TEST:

Oncotype DX Breast Recurrence Score®Test

Our model showed a high specificity with a low false positive rate (8.1%) for identifying low-risk 21-gene RS. As a result, there is a possibility of minimizing the need for testing in low-risk patients. These findings suggest the potential utility of the developed clinical-pathological models in identifying a subset of patients aged 50 and above who may safely omit the 21-gene RS assay.

63.9% of young women age ≤40 who decided for mastectomy elected to have CPM compared to 40.8% of all women aged 18 to 90+. Race, insurance status, education, income level, clinical stage, tumor prognostics and genotype assays all factored into the decision to proceed with CPM. Further studies should explore variables that are not available in the NCDB, such as familial history of breast cancer and genetic mutation.

Patients < 50 with pT1-2N1 HR+/HER2- breast cancer and RS≤25 have an OS benefit from combined adjuvant chemoendocrine therapy regardless of the number of +LNs. However, the OS benefit is least among patients with 1 +LN, and there may be a subset of these patients who derive a limited benefit from chemotherapy, and for whom risks outweigh benefits. Correlation of these findings with disease-free survival and other clinicopathologic features unavailable in this analysis may help to identify a subset of patients with low-risk disease who could safely avoid adjuvant chemotherapy.

Our study demonstrates an increasing trend in use of pretherapy genomic profiling over time, which is consistent with observed clinical trends. Over 50% of patients underwent upfront surgery when pretherapy genomic profiling was used to guide decision-making, who would have otherwise been offered neoadjuvant chemotherapy. We observed de-escalation of breast specific surgery in more patients with pretherapy genomic profiles.

The rate of chemotherapy use for HR+HER2-BC is higher in patients age 18-40 compared to patients older than 40, with patients age 18-30 receiving chemotherapy at the highest rate. In our cohort of young adults, chemotherapy use was associated with larger tumors, higher clinical stage, and higher ODX score. We suspect that increased use of ODX scores may have contributed to the decrease in chemotherapy utilization in this population.

Clinicopathologic features including patient age, race, clinical T category, grade, Ki67, ER/PR expression, and tumor location are associated with nodal positivity in women 50-69 years of age with cT1N0, ER+HER2- breast cancer. The 21-gene RS is not associated with nodal positivity. This predictive model is able to identify women at high risk for nodal metastasis and may help multidisciplinary teams as they look to consider de-escalating SLN surgery in breast cancer.

Our preliminary results suggest that gene expression profiling holds more weight than nodal status in determining adjuvant therapy. Our study is limited by sample size, and data collection is still ongoing. Premenopausal patients were included for the purpose of this report, but ultimately will be evaluated separately from postmenopausal patients, as in other similar studies.

Implementation of the standardized practice for the operative surgeon to order genomic testing following the release of the pathology report has led to a significant decrease in TAT of genomic testing results, by 7.9 days. The increase in volume in reports ordered amongst breast surgeons has not adversely affected TAT. This protocol can easily be implemented and replicated at other institutions to decrease the time from surgery until final treatment plan.

This study demonstrated the feasibility of omitting Oncotype Dx® assay in postmenopausal women with node negative, T1, Nottingham Grade 1, HR positive, HER2 negative breast carcinoma with Magee 2 equation score ≤ 18. Using comparable tools such as Magee 2 equation may reduce financial toxicity to this population and overall cost to the system. Larger study recommended.

Oncotype DX is an excellent predictor of chemotherapy need. Conversely, the test contributes significantly to healthcare costs and expenditures. This scoping review summarizes robust evidence that Grade 1 tumors are an independent predictor of low Oncotype DX recurrence scores, thus calling into question Oncotype DX recurrence score testing in early staged breast cancer patients with Grade 1 tumors.

To our knowledge, this is the largest study using nationwide oncology database to suggest that Black women were associated with higher RS, while HW and API women were not. It also suggested that Black women were associated with worse OS among those with RS < 26, while API women were associated with improved OS regardless of RS when compared to NHW women.

P=N/A, N=258, Active, not recruiting, Fondazione Sandro Pitigliani

Our study showed an overall survival benefit for adjuvant chemotherapy use in patients with ER-positive, N0 premenopausal BC patients, age less than 50 years, with an intermediate RS score, particularly 21-25.

The findings of this cohort study suggest that the consequences of structural racism extend beyond inequities in health care to drive disparities in breast cancer outcome. Additional research is needed with more comprehensive social and environmental measures to better understand the influence of social determinants on aggressive ER-positive tumor biology among racial and ethnic minoritized women from disadvantaged and historically marginalized communities.

BC patients with PVs in BRCA1/2 have higher RS results that stem from distinct gene expression profiles in the majority of genes in the 21-gene assay.

RS testing achieved a 75% reduction in chemotherapy use, resulting in savings of €921,543.84 in treatment costs, and net savings of €387,283.84. The use of this test resulted in a 75% reduction in chemotherapy and a significant cost savings in our publicly funded health system.

The introduction of an educational intervention had no impact on molecular assay requests. However, routine ordering of molecular assays for patients with low-clinical-risk disease is of poor value.

In the largest human social genomics study, objective and subjective ND were significantly associated with TFs of aggressive biology and SNS activation. These TFs also correlated with worse clinical outcomes, implicating SNS activation as one potential mechanism behind ND survival disparities. These findings remain to be validated in a national cohort.

There are tools available to support personalized breast cancer treatment and survivorship care decisions in clinical settings. It is important for both cancer survivors and physicians to carefully consider the quality, validity, and usability of these tools before using them to guide care decisions.

