21-Gene Expression Assay May Clarify Need For Chemotherapy in Early Breast Cancer

MedicalResearch.com Interview with:

Carlos H. Barcenas M.D., M.Sc. Assistant Professor Department of Breast Medical Oncology MD Anderson Cancer Center

Dr. Carlos Barcenas

Carlos H. Barcenas M.D., M.Sc.
Assistant Professor
Department of Breast Medical Oncology
MD Anderson Cancer Center

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

Response: Over the last decade we have realized that we were over-treating many early stage breast cancer patients. In addition to the chemotherapy’s obvious side effects, there are also long term complications for breast cancer survivors. Since 2005, we are using a 21-gene-expression assay that predicts the risk of distant recurrence among early stage breast cancer patients. In 2015, initial results from the international clinical trial, TAILORx, found that women with hormone receptor positive, HER2 and lymph node negative early stage disease that had a low recurrence score (RS) of 0-10 from this assay could have chemotherapy omitted altogether. While these findings changed care for women with a low RS, questions remain regarding the management of women with an intermediate RS, defined by this trial as a RS of 11-25. For our retrospective, single-institution study we identified 1,424 stage I and II breast cancer patients with hormone receptor positive, HER2 and lymph node negative treated between 2005 and 2011 who underwent the 21-gene expression assay. The RS distribution was: 297 (21 percent) scored 0–10; 894 (63 percent) scored 11-25; and 233 (16 percent) scored >25.

Of those groups, 1.7, 15 and 73.4 percent received chemotherapy, respectively. With a median follow up of 58 months, those with a RS of 11-25 had an invasive disease-free survival (IDFS) rate at five years of 92.6 percent, regardless if patients received chemotherapy or not. Among those patients who did not receive chemotherapy, the estimated rates of IDFS and overall survival was 93 percent and 98 percent, respectively, which was comparable to those who did receive chemotherapy.

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For African American Women, Breast Cancer Symptoms Worsen During Initial Treatments

MedicalResearch.com Interview with::

Margaret Q. Rosenzweig PhD, CRNP-C, AOCNP, FAAN Acute and Tertiary Care Department University of Pittsburgh School of Nursing

Margaret Rosenzweig

Margaret Q. Rosenzweig PhD, CRNP-C, AOCNP, FAAN
Acute and Tertiary Care Department
University of Pittsburgh School of Nursing

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

Response: A significant survival disparity still exists between African American and non-Hispanic white women diagnosed with breast cancer. There is evidence that symptom incidence, associated distress, and overall cancer-related distress may be unexplored, important contributing factors. The current study was a secondary, exploratory aim from the Attitudes, Communication, Treatment, and Support (ACTS) Intervention to Reduce Breast Cancer Treatment Disparity study, which is a randomized controlled trial of a psychoeducational intervention to encourage acceptance and adherence to chemotherapy compared with usual care for  African American women with breast cancer. The purpose of the current study was to:

1) describe and compare the number of chemotherapy-related symptoms and associated distress among AA women with breast cancer over the course of chemotherapy at 3 time points (at baseline before initiating chemotherapy, midpoint, and at the completion of chemotherapy); and

2) to describe the relationship between the number of chemotherapy-related symptoms and overall cancer distress compared with the ability to receive at least 85% of the prescribed chemotherapy within the prescribed timeframe.

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Mammaprint Profiling Improves Breast Cancer Adjuvant Treatment Decisions

MedicalResearch.com Interview with:

Dr. med. Rachel Würstlein</strong> Senior Specialist Clinic and Polyclinic for Obstetrics and Gynecology Klinikum der Ludwig-Maximilians-Universität München • Campus Innenstadt Munich

Dr. Rachel Wuerstlein

Dr. med. Rachel Würstlein
Senior Specialist
Clinic and Polyclinic for Obstetrics and Gynecology
Klinikum der Ludwig-Maximilians-Universität München • Campus Innenstadt
Munich

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

Response: Gene expression profiles provide important information on the risk of recurrence, and subtyping in HR+ HER2- early breast cancer, in addition to conventional clinicopathological factors. The PRIMe study was performed by the West German Study Group (WSG) and prospectively investigated the impact of the gene expression tests MammaPrint, a 70-Gene Breast Cancer Recurrence Assay, and the corresponding 80-Gene Molecular Subtyping Assay, BluePrint, on adjuvant chemotherapy decisions for early-stage breast cancer patients.

