Oncotype DX Testing Research Articles

Selection of neoadjuvant treatment based on the 21-GENE test results in luminal breast cancer

Neoadjuvant chemotherapy (NAC) is an optimal option in early breast cancer, but in ER-positive/HER2-negative (luminal) is still controversial, although a survival benefit has recently been observed when a histological response by Symmans’ method type 0 or I is achieved. The 21-gene Oncotype DX Breast Recurrence Score® assay (Oncotype DX®) is a validated test to assess the survival benefit of adjuvant chemotherapy in these patients but its role in the neoadjuvant setting is less established. We analyzed the results of the Oncotype DX® test in a cohort of 122 consecutive patients selected to receive NAC based on classical clinicopathological parameters and the correlation between the Oncotype DX® results and the pathological response assessed by Symmans’ method. Median age was 56.5 (range 31–84) years. Initial tumor size was T1 (<20 mm) in 46 patients (37.7%), 57 (46.7%) had a T2 tumor (20–50 mm), and 19 (15.6%) had a tumor size more than 50 mm. 59 (48.4%) had axillary node involvement. The median expression estrogen and progesteron receptors by immunohistochemistry was 280 and 120 respectively and median Ki67 index was 28%. The Recurrence Score (RS) results were <11 in 21 patients (17.2%) patients, RS 11 to 25 in 58 (47.5%), and RS > 25 in 43 (35.2%). Considering the Oncotype DX test results, neoadjuvant chemotherapy was administered to 60 patients (49%), 11 (9%) received adjuvant chemotherapy and 51 (42%) no chemotherapy. Testing with the assay has therefore led to 42% fewer chemotherapy treatments. Among 60 patients receiving NAC, pathologic response was achieved for 5 patients (8.3%) with RCB-0 and 15 RCB-1 (25%). We did not find any pathological response RCB-0 and RCB-I in the 20 patients who received NAC and had a Recurrence Score result <21 for the premenopausal group, or a RS result <25 for the postmenopausal group. For patients with highest Recurrence Score results (RS > 21 or 25 according to menopausal status) it was 12% (5/40) RCB-0 and 40% (16/40) RCB-I. ConclusionsThe Oncotype DX test could be a useful tool to select patients candidates for neoadjuvant chemotherapy in luminal breast cancer. Neoadjuvant chemotherapy could be avoided in 42% of patients. We found a correlation between Recurrence Score results and pathological response with 14% of RCB-0 and a total of 47% of significant pathological response type RCB-0 and RCB-I in patients with highest Recurrence Score results. Interestingly, patients with a Recurrence Score result inferior to 32 did not get any histological response type 0 and only 5% RCB-I.

Clinical Impact of a Novel Model Predictive of Oncotype DX Recurrence Score in Breast Cancer.

Oncotype DX recurrence score (RS) for breast cancer is a useful tool for determining chemotherapy indication but it is expensive and time-consuming. We determined whether four immuno-histochemical markers, namely human epidermal growth factor 2 (HER2), estrogen receptor (ER), progesterone receptor (PgR), and Ki-67, are predictive of an RS ≥26 in Japanese patients. The study included 95 Japanese patients evaluated for RS. A predictive model was created using logistic regression analysis. The discriminant function was calculated as follows: p=1/{1+exp [-(4.611+1.2342×HER2-0.0813×ER- 0.0489 ×PgR+0.0857×Ki67)]}. Using a probability of 0.5 as the cutoff, the accuracy, sensitivity, specificity, positive predictive and negative predictive values were 90.5%, 72.2%, 94.8%, 76.4% and 93.5%, respectively. The model had a high negative predictive value in predicting RS ≥26 in Japanese patients, indicating that Oncotype DX testing may be omitted in patients with a negative result according to the predictive model.

Evaluating the Clinical Utility of Routine Sentinel Lymph Node Biopsy and the Value of Adjuvant Chemotherapy in Elderly Patients Diagnosed With Oestrogen Receptor Positive, Clinically Node Negative Breast Cancer.

