Oncotype DX Breast Cancer Assay Research Articles

A quality improvement initiative on the utility of the Oncotype DX breast cancer assay in a community hospital.

e13072 Background: Since the advent of Oncotype DX (ODX) breast recurrence score (RS) assay, the use of adjuvant chemotherapy (CT) in the treatment of breast cancer has significantly reduced. This test not only estimates the benefit of CT, but also determines the risk of distant recurrence in patients with early-stage breast cancer with hormone-receptor (ER/PR) positive, human epidermal growth factor receptor (HER) 2-negative, and axillary lymph node negative or positive (1-3 positive nodes) disease. All patients are categorized based on their scores ranging from 0-100 as follows: low (RS≤10), intermediate (RS11-25) and high risk (RS≥26). Further studies proved that adjuvant CT is beneficial in pre-menopausal women with RS 0-25, however offered no benefit to post-menopausal women in the same category. The aim of our study was to assess the implementation of these guidelines in a community hospital in an underserved area. Methods: At Mercy Catholic Medical Center, we performed a retrospective analysis on 303 female patients with newly diagnosed breast cancer, identified between January 2017 – October 2022. We included patients with ER/PR+, HER2-, lymph node negative or positive, who had undergone surgery and were to receive endocrine therapy with or without adjuvant CT. Patients who were lost to follow-up or did not undergo the genetic testing were excluded from the study. We then analyzed the treatment strategies based on RS categories. All patients who did not receive CT was either because it was not indicated (old age, post-menopausal) or patients refused. Results: 81 patients underwent ODX testing among whom, 60.5%, 35.8%, and 3.7% patients were Black, White and Hispanic/Asian, respectively. 1.2%, 9.8%, 18.51%, 34.56%, 35.08% were aged ≤40, 41-50, 51-60, 61-70 and ≥71 years, respectively. Based on the RS, we identified 29.62% in low risk, 56.79% in intermediate risk, and 13.5% in high-risk categories. 100% patients in the high-risk category were prescribed CT and only 7.4% patients with RS 0-25 received CT. 12 patients were found to be lymph node positive, among whom, 3 had RS≥26 and 2 were pre-menopausal, all of whom were prescribed CT. Out of these, 7 were post-menopausal with RS 0-25 and only 1 received CT. Conclusions: Our hospital data suggests that implementation of ODX and adherence to its guidelines has significantly helped avoid CT and its related side effects in the low and intermediate risk categories. Implementation of this cost-effective test has consistently increased in the last two decades and is now an imperative tool in clinical decision-making specially in community hospitals serving underprivileged populations. [Table: see text]

The impact of Oncotype DX breast cancer assay results on clinical practice: a UK experience

BackgroundGenomic tests are increasingly being used by clinicians when considering adjuvant chemotherapy for patients with oestrogen receptor-positive (ER+), human epidermal growth factor 2-negative (HER2−) breast cancer. The Oncotype DX breast recurrence score assay was the first test available in the UK National Health Service. This study looked at how UK clinicians were interpreting Recurrence Scores (RS) in everyday practice.MethodsRS, patient and tumour characteristics and adjuvant therapy details were retrospectively collected for 713 patients from 14 UK cancer centres. Risk by RS-pathology-clinical (RSPC) was calculated and compared to the low/intermediate/risk categories, both as originally defined (RS < 18, 18–30 and > 30) and also using redefined boundaries (RS < 11, 11–25 and > 25).Results49.8%, 36.2% and 14% of patients were at low (RS < 18), intermediate (RS 18–30) and high (RS > 30) risk of recurrence, respectively. Overall 26.7% received adjuvant chemotherapy. 49.2% of those were RS > 30; 93.3% of patients were RS > 25. Concordance between RS and RSPC improved when intermediate risk was defined as RS 11–25.ConclusionsThis real-world data demonstrate the value of genomic tests in reducing the use of adjuvant chemotherapy in breast cancer. Incorporating clinical characteristics or RSPC scores gives additional prognostic information which may also aid clinicians’ decision making.

