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Oncotype DX Breast Recurrence Score®Test

By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients.

P3; NHB women had worse clinical outcomes compared to NHWs in the RxPONDER trial despite similar RS and comparable treatment. Our study emphasizes the persistent racial disparities in breast cancer outcomes while highlighting complex interactions among contributing factors.

RSClinN+ provides improved estimates of prognosis and absolute CET benefit for individual patients compared with RS or with clinical data alone and could be used in patient counseling.

Black patients face more frequent delays throughout the care continuum, likely stemming from different types of access barriers at key junctures. Improving breast cancer care access will require intervention on multiple aspects of SES and healthcare access.

In this study cohort, patients with T1a/bN0 BC, RS > 25 that received aCT, did not have improved outcomes and the 21-Gene RS > 25 was not found to be predictive, possibly due to the low number of events observed.

Our study suggests that RS results can refine treatment decisions for patients with EBC exhibiting uncertain biological behavior initially recommended or considered for CT. (250/250).

The RS-predicted values and the actual Oncotype DX RS were classified into four 2 × 2 groups, by using an RS of 26 as a threshold for adding chemotherapy with a concordance rate of 95.2 % (20/21) and a kappa coefficient of 0.829. RS-predicted values of combined ER, TILs, PgR, and Ki-67 may be an appropriate substitute for Oncotype DX RS in certain situations.

All four multigene assays were cost-effective from a societal perspective, offering low net lifetime costs or savings with improved outcomes compared with clinicopathologic risk assessment alone. These assays can help refine treatment decisions by providing prognostic risk estimates. In the case of the 21-gene assay, it can also predict chemotherapy benefit leading to the highest lifetime cost savings and greatest QALY gain.

Lower HER2 score was associated with higher RS results. Further study is desired to elucidate the role and significance of HER2 expression in early-stage, ER + HER2-negative.

P2, N=77, Recruiting, Asan Medical Center

P=N/A, N=80, Recruiting, Maisonneuve-Rosemont Hospital | Phase classification: P2 --> P=N/A

According to literature, and TailorX trial data, our study confirms the importance of ODX as a tool able to guide therapeutic choices and ensure patients the most appropriate adjuvant treatment.

The Oncotype DX Breast RS result significantly influenced treatment decisions, with 44.3% of patients changing treatment, thus avoiding overtreatment or undertreatment. The Oncotype DX Breast RS test improves patient management and increases physician confidence in treatment recommendations.

Within HR + HER2- breast cancer, HER2-low tumors are associated with high RS, especially for histologically invasive ductal carcinoma. A prognostic influence of HER2-low expression among HR + HER2- breast cancer remains as an area that requires further study.

A cost-effectiveness evaluation comparing the widely used ODX with BCT revealed that BCT is the dominant option in South Korea.

Implementing the Oncotype DX test for women with ER-positive and HER2-negative early breast cancer is of great value. Delayed implementation leads to increased costs, reduced quality of life, and life-years lost.

Conclusions This study demonstrates that PGR expression, as assessed by APIS Breast Cancer Subtyping Kit, could potentially predict low-risk tumours identified by Oncotype Dx reliably, offering a cost-effective pre-screening tool. Additional validation is necessary to affirm its diagnostic accuracy.

Before Oncotype DX results, clinician recommended CT for 60.1% of pts, with docetaxel-cyclophosphamide (59.1%) as the preferred chemotherapy regimen. Without Oncotype DX results, the agreement in treatment recommendations between GTP-4o and clinicians was modest, and this discordancy deserve deeper investigation. Pre-test indications provided by GPT-4o were less impacted by the multigene assay results, maybe due to the capability of AI to better approximate Oncotype DX results. After Oncotype DX results, the agreement between AI and clinicians was extremely high indicating the key role of multigene testing in guiding treatment decisions.

Our study shows that among high genomic risk, node-negative, premenopausal patients, the survival rates are numerically similar between Caucasians and African Americans (AAs) when chemotherapy was administered. However, when chemotherapy was omitted, there were numerical differences in the survival rates within the high-risk RS population. This trend was not observed with the MP cohort.