Background:Sentinel lymph node biopsy (SLNB) provides staging information and guides adjuvant therapy in early breast cancer (EBC). Routine SLNB in oncogeriatricians with low-risk EBC remains controversial.Aims:To evaluate axillary management in elderly patients diagnosed with oestrogen receptor positive (ER+), clinically lymph node negative (cLN−) EBC, and to assess whether SLNB affects further axillary management or adjuvant chemotherapy (ACTX) decision making.Methods:Female patients aged > 65 years, diagnosed with ER+, human epidermal growth factor receptor-2 negative (HER2−), and cLN− breast cancer (BC), who underwent surgery and SLNB were included. Clinicopathological predictors of ACTX and completion axillary lymph node dissection (CALND) were determined. Kaplan-Meier analyses assessed survival outcomes.Results:A total of 253 patients were included (median age: 72 years, range: 66-90), all underwent SLNB; 50 (19.8%) had lymphatic metastasis on SLNB (SLNB+). Of these, 19 proceeded to CALND (38.0%), 10 (52.6%) of whom had further axillary disease (ALND+). 20 of the 50 SLNB+ patients received ACTX (40.0%) as did 31 of the 203 SLNB− patients (15.2%) (P < .001). Oncotype DX (ODX) testing was utilized in 82 cases (32.8%). Younger age (P < .001), SLNB+ (P < .001) and ODX score (P = .003) were all associated with ACTX prescription. ODX > 25 (OR: 4.37, 95% CI: 1.38-13.80, P = .012) independently predicted receiving ACTX. Receiving ACTX and proceeding to CALND did not improve disease-free (P = .485 and P = .345) or overall survival (P = .981 and P = .646).Conclusions:Routine SNLB may not be necessary in elderly patients diagnosed with ER+, cLN− EBC. Future oncogeriatric practice is likely to see genomic testing guiding ACTX prescription in this group.

21-gene recurrence score testing and adjuvant chemotherapy in older women with early breast cancer

Background: The benefit of adjuvant chemotherapy is unclear in women aged 70+ with breast cancer. Oncotype DX is a genomic test predicting recurrence risk for women with early oestrogen receptor-positive, HER2-negative, lymph node-negative cancers, for whom chemotherapy side effects may not outweigh the benefits. This study investigated Oncotype DX testing and chemotherapy in women aged 70+, in whom the test is not yet validated.

Can Oncotype DX testing be omitted in invasive breast cancer patients with clinicopathologic factors predicting very high pretest probability of a concordant result?

To determine if clinicopathologic (CP) factors could identify patients at "very low" and/or "very high" pretest probability of a high Oncotype DX (ODX) score. A retrospective analysis of all patients that had ODX testing 2008-2018 at a single institution. Of 215 patients, all 16 (7.4%) with "all high" risk CP factors had high ODX scores, and all 45 (20.9%) over age 50 with "all low" risk CP factors had ODX recommendations for no chemotherapy. Oncotype DX results did not change chemotherapy recommendations in those with "very low" or "very high" pretest probability of high ODX scores.

Oncoplastic Breast-Conserving Surgery: Can We Reduce Rates of Mastectomy and Chemotherapy Use in Patients with Traditional Indications for Mastectomy?

Traditional indications for mastectomy include multiple ipsilateral lesions and/or disease spanning ≥ 5cm. Neoadjuvant chemotherapy increases breast conservation but does not improve survival. We hypothesized that oncoplastic breast-conserving surgery (OPS) may allow for breast conservation while providing full staging and tumor profiling information to guide systemic therapy decisions, thereby permitting more judicious chemotherapy use. This was an observational cohort of patients with invasive breast cancer with multiple lesions and/or disease spanning ≥ 5cm who underwent OPS from 2012 to 2018. Clinicopathologic features, mastectomy rate, chemotherapy use, and recurrence were evaluated. Overall, 100 patients were identified. Average disease span was 62.8 ± 20.1mm, with an average of 2.9 lesions (range 1-13). 'No ink on tumor' was achieved at the index operation in 80 patients; 13 patients underwent completion mastectomy to achieve adequate margins. Eighty-one patients completed radiation therapy. Breast conservation was possible in 50/58 (86%) patients who did not receive chemotherapy. Forty-two patients received chemotherapy (8 neoadjuvant, 34 adjuvant), of whom 37 (88%) achieved breast conservation. Twenty-six patients with high-risk features received adjuvant chemotherapy. Oncotype DX testing demonstrated the need for chemotherapy in an additional eight patients. After a median follow-up of 40months, four patients had a local recurrence, including two who declined radiation therapy. OPS can facilitate breast conservation in most patients with traditional indications for mastectomy. Additionally, OPS may reduce unnecessary chemotherapy, especially in patients who qualify for Oncotype DX testing. Further study evaluating long-term oncologic and cosmetic outcomes is warranted.