To do this, a risk assessment (chemotherapy followed by endocrine therapy, versus endocrine therapy alone) for distant metastasis was performed in 452 patients from 27 study centers using conventional clinicopathological factors such as tumour size and grade first, then compared to the results of the gene expression tests MammaPrint and BluePrint. Doctors and patients then reviewed the results and made a decision on the optimal treatment plan, namely in deciding whether or not patients would benefit from, and should therefore be treated with adjuvant chemotherapy.

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Cooling System Can Prevent Hair Loss During Chemotherapy

MedicalResearch.com Interview with:

Julie Rani Nangia, M.D. Assistant Professor Breast Center - Clinic Baylor College of Medicine Houston, TX, US

Dr. Julie Nangia

Julie Rani Nangia, M.D.
Assistant Professor
Breast Center – Clinic
Baylor College of Medicine
Houston, TX, US

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

Response: This study was fueled by the feedback from women undergoing chemotherapy treatment for breast cancer. One of the most distressing side effects of their treatment is hair loss. It robs them of their anonymity and, for many, their femininity. Scalp cooling therapy has been available for a few years in the UK, but has faced obstacles in FDA clearance in the states. The makers of the scalp cooling device used in this study, Paxman Coolers Ltd., have a personal connection to breast cancer, as the company founder’s wife passed away from the disease.

This was the first randomized scalp cooling study, and it shows that the Paxman Hair Loss Prevention System is an effective therapy for reducing chemotherapy-induced alopecia. The results show a 50% increase in hair preservation of grade 0 or 1, meaning use of a scarf or wig is not necessary, in patients who received the scalp cooling therapy as opposed to those who did not.

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False Positive Mammograms Can Lead Women To Delay or Skip Next Exam

MedicalResearch.com Interview with:

Mammogram showing small lesion - Wikipedia

Mammogram showing small lesion
– Wikipedia

Firas Dabbous, PhD
Manager, Patient Centered Outcomes Research
Russell Institute for Research & Innovation
Advocate Lutheran General Hospital
Park Ridge, IL 

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

Response: When women are told that there is something abnormal on their screening mammogram that can cause stress and worry while undergoing additional testing, even when they are later told that there is nothing wrong. We wanted to know if receiving a false positive screening mammogram would cause women to think twice before getting their next screening mammogram, and maybe delay coming back for their next screen. This is important because patients who have a false positive experience may have higher chance to develop breast cancer at a later point in time. Therefore, it is important to understand their screening patterns to better educate and inform them about the importance of adhering to mammography guidelines and emphasize the importance of returning on schedule for their next screens.

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Link Between Soy Consumption and Breast Cancer Remains Complicated

MedicalResearch.com Interview with:
Xiyuan Zhang PhD
and Leena Hilakivi-Clarke, PhD
Professor of Oncology
Georgetown University
Research Building, Room E407
Washington, DC 20057

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

Response: Breast cancer is the most common cancer type in women and it also is the second leading cause of death by cancer in the United States. Every year, over 200,000 new cases of breast cancer are diagnosed in the US and this number reached over 1.5 million worldwide in 2012.

