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

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

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

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

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

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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Pembrolizumab – Keytruda- Shows Promise in Subset of Triple Negative Breast Cancer

MedicalResearch.com Interview with:

Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016

Dr. Adams

Sylvia Adams, MD
Associate Professor of Medicine
Breast Cancer and Cancer Immunotherapy Programs
NYU Langone Medical Center
Cancer Institute/Clinical Cancer Center
New York, NY 10016

 

MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings?

Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A).

The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy.

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Guidelines Linked to Reduced Surgery After Lumpectomy for Breast Cancer

MedicalResearch.com Interview with:

Monica Morrow, MD, FACS Chief, Breast Service Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering

Dr. Morrow

Monica Morrow, MD, FACS
Chief, Breast Service
Department of Surgery
Anne Burnett Windfohr Chair of Clinical Oncology
Memorial Sloan Kettering

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

Response: Although we know that bigger surgery does not result in better patient outcomes in breast cancer, since 2005 rates of lumpectomy have been decreasing accompanied by an increase in bilateral mastectomy for unilateral cancer.

High rates of second surgery after initial lumpectomy are one deterrent for patients. In 2013 the SSO and ASTRO developed an evidence based consensus guideline endorsing no ink on tumor as the standard negative margin width for women with stage 1 and 2 cancer having breast conserving surgery with whole breast irradiation. The purpose of our study was to examine time trends in the use of additional surgery after lumpectomy before and after guideline dissemination and to determine the impact of these trends on final rates of breast conservation.

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Better Communication Linked To Reduced Racial Disparities in Breast Reconstruction Surgery

MedicalResearch.com Interview with:

Elham Mahmoudi, PhD, MS Section of Plastic Surgery, University of Michigan Medical School Ann Arbor, Michigan

Dr. Mahmoudi

Elham Mahmoudi, PhD, MS
Section of Plastic Surgery, University of Michigan Medical School
Ann Arbor, Michigan

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

Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups.

In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR.

Our results did not show any effect on the overall rate of immediate  post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication.

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Promising Study of Shorter Course of Radiation Therapy After Mastectomy

MedicalResearch.com Interview with:

Bruce G. Haffty, MD Professor and Chair, Department of Radiation Oncology Rutgers Cancer Institute of New Jersey Rutgers Robert Wood Johnson Medical School and Rutgers New Jersey Medical School

Dr. Haffty

Bruce G. Haffty, MD
Professor and Chair, Department of Radiation Oncology
Rutgers Cancer Institute of New Jersey
Rutgers Robert Wood Johnson Medical School and
Rutgers New Jersey Medical School

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

Response: Shorter courses of radiation for patients treated by lumpectomy are now commonly employed. For patients receiving radiation to the chest wall and lymph nodes after mastectomy, the standard 5 to 6 week course is used and shorter courses have not been adopted.

We initiated this trial of a shorter course of radiation to the chest wall and lymph nodes after mastectomy to test its feasibility, safety and outcome.
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Younger Breast Cancer Patients Have More Later-Stage Disease and Higher Financial Costs

MedicalResearch.com Interview with:

Benjamin Allaire MS RTI International Research Triangle Park Durham, NC, 27709

Benjamin Allaire

Benjamin Allaire MS
RTI International
Research Triangle Park
Durham, NC, 27709

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

Response: More than 22,000 women younger than 45 years of age were diagnosed with breast cancer in 2013. Although less than 10 percent of all breast cancers are diagnosed among women younger than age 45, the types of breast cancer these younger women face are typically more aggressive, are diagnosed at more advanced stages, and result in poorer survival compared to breast cancer in older women. Younger women may also require more intense treatment, exhibit cancers that are less responsive to treatment, and have distinct and more prevalent side effects from treatment than older women. These side effects can include poorer quality of life, fertility problems, and depression.

As a result, breast cancer treatment for younger women is expensive, making them vulnerable to financial hardship. Recent research has shown that 31.8 percent of cancer survivors are likely to have cancer treatment-induced financial troubles, with higher rates among younger cancer patients. These financial difficulties cause some survivors to forego or delay necessary medical treatments.