Integrated Multiparametric Radiomics and Informatics System for Characterizing Breast Tumor Characteristics with the OncotypeDX Gene Assay.

Simple SummaryArtificial Intelligence methods using machine learning and radiomics is an emerging area of research for radiological and oncological applications for patient management. Recent evidence from breast cancer suggests that different breast cancer subtypes may respond differently to adjuvant therapies. The use of a 21-gene array assay called OncotypeDX can predict potential recurrence of cancer in patients with estrogen positive breast cancer after treatment, however, there are potential cost disadvantages that hamper its widespread use. Multiparametric magnetic resonance imaging can simultaneously identify key functional parameters and provide unique imaging phenotypes of breast cancer, which is used in radiomic analysis. Radiomics provide quantitative information of different tissue types. We have developed a new machine learning radiomic informatics tool that integrates clinical and imaging variables, single, and multiparametric radiomics to compare with the OncotypeDX test to stratify patients into three risk groups: low, medium, and high risk of breast cancer recurrence.Optimal use of multiparametric magnetic resonance imaging (mpMRI) can identify key MRI parameters and provide unique tissue signatures defining phenotypes of breast cancer. We have developed and implemented a new machine-learning informatic system, termed Informatics Radiomics Integration System (IRIS) that integrates clinical variables, derived from imaging and electronic medical health records (EHR) with multiparametric radiomics (mpRad) for identifying potential risk of local or systemic recurrence in breast cancer patients. We tested the model in patients (n = 80) who had Estrogen Receptor positive disease and underwent OncotypeDX gene testing, radiomic analysis, and breast mpMRI. The IRIS method was trained using the mpMRI, clinical, pathologic, and radiomic descriptors for prediction of the OncotypeDX risk score. The trained mpRad IRIS model had a 95% and specificity was 83% with an Area Under the Curve (AUC) of 0.89 for classifying low risk patients from the intermediate and high-risk groups. The lesion size was larger for the high-risk group (2.9 ± 1.7 mm) and lower for both low risk (1.9 ± 1.3 mm) and intermediate risk (1.7 ± 1.4 mm) groups. The lesion apparent diffusion coefficient (ADC) map values for high- and intermediate-risk groups were significantly (p < 0.05) lower than the low-risk group (1.14 vs. 1.49 × 10−3 mm2/s). These initial studies provide deeper insight into the clinical, pathological, quantitative imaging, and radiomic features, and provide the foundation to relate these features to the assessment of treatment response for improved personalized medicine.

Correlation between modified Magee equation-2 and Oncotype-Dx recurrence scores using both traditional and TAILORx cutoffs and the clinical application of the Magee Decision Algorithm: a single institutional review.

