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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