21-gene Breast Cancer Assay Research Articles

Abstract PO3-01-13: A study of the impact of the implementation of the Oncotype Dx 21-gene breast-cancer assay during the SARS-CoV-2 pandemic for 1-3 node positive early breast cancer: The Clatterbridge Cancer Centre Experience

Abstract Background: The 21-gene breast cancer (BC) assay (Oncotype Dx) is used to predict chemotherapy benefit in ER+, HER-2- lymph node (LN) negative BC. The RxPONDER trial demonstrated that post-menopausal patients with ER+, HER2- BC with 1-3 LN and a recurrence score (RS) of < 25 did not benefit from adjuvant chemotherapy. In response to the SARS-CoV-2 pandemic Oncotype Dx was implemented for ER+, HER2- 1-3 LN+ BC patients in Merseyside, UK (population 2.6 million) This study sought to understand the impact of this measure on clinical practice. Methods: All patients whose tumours were assessed with Oncotype Dx assay between Mar 20 - Nov 22 were identified through the Exact Sciences portal. Menopausal status, tumour characteristics, RS and chemotherapy regimen were recorded. The impact on cancer care was estimated using the number of infusions and clinic visits specified by our institution chemotherapy protocol for node positive disease. The financial impact was calculated using the test list price, estimated costs of adjuvant chemotherapy in the UK (Annals of Oncology, Volume 32, suppl 2 S46). The number of patients predicted to receive chemotherapy pre-oncotype DX was calculated using data from the UK PONDx trial data. Results: A total of 242 patients were tested over the 32 month period. Table 1 summarises the clinico-pathological characteristics including by RS score. The median age was 58.5 and 77.3% (n=187) were post-menopausal. The median tumour size was 25mm and median LNs with macrometastasis was 1. 198 (81.9%) patients had an RS < 25. Overall 73 patients (30%) received chemotherapy of which 34 had an RS < 25. Pre-menopausal patients were more likely to receive chemotherapy with RS < 25 than post-menopausal patients, 47.9% (23/48) vs 7.3% (11/150) respectively. In the absence of Oncotype Dx testing 169 patients would have received adjuvant chemotherapy. Therefore, 96 patients avoided chemotherapy. This equates to 1,620 chemotherapy infusions and 324 clinic attendances. The estimated cost saving was ~£50K. Conclusions: This real-world study demonstrates that the use of Oncotype DX assay for ER+,HER2- 1-3 LN+ early BC spared a significant number of patients chemotherapy during the SARS-CoV-2 pandemic, so avoiding the risk of adverse effects. This also resulted in benefits to the healthcare system with a reduction in scheduled cancer care and achieved financial savings. This, therefore, demonstrates the benefit of using the Oncotype Dx assay. Table 1: Clinico-pathological information Citation Format: Alexandra Johnson, Sonia Bathla, Leena Chagla, Joanne Cliff, Allison Hall, Anita Hargreaves, Clare Hart, Zafar Malik, Chandeena Roshanlall, Raj Sripadam, Carlo Palmieri, Helen Innes. A study of the impact of the implementation of the Oncotype Dx 21-gene breast-cancer assay during the SARS-CoV-2 pandemic for 1-3 node positive early breast cancer: The Clatterbridge Cancer Centre Experience [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-13.

21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer

BackgroundThe recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary lymph-node–negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear.MethodsIn a prospective trial, we randomly assigned women with hormone-receptor–positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease–free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse–free survival.ResultsA total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease–free survival differed according to menopausal status (P=0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. Among postmenopausal women, invasive disease–free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P=0.89). Among premenopausal women, invasive disease–free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P=0.002), with a similar increase in distant relapse–free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P=0.009). The relative chemotherapy benefit did not increase as the recurrence score increased.ConclusionsAmong premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease–free survival and distant relapse–free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.)