Oncotype Dx (ODX) is used to predict recurrence risk for estrogen-positive (ER +), HER2-negative and lymph node negative breast cancer, however, due to the cost its use maybe limited in low-resource areas. The aim of this study is to assess the concordance between the modified Magee Equation-2 (MME-2) and ODX recurrence scores (RS). The secondary aim is to apply the Magee Decision Algorithm (MDA) using the MME-2 to determine which patients are unlikely to benefit from ODX testing. All newly diagnosed ER + , HER2 negative, lymph node negative breast cancer patients with available ODX-RS from 2008-2018 were included. The original pathology reports were reviewed and chart review was performed. The MME-2 scores were calculated and correlated with the ODX-RS. The MDA was applied to our cohort to assess which patients would not benefit from ODX testing. A total of 579 patients were included. There was an overall moderate correlation between ODX-RS and MME-2 score (Pearson correlation coefficient = 0.635). The overall concordance between ODX and MME-2 scores was similar when using both the traditional and TAILORx cutoffs (63.3% vs. 63.7%, respectively). Applying the MDA, for patients with MME-2 scores < 18, 96.8% of patients had the expected ODX-RS of < 25. For patients with MME-2 RS > 30, 90% had the expected ODX-RS of > 25. Concordance was highest in the high-risk category using both cutoffs. For patients with MME-2 18-25 and a mitotic score of 1, 88.8% had the expected ODX-RS of > 25. There is a moderate correlation between MME-2 score and ODX-RS. The overall concordance was similar for both traditional and TAILORx cutoffs. The strongest concordance was found in the high-risk category for both cutoffs. The MME-2 can be used to identify patients unlikely to benefit from ODX testing using the MDA.

Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center.

In 2016,weinitiated standardized "reflex"Oncotype DX Recurrence Score (RS) testingforpatients ≤ 65yearswith pT1-2N0-1HR+/HER2- breast cancer. Here, we examine RS testing patterns, RS distribution,andfactors associated with chemotherapy use in patients with pN1 breast cancer. Patientswith stage I-IIIHR+/HER2- pN1 breast cancer treated with upfront surgeryfrom February 2016 to March 2019 were identified. Clinical characteristics were compared between patients meeting reflex RS testing criteria, those with RS ordered outside of reflex criteria, and those without RS testing. RS was categorized as low (< 18), intermediate (18-30),and high (≥ 31). Multivariate logistic regressionwas performed toidentifyfactors associated with adjuvant chemotherapy receipt. We examined 3-year recurrence-free survival (RFS) and overall survival (OS) stratified by chemotherapy use. We identified 347HR+/HER2- pN1 patients; 272 (78.4%) received RS testing, and 194 (71.3%) metreflex criteria. RS was < 18 in 164 (61.4%) patients,18-30 in 89 (32.7%) patients, and ≥ 31 in 16 (5.9%) patients.On multivariate analysis, RS < 18 (OR 0.47, 95% CI 0.24-0.92) was associated with lower odds of chemotherapy use, whereas presence of lymphovascular invasion (OR 1.77, 95% CI 1.03-3.07) and lobular subtype (OR 2.40, 95% CI 1.21-4.78) were associated with higher odds. No differences in 3-year RFS (p = 0.97) or OS (p = 0.19) based on chemotherapy receipt were observed. Most RS-tested HR+/HER2- pN1 patients at our center had low genomic risk. A low RS independently influenced chemotherapy omission and in RS-tested patients, short-term outcomes were excellent. Our study demonstrates increased use of RS in guiding adjuvant treatment decisions in node-positive disease.

Delays to Adjuvant Breast Cancer Radiotherapy Resulting from Oncotype Dx Testing in Patients with Low/Intermediate Recurrence Risk Scores

Purpose: Oncotype Dx is a 21 gene recurrence score assay that risk stratifies patients who have completed primary surgical treatment for breast cancer to low or intermediate (adjuvant chemotherapy not routinely recommended) versus high risk of recurrence (adjuvant chemotherapy recommended). 73% of patients tested are stratified to the low/intermediate risk of recurrence group [1]. However, a proportion of these patients may have delays to commencing adjuvant radiotherapy. The current median time to adjuvant radiotherapy following surgery is recorded as 60 days [2].

Propensity score analysis of the prognostic value of genomic assays for breast cancer in diverse populations using the National Cancer Data Base.

