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Oncotype Dx

Frederick L Baehner
In vitro diagnostic multivariate index assays are highly complex molecular assays that can provide clinically actionable information regarding the underlying tumour biology and facilitate personalised treatment. These assays are only useful in clinical practice if all of the following are established: analytical validation (i.e., how accurately/reliably the assay measures the molecular characteristics), clinical validation (i.e., how consistently/accurately the test detects/predicts the outcomes of interest), and clinical utility (i...
2016: Ecancermedicalscience
Yesim Gökmen-Polar, Sunil Badve
Heat shock transcription factor 1 (HSF1), a key regulator of the heat-shock response, is deregulated in many cancers. HSF1 can mediate cancer cell survival and metastasis. High levels of HSF1 have been associated with poor prognosis in breast cancer. The nature of HSF1 upregulation needs to be validated in different cohorts to further validate its prognostic utility in breast cancer.We first evaluated its expression in a cohort of breast cancer tissue microarrays with Oncotype DX recurrence scores available using immunohistochemistry...
October 4, 2016: Oncotarget
Atilla Soran, Rohit Bhargava, Ronald Johnson, Gretchen Ahrendt, Marguerite Bonaventura, Emilia Diego, Priscilla F McAuliffe, Merida Serrano, Ebru Menekse, Efe Sezgin, Kandace P McGuire
BACKGROUND: Oncotype DX® test is beneficial in predicting recurrence free survival in estrogen receptor positive (ER+) breast cancer. Ability of the assay to predict response to neoadjuvant chemotherapy (NCT) is less well-studied. OBJECTIVE: We hypothesize a positive association between the Oncotype DX® recurrence score (RS) and the percentage tumor response (%TR) after NCT. METHODS: Pre-therapy RS was measured on core biopsies from 60 patients with ER+, HER2- invasive breast cancer (IBC) who then received NCT...
July 28, 2016: Breast Disease
Hadar Goldvaser, Shulamith Rizel, Daniel Hendler, Victoria Neiman, Daniel Shepshelovich, Tzippy Shochat, Aaron Sulkes, Baruch Brenner, Rinat Yerushalmi
Purpose. To evaluate the associations between metformin, insulin, statins, and levothyroxine and breast cancer characteristics and outcome. Methods. Retrospective chart review of patients treated in our institute for early estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative breast cancer, whose tumors were sent to Oncotype DX (ODX) analysis. Patients were grouped according to medications usage during the time of breast cancer diagnosis. Each group was compared to the rest of the study population...
2016: International Journal of Endocrinology
C Markopoulos, C van de Velde, D Zarca, V Ozmen, R Masetti
Breast cancer (BC) has historically been treated as a single disease entity; however, in the last decade, insights into its molecular heterogeneity have underpinned the development/commercialisation of several genomic tools whose goal is to guide patient management in early BC. These include the Oncotype DX(®) Breast Recurrence Score™ assay, MammaPrint(®), Prosigna(®), and EndoPredict(®). Although these assays are similar in that they are all multigene assays reflecting risk of recurrence, they differ substantially in the technological platform used to measure gene expression; the number and identity of genes assessed; the patient populations used for development and validation; and the level of evidence supporting clinical utility...
August 31, 2016: European Journal of Surgical Oncology
Ann C Raldow, David Sher, Aileen B Chen, Abram Recht, Rinaa S Punglia
PURPOSE: The Oncotype DX DCIS Score short form (DCIS Score) estimates the risk of an ipsilateral breast event (IBE) in patients with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery without adjuvant radiation therapy (RT). We determined the cost effectiveness of strategies using this test. MATERIALS AND METHODS: We developed a Markov model simulating 10-year outcomes for 60-year-old women eligible for the Eastern Cooperative Oncology Group E5194 study (cohort 1: low/intermediate-grade DCIS, ≤ 2...
September 12, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Lindsay A Renfro, Nan Zhang, Margarita Lopatin, Calvin Chao, Steven R Alberts
BACKGROUND: The Oncotype DX colon cancer assay is a validated predictor of recurrence risk in patients with resected stage II colon cancer. We previously reported that Oncotype DX led to a change in treatment recommendations for 45% of patients with T3 mismatch repair proficient (MMR-P) stage II tumors in a prospective study. In the present study, we report the assay's influence on patient treatment decisions, physician confidence, concordance between physicians and patients, and patient decisional conflict...