ODX does not appear to add significant additional information to inform treatment decisions for most patients with ER-low BC. Incorporating weak ER staining intensity in addition to low percentage of nuclear positivity identifies about twice as many ER-low patients, although with reduced specificity for high RS. Our study supports the contention that most ER-low early BC should be regarded similarly to ER-negative BC.

We observed racial disparities in the initiation of chemotherapy overall and by sociodemographic and clinical factors, and more equitable outcomes when clinical guidelines were followed.

While the test influences treatment decisions, particularly the use of chemotherapy, this study did not find a significant correlation between Oncotype DX risk categories and actual recurrence events. These findings underscore the need for further research to optimize the use of genomic testing in the UAE's diverse patient population and enhance personalized treatment strategies in breast cancer management.

Secondary endpoints include time from diagnosis to offer and prescription of the first adjuvant treatment, patient-reported anxiety scores and health cost impact analysis collected at baseline, following the post-operative clinic and following the offer of adjuvant treatment, and number of alterations in treatment sequence from original planned surgical treatment to neoadjuvant therapy. The study was registered on ISRCTN (ISRCTN14337451) on the 16th August 2022.

A cut-off of ≤5 ultrasound-detected abnormal nodes can distinguish between patients with limited versus high nodal burden, with high specificity. Hence, incorporating the number of abnormal ultrasound-detected nodes into clinical practice may prove useful in guiding between upfront surgery and gene assay testing or neoadjuvant chemotherapy in this group of patients.

No abstracts available

P=N/A; N=300; Not yet recruiting; Sponsor:Precise Dx, Inc.

Overview: Join speakers, Drs. Yao, Lipsyc-Sharf and Racz, as they review the expanded use of Oncotype DX Breast Recurrence Score test in early-stage breast cancer patients, as well as the use of germline testing and molecular residual disease (MRD) in breast cancer patients.

"NYU Langone Health published their study in Journal of Clinical Pathology showing that increased PI3K pathway activity, independent of PIK3CA mutations, may play a role in the recurrence of early-stage breast cancer with low and intermediate 21-gene RS."

This study presents the largest database-derived prognostic data in Japanese patients, utilizing the Oncotype DX® treatment selection. Further studies are needed to determine the impact on treatment choice, considering the clinical risk, and the need for additional postoperative treatment.

In our study we demonstrate that in certain subgroups of early-stage breast cancer there is inconsistency in clinical practice when prescribing chemotherapy to patients factoring in their Oncotype DX scores. There is need for larger trials to guide clinicians on using Oncotype DX in those subgroups of patients.

Oncologists frequently use ODX testing to guide chemotherapy management. Despite high risk ODX scores, older patients received less chemotherapy compared to their younger counterparts. Further investigation is needed to determine how age impacts clinician decision making and clinical outcomes following ODX testing.

Our model could enable hospitals to rapidly triage the need for genomic risk testing, possibly precluding one third of orders without loss of accuracy. This helps allocate scarce resources for genomic tests and valuable weeks prior to beginning therapy while maintaining the standard of precision oncology.

Implementing Oncotype DX testing in this population can prevent unnecessary overtreatment, reducing clinical and economic burden on the patient and Dutch healthcare system.

P=N/A; Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Jun 2025

The prediction accuracy exceeded 90% in several subgroups, with the highest prediction accuracy of 95.7% in the subgroup that met Ki-67 <20 and HG 1~2 and premenopausal status. Our machine learning-based predictive model has the potential to complement existing MGAs in ER+/HER2- breast cancer.

Analogous to the pN0 situation, this budget impact model demonstrates that the Oncotype DX Breast Recurrence Score test can also reduce healthcare costs in Germany in treatment of node-positive (pN1: 1-3 positive lymph nodes) patients by minimizing both unnecessary chemotherapy and undertreatment. Additional benefits to patients would include reduced morbidity and improved quality of life for those patients who can safely avoid chemotherapy or undertreatment.

Higher Ki67 gene expression was associated with recurrences (p=0.042) Increased PI3K pathway activity, independent of PIK3CA mutations, may play a role in the recurrence of early-stage breast cancer with low and intermediate 21-gene RS. Pathway analysis can help to identify high-risk patients in this setting.

Implementation of a test send out protocol that supports trained nurses in identifying which patients are eligible for Oncotype DX® testing can significantly decrease turn-around times and lead to more meaningful and productive oncology visits. When clinical oncologists and surgical oncologists work together with nurses to establish clear workflows and document appropriately, care coordination improves. Tracking send out test orders in the pathology lab allows pathologists to identify trends in ordering practices and track turn-around times.

Our data show a statistically significant difference in mean H2 RT-PCR/O among all 3 previously defined "categories" of HER2 expression, as well as between H2/N and H2/L and between H2/UL and H2/L. There is also a statistically significant difference in grade among the 3 "categories". Ongoing analysis may determine cut-offs of H2 RT-PCR/O scores between "categories" - which could be of theragnostic use.

In our patient population, there is an incremental difference in the average HER2 score by the Oncotype assay as the tumors progress from IHC score 0 to IHC score 2+/ISH negative. The negative/score 0 had an average HER2 of 8.9 while the negative/"HER2 low" averaged 9.4. However, whether this slight change reflects a meaningful biologic difference between the tumors is unknown.

HER2 IHC scores significantly correlated with their median ODX mRNA expression scores. However, significant overlaps in ODX HER2 mRNA expression scores existed between the different HER2 IHC scores, limiting the use of ODX HER2 mRNA expression scores as a predictor of HER2 IHC scores.

The distribution of RS among LN(+) and LN(-) women age ≥50 years in our cohort was similar. Our results show that in the post-RxPONDER era, over 80% of women age ≥50 y with early-stage ER+/HER2- BC with ≤3 positive ALNs would be spared chemotherapy based on RS, regardless of nodal status.