Abstract OT3-17-03: Impact of the Oncotype DX breast cancer assay on treatment decisions in a UK population of patients with oestrogen receptor positive early breast cancer with 1-3 lymph nodes positive who are candidates for chemotherapy, but for whom the benefits are uncertain - Interim results

Abstract Introduction: The addition of adjuvant chemotherapy to hormonal therapy is recommended for patients with lymph node-positive (LN+ve), estrogen receptor positive (ER+), HER2-ve early breast cancer, despite the fact that many women will remain disease-free even if they do not receive chemotherapy. Therefore, a number of patients with LN+ EBC may be unnecessarily exposed to the toxicities of chemotherapy with no treatment benefit. In the UK, the Oncotype DX® Recurrence Score (RS) is recommended by NICE for routine testing in patients with ER+ HER2-ve, lymph node negative early stage breast cancer. Approximately 32% of newly diagnosed breast cancer patients will have lymph node involvement but do not have distant metastasis at the time of diagnosis. Objectives: Primary objective is to characterize how the results on the Oncotype DX® assay impact the decision-making process of physicians in the UK for women with ER+ HER2-ve EBC with 1-3 lymph nodes involved who are potential candidates for chemotherapy, but for whom the benefits may be uncertain. Secondary objectives include; (1) Assess the impact of the Oncotype DX RS in clinical practice in patients with 1-3 lymph nodes positive EBC, (2)Analyse distribution of RS and (3)Observe the percentage of patients not receiving chemotherapy as a result of the Oncotype DX RS. Methods: Postoperative patients with lymph node positive disease: N=720. Micrometastasis = 70patients, 1 Lymph Node Positive = 400patients, 2 Lymph Node Positive = 200patients &amp; 3 Lymph Node Positive = 50patients (exploratory analysis). Study start date October 2017 to projected study end date of December 2021. INTERIM Results: To date, 194 patients have entered the Oncotype DX Node POS Study since October 2017 from 13 recruiting institutions across the UK. The nodal status is as follows; micrometastasis = 21patients (10%), 1 lymph node positive = 103 patients (53%), 2 lymph node positive = 53 patients (27%) and 3 lymph node positive =17 patients (9%). The average age of patient was 57.5years (range 27-79). Of 194 patients, 189 have received a recurrence score in the 1-3 lymph node positive setting. Average RS was 13.8 (range 0-63). Micrometastasis category received an average RS of 15, 1 LN+ve category received an average RS of 15.5, 2 LN+ve category received an average RS of 15.8 and 3 LN+ve category received an average RS of 20.8. Of 189 patients the decision to administer chemotherapy changed in 140 patients (74%) once the Oncotype DX score had been received. Decision to administer chemotherapy remained the same in 49 patients (26%). This shows that Oncotype DX greatly alters the decision-making process in patients with 1-3 LN+ve, despite the trial not setting a chemotherapy cut-off score. Those patients who received a recurrence score of 18 or below = 129 (68%). Patients who received a recurrence score of above 18 = 60 (32%). The largest nodal category (1 LN+ve) witnessed the highest rate of patients receiving a RS of below 18 (70%), followed by 2 LN+ve (66%) and 3 LN+ve (43%). One patient with 2 lymph nodes positive received a RS of zero. Weak correlation was observed between histopathological factors and recurrence score. Conclusion: Interim results show the use of the Oncotype DX assay in patients with 1-3 lymph node-positive (LN+ve), ER+ HER2-ve, EBC significantly alters the decision-making process in guiding use of chemotherapy. Result show that 74% of patients were spared chemotherapy where there was deemed to be no additional benefit over hormonal therapy alone. This resulted in 140 patients being spared the unnecessary side effects and exposure to toxicities of chemotherapy. This also prevented overtreatment of patients from a healthcare economic cost perspective. Citation Format: Daniel Thomas, William Maxwell, Caroline Archer, Anne Rigg, Tamas Hickish, Jo Dent, Laura Pettit, Marianne Dillon, Christy Goldsmith, Mark Verrill, Ludger Barthelmes, Saira Khawaja, Yousef Sharaiha, Mark Davies, Fawaz Arikat, Sahail Khan, Asma Munir, Anita Huws, Simon DavidHenry Holt. Impact of the Oncotype DX breast cancer assay on treatment decisions in a UK population of patients with oestrogen receptor positive early breast cancer with 1-3 lymph nodes positive who are candidates for chemotherapy, but for whom the benefits are uncertain - Interim results [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-17-03.

