Real-world evidence evaluating the use of an NK-1 antiemetic in the systemic chemotherapy treatment of metastatic breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12599-e12599
Author(s):  
Kevin Lord ◽  
Bruce A. Feinberg ◽  
Jonathan Kish ◽  
Jalyna R. Laney ