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Oncotype Dx

Amirali Salmasi, Jonathan Said, Alan W Shindel, Pooria Khoshnoodi, Ely R Felker, Anthony E Sisk, Tristan Grogan, Debbie McCullough, John Bennett, Helen Bailey, H Jeffrey Lawrence, David A Elashoff, Leonard S Marks, Steven S Raman, Phillip G Febbo, Robert E Reiter
PURPOSE: Multiparametric MRI (mpMRI) and biopsy-based molecular tests such as the 17-gene Oncotype DX® Genomic Prostate Score™ (GPS) assay are increasingly used to improve risk stratification in men with clinically localized prostate cancer (PCa). The GPS assay was previously shown to be a significant independent predictor of adverse pathology (AP) at radical prostatectomy (RP) in men diagnosed with systematic biopsies only. We therefore investigated the ability of GPS to predict AP in the setting of MRI-guided prostate biopsy...
March 7, 2018: Journal of Urology
Zhen Rong Siow, Richard H De Boer, Geoffrey J Lindeman, G Bruce Mann
The Oncotype DX® assay was developed to address the need for optimizing the selection of adjuvant systemic therapy for patients with estrogen receptor (ER)-positive, lymph node-negative breast cancer. It has ushered in the era of genomic-based personalized cancer care for ER-positive primary breast cancer and is now widely utilized in various parts of the world. Together with several other genomic assays, Oncotype DX has been incorporated into clinical practice guidelines on biomarker use to guide treatment decisions...
2018: International Journal of Women's Health
Gary H Tozbikian, Debra L Zynger
In breast cancer, human epidermal growth factor receptor 2 (HER2) status is determined by immunohistochemistry (IHC) and/or in situ hybridization. Oncotype DX also reports HER2 status by an rt-PCR-based assay. Assay concordance between IHC and fluorescent in situ hybridization (FISH) (including alternative probe HER2 FISH) vs Oncotype DX HER2 rt-PCR has not been described in the post-2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guideline revision setting. We performed a retrospective review of HER2 equivocal invasive breast carcinoma from 2014 to 2016 with the Oncotype DX HER2 result...
March 2, 2018: Breast Journal
Ivana Sestak, Richard Buus, Jack Cuzick, Peter Dubsky, Ralf Kronenwett, Carsten Denkert, Sean Ferree, Dennis Sgroi, Catherine Schnabel, Frederick L Baehner, Elizabeth Mallon, Mitch Dowsett
Importance: Multiple molecular signatures are available for managing estrogen receptor (ER)-positive breast cancer but with little direct comparative information to guide the patient's choice. Objective: To conduct a within-patient comparison of the prognostic value of 6 multigene signatures in women with early ER-positive breast cancer who received endocrine therapy for 5 years. Design, Setting, and Participants: This retrospective biomarker analysis included 774 postmenopausal women with ER-positive ERBB2 (formerly HER2)-negative breast cancer...
February 15, 2018: JAMA Oncology
Dean A Shumway, Chandler M McLeod, Monica Morrow, Yun Li, Allison W Kurian, Aaron Sabolch, Ann S Hamilton, Kevin C Ward, Steven J Katz, Sarah T Hawley, Reshma Jagsi
PURPOSE: To evaluate patient experiences with decisions regarding radiation therapy (RT) for ductal carcinoma in situ (DCIS), and to assess clinician views on the role of RT for DCIS with favorable features in the present era. METHODS AND MATERIALS: A sample of women with newly diagnosed breast cancer from the population-based Georgia and Los Angeles County Surveillance, Epidemiology, and End Results (SEER) registries were sent surveys approximately 2 months after undergoing breast-conserving surgery (BCS), with a 70% response rate...
January 9, 2018: International Journal of Radiation Oncology, Biology, Physics
Ashirbani Saha, Michael R Harowicz, Weiyao Wang, Maciej A Mazurowski
PURPOSE: To determine whether multivariate machine learning models of algorithmically assessed magnetic resonance imaging (MRI) features from breast cancer patients are associated with Oncotype DX (ODX) test recurrence scores. METHODS: A set of 261 female patients with invasive breast cancer, pre-operative dynamic contrast enhanced magnetic resonance (DCE-MR) images and available ODX score at our institution was identified. A computer algorithm extracted a comprehensive set of 529 features from the DCE-MR images of these patients...
February 9, 2018: Journal of Cancer Research and Clinical Oncology
Sofia Torres, Maureen Trudeau, Sonal Gandhi, Ellen Warner, Sunil Verma, Kathleen I Pritchard, Teresa Petrella, Mark Hew-Shue, Calvin Chao, Andrea Eisen
BACKGROUND: The 21-gene Recurrence Score (RS) assay is only reimbursed in Ontario for node-negative and micrometastatic node-positive (N+) early-stage breast cancer (EBC). We carried out a prospective study to evaluate the impact of the assay on treatment decisions for women with N+ EBC. Subjects, Materials, and Methods . Women with estrogen receptor-positive, human epidermal growth receptor 2-negative EBC and one to three positive axillary lymph nodes, who were candidates for adjuvant chemotherapy in addition to hormonal treatment, but in whom the benefit of chemotherapy was uncertain, were eligible...