P097. The Impact of TAILORx study on the recommendation of chemotherapy - the Warwick experience

Background: The Oncotype DX breast cancer assay provides a marker for risk of distant recurrence and patients in the intermediate risk group were often advised chemotherapy. The TAILORx study showed, in patients over 50 with a risk score of less than 25 and in patients younger than 50, with a risk score less than 20, that chemotherapy could be spared.

Using the National Cancer Data Base (NCDB) and Oncotype DX data to predict adjuvant therapy effect on overall survival (OS) of N0 & N1 breast cancer patients.

e12529Background: The newest 4.2017 version of the NCCN guidelines incorporates the Oncotype DX (ODX) breast cancer (BC) assay into the algorithm for utilization of systemic adjuvant therapy (tx) f...

Abstract P4-09-13: A prognostic predictive model based on the correlation of standard clinicopathologic characteristics with oncotype Dx 21-gene recurrence score for node-negative and ER positive breast cancer

Abstract BACKGROUND: The Oncotype Dx Breast Cancer Assay (21-gene recurrence assay) is a prognostic tool that produces a recurrence score, which estimates the probability of distant recurrence within 10 years, given 5 years of adjuvant endocrine therapy as well as predicts benefit from adjuvant chemotherapy. The primary objective of this study was to explore if standard clinicopathologic variables independently correlate to the recurrence score. As a secondary objective, we explored if a model based on the clinicopathologic variables can accurately predict recurrence score. METHODS: We conducted a retrospective chart review of 507 patients with node-negative, estrogen receptor (ER) positive breast cancer from the UF Health Cancer Center at Orlando Health. Of the 507 patients, 84 did not meet inclusion criteria (n = 423). The following factors were correlated with recurrence score (RS): age, tumor size, ER, PR, ki67, HER2 (IHC), HER2 (FISH), and tumor grade. Although the RS is a continuous variable, scores are also used to categorize patients into three risk groups: low (RS&amp;lt;18), intermediate (18≤RS&amp;lt;31), and high (RS≥31). This study evaluated variation of the HER2 levels within this subset of HER2 negative patients. RESULTS: In univariate analysis, there were no significant correlations between age, ER, tumor size, Ki67 and RS. There were statistically significant correlations between PR (r=-.42, p&amp;lt;.001), HER2 (IHC) (r=.097, p&amp;lt;.05), HER2 (FISH) (r=0.40, p&amp;lt;.001), and tumor grade (r=0.37, p&amp;lt;.001) and RS. As a second step, we used these results and clinical expertise to guide a predictive model. As expected, independently, PR and tumor grade were significant predictors of RS (βs= -.096, .37, respectively; p&amp;lt;.05). However, HER2 (IHC) was not, β=.097, p = .054. As a final step, three pathologic factors (PR, HER2 by IHC, and tumor grade) were used to predict recurrence score. In the multivariate analysis, we found a statistically significant model, (R = 0.54, RAdj = .30; F (3, 399) = 57.17, p &amp;lt; .001), where, PR (β= -.096), HER2 (IHC) (β= 2.007), and tumor grade (β= 4.778). Concordance with the 21-gene assay was as follows: 76.0%, 54.5%, and 66.7% for low, intermediate, and high-risk groups, respectively. As clinical guidelines are not firmly established for the use of chemotherapy in the intermediate risk group it is also valuable to estimate the two-step discordance, an estimated RS that is high, when the 21-Gene recurrence score is low and vice versa. The two-step discordance was 2.2% and 0.0% for the low and high risk groups, respectively. CONCLUSION: The data presented here suggests that it may be possible to create a model based on standard clinicopathologic parameters to predict the 21-gene recurrence score in node-negative, ER positive breast cancer patients. In practice, a 21-gene recurrence score assay is not always possible. We present an option to identify patients whose risk category can be confidently determined from the standard clinicopathologic variables alone, thereby reducing medical cost. Admittedly, this model has not undergone validation nonetheless, the data suggest the potential for a novel; low-cost; high reach diagnostic tool. Citation Format: Mankbadi MR, Luo Y, Yasin M, Ben Khallouq B, Moroose R. A prognostic predictive model based on the correlation of standard clinicopathologic characteristics with oncotype Dx 21-gene recurrence score for node-negative and ER positive breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-09-13.