August 9, 2016: Clinical Colorectal Cancer
David Romo-Bucheli, Andrew Janowczyk, Hannah Gilmore, Eduardo Romero, Anant Madabhushi
Early stage estrogen receptor positive (ER+) breast cancer (BCa) treatment is based on the presumed aggressiveness and likelihood of cancer recurrence. Oncotype DX (ODX) and other gene expression tests have allowed for distinguishing the more aggressive ER+ BCa requiring adjuvant chemotherapy from the less aggressive cancers benefiting from hormonal therapy alone. However these tests are expensive, tissue destructive and require specialized facilities. Interestingly BCa grade has been shown to be correlated with the ODX risk score...
2016: Scientific Reports
Raquel A Nunes, Lynette Wray, Mihriye Mete, Pia Herbolsheimer, Karen L Smith, Lana Bijelic, Marc E Boisvert, Sandra M Swain
Breast cancer in African-American females (AAF) has a less favorable outcome than that in Caucasians. More information is needed regarding its biology. We evaluated gene expression in tumors from AAF presenting with early stage or locally advanced breast cancer using MammaPrint(®), BluePrint (®) (molecular subtype) and TargetPrint (®) [estrogen receptor (ER), progesterone receptor, and Human Epidermal Growth Factor Receptor 2 (HER2) mRNA levels]. Genomic information was correlated with clinical and pathologic characteristics and Oncotype DX(®) Recurrence Score(®) (RS)...
October 2016: Breast Cancer Research and Treatment
Joan Albanell, Christer Svedman, Joseph Gligorov, Simon D H Holt, Gianfilippo Bertelli, Jens-Uwe Blohmer, Roman Rouzier, Ana Lluch, Wolfgang Eiermann
PURPOSE: The 21-gene Recurrence Score assay (Oncotype DX) provides prognostic/predictive information in oestrogen receptor positive (ER+) early breast cancer, but access/reimbursement has been limited in most European countries in the absence of prospective outcome data. Recently, two large prospective studies and a real-life 5-year outcome study have been reported. We performed a pooled analysis of prospective European impact studies to generate robust data on impact of use in different clinical subgroups...
October 2016: European Journal of Cancer
Hadar Goldvaser, Shulamit Rizel, Daniel Hendler, Victoria Neiman, Daniel Shepshelovich, Tzippy Shochat, Aaron Sulkes, Baruch Brenner, Rinat Yerushalmi
PURPOSE: To evaluate the association between angiotensin receptor blocker (ARB) usage and breast cancer characteristics and outcomes. METHODS: All patients who were treated in our institute for estrogen receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer between April 2005 and March 2012 and whose tumors were sent for Oncotype-DX analysis were included. Medical records were retrospectively reviewed. Data regarding ARB usage were retrieved...
2016: Oncology
Daniel L Hertz, N Lynn Henry, Kelley M Kidwell, Dafydd Thomas, Audrey Goddard, Faouzi Azzouz, Kelly Speth, Lang Li, Mousumi Banerjee, Jacklyn N Thibert, Celina G Kleer, Vered Stearns, Daniel F Hayes, Todd C Skaar, James M Rae
Hormone receptor-positive (HR+) breast cancers express the estrogen (ERα) and/or progesterone (PgR) receptors. Inherited single nucleotide polymorphisms (SNPs) in ESR1, the gene encoding ERα, have been reported to predict tamoxifen effectiveness. We hypothesized that these associations could be attributed to altered tumor gene/protein expression of ESR1/ERα and that SNPs in the PGR gene predict tumor PGR/PgR expression. Formalin-fixed paraffin-embedded breast cancer tumor specimens were analyzed for ESR1 and PGR gene transcript expression by the reverse transcription polymerase chain reaction based Oncotype DX assay and for ERα and PgR protein expression by immunohistochemistry (IHC) and an automated quantitative immunofluorescence assay (AQUA)...
September 1, 2016: Physiological Genomics
Hannah Y Wen, Melissa Krystel-Whittemore, Sujata Patil, Fresia Pareja, Zenica L Bowser, Maura N Dickler, Larry Norton, Monica Morrow, Clifford A Hudis, Edi Brogi
BACKGROUND: A 21-gene expression assay (Oncotype DX recurrence score [RS]) that uses reverse transcriptase-polymerase chain reaction is used clinically in patients with early-stage, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast carcinoma (ER+/HER2- BC) to determine both prognosis with tamoxifen therapy and the usefulness of adding adjuvant chemotherapy. Use of the assay is associated with reductions in overall chemotherapy use. The current study examined the treatments and outcomes in patients with low RS...
August 15, 2016: Cancer
Michael J Duffy, Norma O'Donovan, Enda McDermott, John Crown
Recent DNA sequencing and gene expression studies have shown that at a molecular level, almost every case of breast cancer is unique and different from other breast cancers. For optimum management therefore, every patient should receive treatment that is guided by the molecular composition of their tumor, i.e., precision treatment. While such a scenario is still some distance into the future, biomarkers are beginning to play an important role in preparing the way for precision treatment. In particular, biomarkers are increasingly being used for predicting patient outcome and informing as to the most appropriate type of systemic therapy to be administered...