In our cohort of HR+/HER2- early BC patients, patient menopausal status influenced the correlation between the RS and classical histopathological features. The rate of PgR expression was the only variable consistently correlating with the RS, regardless of menopausal status. Hence, the prognostic and predictive role of this, often overlooked, parameter deserves further investigation in larger and multicentric cohorts, along with a prospective validation.

In this national cohort, the RSA was requested in mostly hormone receptor (HR)-strongly positive, good prognosis, BC with low risk of early recurrence disease. Pts characteristics are similar to the general characteristics of TAILORx and RxPONDER studies. The analysis of TAILORx suggested potential benefit of ACT in women ≤ 50 yo with tumours RS 16-25; however it did not result in more frequent prescription of ACT after July 2018.

Among breast cancer patients with pT2N0, cM0 ER+/HER2- tumors, 20% had a RS<11. All these patients based on the AJCC 8th Edition Cancer Staging Manual are assigned Pathological Prognostic Stage Group IA. These patients based on TAILORx data have 0,7% distant recurrence risk at 5 years, 3% distant recurrence risk at 9 years and no chemotherapy benefit.

Treatment regimens in the T-AC group included anthracycline + cyclophosphamide (dose dense or standard) followed by taxane (n = 298, 68%), concurrent anthracycline, cyclophosphamide, and docetaxel (n = 59, 14%), and other anthracycline + taxane combinations (n = 80, 18%). Patients with early-stage, HR+/HER2-negative breast cancer and high RS values (> 31) may benefit from adjuvant taxane and anthracycline-containing therapy more than from TC. Genomic RS testing may predict anthracycline benefit more accurately than other factors such as nodal status.

ME3 is a free online tool that demonstrated significant predictive and prognostic value for DFS in our study, serving as a low-cost alternative to Oncotype DX. While our results indicate a trend towards a statistically significant association between ME3 and OS (p=0.07), this finding should be further evaluated in larger studies. TILs were not associated with OS or DFS in our cohort; however, our results showed an inverse association with pCR.

This retrospective chart review underscores the effectiveness of NET in decreasing tumor size among HR-positive/HER2-negative early-stage breast cancer patients, notably in an underserved demographic. There was no association between histological subtype and response to NET. Additionally, there were no significant differences between ethnic groups in OncotypeDX scores or breast-conserving therapy decisions, suggesting standardized treatment approaches and similar clinical characteristics across diverse patient groups.

Stratifying patients according to Ki67 levels (% <= 14% and % <= 20%) revealed significant differences in RS (p=0.03 and p=0.02, respectively). This underscores the importance of Ki67 as a potential biomarker for predicting recurrence scores and, consequently, the risk of recurrence in ILC.

57.14% (4/7) received adjuvant Letrozole for a minimum of 5 years. The patient with a recurrence score of 24 received adjuvant chemotherapy and developed metastatic 4 years post diagnosis while on Tamoxifen...Genomic tests have resulted in a significant reduction in the number of patients receiving adjuvant chemotherapy. However, a more multifacted approach may be required to tailor treatment decisions incorporating genomic testing, clinicopathological features and individual characteristics with the aim of improving outcomes for patients with hormone receptor positive early breast cancer.

Pembrolizumab (n=92/151, 61%) and CT (n=54/151, 36%) were the most common neoadjuvant therapies for TNBC. Recently updated cancer guidelines endorse gBRCAm testing in all pts ≤65 years with a breast cancer diagnosis, pts >65 years who are candidates for PARP inhibitor therapy, and other high-risk individuals. This real-world analysis of pts diagnosed since 2021 showed that 55% of pts with HR+/HER2− eBC and 27% with TNBC did not receive a gBRCA test, and utilization of adjuvant olaparib was low, particularly among pts with HR+/HER2− eBC. Wider implementation of genetic testing is needed to ensure appropriate utilization of olaparib in eligible pts with eBC.