Constructive Deep Neural Network for Breast Cancer Diagnosis

Abstract The Oncotype DX (ODX) breast cancer assay is the worldwide most common and used Gene Expression Profiling (GEP) test. This ODX assay has a great impact on Adjuvant ChemoTherapy (ACT) decision. However, many standard approaches have been proposed and suggested to practitioners. The accuracy of such methods never reached the highest level. This paper deals with the Breast Cancer Computer Aided Diagnosis (BC-CAD) based on a Deep Constructive Neural Network used for the Recurrence Score (RS) prediction of the ODX assay. The proposed ConstDeepNet algorithm was tested to build two classifiers. In the first architecture, a ”one against all” structure is used where one Deep Neural Network is built for each class. In the second architecture, one DNN is used for the three classes. The proposed BC-CAD algorithm is tested on a real data-set and exhibits good performance. The study data set contains 92 cases carcinoma mammary luminal B with available Oncotype DX test results from 2012 to 2017 taken from the Georges Francois Leclerc cancer centre and the North Trevenans County Hospital located respectively in Dijon and Belfort in France.

188P - The impact of Oncotype DX breast cancer assay results on clinical practice: A UK experience

188P - The impact of Oncotype DX breast cancer assay results on clinical practice: A UK experience

Has the Oncotype DX Breast Cancer Assay influenced the use of chemotherapy? – The Warwick experience

Has the Oncotype DX Breast Cancer Assay influenced the use of chemotherapy? – The Warwick experience

P114 - PONDx, Prospective Multicenter Study of the Oncotype DX Breast Cancer assay: real-life utilization in French clinical practice

P114 - PONDx, Prospective Multicenter Study of the Oncotype DX Breast Cancer assay: real-life utilization in French clinical practice

The Impact of the Oncotype DX Breast Cancer Assay on Treatment Decisions for Women With Estrogen Receptor-Positive, Node-Negative Breast Carcinoma in Hong Kong

BackgroundThe Oncotype DX Breast Cancer Assay is validated to assess risk of distant recurrence and likelihood of chemotherapy (CT) benefit in estrogen receptor-positive ESBC in various populations. In Hong Kong, > 80% of breast cancers are early stage breast cancer (ESBC) and > 60% of these women receive CT. This prospective study measured changes in CT type and recommendations, as well as physician impression of assay impact in a homogenous Chinese population. MethodsConsecutive patients with estrogen receptor-positive, T1-3 N0-1mi M0 ESBC were offered enrollment. After surgery, physicians discussed treatment options with patients, then ordered the assay, then reassessed treatment recommendation considering assay results. Changes in treatment recommendation, CT utilization, physician confidence, and physician rating of influence on their treatment recommendations were measured. ResultsA total of 146 evaluable patients received pre- and post-testing treatment recommendations. CT recommendations (including changes in intensity of CT) were changed for 34 of 146 patients (23.3%; 95% confidence interval, 16.7%-31.0%); change in intensity occurred in 7 of 146 (4.8%). There were 27 changes in treatment recommendations of adding or removing CT altogether (18.5% change; 95% confidence interval, 12.6%-25.8%). CT recommendations decreased from 52.1% to 37.7%, a net absolute reduction of 14.4% (P < .001; 27.6% net relative reduction). Pre-assay, 96% of physicians agreed/strongly agreed that they were confident in their treatment recommendation; post-assay, 90% of physicians agreed/strongly agreed with the same statement. Thirty percent of physicians agreed/strongly agreed that the test had influenced their recommendation, similar to the proportion of changed recommendations. ConclusionsThe Oncotype DX Assay appears to influence physician ESBC adjuvant treatment recommendations in Hong Kong.

