Clinical utility and therapeutic implications of oncotype analysis in patients with breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11084-e11084
Author(s):  
Stephanie A. Williams ◽  
Talar Tatarian ◽  
Christine B. Teal ◽  
Anita P. McSwain ◽  
Robert S. Siegel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
Cancer Patients ◽  
Hormonal Therapy ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Radiation Oncologists ◽  
Medical Oncologists ◽  
Gene Assay

e11084 Background: Oncotype DX is a 21-gene assay developed for early stage, hormone receptor positive breast cancer that generates a Recurrence Score which estimates response to chemotherapy and the likelihood of systemic recurrence at 10 years. It differentiates between patients who would benefit from chemotherapy plus hormonal therapy versus hormonal therapy alone. This study’s goal was to determine if the Recurrence Score affected clinical management at our institution and physicians’ accuracy at predicting Recurrence Scores. Methods: A retrospective review was conducted of 116 breast cancer patients treated over a 7 year period. Clinic notes, pathology reports, and additional relevant information were presented to breast surgeons, oncologists, radiation oncologists, and surgical pathologists. Individual physicians estimated recurrence risks and recommended treatment based on those estimates. The Recurrence Score was revealed and changes in therapeutic recommendations were recorded. Results: Treatment recommendations changed in 43% of patients. 29% had a change from chemotherapy followed by hormone therapy to hormone therapy alone due to a low recurrence score, while 14% initially recommended hormonal therapy were changed to chemotherapy plus hormonal therapy due to an intermediate range score. Surgical oncologists accurately predicted Recurrence Scores 52% of the time, medical oncologists 46%, radiation oncologists 45%, and surgical pathologists 15%. A nested mixed model showed that pathologists were statistically significantly worse at predicting recurrence scores than surgical oncologists, medical oncologists, and radiation oncologists. Conclusions: The Oncotype DX assay changes management of breast cancer patients at our institution, frequently downgrading the intensity of systemic therapy. Clinicians were able to accurately estimate recurrence categories about 50% of the time. We recommend the use of Oncotype DX assay along with assessment of clinicopathologic features of an individual’s disease in eligible patients to enhance the selection of appropriate adjuvant therapy.

Predictors of adjuvant chemotherapy for breast cancer patients with an intermediate Oncotype-DX score: A SEER-based population study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12014-e12014
Author(s):  
Sowmya Goranta ◽  
Tarek Haykal ◽  
Areeg Bala ◽  
Ragheed Al-Dulaimi ◽  
Ghassan Bachuwa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
T Stage ◽  
Grade Iii

e12014 Background: Oncotype-DX Assay is a 21-gene based recurrence score (RS) that helps stratify breast cancer patients based on their risk of recurrence. It is often used to help identify patients that may benefit from adjuvant chemotherapy (AC). Prior to the TAILORx Trial results, there were no guidelines for AC in patients with an intermediate score (18-30). Management of these patients was often at the clinical judgement of the provider. We sought to determine predictors of AC among these patients, and measure treatment effect on survival. Methods: We queried the Surveillance, Epidemiology, and End-Results database for breast cancer patients newly diagnosed between 2010-2015. We included patients with T1-T3, hormone receptor positive, HER2-negative, and lymph node-negative breast cancer with an intermediate RS. Male patients, those younger than 40 years, tumors 5 mm or less, and incomplete records were excluded. Univariate and multivariate analysis was performed to derive independent predictors of AC. Cox Proportional-Hazards Model was done to examine the effect of AC on survival. Results: We included 14,710 patients of whom 4,508 (30.6%) received AC. Patients that received AC were younger (55.4 years [8.8] vs 60.0 [9.7], p < 0.001), grade III or higher (29.8% vs 16.4%, p < 0.001), and had a higher RS (23.9 [3.6] vs 21.5 [3.1], p < 0.001). Higher T stage was associated with a higher rate of patients receiving AC (p < 0.001). Marital status was also associated with AC; a higher proportion of patients who received AC were married (67.9% vs 64.4%, p < 0.001). There was no significant association between race/ethnicity or insurance type with AC. Multivariate analysis showed that RS (OR: 1.24 [1.23-1.26], p < 0.001), T stage (OR: 1.67 [1.21-2.30], p < 0.001), and a grade III tumor (OR: 1.85 [1.64-2.09], p < 0.001) were the strongest predictors of AC. The age decile 80-89 years (OR: 0.05 [0.02-0.10], p < 0.001) was the most negative predictor of AC. AC did not have an effect on 5 year overall survival (97.6% vs 96.0%, p = 0.28). Conclusions: Between 2010-2015, our study shows 30.6% of breast cancers patients with an intermediate Oncotype-DX score were given AC. The decision to treat was largely based on tumor size, grade and age. AC had no effect on overall survival.