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No Magic Age To Stop Performing Screening Mammograms

MedicalResearch.com Interview with:
Cindy S. Lee, MD

Department of Radiology and Biomedical Imaging
University of California, San Francisco, San Francisco
Now with Department of Radiology
NYU Langone Medical Center, Garden City, New York

MedicalResearch.com: What led you and colleagues to conduct this study?

Response: I am a breast imager. I see patients who come in for their screening mammograms and I get asked, a lot, if patients aged 75 years and older should continue screening, because of their age. There is not enough evidence out there to determine how breast cancer screening benefits women older than 75. In fact, all previously randomized trials of screening mammography excluded people older than 75 years.

Unfortunately, age is the biggest risk factor for breast cancer, so as patients get older, they have higher risks of developing breast cancer. It is therefore important to know how well screening mammography works in these patients.

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Some Breast Cancer Patients With Complete Response To Neoadjuvant Therapy Can Avoid Further Surgery

MedicalResearch.com Interview with:

Audree Tadros, MD, MPH Chief Administrative Fellow, Breast Surgical Oncology Training Program Department of Breast Surgical Oncology MD Anderson Cancer Center and

Dr. Tadros

Audree Tadros, MD, MPH
Chief Administrative Fellow, Breast Surgical Oncology Training Program
Department of Breast Surgical Oncology
MD Anderson Cancer Center and

Henry M. Kuerer, MD, PhD, FACS Executive Director, Breast Programs MD Anderson Cancer Network PH and Fay Etta Robinson Distinguished Professor in Cancer Research Department of Breast Surgical Oncology Director, Breast Surgical Oncology Training Program

Dr. Kuerer

Henry M. Kuerer, MD, PhD, FACS
Executive Director, Breast Programs
MD Anderson Cancer Network
PH and Fay Etta Robinson Distinguished Professor in Cancer Research
Dept of Breast Surgical Oncology
Director, Breast Surgical Oncology Training Program

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

Response: Neoadjuvant chemotherapy (NCT) has the ability to confer a pCR (pathologic complete response-when no residual cancer is found) in both the breast and axillary lymph nodes. We know that this is most likely to occur in women with HER2 positive and triple negative disease. The high rate of pCR among these patients raises the question of whether surgery is still required, particularly among those who will receive adjuvant radiation therapy.

Until recently, we lacked the ability to pre-operatively predict patients who achieved a breast pCR. Recently, we completed a clinical feasibility trial examining the ability of image-guided biopsy to predict a pCR after neoadjuvant chemotherapy. Our biopsy technique was able to accurately predict a pCR in 98% of patients with only a 5% false negative rate. Based upon these findings, we believe we can accurately determine which patients achieve a breast pCR. This led us to develop a clinical trial to see if breast surgery is redundant in patients who achieve a pCR. An important question that remained was if we are going to omit breast surgery in these exceptional responders, can we also omit axillary surgery?

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Sleep Difficulties Linked to Survival Among Women With Breast Cancer

MedicalResearch.com Interview with:

Claudia Trudel-Fitzgerald Ph.D. FRQS Postdoctoral research fellow & Clinical psychologist (OPQ) Department of Social and Behavioral Sciences Harvard T.H. Chan School of Public Health Boston, MA 02115

Dr. Trudel-Fitzgerald

Claudia Trudel-Fitzgerald Ph.D. 
FRQS Postdoctoral research fellow & Clinical psychologist (OPQ)
Department of Social and Behavioral Sciences
Harvard T.H. Chan School of Public Health
Boston, MA 02115

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

Response: There is very limited research on the association between sleep characteristics and survival among individuals with cancer. However, this is an important question, especially among breast cancer patients because sleep disturbances are frequently reported by these women. Preliminary studies have suggested that sleep duration is related to mortality. The novel findings of our research indicate that not only sleep duration, but also changes in sleep duration before versus after diagnosis, as well as regular difficulties to fall or stay asleep, may also be associated with mortality among women with breast cancer over a period of up to 30 years.

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Founder of ‘The Pink Fund’ Describes Her Journey With Breast Cancer

MedicalResearch.com Interview with:

Molly MacDonald

Molly MacDonald

Molly MacDonald
Founder/President/CEO
SurThrivor™

MedicalResearch.com: Would you tell us a little about yourself, especially your life before/outside of your cancer diagnosis?