Abstract P3-07-17: Analysis of the National cancer data base 2010-2012 oncotype DX breast cancer assay: Lessons learned

Abstract Oncotype DX (OD) 21-gene breast cancer (BC) assay is used for testing of estrogen receptor positive (ER+) early stage BC and provides a low, intermediate or high 10-year risk recurrence score (LRS, IRS, HRS) for BC. Scores are used as guidelines to predict the probability of successfully adding adjuvant chemotherapy (AC) to endocrine therapy (ET) to reduce the risk of BC recurrence. In retrospective analysis of 2 clinical trials, patients (pts) with HRS benefited from addition of AC to ET, no benefits were shown for LRS, and benefits of AC for IRS were not clear. The OD assay has been utilized since 2004, but data on the impact of using assay results in clinical practice across the US are lacking. The TAILORx and RxPONDER prospective clinical trials which are using OD scores are ongoing (results will be available in 2017 and 2022, respectively) and may help clinicians better understand the predictive capabilities of the IRS OD score. We analyzed the current impact of IRS OD score in a retrospective observational study of the National Cancer Data Base (NCDB) (which represents 75% of the US population) from 2010-2012. This time period encompasses the beginning of required recording of molecular assays and the latest data released by NCDB in 4/2015. Demographic and clinical variables of all pts with IRS results were analyzed using frequency statistics, chi-square and logistic regression analysis. Data from 24260/27995 pts with IRS and documented AC information was analyzed. 11520=47.4% pts received AC. Age ranged from 20-90 (mean 58.4, median 59 years); 99.2% were ER+ and females, 2.7% were HER2+; 6143=25.3% had T1a, T1b or T3 tumors; 19791=81.5% were N0, 3684=15.1% N1; 17950=73.6% had ≥G2 tumors and 3389=14% had lymphvascular invasion (LVI). Selected demographic and clinical characteristics of patients (pts) with -/+ chemotherapy (AC) ACAC NoYes# Pts12740=52.6%11520=47.4%**Mean age61.255.3*Race White11328=46.9%9973=41.1%Black868=3.5%966=3.9%*Other431=1.7%491=2%Unknown113=0.4%90=0.3%Insurance (I) Private7181=29.6%8227=33.9%Medicaid550=2.2%646=2.6%Medicare4605=18.9%2201=9%*No I182=0.7%197=0.8%Tumor size mm 1-5487=2%238=1%6-103162=13%1890=7.8%11-508874=36.5%9060=37.3%*&amp;gt;50132=0.5%234=1%*Grade G13450=14.2%1760=7.2%G26887=28.3%6210=25.5%G3 &amp; undifferentiated1775=7.2%3078=12.6%*LVI No9911=40.8%8045=33.1%Yes1288=5.3%2101=8.7%*Stage I9586=39.5%7028=28.9%II2970=12.2%4172=17.1%*III-IV99=0.4%243=1%*Lymph node+ (LN+) 010984=45.2%8807=36.3%1-31346=5.5%2338=9.6%*&amp;gt;328=0.1%154=0.6%**p&amp;lt;.001 **positive predictive value=PPV IRS OD result had poor PPV for the administration of AC (47.4%). AC administration was significantly associated with larger tumors, LN+, LVI, high tumor grade, higher TNM stage, younger age and black race (p&amp;lt;.001), but not with facility type (community/comprehensive/academic-research program), income, or education (p&amp;gt;0.05). Medicare pts were less likely to receive AC than ones with private insurance (p&amp;lt;.001). Our data analysis reveals that additional guidelines for selection of pts for OD testing and new algorithms for AC administration in the IRS subsets are needed. The authors of this abstract solicit a call to action from interested parties on behalf of the patients affected by this conundrum. Citation Format: Orucevic A, Heidel RE, Bell JL. Analysis of the National cancer data base 2010-2012 oncotype DX breast cancer assay: Lessons learned. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-07-17.