Oncotype-DX recurrence score distribution in breast cancer patients with BRCA1/2 mutations

2016 ◽  
Vol 157 (3) ◽  
pp. 511-516 ◽  
Author(s):  
R. Lewin ◽  
A. Sulkes ◽  
T. Shochat ◽  
D. Tsoref ◽  
S. Rizel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Score Distribution ◽  
Oncotype Dx Recurrence Score

scholarly journals Germline variants associated with leukocyte genes predict tumor recurrence in breast cancer patients

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Jean-Sébastien Milanese ◽  
Chabane Tibiche ◽  
Jinfeng Zou ◽  
Zhigang Meng ◽  
Andre Nantel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Cell Function ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Sequencing Data ◽  
Germline Variants ◽  
Gene Signatures

Abstract Germline variants such as BRCA1/2 play an important role in tumorigenesis and clinical outcomes of cancer patients. However, only a small fraction (i.e., 5–10%) of inherited variants has been associated with clinical outcomes (e.g., BRCA1/2, APC, TP53, PTEN and so on). The challenge remains in using these inherited germline variants to predict clinical outcomes of cancer patient population. In an attempt to solve this issue, we applied our recently developed algorithm, eTumorMetastasis, which constructs predictive models, on exome sequencing data to ER+ breast (n = 755) cancer patients. Gene signatures derived from the genes containing functionally germline variants significantly distinguished recurred and non-recurred patients in two ER+ breast cancer independent cohorts (n = 200 and 295, P = 1.4 × 10−3). Furthermore, we compared our results with the widely known Oncotype DX test (i.e., Oncotype DX breast cancer recurrence score) and outperformed prediction for both high- and low-risk groups. Finally, we found that recurred patients possessed a higher rate of germline variants. In addition, the inherited germline variants from these gene signatures were predominately enriched in T cell function, antigen presentation, and cytokine interactions, likely impairing the adaptive and innate immune response thus favoring a pro-tumorigenic environment. Hence, germline genomic information could be used for developing non-invasive genomic tests for predicting patients’ outcomes in breast cancer.

scholarly journals Impact of Oncotype DX testing on ER+ breast cancer treatment and survival in the first decade of use

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Evelien Schaafsma ◽  
Baoyi Zhang ◽  
Merit Schaafsma ◽  
Chun-Yip Tong ◽  
Lanjing Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Temporal Trends ◽  
Recurrence Score ◽  
Low Risk ◽  
Oncotype Dx ◽  
Risk Scores ◽  
Breast Cancer Patients ◽  
Risk Patients

Abstract Background The Oncotype DX breast recurrence score has been introduced more than a decade ago to aid physicians in determining the need for systemic adjuvant chemotherapy in patients with early-stage, estrogen receptor (ER)+, lymph node-negative breast cancer. Methods In this study, we utilized data from The Surveillance, Epidemiology, and End Results (SEER) Program to investigate temporal trends in Oncotype DX usage among US breast cancer patients in the first decade after the introduction of the Oncotype DX assay. Results We found that the use of Oncotype DX has steadily increased in the first decade of use and that this increase is associated with a decreased usage of chemotherapy. Patients who utilized the Oncotype DX test tended to have improved survival compared to patients who did not use the assay even after adjusting for clinical variables associated with prognosis. In addition, chemotherapy usage in patients with high-risk scores is associated with significantly longer overall and breast cancer-specific survival compared to high-risk patients who did not receive chemotherapy. On the contrary, patients with low-risk scores who were treated with chemotherapy tended to have shorter overall survival compared to low-risk patients who forwent chemotherapy. Conclusion We have provided a comprehensive temporal overview of the use of Oncotype DX in breast cancer patients in the first decade after Oncotype DX was introduced. Our results suggest that the use of Oncotype DX is increasing in ER+ breast cancer and that the Oncotype DX test results provide valuable information for patient treatment and prognosis.

scholarly journals Clinical Significance and Genetic Characteristics in HER2 Low Expression Tumors of Hormone Receptor Positive Breast Cancer Patients

2021 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Hormone Receptor ◽  
Disease Free Survival ◽  
Recurrence Score ◽  
Breast Cancer Patients ◽  
Genetic Characteristics ◽  
Significant Difference ◽  
Gene Assay ◽  
Low Expression

Abstract BackgroundHuman epidermal growth factor receptor 2 (HER2) low expressed breast cancer was considered as a distinct subtype different from HER2 negative tumors. We investigated the clinicopathological features and recurrence score (RS) of HER2-low and HER2- patients and their prognostic value in hormone receptor (HR) positive breast cancer.MethodsA total of 2,099 HR-positive primary female breast cancer patients between Jan 2009 and Jan 2019 were collected and tumors with immunohistochemistry 1 + or 2 + with negative in situ hybridization results was defined as HER2 low. We retrospectively compared the clinical and genetical features of HER2-low (n = 1,732) and HER2- (n = 367) breast cancer and theirs impacts on disease-free survival (DFS).ResultsThe HER2 low tumors had a higher ratio of concurrent estrogen receptor (ER) high expression than HER2- patients both at protein level (ER > 90%: 78.2% vs 58.6%, p < 0.01) and mRNA level (Spearman R = 0.5 vs 0.3). Analysis about DFS showed no significant difference between HER2 negative and low subgroups (5-year DFS: 92.3% vs 93.3%, p = 0.83). However, RS range (cut-off: 18 and 30) didn’t maintain its predictive value in HER2 low patients (p = 0.11) unlike that in HER2- group (p = 0.003). Further research for respective gene suggested that proliferation related genes performed well in predicting DFS in HER2- patients but lost its value in HER2 low group (p for interaction < 0.01). Contrarily, higher HER2 module was associated with worse DFS only in HER2 low patients (p = 0.04).ConclusionOur study found that HER2 low expression couldn’t be a prognostic factor in HR + patients. HER2-low patients had a higher proportion of ER high expressed tumors than HER2- ones did. The 21-gene assay and its proliferation module might be less applicable to HER2-low patients compared with HER2- patients.