362 Comparison of PREDICT Score to Oncotype Dx Score in Early Invasive Breast Cancer

Abstract Aim The PREDICT score is used to help define decisions about benefits of chemotherapy in early invasive breast cancer. With a PREDICT score of 5% or more chemotherapy should be considered, 3% to 4% is a borderline decision and less than 3% chemotherapy is not pursued. We set out to compare the PREDICT score to Oncotype Dx recurrence score (RS), which predicts chemotherapy benefit based on 21-gene breast cancer assay. Method Data for patient and tumour characteristics, and treatment choice was collected from electronic patient records of 98 patients who had an RS score done between February 2017-September 2020. This data was then compared to the patients’ PREDICT scores. Results 98 patients were analysed with 2 excluded due to having nodal macro-metastases. Mean patient age was 53 years with an average tumour size of 27mm. 31/96 (32%) patients had a PREDICT score ≥5%, with 21/31 (68%) having a low RS score (<26). 57/96 (59%) patients had a PREDICT score of 3-4%, with 40/57 (70%) having a low RS score. 8/96 (8%) patients had a PREDICT score of < 3%, with 7/8 (88%) having a low RS score. Additionally, 7/8 (88%) patients in this group were pre-menopausal. Conclusions 68% of patients in the ≥5% PREDICT group had a low RS score and so have avoided chemotherapy. In the 3-4% group, approximately 1 in 3 tested were shown to have a chemotherapy benefit. In the <3% group most patients were pre-menopausal, and chemotherapy was safely avoided. A bigger dataset and comparison to other health boards is required.

Can high Ki67 predict distant recurrence in early-stage breast cancer with low Oncotype Dx score?

e12561 Background: Ki-67 is a marker of proliferating cells. The recurrence score based on the 21-gene breast cancer assay also called Oncotype Dx provides prognostic and predictive information for recurrence in early stage breast cancer patients. We previously showed that there is a moderate correlation between Ki67 and oncotype Dx recurrence score. In this retrospective study, we aimed to examine whether high Ki67 could predict the distant recurrence in early stage breast cancer with low oncotype Dx scores ( < 25). Methods: This retrospective study included 278 consecutive cases of hormone receptor-positive, HER2 negative (T1-2 N0 M0) breast cancer who were diagnosed between 2008 and 2015 with low oncotype Dx ( < 25). Patients’ clinical outcome in terms of distant recurrence after breast surgery was determined up to December 2020 (median follow-up of 7 years). Patients were divided in to low risk (Ki67 < 15%) and high risk (Ki67 > = 15%) groups. Results: Of 278 cases with average and median age of 59 and 60 respectively, 148 (53%) were in Ki67 low risk and 130 (47%) were in Ki67 high risk group. Average and median oncotype Dx were 13.86 and 15 respectively in Ki67 low risk versus 15.23 and 16 respectively in Ki67 high risk group. 13 patients (4%) experienced distant metastasis in lung, liver, bone and skin. Of these 13 cases with average and median oncotype Dx 15.84 and 19 respectively, 12 (92%) were in the Ki67 high risk group and only 1 (8%) belonged to the low risk category. High Ki67 patients were overrepresented in group with recurrent distant metastasis compare to group without recurrent disease (Pearson Chi-Square = 51.18 with 1 degree of freedom and P = < 0.001). Conclusions: Ki67 high patients in the low risk oncotype Dx group are relapsing at a significantly higher rate suggesting that Ki67 combined with low oncotype Dx further refines the risk of distant relapse.

P057. The implementation of oncotype DX score on MDT decision making - A service evaluation

Introduction: The Oncotype Dx recurrence score (RS) predicts chemotherapy benefit based on the 21-gene breast cancer assay. We set out to evaluate the implementation of the Oncotype Dx score on MDT decision making and to investigate its' impact on our service.

LBA18 - Clinical outcomes by chemotherapy regimen in patients with RS 26-100 in TAILORx