Utilization of Oncotype DX testing in a community hospital system: How did this affect patient care?

19 Background: The Oncotype DX Breast Cancer Assay is a multigene assay which quantifies risk of distant recurrence at 10 years and predicts benefit of chemotherapy in women with stage I/II, lymph node negative, estrogen receptor positive breast cancer. This retrospective study examines utilization of Oncotype DX for appropriate patients in a community hospital system. We hypothesize that chemotherapy administration follows the Oncotype DX score recommendation that patients with low recurrence scores not receive chemotherapy and patients with high recurrence scores receive chemotherapy and intermediate recurrence scores receive chemotherapy half of the time. Methods: In this retrospective study, 302 female patients from 1/1/12 – 1/1/14, were identified by breast cancer ICD9 codes from the system’s cancer registry. Data including imaging findings, pathology, and treatment information was then compared using chi square tests for categorical variables and two sample t tests or Wilcoxon rank sum tests for continuous variables. Results: Three hundred two female patients with stage I/II, lymph node negative, HR+, HER2/neu, breast cancer from a community hospital system were identified as appropriate candidates by NCCN guidelines, for Oncotype DX testing between 1/1/12 - 1/1/14. In patients receiving Oncotype DX, mass sizes were larger and were a higher proportion of stage 2 cancers (p &lt; 0.001). Utilization of Oncotype DX in our CoC and NAPBC accredited hospital system was lower than hypothesized with only 73% of patients receiving testing. Following Oncotype DX testing, appropriate treatment ensued 94% of the time (low and high recurrence risk). Intermediate recurrence scores received treatment 36% of the time. Conclusions: In our CoC and NAPBC accredited hospital system, utilization of Onocotype DX testing was lower than hypothesized. For the patients who received testing, expected treatment was administered. Oncotype DX testing when performed influences patient care, however with 27% of patients not receiving testing and 25 % of the time this was due to patient preference, this observation supports that testing not be ordered reflexively, but rather with patient input and appropriate consent.

Correlation of histopathologic features of ductal carcinoma in situ of the breast with the oncotype DX DCIS score

The Oncotype DX Breast Cancer Assay for ductal carcinoma in situ is used to determine local recurrence risk in patients with ductal carcinoma in situ. The results help select patients with low-risk ductal carcinoma in situ who could forgo radiation therapy after conservative surgery. The genes assessed include five proliferation genes, progesterone receptor (PR), and GSTM-1. Our objective was to determine if PR, mitotic counting, or any other pathologic feature of ductal carcinoma in situ could predict the Oncotype DX DCIS Score. We identified 46 cases of ductal carcinoma in situ with a Oncotype DX DCIS Score. In addition to information obtained from routine pathology, we counted mitotic figures in the ductal carcinoma in situ and noted presence of dense chronic inflammatory infiltrate surrounding ductal carcinoma in situ. We found that PR ≥90% (P=0.004), mitotic count ≤1 (P=0.045), estrogen receptor ≥90% (P=0.046), and low nuclear grade (P<0.0001) were associated with a low score. Dense chronic inflammation surrounding ductal carcinoma in situ was associated with a high score (P=0.034).All 13 cases with PR ≥90%, ≤1 mitotic figure and absence of dense chronic inflammation around ductal carcinoma in situ had a low score (100% specificity). A low score was not observed in any case with at least two of the following—negative PR, >1 mitotic figure, and/or presence of dense chronic inflammation around ductal carcinoma in situ (100% specificity). Our study suggests using a combination of PR (≥90% vs negative) with mitotic count in ductal carcinoma in situ (≤1 vs >1) and dense chronic inflammation around ductal carcinoma in situ one could predict the Oncotype DX DCIS score. Mitotic counting and evaluation of immune response might provide prognostic information in ductal carcinoma in situ.