 Response: My life before cancer was a struggle of a different sort.  In 1997 I drove up the driveway to our lovely home with five children ages 4-13 safely strapped into the back of my gus guzzling suburban.  As I approached the front of the house, I noticed a small paper, about the 4X10 inches tacked to our front door, and where we lived no one tacked notes to the front door and all service providers went around to the side.

Pulling it off I read that the house was to auctioned off in 30 days.  That night I had a very unpleasant conversation with my husband during which I learned the deal he was pursuing, among other things, had not come to fruition and he was fronting it with our assets.

Within a monthI liquidated what I could, rented a house for cash and began the process of transitioning our lives from a life of luxury to living paycheck to paycheck.

Trying to find work, while navigating a nasty divorce and helping my children adjust was a huge challenge.
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Exposure to BPA Substitute, BPS, Multiplies Breast Cancer Cells

Sumi Dinda

Dr. Sumi Dinda

MedicalResearch.com Interview with:
Sumi Dinda, PhD, NRP, IC.

Associate Professor
Biomedical Diagnostic and Therapeutic Sciences,
School of Health Sciences and
Adjunct Associate Professor
Department of Biological Sciences
School of Health Sciences
Oakland University
Rochester, MI 48309.


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

Response: Bisphenol-S (BPS), a substitute for bisphenol-A (BPA), has been suggested to be an endocrine disrupting compound interfering with normal hormonal activity. This bisphenol analogue is found in plastic substitutes, paper currency, and most products marked “BPA free.” Endocrine disrupting compounds interfere with the normal hormonal activity in the body.

Bisphenols, specifically, disrupt the proper functioning of estrogen receptors, such as ERα causing interference with the normal activity of the hormone estrogen. Studies suggest BPS induces ERα pathways via its estrogen-mimicking properties in the body causing increased cell proliferation resulting in increased breast cancer risk. Despite the hope of a safer substitute, studies have shown that BPS exhibits similar estrogenic activity compared to its analogue BPA, due to their structural commonalities.

BRCA1 is a commonly mutated gene in breast cancer; therefore, it is also important to study the effects of BPS on the expression of this protein. The potency of the endocrine disrupting abilities of BPS compared to BPA could show whether BPS is a suitable alternative to BPA in many everyday products.

The results of this study may contribute to the understanding of the relationship between ERα, BRCA1 expression and Bisphenol-S in breast cancer treatment and prevention.

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Study Finds Statin Use Not Associated With Breast Cancer Prognosis

MedicalResearch.com Interview with:

Amanda Leiter, MD MSCR Medical Resident, Internal Medicine Icahn School of Medicine at Mount Sinai

Dr. Leiter

Amanda Leiter, MD MSCR
Medical Resident, Internal Medicine
Icahn School of Medicine at Mount Sinai

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

Response: Black women are more likely than White women to have breast cancer with poor prognostic features, which cannot be completely explained by differences in screening, treatment and established risk factors for breast cancer mortality. Black women have higher rates of obesity, insulin resistance and dyslipidemia when compared to White women. Prior studies have shown a decreased risk of breast cancer recurrence and improved survival with statin use.

As statins have an association with decreased breast cancer recurrence and potentially improved survival, disparities in statin use between Black and White women with breast cancer are important to investigate. We aimed to elucidate whether or not statin use differs between Black and White women with breast cancer and if racial disparities in breast cancer can be partially explained by differences in statin use.
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Rate of Contralateral Prophylactic Mastectomy Varies Among States

MedicalResearch.com Interview with:
Ahmedin Jemal, DVM, PHD

Vice President, Surveillance and Health Services Research
American Cancer Society, Inc.
Atlanta, GA 30303

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

Response: Previous studies reported that Contralateral Prophylactic Mastectomy (CPM) increased in the United States among women diagnosed with unilateral early-stage breast cancer with surgery without evidence for survival benefit. Previous studies also reported that receipt of this procedure is more common in younger than older patients, in white than in black patients, and in privately insured than uninsured patients. However, the extent of variation in receipt of CPM by state of residence was unknown.