Asian women exhibit much lower risk of breast cancer than Caucasian women, accounting for about one fifth of the breast cancer incidence in Western women. Therefore, researchers have been intensively studying and aiming to decipher the difference between these two populations. Results of previous research from our laboratory and by others, in animal models and humans, indicate that higher intake of soy foods or soy isoflavone genistein during childhood is associated with reduced breast cancer risk. However, findings done using human breast cancer cells indicate that soy isoflavones stimulate growth of breast cancer cells. Thus, there is an apparent controversy regarding soy isoflavones and breast cancer.

70% of all breast cancer cases are estrogen receptor positive (ER+) and are therefore treated with endocrine therapy, including with tamoxifen. Although these treatments effectively prevent recurrence in half of the ER+ breast cancer patients, the other half are resistant or develop resistance to the endocrine therapy and recur. Intriguingly, several studies done using human breast cancer cells in culture or in mice found that soy isoflavone genistein negates tamoxifen’s effects. However, observational studies in women suggest that those patients who consume most soy foods have the lowest risk of breast cancer recurrence. The present study was designed to address these conflicting findings using a preclinical animal model and to determine if lifetime isoflavone intake has different effect on tamoxifen’s ability to treat breast cancer than intake that starts when cancer is detected.

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Better Means to Reduce Breast Density Needed To Decrease Breast Cancer Risk

MedicalResearch.com Interview with:

Natalie Engmann, MSc PhD Candidate, Epidemiology and Translational Science Department of Epidemiology & Biostatistics University of California, San Francisco

Natalie Engmann

Natalie Engmann, MSc
PhD Candidate, Epidemiology and Translational Science
Department of Epidemiology & Biostatistics
University of California, San Francisco

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

Response: Breast density is well-established as a strong risk factor for breast cancer. Our study looked at what proportion of breast cancer cases in the entire population can be attributed to risk factors routinely collected in clinical practice, including breast density, measured using the clinical Breast Imaging and Reporting Scale (BI-RADS) categories.
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Gene Variant That Controls Tumor Metabolism Linked To Breast Cancer Risk

MedicalResearch.com Interview with:

Ulrich Pfeffer, PhD Head of the Functional Genomics lab IRCCS AOU San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genova, Italy

Dr. Ulrich Pfeffer

Ulrich Pfeffer, PhD
Head of the Functional Genomics lab

IRCCS AOU San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy

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

Response: In recent years our knowledge on genetic variants that are associated with the risk to develop breast cancer has grown substantially. In addition to the two breast cancer genes, BRCA1 and BRCA2 we know approximately 100 other genes that are present in the population in two variants. In the presence of a single of these variants the breast cancer risk is slightly increased and several variants together determine a significant increase in risk. We also know that certain variants are associated with specific subtypes of breast cancer such as the estrogen receptor positive breast cancer.

We show in our work for the first time that some of these variants are more frequent in breast cancers that carry a specific somatic, non-inherited, mutation. In particular, we show this for the most frequent somatic mutation in breast cancer, PIK3CA, a gene involved in the control of tumor metabolism and many other aspects, a fundamental gene. The knowledge of this association tells us a lot on cancer biology. But most important, it might help to design specific prevention strategies. Since when you carry a germline allele that is associated with a specific somatic mutation you know your risk of a specific molecular type of breast cancer and eventually you can do something specific to prevent it.

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Breast and Prostate Cancer Screenings Have Similar Potential for OverDiagnosis

MedicalResearch.com Interview with:
Karsten Juhl Jørgensen, MD, Dr. MedSci
The Nordic Cochrane Centre
Rigshospitalet, Copenhagen 

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

Response: Our systematic Cochrane review of the original randomised breast screening trials showed substantial conflict between their estimates of the benefit. Some trials showed a large benefit, others none or a small benefit. This difference was related to the design of the trials.

The most optimistic trials were those with suboptimal randomisation.

The main findings of our current study support those of the most rigorously performed randomised trials: breast screening does not fulfill its fundamental premise, which is to reduce the occurrence of late stage disease. This means a mortality reduction is unlikely and that use of less invasive surgery due to breast screening is also unlikely.