Genomic assays such as Oncotype Dx (ODX) and MammaPrint are used for risk-adapted treatment decisions among patients with early breast cancer. However, to the authors' knowledge, concordance between genomic assays is modest. Using real-world data, the authors performed a comparative analysis of ODX and MammaPrint. A cohort of women diagnosed with early-stage, hormone receptor-positive breast cancer who received ODX or MammaPrint was established using the National Cancer Data Base (NCDB) for 2010 through 2016. Using the propensity score matching method, 2 groups of patients with similar clinical and demographic characteristics were defined: one group received ODX and the other received MammaPrint. The authors examined the association between use of the ODX or MammaPrint assays and overall survival using Cox models. Of the 451,693 eligible patients, approximately 45.3% received ODX and 1.8% received MammaPrint testing. The use of ODX increased from 36.1% in 2010 to 49.9% in 2016, whereas use of MammaPrint increased from 0.5% in 2010 to 3.3% in 2016. The authors matched 5042 patients who received ODX with 5042 patients who received MammaPrint. The 5-year risks of death for the MammaPrint low-risk group and the ODX low-risk group were 3.4% and 4.7%, respectively. The prognostic value of MammaPrint was similar to that of ODX; the C-index was 0.614 (95% confidence interval, 0.572-0.657) for MammaPrint and 0.581 (95% confidence interval, 0.530-0.631) for ODX. There was a difference in the performance of the ODX assay observed across racial and/or ethnic groups (P<.001), with a slightly better performance noted among white compared with African American and Hispanic individuals. Both the ODX and MammaPrint tests are good at identifying low-risk individuals who could be spared chemotherapy. The suboptimal performance of ODX in ethnic minority individuals deserves further investigation.

Abstract A099: Oncotype Dx test receipt among Latina women with breast cancer: A population-based retrospective cohort study

Abstract Introduction. The clinical utility of Oncotype Dx (ODx) testing, in order to estimate breast cancer (BrCa) recurrence risk and chemotherapy benefit, is widely accepted. However, population-based data on the utilization of ODx testing among Latina BrCa patients are limited. In this study, we are examining eligibility and receipt of ODx testing among Latinas in New Jersey diagnosed with breast cancer from 2008 to 2013, and assessing factors associated with ODx test receipt in the population. Methods. Data on all primary, histologically confirmed, invasive BrCa cases diagnosed among women between January 1, 2008 and December 31, 2013 (N=32,770) were retrieved from the New Jersey State Cancer Registry. In order to identify Latina cases, those that were coded not as Non-Hispanic on the North American Association of Central Cancer Registries Hispanic Identification Algorithm were included in the analytic sample. Guideline-concordant ODx testing was classified as testing among Stage IA, Stage IB, Stage IIA or Stage IIB, node-negative, estrogen receptor-positive and/or progesterone receptor-positive, human epidermal growth factor receptor-negative cases. Results. Approximately 9% of the total population-based sample of invasive BrCa cases were Latinas (n= 3,036). Among them, the average age at diagnosis was 55.8±13.3 years, 76.0% had ductal carcinoma histology, and 7.8% and 11.1% were non-luminal HER2-expressing and triple-negative subtypes, respectively. In terms of eligibility for ODx testing, 45.8% (1,391/3,306) were eligible and among them, 23.9% (333/1,391) received the test. Among those ineligible for ODx testing, 2.6% (43/1,645) received the test. Conclusions. The underutilization of guideline-concordant ODx testing among eligible Latina BrCa cases in New Jersey (&amp;lt;50%) could indicate that there is unequal access to appropriate genetic testing and optimal adjuvant chemotherapy. This might exacerbate disparities as BrCa is a leading cause of cancer death among Latinas. Our future aims include assessment of factors associated with guideline-concordant ODx test receipt among Latinas, and the impacts of ODx test receipt on BrCa treatment and survival. Citation Format: Nicholas Acuna, Antoinette M. Stroup, Jennifer Tsui, Adana A.M. Llanos. Oncotype Dx test receipt among Latina women with breast cancer: A population-based retrospective cohort study [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A099.

P101: Oncotype DX testing provides valuable prognostic information for guiding adjuvant chemotherapeutic treatment of breast cancer patients with intermediate/high risk predict or NPI scores

Introduction: Risk calculators (PREDICT/NPI) estimate a patient's risk of breast cancer recurrence based on clinico-pathological features, whereas Oncotype DX (ODX) utilises genetic profiling. This study aimed to assess the correlation between the risk of recurrence estimated by PREDICT and NPI in comparison with ODX.

P134: Does the use of oncotype DX testing in patients with breast cancer aged 65 and over affect management of adjuvant chemotherapy?