Is There a Role for Oncotype Dx Testing in Invasive Lobular Carcinoma?

Oncotype Dx Breast Cancer Assay is a 21-gene assay used in estrogen receptor (ER)-positive breast cancer to predict benefit from chemotherapy (CT). Tumors are placed into one of three risk categories based on their recurrence score (RS). This paper explores the impact of tumor histopathologic features and Oncotype Dx RS on the treatment plan for invasive lobular carcinoma (ILC). Invasive lobular carcinoma cases submitted for Oncotype Dx testing were identified from a clinical data base. The histopathologic and immunohistochemical features and RS subcategory of each tumor, and treatment regimen and medical oncologic assessments of each patient were reviewed. A total of 135 cases of ILC had RS testing, which represented 15% of all ILC diagnosed at the institution over the time period. 80% of ILC was of the classical subtype and all tumors were ER positive and human epidermal growth factor receptor 2 (HER-2) negative by immunohistochemistry. Sixty three percent of cases were low risk (LR), 35.5% were intermediate risk (IR) and 1.5% were high risk (HR). Both HR cases were pleomorphic ILC. Sixty eight percent of classical ILC had a LR score, while 70% of pleomorphic ILC had an IR score. Patients in the IR category were significantly more likely to undergo CT than patients in the LR category (54% versus 18%; p < 0.0001). In the LR category, those undergoing CT were significantly younger and more likely to have positive lymph nodes (p < 0.05). Qualitative analysis of medical oncologic assessments showed that RS played a role in decision-making on CT in 74% of cases overall. At our institution, Oncotype Dx RS currently plays a role in the management of a proportion of ILC and impacts on treatment decisions.

Impact of the Intermediate Oncotype DX Recurrence Score results on adjuvant treatment recommendations in hormone receptor-positive early breast cancer in a single center.

e11560 Background: The Oncotype DX (ODX) Breast Cancer assay (Genomic Health NC., Redwood City, CA) has been validated as a predictor of the likelihood of chemotherapy benefit in hormone receptor p...

Erratum to: The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis

Erratum to: The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis

Abstract P6-06-15: Cost impact of oncotype Dx® breast cancer assay use in a fully integrated healthcare delivery system

Abstract Background: The Oncotype Dx Breast Cancer Assay (ODX) provides relevant information on the risk of distant recurrence and the treatment effect for adjuvant chemotherapy (ACT) in early stage breast cancer. However, no studies to date have evaluated the impact of ODX use on total and oncology specific costs. The objective of this study was to explore the impact of ODX use on total and oncology specific costs within the Group Health Cooperative health plan. Methods: Our study sample included women diagnosed between 2004-2012 with ER positive, node negative, early stage (I, IIA, or IIB) breast cancer. Data were collected from SEER and automated health plan data. We used multiple logistic regression to model receipt of adjuvant chemotherapy as a function of OncotypeDx Breast Cancer Assay receipt. Further, we used multiple linear regression to model total and oncology specific one-year costs as a function of OncotypeDx Breast Cancer Assay receipt. In both analyses, we adjusted for key patient, tumor, and health system factors. Results: The study population consisted of 1510 women, 13% of which received the ODX test. The groups were similar across relevant clinical and demographic characteristics with the exception of age at diagnosis, stage, tumor grade and drug benefits. In the logistic regression analysis, patients who received ODX were 51% less likely to receive adjuvant chemotherapy versus those who did not receive the test. In the multiple linear regression analysis, those who received ODX had fewer total and oncology specific one-year costs (total costs difference: -$9,149 (95% CI: -$13,818, -$4,481, P-Value: &amp;lt;0.001); oncology specific cost difference: -$1,380 (95% CI: -$2,361, -$400, P-Value: &amp;lt;0.006). Study Results ODX vs. No ODX95% CIP-valueTotal cost difference*-$9,149-$13,818 to -$4,481&amp;lt;0.000Oncology cost difference*-$1,380-$2,361 to -$4000.006Adjuvant chemotherapy use (OR)*0.490.33 to 0.73&amp;lt;0.000* Model covariates: stage, Charlson comorbidity score, age at diagnosis, tumor size, tumor grade, race, and pharmacy benefits Conclusions: Our results are the first to report on the impact of the ODX test directly on total and oncology specific costs. In accordance with previous studies that used modeled cost estimates, i.e. through cost projections focusing solely on the adjuvant chemotherapy reductions, we found a statistically significant difference in both total and oncology specific costs. These data further bolster the evidence that suggests the ODX lowers total and oncology specific costs. Further evidence is needed to evaluate the impact of ODX on clinical outcomes. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-15.