The first report of multicenter validation study on curebest 95GC breast, a multi-gene assay to predict prognosis of node negative and ER positive breast cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12107-e12107
Author(s):  
Ken-ichi Ito ◽  
Takaaki Oba ◽  
Kenjiro Aogi ◽  
Shozo Ohsumi ◽  
Mina Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Hormonal Therapy ◽  
Validation Study ◽  
Histological Grade ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Gene Assay ◽  
Er Positive ◽  
Positive Breast Cancer

e12107 Background: Curebest™ 95GC Breast (95GC) is one of the multi-gene assays to predict prognosis of node negative and estrogen receptor (ER) - positive breast cancer patients, developed using 95 gene-set without overlap with that used in Oncotype DXⓇ(ref 1). It has been shown to have the capability to classify the “intermediate” patients determined using Recurrence Online (microarray-based simulation model for Oncotype DXⓇ) but was validated only using the data from single institute and public database. Here we report the result of the first multi-center validation study for this multi-gene assay. Methods: ER-positive and T1-2/N0/M0 breast cancer patients who received adjuvant hormonal therapy were enrolled retrospectively. Fresh frozen tissues were applied to the assay, resulting classification into “L” and “H”, which was used for the validation on 5 year recurrence free survival (5Y-RFS) data of each patient. Results: 73 cases out of 150 enrolled cases were eligible and analyzed. 46 patients were classified as “L” whose 5Y-RFS was 96.5% (95%CI:89.5-98.9) while 27 patients were classified as “H” whose 5Y-RFS was 79.0% (95%CI:63.6-88.5). There was a statistically significant difference between RFS of “L” and “H” group by Log-Rank test (p = 0.0016). Significant association with 95GC were seen in histological grade (p = 0.0012), Recurrence Online (p < 0.001) and PAM50 (p < 0.001). The assay could classify the patients of histological grade 2, intermediate group by Recurrence Online (RS > 17, RS < 31) and Luminal B patients into “L” and “H”. Conclusions: Curebest™ 95GC Breast was well validated by this first multi-centered retrospective study on 5Y-RFS of the ER positive, node-negative patients who received only hormonal therapy in adjuvant setting. This result indicates the usefulness of 95GC as a novel multi-gene assay, as it can classify target patients into 2 groups, “H” and “L” according to predicted prognosis of 5Y-RFS. Reference: 1. Naoi et al. Breast Cancer Res Treat (2011) 128:632-641

scholarly journals Oncotype DX Breast Cancer recurrence score resists inter-assay reproducibility with RT2-Profiler Multiplex RT-PCR

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Verena Schildgen ◽  
Mathias Warm ◽  
Michael Brockmann ◽  
Oliver Schildgen
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Cancer Patients ◽  
Single Gene ◽  
Cancer Recurrence ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Predictive Values ◽  
Individual Gene

AbstractThe Oncotype Dx assay is frequently used to test if breast cancer patients can be spared from chemotherapy without negative effects for their future clinical course. However, due to conflicting data on the assay utility, in the recent past its reimbursement situation in Germany was revised; due to continued requests by clinicians for predictive values, our group decided to implement an Oncotype Dx like alternative assay with the objective of obtaining quality and cost optimization. Customized RT2-Profiler assays covering the 21 gene panel of the Oncotype Dx assay were applied to a pilot cohort of breast cancer patients with known Oncotype Dx Recurrence Score (RS). The Ct values obtained with RT2-Profiler-assays were used to calculate the unscaled Recurrence Score (RSu) values and the thereon based RS according to the Oncotype DX assay rules if available. Despite consistent assay performance it was impossible to establish correlations between RT2-Profiler recurrence scores with the respective Oncotype DX values not to mention exact matches. By following the Oncotype DX assay and its interpretation as close as possible we faced several obstructions such as lack of information on RNA amount used, missing units in the single gene expression report, missing references cited in the original study that should explain the determination of the recurrence score formula, and vague information on the normalization of the gene expression impeding the reproduction of Oncotype Dx results in other laboratories. Unfortunately, the Oncotype Dx assay cannot be confirmed by the customized RT2-profiler assay, not least because of the fact that the individual gene measurements are not provided in the medical report, although these are mandatory for the RS calculation. In fact, the “single gene report” only contains unscaled scores of the ER, PR, and Her2 genes without any internationally accepted unit used to describe a transcript quantity. Therefore a direct comparison with the in-house measurement to evaluate its performance is impossible. With regard to our findings and the fact that the Oncotype RS represents a likelihood of the risk of relapse it thus remains impossible to assess the clinical necessity of this assay.

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