January 25, 2018: Oncologist
Neal Bhutiani, Michael E Egger, Nicolás Ajkay, Charles R Scoggins, Robert Cg Martin, Kelly M McMasters
INTRODUCTION: A growing body of evidence supports the use of multigene signature panels (MSPs) in predicting recurrence risk in patients with invasive breast cancer. This study aimed to evaluate trends in MSP use over time and the effect of MSPs on administration of postoperative chemotherapy. METHODS: The National Cancer Database was queried for all women with invasive breast cancer who underwent resection between 2011 and 2014 and had information regarding performance of an MSP, hormone receptor (HR) status, and receipt of chemotherapy...
January 20, 2018: Journal of the American College of Surgeons
Julie A Lynch, Megan P Rothney, Raoul R Salup, Cesar E Ercole, Sharad C Mathur, David A Duchene, Joseph W Basler, Javier Hernandez, Michael A Liss, Michael P Porter, Jonathan L Wright, Michael C Risk, Mark Garzotto, Olga Efimova, Laurie Barrett, Brygida Berse, Michael J Kemeter, Phillip G Febbo, Atreya Dash
BACKGROUND: Active surveillance (AS) has been widely implemented within Veterans Affairs' medical centers (VAMCs) as a standard of care for low-risk prostate cancer (PCa). Patient characteristics such as age, race, and Agent Orange (AO) exposure may influence advisability of AS in veterans. The 17-gene assay may improve risk stratification and management selection. OBJECTIVES: To compare management strategies for PCa at 6 VAMCs before and after introduction of the Oncotype DX Genomic Prostate Score (GPS) assay...
January 2018: American Journal of Managed Care
Ian S Fentiman
Important differences have begun to emerge concerning the molecular profile of female and male breast cancer which may prove to be of therapeutic value. This review examined all the available data on the genomics of MBC. Most male cancers are ER+ve but without a corresponding increase in PR positivity and only a weaker association with estrogen-controlled markers such as PS2, HSP27 and Cathepsin-D. HER2 +ve cancers are rare in males and the role of androgen receptor is controversial. Although the Luminal A phenotype was the most frequent in both MBC and FBC, no Luminal B or HER2 phenotypes were found in males and the basal phenotype was very rare...
January 6, 2018: Breast: Official Journal of the European Society of Mastology
Jane Meisel, Chao Zhang, Cameron Neely, Pia Mendoza, Shuo You, Tatiana Han, Yuan Liu, Aysegul A Sahin, Ruth O'Regan, Xiaoxian Li
INTRODUCTION: Hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancers without lymph node metastasis have good prognosis. We compared the prognosis of hormone receptor-positive, HER2-negative, lymph node-negative cancers with Oncotype DX score ranges of 1 to 10 (1-10 group) and 11 to < 18 (11-18 group). PATIENTS AND METHODS: A total of 107 cases in the 1-10 group and 225 cases in the 11-18 group were reviewed. All patients received surgery...
December 14, 2017: Clinical Breast Cancer
Satbir Singh Thakur, Haocheng Li, Angela M Y Chan, Roxana Tudor, Gilbert Bigras, Don Morris, Emeka K Enwere, Hua Yang
Ki67 is a commonly used marker of cancer cell proliferation, and has significant prognostic value in breast cancer. In spite of its clinical importance, assessment of Ki67 remains a challenge, as current manual scoring methods have high inter- and intra-user variability. A major reason for this variability is selection bias, in that different observers will score different regions of the same tumor. Here, we developed an automated Ki67 scoring method that eliminates selection bias, by using whole-slide analysis to identify and score the tumor regions with the highest proliferative rates...
2018: PloS One
R Colomer, I Aranda-López, J Albanell, T García-Caballero, E Ciruelos, M Á López-García, J Cortés, F Rojo, M Martín, J Palacios-Calvo
This consensus statement revises and updates the recommendations for biomarkers use in the diagnosis and treatment of breast cancer, and is a joint initiative of the Spanish Society of Medical Oncology and the Spanish Society of Pathology. This expert group recommends determining in all cases of breast cancer the histologic grade and the alpha-estrogen receptor (ER), progesterone receptor, Ki-67 and HER2 status, in order to assist prognosis and establish therapeutic options, including hormone therapy, chemotherapy and anti-HER2 therapy...