Introduction: Genomic profiling of intermediate risk ER positive/HER2 negative breast cancers to identify the likelihood of distant recurrence, and therefore benefit from chemotherapy was approved as a quality standard by NICE in June 2016. There is limited research however, regarding the usage of it in patients aged 65 and over. This study therefore aimed to assess the role of Oncotype DX within this population, and its effect on subsequent treatment.

P020: Use of multi-gene assays - Nursing impact

Multi-gene assays have been commonly used in our Breast Unit since 2016, both outside of and within clinical trials. Breast CNSs routinely discuss the pros and cons of chemotherapy with patients and discuss the Oncotype DX test used predominantly in our unit. Women who have oestrogen receptor-positive, HER2-negative and lymph node-negative early breast cancer are offered gene expression profiling with Oncotype DX depending on their NPI score (Nottingham Prognostic Index) and fitness for chemotherapy.

Economic evaluation of the oncotype DX test for hormone receptor positive (HR+) early-stage breast cancer (BC) from the Brazilian societal perspective.

e19380 Background: Selecting appropriate patients for AC (adjuvant chemotherapy) remains an important issue in BC treatment. Although AC improves clinical outcomes toxicity and economic burden is substantial. The Oncotype DX test identifies high-risk patients likely to benefit from AC who otherwise might not be identified through standard parameters (SP), and low-risk patients unlikely to benefit from AC, avoiding toxicities and inherent risks. This study estimated the incremental cost-effectiveness ratio and budget impact (BI) of Oncotype DX testing from the perspective of the Brazilian Public Health System. Methods: A Markov transitional state model was developed with 3 states: recurrence free, distant recurrence, and death. The model compared the scenario in which patients are screened by SP with a proposed scenario with Oncotype DX testing. Changes in therapeutic recommendations and cost of treatment were obtained from a prospective clinical survey at Pérola Byington Hospital. Additional data was obtained from literature. As a societal perspective analysis, medical costs (test, AC, and adverse events), costs of productivity loss, transportation and employment leave were considered. Population was estimated from BC incidence, proportion of early stage cases, and HR expression. An incremental proportion of 10% per year of patients using Oncotype DX testing was assumed. BI analysis had a 5-year horizon and cost-effectiveness a lifetime horizon (5% annual discount). Results: Oncotype DX results as identifier of a subgroup at higher risk of relapse and greater benefit with AC was dominant over SP. Oncotype DX testing resulted in clinical benefits in terms of life-years gained (0.62) and quality-adjusted life years (0.54), related to lower incidence of distant recurrence and use of AC, both of which greatly impacted quality of life. Testing resulted in economic benefits, with lower average cost per patient (−BRL 3,855). Incorporation of Oncotype DX testing resulted in potential savings reaching BRL 107 million in the 5th year stemming from the decrease in AC and consequent decrease in indirect costs. Conclusions: Patients with HR+, HER2− early stage BC may present different risks of relapse and likelihoods of benefiting from AC. With high clinical impact for patients and high economic impact for the health system, a tool that safely and accurately identifies the subgroup of patients who really needs AC is essential. Oncotype DX test incorporation in the Brazilian Public Health System should be considered.

21-gene recurrence score assay as a predictor of pathological response in neoadjuvant chemotherapy administration for ER-positive/HER2-negative early-stage breast cancer.