The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis

The impact of the Oncotype Dx (ODX) breast cancer assay on adjuvant chemotherapy (ACT) treatment decisions has been evaluated in many previous studies. However, it can be difficult to interpret the collective findings, which were conducted in diverse settings with limited sample sizes. We conducted a systematic review and meta-analysis to synthesize the results and provide insights about ODX utility. Studies, identified from PubMed, Embase, ASCO, and SABCS, were included if patients had ER+, node -, early-stage breast cancer, reported use of ODX to inform actual ACT decisions. Information was summarized and pooled according to: (1) distribution of ODX recurrence scores (RS), (2) impact of ODX on ACT recommendations, (3) impact of ODX on ACT use, and (4) proportion of patients following the treatment suggested by the ODX RS. A total of 23 studies met inclusion criteria. The distribution of RS categories was 48.8 % low, 39.0 % intermediate, and 12.2 % high (21 studies, 4,156 patients). ODX changed the clinical-pathological ACT recommendation in 33.4 % of patients (8 studies, 1,437 patients). In patients receiving ODX, receipt of ACT were: 28.2 % overall, 5.8 % low, 37.4 % intermediate, and 83.4 % high. Low RS patients were significantly more likely to follow the treatment suggested by ODX versus high RS patients RR: 1.07 (1.01–1.14) [corrected].The pooled results are consistent with most individual studies to date. The increased proportion of intermediate scores relative to original estimates may have implications for the clinical utility and cost impacts of testing. In addition, low versus high RS patients were significantly more likely to follow the ODX results, suggesting a tendency toward less aggressive treatment, despite a high ODX RS. Finally, there was a lack of studies on the impact of ODX on ACT use versus standard approaches, suggesting that additional studies are warranted.

The impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancer

To assess how the recurrence score of the Oncotype DX breast cancer assay influences adjuvant systemic treatment decisions in the multidisciplinary meeting (MDM) for patients with early breast cancer (EBC) in Australia. A before-and-after study at three academic medical centres in Melbourne with patients and physicians serving as their own controls. Paired systemic adjuvant treatment recommendations were made in multidisciplinary meetings (MDMs) before and after Oncotype DX testing. Medical oncologists and surgeons, treating patients with unifocal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or node-positive early breast cancer. Changes in physician treatment recommendations. This study enrolled 151 eligible patients between 1 November 2010 and 30 September 2011. Of these, 101 patients (67%) had node-negative and 50 (33%) had node-positive tumours. Recurrence score information resulted in treatment recommendation changes for 24 patients with node-negative tumours (24%) and for 13 patients with node-positive tumours (26%). The proportional change from chemo-hormonal therapy (CHT) to hormonal therapy (HT) was significantly greater than from HT to CHT for patients with node-negative tumours (23% difference in proportions; P= 0.02), and of similar magnitude for patients with node-positive tumours (25% difference in proportions; P = 0.14). The Oncotype DX recurrence score has a major impact on adjuvant treatment decision making in the MDM setting.