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Large Regional Variations in Rates of Contralateral Prophylactic Mastectomy

MedicalResearch.com Interview with:
Rebecca Nash, MPH
Rollins School of Public Health
Emory University

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

Response: Contralateral prophylactic mastectomy (CPM) in women with invasive early-stage unilateral breast cancer has significantly increased in the U.S. over the past decade, despite the lack of evidence for a survival benefit. This procedure is particularly common among patients younger than 45 years old. It is also more common in whites compared to blacks, and in privately insured patients compared to uninsured or Medicaid insured patients. However, the extent of regional variation across the United States was unknown.

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Gene Expression-based Breast Cancer Index Can Improve Decision Making For ER+ Patients

MedicalResearch.com Interview with:

Tara Sanft, MD Assistant Professor of Medicine (Medical Oncology) Medical Director of Adult Survivorship Yale Cancer Center Survivorship Clinic

Dr. Tara Sanft

Tara Sanft, MD
Assistant Professor of Medicine (Medical Oncology)
Medical Director of Adult Survivorship
Yale Cancer Center Survivorship Clinic 

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

Response: Previous studies have demonstrated the benefit of extended endocrine therapy (EET) for hormone receptor-positive (HR+) breast cancer in preventing late relapse, however that benefit is limited to 3-5% of women where late recurrence was prevented or staved off. However, EET has become common practice and as a result we are exposing many patients to risks of side effects and toxicities associated with anti-estrogen therapies when they may not be benefitting, and, conversely may not be treating the patients that might actually benefit. There is a real need to better identify the patients who are both at most risk of late distant recurrence, and most likely to benefit from EET.

This prospective study included 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I.

Breast Cancer Index (BCI) is a gene expression-based test and is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. The purpose of this prospective study was to assess the impact of BCI on: physician EET recommendations; physician confidence; patient satisfaction, anxiety, and decision-conflict; and the cost impact of BCI.

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BRCA Testing Shifts From Cancer Patients to Unaffected Women

MedicalResearch.com Interview with:

Fangjian Guo, MD, PhD Department of Obstetrics and Gynecology Center for Interdisciplinary Research in Women’s Health University of Texas Medical Branch Galveston TX

Dr. Fangjian Guo

Fangjian Guo, MD, PhD
Department of Obstetrics and Gynecology
Center for Interdisciplinary Research in Women’s Health
University of Texas Medical Branch
Galveston TX

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

Response: BRCA testing in patients diagnosed with early-onset breast or ovarian cancer can identify women with high-risk mutations, which can guide treatment. Women who learn they have a high-risk mutation may also want to inform family members that they may also carry a high-risk mutation.

Additionally, BRCA testing can be used to identify high-risk mutation carriers before they develop breast or ovarian cancer. Carriers can then manage their cancer risks with screening (MRI/mammogram), chemoprevention, or prophylactic surgery. Current guidelines recommend BRCA testing for individuals who are considered high-risk for breast or ovarian cancer based on personal or family history.  However, this practice fails to identify most BRCA mutation carriers. It is estimated that more than 90% of mutation carriers have not been identified. One of the issues is that many women who do get tested are actually low-risk and do not have any personal or family history of breast or ovarian cancer.

This study assessed how BRCA testing was used in the US health care system during the past decade. We found that in 2004 most of the tests (75.7%) were performed in patients who had been diagnosed with breast or ovarian cancer. Only 24.3% of tests were performed in unaffected women. However, since 2006, the proportion of BRCA tests performed in unaffected women has increased sharply, with over 60% of the tests performed in unaffected women in 2014.

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70-Gene Signature Changes 50% of Breast Cancer Chemotherapy Advice

MedicalResearch.com Interview with:
Anne Kuijer, MD

Departments of Surgery and Radiology
University Medical Center Utrecht and
Thijs van Dalen, PhD
Department of Surgery
Netherlands Cancer Institute, Amsterdam

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

Response: In recent years it has become evident that clinicopathological factors fail to accurately determine prognosis in hormone receptor positive early stage breast cancer patients at intermediate risk of developing metastases. Gene-expression profiles, such as the 70-gene signature (MammaPrint) are therefore increasingly used for chemotherapy decision-making. In the current multicentre study we assessed the impact of 70-gene signature use on chemotherapy decisions in these patients. We demonstrated that, without the use of the 70-gene signature, half of patients was advised chemotherapy, which reflects the current controversy regarding chemotherapy benefit. Use of the 70-gene signature changed the chemotherapy advice in half of all patients and adherence to the 70-gene signature result was high.