e12630 Background: Neoadjuvant chemotherapy (NAC) is an optimal option in early breast cancer, but in ER-positive/HER2-negative (luminal) is still controversial, although a survival benefit has recently been observed when a histological response by symmands method type 0 or I is achieved. The 21-Gene recurrence score assay (Oncotype DX) is a validated test to assess the survival benefit of adjuvant chemotherapy in these patients but its role in neoadjuvant setting is not yet well established unknown. We analyze the correlation between Oncotype DX Recurrence Score result and the pathological response assessed by symmands method. Methods: We analyzed a prospective cohort of 63 early luminal breast cancer patients who received NAC after performing an Oncotype DX test. Patients with an Oncotype DX Recurrence Score result lower 11 were excluded. The median age was 54 years (31-84), initial tumor size was 37 mm (12 -97), 41 patients (65%) had initial nodal involvement and the median Ki67 index was 34% (8 – 85). Results: An Oncotype DX results inferior or equal to 25 (considered as a limited benefit of chemotherapy treatment) was observed in 25 patients (40%) and a Recurrence Score higher than 25 in 38 (60%). Pathological response type 0 was achieved in 5 patients (8%) and type I in 16 (25%). A strong correlation between pathological response type 0 and I and Recurrence Score result in the univariate and multivariate analysis (OR 0,946 p:0,023) was found. We have performed a threshold analysis finding the Oncotype DX the most significant predictor of pathological response (AUC:0,75 p:0,0 01 ) compared to Ki67 (AUC:0,61 p:171), Estrogen receptor (AUC:0,41 p:0,21) and initial tumor size (AUC:0,671 p:0,028). All the patients who achieved a complete pathological response had a Recurrence Score result ≥ 26. Conclusions: The Oncotype DX Recurrence Score could be a useful tool to select early breast cancer patients who will benefit from neoadjuvant chemotherapy. Oncotype DX is the most significant predictor variable of pathological response and patients with a Recurrence Score of 25 or greater are five times more likely to obtain a histological response type 0-1 (OR: 5,3 p &lt; 0,016). In our series the Oncotype DX test reaches the highest rate of complete pathological responses in this group of patients.

Omitting chemotherapy in more patients with early breast cancer in the post-TAILORx era.

e12534 Background: The purpose of this analysis is to evaluate how many patients previously treated according to OncotypeDX Recurrence Score (RS) could have been spared of Chemotherapy if the TAILORx RS data had been taken into account in the clinical treatment decisions. Methods: A series of 182 patients, 34-74 years of age with early breast cancer, treated in our Breast Unit during the last 10 years, for whom treatment decisions were based on OncotypeDX RS. The Recurrence Scores of all these patients were obtained and the actual treatment decisions that were made based on the pre-TAILORx cut-offs of RS 18 and 31 were recorded. These decisions were then re-evaluated based on the after TAILORx cut-off scores, by taking also into consideration the patients’ age. Descriptive statistics were used as well as logistic regression models to estimate the potential change in treatment decisions based on the new Oncotype Dx cut-offs. Results: In the cohort of patients we analyzed that underwent Oncotype Dx testing, 34.1% (62/182) received Chemotherapy, based on the initial pre-TAILORX cut-offs of the RS. When utilizing the new cut-offs (after TAILORx results) in combination with age, we have estimated that, for the patients &gt; 50 years of age, a 12.7% was potentially over-treated and for those ≤50 years old, 9.1% was potentially over-treated since they have received chemotherapy with a RS below 16; additionally, 30.8% of the patients of that age that have RS between 16 and 20 have received chemotherapy even though the average chemotherapy benefit for this group is 1.6% and can go up to 6.7% if they have a high clinical risk as it was defined by the investigators of the TAILORx trial. Finally, 84,6% of patients ≤50 years old with RS between 21-25 received chemotherapy with a 6.5% potential benefit demonstrated in the TAILORx trial. Conclusions: Our analysis suggests that, by using the cut-offs of TAILORx trial, adjuvant chemotherapy could had been omitted in at least a further 11.5% of patients with early breast cancer, reassuring their quality of life without declining their prognosis.

Impact of Recurrence Score on type and duration of chemotherapy in breast cancer.