Our study found that AA women with early-stage breast cancer had higher proportions of intermediate- and high-risk ODX scores compared to White women. Despite this, the long-term RFS and OS outcomes were generally similar between the two groups, with some suggestion of worse outcomes for AA with intermediate-risk scores. ODX remained prognostic for RFS across all racial groups.

The APIS Breast Cancer Subtyping Kit shows improved subtype call agreement with PAM50 in patients ≥65, indicating that molecular testing may be a more suitable method for determining proliferation and distinguishing between luminal A and B subtypes. Significant correlation between the APIS kit's PS, PAM50 and ODx indicates that APIS kit has the potential to accurately identify patients at risk of recurrence, although additional studies are needed to validate these results.

Hormonal therapy consisted of letrozole for post-menopausal patients and tamoxifen plus LH-RH agonist for pre/peri-menopausal patients. Neoadjuvant endocrine therapy for 16 weeks changes subtype classification by PAM50 from luminal B to luminal A and the ROR drastically. Greater effects were noted for the combination, not statistically significant, but this warrants further investigation in a larger cohort. There were 3 HER2-enriched cases with poor response, but this was not significant because of the small sample size.

Using the Oncotype DX test to guide chemotherapy treatment decision for women with early-stage N0 HR+/HER2- breast cancer is expected to be cost saving and a cost-effective strategy in Japan. It is expected to yield substantial net costs savings in most of the subgroups considered while increasing QALYs gained from avoiding chemotherapy adverse events and distant recurrence.

In this retrospective analysis, there were differences in treatment assignments based on clinical risk of PMBC that were consistent with treatment recommendations according to RS outcomes in EBC. The binary RS result cut offs (RS ≤25; RS >25) were prognostic for PFS and OS in this retrospective analysis of patients with ER+/HER2- PMBC. These findings suggest that the Oncotype DX® assay also reflects tumor biology in PMBC, and genomic assays standardly used in early breast cancer might warrant further prospective investigation in the treatment-naïve advanced setting.

Background In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials... There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs.

Our study confirms that ODX and Prosigna provide different types of clinical information for postmenopausal HR+ EBC patients, as they analyze distinct genes and pathways. In our real-world cohort, Prosigna generally assigned a higher risk category compared to ODX. Therefore, integrating multiple molecular assays could potentially refine risk assessment and enhance personalized treatment strategies in this patient population.

This observational study provides valuable insights into the management of HR+ eBC in older patients, emphasizing the importance of considering Oncotype DX® to optimize treatment strategies in these patients.

In PR-negative, pT1-3N0, cM0/ER+/HER2- breast cancer patients, PR status alone does not predict the RS and hence, the benefit of chemotherapy. The Oncotype DX assay effectively stratifies these patients, highlighting those with high RS (>25) who will benefit from chemotherapy. These findings underscore the importance of using Oncotype DX scores rather than PR status alone to guide chemotherapy decisions in PR-negative breast cancer patients.

In conclusion, this study will be the first prospective multicenter study to evaluate the risk-prediction value of RI testing in the Chinese population. Those findings will provide valuable evidence for the recommendation of RI testing for guiding adjuvant chemotherapy in early luminal breast cancer patients in China.

In this surveillance study of high-risk BC pts, DTC+ pts were identified who subsequently developed detectable ctDNA and clinical relapse. Where there were discordant results, the timing of DTC and ctDNA positivity revealed a window of opportunity for intervention. A strategy combining both markers for surveillance and intervention to prevent metastatic disease may be of value.

HR-Low and HR-Int HER2-negative BC are rare subtypes with distinct biologic features compared to HR-High BC. This real-world analysis reveals significant differences in the survival outcomes, management, and treatment responses of HR-Low and HR-Int BCs. ET use is less common with lower HR expression yet associated with improved 5y OS.

Only the established Johns Hopkins University calculator demonstrated good performance in correctly stratifying our patients. This highlights the need for further refinement and validation in predictive models across diverse patient populations to optimize medical decisions.

In advanced breast cancer, the decrease in its expression is associated with a good response. The expression of kinase activity should be considered in large prospective studies to validate its role as a prognostic biomarker.