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Racial Disparities in Genetic Testing of Women With Breast Cancer

MedicalResearch.com Interview with:

Cary P. Gross, MD Section of General Internal Medicine Yale University School of Medicine New Haven, CT

Dr. Cary Gross

Cary P. Gross, MD
Section of General Internal Medicine
Yale University School of Medicine
New Haven, CT

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

Response: Prior work has demonstrated racial and socioeconomic disparities in breast cancer diagnosis, treatment, and outcomes.  As the oncology field has progressed over the past decade, the use of genetic testing to guide treatment decisions is one of the most exciting new developments.

Our team was concerned that these new gene tests, which can offer important benefits, may have the potential to exacerbate disparities further.  That is, if there is unequal access to gene testing among patients for whom it is recommended, then our progress against cancer will not be equitably shared among people of all races and ethnicities.

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Drug For Diabetic Neuropathy May Also Target an Aggressive Form of Breast Cancer

MedicalResearch.com Interview with:
Chenfang Dong
Department of Pathology and Pathophysiology
Zhejiang Key Laboratory for Disease Proteomics
Zhejiang University School of Medicine
Hangzhou China 

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 an aggressive clinical history, early recurrence, distant metastasis and shorter survival. The treatment of BLBC is an unmet medical need due to the absence of effective targeted therapies and poor response to standard chemotherapy. Therefore, elucidating the determinants of aggressiveness and identifying the relevant targets in BLBC are urgently needed. In this study, we report that aldo-keto reductase 1 member B1 (AKR1B1) overexpression occurs specifically in BLBC and predicts poor prognosis in breast cancer patients.

Our data reveal that AKR1B1 as a key modulator of tumor aggressiveness provides tumorigenic and metastatic advantage in basal-like breast cancer through a positive regulatory feedback loop that activates the EMT program and enhances CSC-like properties. Interestingly, epalrestat, the only AKR1B1 inhibitor that has been approved in Japan for the targeted treatment of diabetic complications, significantly inhibited cancer cell migration and invasion in vitro, suppressed tumorigenicity and metastasis of BLBC cells in mice models, displaying potent efficacy against BLBC.

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Genetic Variant of p53 Gene May Explain Increased Breast Cancer Risk in African American Women

MedicalResearch.com Interview with:

Maureen E. Murphy, Ph.D. Professor and Program Leader, Molecular and Cellular Oncogenesis Program Associate Vice President for Faculty Affairs Associate Director for Education and Career Development The Wistar Institute Philadelphia, PA 19104

Dr. Murphy

Maureen E. Murphy, Ph.D.
Professor and Program Leader, Molecular and Cellular Oncogenesis Program
Associate Vice President for Faculty Affairs
Associate Director for Education and Career Development
The Wistar Institute
Philadelphia, PA 19104

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

Response: The Murphy group discovered a coding-region variant of the p53 tumor suppressor gene, called Pro47Ser, that exists in individuals of African descent. In previous studies this group reported that this amino acid change reduces the ability of p53 to function as a tumor suppressor.

In this study, African American women from two different large cohorts were assessed for the incidence of the Pro47Ser variant in pre-menopausal breast cancer. A modest but statistically significant association was found between Pro47Ser and pre-menopausal breast cancer.

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Precision Therapy In Early Stages For Triple Negative Breast Cancer

MedicalResearch.com Interview with:
Eran Andrechek, PhD

Eran Andrechek, PhD Associate Professor Department of Physiology Michigan State University East Lansing, MI

Associate Professor
Department of Physiology
Michigan State University
East Lansing, MI 

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

Response: Of the various types of breast cancer, triple negative breast cancer (lacking estrogen receptor, progesterone receptor and HER2) has the worst outcome and is largely limited to chemotherapy for treatment.  Other types can be treated with personalized medicine, resulting in better outcome.  For instance, a HER2+ve breast cancer can be treated with Herceptin, which targets HER2 itself.  The fact that triple negative breast cancer lacks these sort of targeted treatments presents a clear need in breast cancer therapy.

The goal of this study was to bring together our computational work using large databases from breast cancer with research into therapeutic options.  Essentially we wanted to ask if we could use patterns in what genes were being expressed to predict optimal therapy for triple negative breast cancer.  Continue reading