The use of Oncotype dx (Genomic Health, Redwood City, CA, U.S.A.) testing has been shown to change treatment decisions in approximately 30% of breast cancer (bca) cases, but research on how Recurrence Score testing has affected the type of chemotherapy offered is limited. We sought to determine if the availability of Oncotype dx testing resulted in a change to the type and duration of chemotherapy regimens used in the treatment of early-stage hormone receptor-positive bca. In a population-based cohort study, patients treated in the 2 years before the availability of Oncotype dx testing were compared with patients treated in the 2 years after testing availability. Charts were audited and divided into 2 groups: pre-Oncotype dx and post-Oncotype dx. The groups were compared for differences in duration of chemotherapy (12 weeks vs. >12 weeks), types of agents used (anthracycline vs. non-anthracycline), and myelosuppressive potential of the chosen regimen. Of 834 patients who fulfilled the enrolment criteria, 360 fell into the pre-Oncotype dx era, and 474, into the post-Oncotype dx era. An increase of 11.2 percentage points, to 69.5% from 58.3%, was observed in the proportion of patients receiving short-course compared with long-course chemotherapy (p = 0.068). The proportion of patients prescribed anthracycline-containing regimens declined in the post-Oncotype dx era (47.7% pre vs. 32.2% post, p = 0.016). The selection of more-myelosuppressive chemotherapy protocols increased in the post-Oncotype dx era (67.4% pre vs. 78.8% post, p = 0.044). In the present study, the availability of Oncotype dx testing was observed to influence the choice of chemotherapy type in the setting of early-stage bca.

Correlation Between Oncotype DX, PREDICT and the Nottingham Prognostic Index: Implications for the Management of Early Breast Cancer.

IntroductionBreast cancer remains the most common cancer diagnosis in the UK. The current clinical practice utilises two different types of modalities to estimate the prognosis, risk of recurrence and benefit from adjuvant chemotherapy treatment in patients with early breast cancer. The first set of modalities includes risk calculators based on clinicopathological features, e.g. PREDICT or the Nottingham Prognostic Index (NPI); the second includes genetic profiling of tumour tissue using Oncotype DX (ODX; Genomic Health, Redwood City, CA) testing. PREDICT, NPI and ODX stratify breast cancers into high-, intermediate- and low-risk categories to help guide adjuvant chemotherapy treatment decisions. This study compares PREDICT, NPI and ODX Recurrence Scores (RS), with the aim of assessing 1) the correlation between the RS for PREDICT, NPI and ODX and 2) whether early breast cancer patients are stratified into similar risk categories by all three modalities.MethodsThis retrospective study included early breast cancer patients treated at a National Health Service (NHS) hospital over a 12-month period (October 1, 2017 to September 30, 2018). Inclusion criteria: consecutive patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node-negative breast cancer. All patients were discussed at the local multidisciplinary team (MDT) meeting and underwent ODX testing. Exclusion criteria: patients without ODX test scores; patients with an in-breast recurrence; patients who did not undergo a sentinel lymph node biopsy (SLNB); and patients with ductal carcinoma in situ (DCIS) only. NPI and PREDICT scores were calculated for each patient using online tools, and ODX data was obtained through Genomic Health and MDT records. Patients were risk-stratified into high, intermediate and low risk of recurrence groups based on their PREDICT, NPI and ODX scores. The thresholds for risk stratification were based on current practice, which is evidence-based. Correlations between PREDICT, NPI and ODX scores were analysed using Spearman's correlation coefficient.ResultsForty-six patients (mean age: 56 years), with a total of 57 early breast cancers, underwent ODX testing. Risk categories generated by PREDICT very strongly correlated with NPI for all patients (r=0.92; P<0.0001). However, the RS generated by ODX testing only strongly correlated for patients with low-risk PREDICT scores (r=0.51; P=0.0134), while no correlation between RS and PREDICT was observed for patients with intermediate- or high-risk PREDICT scores (r=-0.0064; P=0.9767). Similar results were seen between NPI and RS. Overall, only 19/46 (41.3%) patients had an RS which corresponded to PREDICT risk category, while 18/46 (39.1%) patients had an RS that indicated a higher risk of recurrence than PREDICT, and 9/46 (19.6%) patients had an RS indicating a lower risk of recurrence than PREDICT. Similar results were found when comparing RS and NPI.ConclusionThe risk of recurrence estimated by ODX in patients deemed low risk by PREDICT or NPI highly correlated, while no such correlation existed in patients with an estimated intermediate- or high-risk breast cancer. In PREDICT- or NPI-estimated intermediate- and high-risk patients, ODX provided valuable additional prognostic information to guide adjuvant treatment, while the potential avoidance of ODX testing in low-risk patients presents significant cost-savings.