Most Women Unaware of Breast Cancer Overdiagnosis and Overtreatment

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

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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Hyperlipidemia Linked To Lower Breast Cancer Mortality, Perhaps Due To Statin Therapy

MedicalResearch.com Interview with:

Dr Rahul Potluri Senior author and founder of the ACALM Study Unit Aston Medical School Aston University Birmingham, UK

Dr. Potluri

Dr Rahul Potluri
Senior author and founder of the ACALM Study Unit
Aston Medical School
Aston University
Birmingham, UK

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

Response: The links between hyperlipidaemia and cancer has been exciting scientists in recent years.  We have previously shown an association with breast cancer and hyperlipidaemia using a cross-sectional dataset in 2014.

In 2016 we showed that in patients with the four main cancers in the UK (namely Breast, Lung, Colon and Prostate) that the presence of hyperlipidaemia improved the long term mortality and prognosis of these patients.  In this study utilising a big data, longitudinal study methodology, we looked at 16043 healthy women above the age of 40 with hyperlipidaemia and compared these to an age and gender matched control sample of 16043 healthy women without high cholesterol. We then followed up these patients and found that subsequent breast cancer rates in the women with hyperlipidaemia were 45% lower. Subsequent mortality in those patients who developed breast cancer was also 40% lower in the hyperlipidaemia group compared to the non-hyperlipidaemia controlled sample.

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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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Herceptin Biosimilar CT-P6 Found Safe and Effective in Early Breast Cancer

MedicalResearch.com Interview with:

Prof Francisco J Esteva MD PhD</strong> Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center

Prof. Esteva

Prof Francisco J Esteva MD PhD
Director of the breast medical oncology program at Perlmutter Cancer Center.
NYU Langone Medical Center

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

Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer.

In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial.

We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar.

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