October 2016: Breast: Official Journal of the European Society of Mastology
Ian S Hagemann
CONTEXT: -Molecular diagnostics play a role in the management of many cancers, including breast cancer. OBJECTIVE: -To provide an update on molecular testing in current clinical practice, targeted at practicing pathologists who are not breast cancer specialists. DATA SOURCES: -This study is a narrative literature review. CONCLUSIONS: -In addition to routine hormone (estrogen and progesterone) receptor testing, new and recurrent tumors are tested for HER2 amplification by in situ hybridization or overexpression by immunohistochemistry...
August 2016: Archives of Pathology & Laboratory Medicine
Jessica G Cockburn, Robin M Hallett, Amy E Gillgrass, Kay N Dias, T Whelan, M N Levine, John A Hassell, Anita Bane
BACKGROUND: Lymph node (LN) status is the most important prognostic variable used to guide ER positive (+) breast cancer treatment. While a positive nodal status is traditionally associated with a poor prognosis, a subset of these patients respond well to treatment and achieve long-term survival. Several gene signatures have been established as a means of predicting outcome of breast cancer patients, but the development and indication for use of these assays varies. Here we compare the capacity of two approved gene signatures and a third novel signature to predict outcome in distinct LN negative (-) and LN+ populations...
2016: BMC Cancer
Lei Wei, Jianmin Wang, Erika Lampert, Simon Schlanger, Adam D DePriest, Qiang Hu, Eduardo Cortes Gomez, Mitsuko Murakam, Sean T Glenn, Jeffrey Conroy, Carl Morrison, Gissou Azabdaftari, James L Mohler, Song Liu, Hannelore V Heemers
BACKGROUND: Next-generation sequencing is revealing genomic heterogeneity in localized prostate cancer (CaP). Incomplete sampling of CaP multiclonality has limited the implications for molecular subtyping, stratification, and systemic treatment. OBJECTIVE: To determine the impact of genomic and transcriptomic diversity within and among intraprostatic CaP foci on CaP molecular taxonomy, predictors of progression, and actionable therapeutic targets. DESIGN, SETTING, AND PARTICIPANTS: Four consecutive patients with clinically localized National Comprehensive Cancer Network intermediate- or high-risk CaP who did not receive neoadjuvant therapy underwent radical prostatectomy at Roswell Park Cancer Institute in June-July 2014...
July 20, 2016: European Urology
Richard Buus, Ivana Sestak, Ralf Kronenwett, Carsten Denkert, Peter Dubsky, Kristin Krappmann, Marsel Scheer, Christoph Petry, Jack Cuzick, Mitch Dowsett
BACKGROUND: Estimating distant recurrence (DR) risk among women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer helps decisions on using adjuvant chemotherapy. The 21-gene Oncotype DX recurrence score (RS) is widely used for this. EndoPredict (EPclin) is an alternative test combining prognostic information from an eight-gene signature (EP score) with tumor size and nodal status. We compared the prognostic information provided by RS and EPclin for 10-year DR risk...
November 2016: Journal of the National Cancer Institute
Eun Young Chae, Woo Kyung Moon, Hak Hee Kim, Won Hwa Kim, Joo Hee Cha, Hee Jung Shin, Woo Jung Choi, Wonshik Han, Dong-Young Noh, Sae Byul Lee, Sei Hyun Ahn
A multigene expression assay corresponds to the likelihood of breast cancer recurrence after the initial diagnosis and can be used to guide the decision for additional chemotherapy. However, only few studies have investigated the associations between the imaging features of breast cancer and the results of multigene expression assays. Our study was to identify the relationship between imaging features on ultrasound (US) and the recurrence score (RS) on a 21-gene expression assay in patients with oestrogen receptor (ER)-positive, HER2-negative breast cancer...
2016: PloS One
Rangaswamy Govindarajan, James Posey, Calvin Y Chao, Ruixiao Lu, Trafina Jadhav, Ahmed Y Javed, Awais Javed, Fade A Mahmoud, Raymond U Osarogiagbon, Upender Manne
BACKGROUND: African American (AA) colon cancer patients have a worse prognosis than Caucasian (CA) colon cancer patients, however, reasons for this disparity are not well understood. To determine if tumor biology might contribute to differential prognosis, we measured recurrence risk and gene expression using the Oncotype DX® Colon Cancer Assay (12-gene assay) and compared the Recurrence Score results and gene expression profiles between AA patients and CA patients with stage II colon cancer...
2016: BMC Cancer
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