BackgroundThe recurrence score (RS) based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low. There is little information from prospective clinical trials, however, regarding outcomes for patients with a high RS treated with chemotherapy regimens including taxanes and/or anthracyclines. MethodsWomen with hormone-receptor-positive, HER2-negative, axillary-node-negative breast cancer and a high RS of 26-100 were assigned to receive endocrine therapy plus a chemotherapy regimen selected by the treating physician. ResultsAmong the 9719 eligible women, 1389 (14%) had a RS of 26-100.The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-FU in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). The estimated rates of freedom from recurrence of breast cancer at a distant site were 93.0% (standard error [SE]+0.8%) at 5 years and 86.8% (SE+1.7%) at 9 years. In contrast, the projected rates of freedom from distant recurrence in this population if treated with endocrine therapy alone was estimated to be 78.8% (SE±14.0%) at 5 years and 65.4% (SE±10.4%) at 9 years when estimating outcomes based on the treatment effect of chemotherapy noted in the HER2-negative cohort of the B20 trial. Five-year rates of freedom from distant recurrence ranged from 92.3% to 95.5% for all chemotherapy regimens with the exception of CMF (88.5%). ConclusionsThe estimated rate of freedom from distant recurrence in women with a RS of 26-100 treated with a variety of adjuvant taxane and/or anthracycline-containing chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population. Clinical trial identificationNCT00310180. Legal entity responsible for the studyECOG-ACRIN Cancer Research Group. FundingUSA National Cancer Institute, Genomic Health. DisclosureAll authors have declared no conflicts of interest.

Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1-T3, N0-N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study.

The ROXANE Italian prospective study evaluated the impact of the 21-gene Recurrence Score (RS) results on adjuvant treatment decision for patients with early breast cancer. Nine centers participated. Physicians used the RS test whenever unsure about adjuvant treatment recommendation for patients with estrogen receptor-positive/human epidermal growth receptor 2-negative, T1-T3, N0-N1 early breast cancer. Pre-RS and post-RS treatment recommendations were collected. A total of 251 patients were included. N0 patients (61%) showed higher grade (p < .001) and higher Ki67 (p = .001) and were more frequently progesterone receptor negative (p = .012) as compared with N1 patients. RS results were as follows: <11, n = 63 (25.1%); 11-25, n = 143 (57%); and ≥26, n = 45 (17.9%). Higher RS was found in N0 vs. N1 patients (p = .001) and in cases of G3 (p < .001) and higher Ki67 (p < .001). The rate of change in treatment decision was 30% (n = 75), mostly from chemotherapy (CT) plus hormone therapy (CT + HT) to hormone therapy (HT; 76%, n = 57/75). The proportion of patients recommended to CT + HT was significantly reduced from pre-RS to post-RS (52% to 36%, p < .0001). CT use reduction was more evident for N1 patients (55% to 27%) than for N0 patients (50% to 42%) and was observed only in cases of RS ≤17. Physicians predominantly used the 21-gene assay in N0 patients with a more aggressive biology or in N1 patients showing more indolent biology. In this selected patient population, the use of RS testing led to a 30% rate of change in treatment decision. In the N1 patient subgroup, the use of RS testing contributed to reduce CT use by more than half. This study shows that, even in a context in which physicians recommend a high proportion of patients to endocrine treatment alone before knowing the results of the Recurrence Score (RS) assay, the use of the RS test, whenever uncertainty regarding adjuvant treatment recommendation is present, significantly contributes in further reducing the use of chemotherapy, especially for N1 patients.

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

ObjectivesOncotype DX (ODX), 21-gene breast cancer (BC) assay, predicts risk of recurrence and benefits of addition of chemotherapy to hormonal therapy for early-stage BC. We previously published a nomogram/calculator that could predict ODX results without performing the test by using clinicopathologic characteristics of BC available from pathology reports. Patients with intermediate-risk (11–25) ODXRS (RS) were excluded from that nomogram. This update tests the predictive value of clinicopathologic variables for forecasting the ODXRS while including intermediate-risk-ODXRS patients and stratifying ODXRS based on recently published TAILORx clinical trial results (0–25 = low-risk, 26–100 = high-risk-ODXRS; intermediate-risk-ODXRS belongs to the low-risk category). Material and methodsThe nomogram was built on 65,754 ODX-tested ER+/HER2-/lymph-node-negative patients with 6–50 mm tumor, captured by the National Cancer Data Base (NCDB) from 2010 to 2014. Five clinicopathologic variables (age, tumor size, grade, progesterone-receptor status (PR) and BC-histologic type) were assessed with logistic regression to predict for a low-risk (0–25) or a high-risk (26–100) ODXRS. Results were validated on a separate 18,585 ODX-tested cohort from 2015. ResultsGrade and PR were the highest significant predictors of both low-risk and high-risk-ODXRS, followed by histologic type, tumor size and age. The Receiver Operator Characteristic (ROC) curve showed strong statistical model for both low-risk and high-risk-ODXRS prediction outcomes (c-index = 0.81). ConclusionsAn updated nomogram is now developed/validated on the entire population of ODX-tested patients (84,339) captured by the NCDB. The nomogram/calculator, available on-line at the UTMCK/Shiny website (https://utgsm.shinyapps.io/OncotypeDXCalculator/), will continue serving as a surrogate for BC patients for which ODX testing is not affordable, available or necessary.

Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

BackgroundThe recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score.MethodsWe performed a prospective trial involving 10,273 women with hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary node–negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease–free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death).ResultsEndocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease–free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease–free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local–regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease–free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25.ConclusionsAdjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180.)

Uptake of a 21-gene expression assay in breast cancer practice: views of academic and community-based oncologists.

Advances in personalized medicine have produced novel tests and treatment options for women with breast cancer. Relatively little is known about the process by which such tests are adopted into oncology practice. The objectives of the present study were to understand the experiences of medical oncologists with multigene expression profile (gep) tests, including their adoption into practice in early-stage breast cancer, and the perceptions of the oncologists about the influence of test results on treatment decision-making. We conducted a qualitative descriptive study involving interviews with medical oncologists from academic and community cancer centres or hospitals in 8 communities in Ontario. A 21-gene breast cancer assay was used as the example of gep testing. Qualitative analytic techniques were used to identify the main themes. Of 28 oncologists who were approached, 21 (75%) participated in the study [median age: 43 years; 12 women (57%)]. Awareness and knowledge of gep testing were derived from several sources: international scientific meetings, participation in clinical studies, discussions with respected colleagues, and manufacturer-sponsored meetings. Oncologists observed that incorporating gep testing into their clinical practice resulted in several changes, including longer consultation times, second visits, and taking steps to minimize treatment delays. Oncologists expressed divergent opinions about the strength of evidence and added value of gep testing in guiding treatment decisions. Incorporation of gep testing into clinical practice in early-stage breast cancer required oncologists to make changes to their usual routines. The opinions of oncologists about the quality of evidence underpinning the test affected how much weight they gave to test results in treatment decision-making.

Compliance with guidelines and factors associated with ordering the 21-gene breast cancer assay.

6552Background: The 21-gene Recurrence Score result estimates the likelihood of distant recurrence and predicts the benefit of chemotherapy in early stage, hormonal receptor positive (HR+), HER2 ne...

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.

Use of a recurrence score in second breast cancers

IntroductionSystemic treatment for second estrogen receptor positive (ER+) invasive breast cancer is controversial. The Recurrence Score (RS) from the 21-gene breast cancer assay (ODX) is used for adjuvant therapy recommendations in primary, early-stage ER+ disease, but has unknown utility in locally recurrent tumors. MethodsAn IRB-approved, single-institution retrospective chart review of a prospective ODX database of was performed. Most patients had ODX performed on an initial invasive breast cancer (1° Cancer); a minority had ODX performed on an ipsilateral local recurrence (2nd Cancer); none had clinical evidence of concurrent regional or distant metastasis at presentation. Eligibility for the ODX assay was based on NCCN guidelines (1° breast cancer) or physician discretion (2nd cancer). Data collected included demographics, clinical-pathologic variables, surgery type, RS, adjuvant treatment and outcomes. Comparisons between 1° breast cancer and 2nd were made by general linear regression model and the exact Wilcoxon Rank Sum Test. Results594 Patients with 1° breast cancer and 7 patients with 2nd breast cancer had ODX and RS. Median invasive tumor size of both 1° cancer and 2nd cancer was 1.5 (range 0.6–2.0cm). All 1° and 2nd breast cancers were ER+. Median RS was higher in patients with 2nd cancer [25; range 15–40] compared to 1° cancer [16; range 0–63](p=0.0084). Categorically, more 2nd cancer patients had a high RS (37.5%) than those with 1° cancer (8.1%) (p=0.0136). ConclusionPerformance of ODX in ER+, locally recurrent breast cancer (2nd breast cancer) should be considered for prognostication and adjuvant systemic treatment recommendations