December 22, 2017: Clinical & Translational Oncology
Chieh-Yu Lin, Kelly Mooney, Winward Choy, Soo-Ryum Yang, Keegan Barry-Holson, Kathleen Horst, Irene Wapnir, Kimberly Allison
Given the increased detection rates of ductal carcinoma in situ (DCIS) and the limited overall survival benefit from adjuvant breast irradiation after breast-conserving surgery, there is interest in identifying subsets of patients who have low rates of ipsilateral breast tumor recurrence such that they might safely forgo radiation. The Oncotype DCIS score is a reverse transcription-PCR (RT-PCR)-based assay that was validated to predict which DCIS cases are most likely to recur. Clinically, these results may be used to assist in selecting which patients with DCIS might safely forgo radiation therapy after breast-conserving surgery; however, little is currently published on how this test is being used in practice...
December 15, 2017: Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc
Peter S Hall, Alison Smith, Claire Hulme, Armando Vargas-Palacios, Andreas Makris, Luke Hughes-Davies, Janet A Dunn, John M S Bartlett, David A Cameron, Andrea Marshall, Amy Campbell, Iain R Macpherson, Dan Rea, Adele Francis, Helena Earl, Adrienne Morgan, Robert C Stein, Christopher McCabe
BACKGROUND: Precision medicine is heralded as offering more effective treatments to smaller targeted patient populations. In breast cancer, adjuvant chemotherapy is standard for patients considered as high-risk after surgery. Molecular tests may identify patients who can safely avoid chemotherapy. OBJECTIVES: To use economic analysis before a large-scale clinical trial of molecular testing to confirm the value of the trial and help prioritize between candidate tests as randomized comparators...
December 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Michelle G Rath, Lorenz Uhlmann, Marita Fiedler, Joerg Heil, Michael Golatta, Christine Dinkic, Andre Hennigs, Sarah Schott, Veronika Ernst, Thorsten Koch, Christof Sohn, Cosima Brucker, Joachim Rom
PURPOSE: Breast cancer is the leading cause of death from cancer in women and the most common cancer in the world [1]. To date, many patients with estrogen-receptor-positive (ER+) breast cancer are overtreated with chemotherapy when the rationale for adjuvant chemotherapy is based on clinicopathologic parameters. Different studies were able to demonstrate that a 21-gene expression assay (Oncotype DX® Genomic Health, Redwood City, CA) can predict the benefit from adjuvant chemotherapy in ER+ breast cancers [2, 3] and provide additional prognostic information independent of clinicopathological features [4]...
February 2018: Archives of Gynecology and Obstetrics
Kamaljeet Singh, Xin He, Elizabeth T Kalife, Shahrzad Ehdaivand, Yihong Wang, C James Sung
PURPOSE: Oncotype Dx (ODx) is a multigene assay that is prognostic and predictive in estrogen receptor (ER) positive early breast cancer. ODx recurrence score (RS) is reported to be histologic grade dependent. Relationship of RS with breast cancer histologic subtypes is unknown. This study was designed to assess the relationship of histologic subtype with RS. Histologic grade dependence of RS was also investigated. METHODS: Results of consecutive ODx tests (1/2007-7/2016) from two institutions were reviewed...
February 2018: Breast Cancer Research and Treatment
Mayako Terao, Naoki Niikura, Yasuhiro Suzuki, Norihiko Sengoku, Hitoshi Arioka, Takashi Ishikawa, Koichiro Tsugawa, Yutaka Tokuda
OBJECTIVE: Many different options for adjuvant chemotherapy are recommended in guidelines for the treatment of breast cancer. Therapeutic strategies vary among physicians. The major goals for this project were to gain a better understanding of how biomarkers are integrated into practice and how physicians select adjuvant chemotherapy. METHODS: We assembled a questionnaire with 23 example scenarios of breast cancer cases, including 6 items relevant to postoperative adjuvant therapy...
December 20, 2017: Tokai Journal of Experimental and Clinical Medicine
Nicole Mittmann, Craig C Earle, Stephanie Y Cheng, Jim A Julian, Farah Rahman, Soo Jin Seung, Mark N Levine
Purpose The 21-gene assay Oncotype Dx (Genomic Health, Redwood City, CA) test is used to aid the decision about chemotherapy in patients with hormone receptor-positive breast cancer who received endocrine therapy. Economic studies to support test adoption used decision-analytic models with assumptions and data derived from disparate sources. The objective was to evaluate whether the 21-gene assay test resulted in an overall cost expense or saving to the health system. Patients and Methods One thousand participants enrolled in a field evaluation study, were linked to population-level health system administrative databases, and were observed for 20 months...
January 20, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
David J Press, Abiola Ibraheem, M Eileen Dolan, Kathleen H Goss, Suzanne Conzen, Dezheng Huo
PURPOSE: To examine racial/ethnic disparities in Oncotype DX (ODX) testing among patients with node-negative, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers and possible racial/ethnic disparities in chemotherapy receipt following ODX testing within Recurrence Score (RS) category (Not Done, Low, Intermediate, High), as well as chemotherapy receipt time trends within RS categories. METHODS: A retrospective cohort list of 125,288 women who were potentially indicated for ODX testing from 2010 to 2014 was obtained using the National Cancer Database...
February 2018: Breast Cancer Research and Treatment
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