). More than half of patients (55%) with measurable disease taking Kisqali plus letrozole experienced a tumor reduction of at least 30%. Finally, Kisqali plus letrozole demonstrated rapid clinical improvement in patients with measurable disease, with 76% seeing a reduction in tumor size after only eight weeks versus 67% with letrozole alone.

Most side effects in the MONALEESA-2 trial were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and/or reduction. The most common grade 3/4 adverse events (reported at a frequency ≥5%) for Kisqali plus letrozole compared to letrozole alone were neutropenia (60% vs 1%, respectively), leukopenia (21% vs 1%), hypertension (10% vs. 11%), increased alanine aminotransferase level (9% vs. 1%), lymphopenia (7% vs. 1%) and increased aspartate aminotransferase level (6% vs. 1%).

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Early Breast Cancer: Radiation Before Surgery Reduce Risk of Second Tumors

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MedicalResearch.com Interview with:

Heiko Enderling, Ph.D. Associate Member & Director for Education and Outreach Dept. of Integrated Mathematical Oncology Dept. of Radiation Oncology H. Lee Moffitt Cancer Center & Research Institute Tampa, FL 33612

Dr.Enderling

Heiko Enderling, Ph.D.
Associate Member & Director for Education and Outreach
Dept. of Integrated Mathematical Oncology
Dept. of Radiation Oncology
H. Lee Moffitt Cancer Center & Research Institute
Tampa, FL 33612

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

Response: Although radiation therapy after breast-conserving surgery for early-stage breast cancer has significantly improved patient prognosis, many patients will face a second cancer diagnosis within 20 years of primary treatment. Experimental and clinical studies have shown that local radiation therapy can activate an immune response that can propagate systemically to attack distant untreated metastases. However, current radiotherapy practice has not specifically focused on enhancing immune responses.

We asked the question if pre-operative irradiation, when applied to the bulk of disease, could have potentially higher immune stimulatory effects. To study this, we analyzed historic outcomes of breast cancer patients treated with either adjuvant (radiation after surgery) or neoadjuvant (radiation before surgery) radiotherapies.

Our analysis showed that the risk of developing a second tumor after neoadjuvant compared with adjuvant RT was significantly lower, especially for estrogen receptor-positive women who underwent breast conserving surgery or mastectomy. Historic data revealed an increase in disease-free survival of 12% over 20 years after treatment of the original tumor.

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Repeated Breast-Conserving Surgeries Come With Significant Complications and Costs

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MedicalResearch.com Interview with:

Dr. Lisa K. Jacobs MD Johns Hopkins School of Medicine Baltimore, Maryland

Dr. Jacobs

Dr. Lisa K. Jacobs MD
Johns Hopkins School of Medicine
Baltimore, Maryland

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

Response: Breast preservation is the preferred treatment for many women diagnosed with breast cancer.  The most common question that a patient will ask after the surgery is, “Did you get it all?” In the ideal case, this is accomplished in a single outpatient surgery with very good cosmetic results.  In our study, Beyond the Margins-Economic Costs and Complications Associated with Repeated Breast-Conserving Surgeries we evaluated the detrimental effects of an unsuccessful initial surgery due to positive surgical margins. Using private insurance claims data, we found that 16% of patients planning breast preservation required a second breast-conserving surgery and an additional 7% converted to mastectomy.  Of those patients that required additional surgery there was a 56% ($16,072) increase in cost and a 48% increase in complications.  Those complications include infection, hematoma, seroma, and fat necrosis.  This study demonstrates that repeated surgery has not only cosmetic consequences, but also has financial implications and increased risk.

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One Year Follow Up of Kisqali® (ribociclib) plus Letrozole in HR+, HER2- Advanced Breast Cancer Demonstrates Continued Efficacy

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MedicalResearch.com Interview with:

Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX

Dr. Hortobagyi

Gabriel N. Hortobagyi, MD, FACP
Professor of Medicine, Department of Breast Medical Oncology,
Division of Cancer Medicine, UTMDACC,
Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine
Program Director, Department of Breast Medical Oncology
Susan G. Komen Interdisciplinary Breast Fellowship Program
The University of Texas MD Anderson Cancer Center
Houston, TX

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

Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease.

MedicalResearch.com: What are the main findings?

o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer:
• After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone.
• The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone.
• In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo.
• Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo.

o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis.

• The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%).

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No Angelina Jolie Effect Found In Rates of Breast Cancer Screening

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MedicalResearch.com Interview with:

Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA 

Dr. Huesch

Marco D. Huesch, MBBS, PhD
Department of Radiology
Milton S. Hershey Medical Center
Hershey, PA  

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

Response: Public health depends on coordinated actions between patients, payors and providers. Important preventative care and evidence-based screenings need to be understood and sought out by patients, need to be reimbursed by or subsidized by insurance plans, and offered and recommended by physicians and care team members.

Women’s breast health is a good example of how – in theory – all these come together and allow women to obtain regular screenings for breast cancer through mammograms. Yet it is commonly accepted that perhaps as many as 1 in 3 women are not adequately screened or are not screened at all.

In this study we hypothesized that a prominent global celebrity, Ms Angelina Jolie’s, highly public announcement of her own risk-reducing surgery to prevent breast cancer and her recommendation to women to understand whether they were at high risk might spur uptake of breast screenings at our institution.

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