PMD66 - Characterization of early stage Breast Cancer patient management in a practice setting with the 21-Gene Breast Cancer assay

PMD66 - Characterization of early stage Breast Cancer patient management in a practice setting with the 21-Gene Breast Cancer assay

Abstract P2-03-15: Re-assessment of 21-gene breast cancer assay utilization as a quality indicator by the Florida Initiative for Quality Cancer Care (FIQCC) Consortium

Abstract Background: In 2006, the FIQCC conducted a comprehensive review of quality of care indicators specific to breast cancer (BC) based on QOPI/NCCN/ACOS and panel consensus, with feedback provided on indicator performance to encourage quality improvement efforts. In 2009, at re-assessment of adherence to the previous indicators, we introduced a pilot quality indicator from the NCCN treatment guidelines: discussion/recommendation of the 21-gene BC assay for treatment decisions. The current study assesses quality improvement efforts targeting specifically the 21-gene BC assay. Methods: After disclosure of results in 2012, 5 FIQCC sites agreed to participate in a re-assessment sub-study focused on the 21-gene BC assay. Following IRB approval, each site developed and implemented a site-specific quality improvement plan focused on the discussion/utilization of this assay. Following this intervention, chart reviews were conducted for ER+ BC patients first seen by a medical oncologist in 2013 and eligible for the 21-gene BC assay based on NCCN criteria (n=130). Data collected included: 1) documentation of a discussion with the patient of the 21-gene BC assay; 2) documentation of ordering/performance/results of the 21-gene BC assay; and 3) treatment decisions based on results and/or documentation of reasons for non-compliance. Statistical comparisons of the previously collected 2009 data (n=262) for these 5 FIQCC sites and new 2013 data were performed using the Pearson Chi-Square exact test based on Monte Carlo estimation. Results: Overall, the mean age of patients was 62 years (range 30-89) for the combined 2009 and 2013 years. More women had her2 negative BC in 2013 compared to 2009 (p=0.003). Since the 2009 dataset was not specific to the 21-gene BC assay eligibility, a smaller proportion of patients had tumor sizes staged as T1c/T2/T3 [80.3% vs. 92.2% for 2009 as compared to 2013, p=0.005] and less were node negative in 2009 [56.8% vs. 96.6%; p&amp;lt;0.001]. Based on NCCN criteria, only 60.9% of eligible patients had a documented discussion or recommendation for the 21-gene assay in 2009 with significant variability among the 5 sites (p=0.011). A significant improvement was seen in 2013 (p&amp;lt;0.001) with 91.4% of eligible patients having documentation of a discussion or recommendation for the 21-gene assay without significant variability amongst the practice sites. Significant improvement in the percentage of patients having the assay ordered from 2009 to 2013 was seen (p&amp;lt;0.001) but variability amongst the sites persisted (2009: p=0.002; 2013: p=0.018). Recurrence Score (RS) results were completely s recorded in both 2009 and 2013. All patients with high-risk RS were referred for chemotherapy. A small fraction of patients with low-risk RS was referred for chemotherapy both years (2009: 5.4%, 2013: 3.8%; p=1.00). Conclusions: Previously, the FIQCC identified quality improvement needs in multiple aspects of BC care, including recommendation and ordering of the 21-gene BC assay. A dedicated quality improvement effort can significantly increase both the discussion/recommendation and ordering of the 21-gene BC assay among eligible patients. These improvements have the potential to alter treatment recommendations. Citation Format: Christine Laronga, Weihong Sun, Erin Siegel, Ji-Hyun Lee, William J Fulp, Paul B Jacobsen, Jhanelle E Gray. Re-assessment of 21-gene breast cancer assay utilization as a quality indicator by the Florida Initiative for Quality Cancer Care (FIQCC) Consortium [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-03-15.

Cost-effectiveness of the 21-gene breast cancer assay in Mexico.