However, we did find very substantial increases in early stage breast cancer, which persisted over our 17 year observation period. This means that breast screening likely leads to substantial overdiagnosis of breast cancers that would otherwise not have caused health problems during a woman’s lifetime. We estimate that 1 in 3 breast cancers detected in a screened population is likely overdiagnosed.

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ACA: Screening Disparities Fall For Mammograms But Not Colonoscopies

MedicalResearch.com Interview with:

Dr. Gregory Cooper, MD Program Director, Gastroenterology, UH Cleveland Medical Center Co-Program Leader for Cancer Prevention and Control, UH Cleveland Medical Center Professor, Medicine, CWRU School of Medicine Co-Program Leader for Cancer Prevention and Control UH Seidman Cancer Center

Dr. Gregory Cooper

Dr. Gregory Cooper, MD
Program Director, Gastroenterology
UH Cleveland Medical Center
Co-Program Leader for Cancer Prevention and Control, UH Cleveland Medical Center
Professor, Medicine, CWRU School of Medicine
Co-Program Leader for Cancer Prevention and Control
UH Seidman Cancer Center

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

Response: The Affordable Care Act, among other features, removed out of pocket expenses for approved preventive services, and this may have served as a barrier to cancer screening in socioeconomically disadvantaged individuals. If so, then the gap in screening between socioeconomic groups should narrow following the ACA.

The main findings of the study were that although in the pre-ACA era, there were disparities in screening, they narrowed only for mammography and not colonoscopy.

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ER-beta May Identify Breast Cancer Patients For Whom Chemotherapy is Sufficient

MedicalResearch.com Interview with:
Helena Jernström, PhD
Associate Professor in Experimental Oncology
Study Coordinator for Graduate studies Division of Oncology and Pathology
Coordinator of the programmes in statistics and epidemiology for doctoral students at the Medical Faculty, Lund University
Division of Oncology and Pathology, Department of Clinical Sciences, Lund
Lund University Cancer Center/Kamprad
Lund, Sweden

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

Response: There is a need for better predictive markers to guide selection of therapy in breast cancer patients. Estrogen receptor beta (ER-beta) may confer prognostic information beyond what is currently obtained by the established clinical markers, including ER-alpha, which is routinely evaluated.

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First-line ribociclib + letrozole in patients with de novo HR+, HER2- Advanced Breast Cancer

MedicalResearch.com Interview with:

Joyce O'Shaughnessy, MD Co-Chair, Breast Cancer Research Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dr. Joyce O’Shaughnessy

Joyce O’Shaughnessy, MD
Co-Chair, Breast Cancer Research
Texas Oncology-Baylor Charles A. Sammons Cancer Center

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

Response: The MONALEESA-2 trial is a Phase III, randomized, double-blind, international study of LEE011 in combination with letrozole vs. letrozole alone, in postmenopausal women with HR+/HER2- advanced breast cancer who had received no prior systemic therapy for advanced disease.

Because de novo disease has not been previously treated with systemic treatment for early-stage breast cancer, tumors may exhibit a different disease biology, which could result in varied responses compared to patients who experience recurrence of their initial breast cancer. We analyzed a pre-defined subgroup of women with de novo HR+/HER2- advanced breast cancer to better understand the response of LEE011 plus letrozole in this patient population.

In the de novo advanced breast cancer patient sub-group, progression free survival was significantly prolonged; LEE011 plus letrozole reduced the risk of disease progression or death by 55% over letrozole alone (HR=0.448 [95% CI: 0.267–0.750]). The 12-month PFS rate was 82% in the LEE011 plus letrozole arm compared to 66% with letrozole alone.

Most adverse events were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and reduction. The most common all-grade adverse events (≥30% of patients with de novo advanced breast cancer) in the LEE011 plus letrozole arm were neutropenia (70.2%), nausea (48.2%), fatigue (42.1%), alopecia (39.5%), and leukopenia (31.6%).

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