The 21-gene breast cancer assay (Oncotype DX(®); Genomic Health, Inc.) is a validated diagnostic test that predicts the likelihood of adjuvant chemotherapy benefit and 10-year risk of distant recurrence in patients with hormone-receptor-positive, human epidermal growth receptor 2-negative, early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Mexico. A Markov model was developed to make long-term projections of distant recurrence, survival, and direct costs in scenarios using conventional diagnostic procedures or the 21-gene assay to inform adjuvant chemotherapy recommendations. Transition probabilities and risk adjustment were taken from published landmark trials. Costs [2011 Mexican Pesos (MXN)] were estimated from an Instituto Mexicano del Seguro Social perspective. Costs and clinical benefits were discounted at 5% annually. Following assay testing, approximately 66% of patients previously receiving chemotherapy were recommended to receive hormone therapy only after consideration of assay results. Furthermore, approximately 10% of those previously allocated hormone therapy alone had their recommendation changed to add chemotherapy. This optimized therapy allocation led to improved mean life expectancy by 0.068 years per patient and increased direct costs by MXN 1707 [2011 United States Dollars (USD) 129] per patient versus usual care. This is equated to an incremental cost-effectiveness ratio (ICER) of MXN 25,244 (USD 1914) per life-year gained. In early-stage breast cancer patients in Mexico, guiding decision making on adjuvant therapy using the 21-gene assay was projected to improve life expectancy in comparison with the current standard of care, with an ICER of MXN 25,244 (USD 1914) per life-year gained, which is within the range generally considered cost-effective.

21-Gene breast cancer assay cost effective in Mexico

21-Gene breast cancer assay cost effective in Mexico

P248 The 21-gene breast cancer assay: a roadmap of clinical evidence

P248 The 21-gene breast cancer assay: a roadmap of clinical evidence

A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital.

The majority of breast cancer patients in Mexico are treated through the public health system and >80% receive adjuvant chemotherapy. The aim of this prospective study was to characterize the impact of the Oncotype DX assay on adjuvant therapy decision making and the confidence in those decisions amongst public sector physicians in Mexico. Ninety-eight consecutive patients with ER+, HER2-, stage I-IIIa, N0/N1-3 node-positive breast cancer from the Instituto Nacional de Cancerología were eligible for the study. The primary endpoint was the overall change in treatment recommendations after receiving the assay results. Of 96 patients, 48% received a chemohormonal therapy recommendation prior to testing. Following receipt of results, treatment decisions changed for 31/96 (32%) patients, including 17/62 (27%) node-negative patients and 14/34 (41%) node-positive patients. The proportion of patients with a chemotherapy-based recommendation decreased from 48% pre- to 34% post-assay (P=0.024). 92% of physicians agreed that they were more confident in their treatment recommendation after ordering the assay. These results suggest that use of the 21-gene assay in the Mexican public health system has a meaningful impact on adjuvant treatment recommendations that may reduce the overall use of chemotherapy.

The clinical impact of 21-gene recurrence score on treatment decisions for patients with hormone receptor-positive early breast cancer in Korea.

PurposeThe 21-gene (Oncotype DX) recurrence score (RS) assay is useful in predicting the benefits of adjuvant chemotherapy for early breast cancer patients and is widely used in Western countries. However, to date, it has not gained much popularity in East Asia. We analyzed the results from five institutions’ experience from using the 21-gene assay and examined the impact of assay results on decision making of chemotherapy in Korean breast cancer patients and the associations between RS and clinicopathologic characteristics.Materials and MethodsThe 21-gene assay was performed on 212 patients with estrogen receptor-positive early breast cancer in five institutions. Each center made systemic treatment decisions both before and after the knowledge of assay results.ResultsAmong the 212 patients, 132 (62.3%) had a low RS of < 18, 60 (28.3%) had an intermediate RS of 18-30, and 20 (9.4%) had a high RS of ≥ 31. Histologic grade, presence of micrometastases, Ki-67, and presence of lymphatic invasion were statistically associated with the RS results. Treatment decisions were changed in 115 of 212 patients (54.2%) in 109 of 212 (51.4%) from chemotherapy plus hormone therapy to hormone therapy, and in six of 212 (2.8%) from hormone therapy to chemotherapy plus hormone therapy.ConclusionThe 21-gene breast cancer assay proved to have a significant impact on treatment decision- making. The test reduces chemotherapy use in more than 50% of Korean estrogen receptor-positive, early breast cancer patients.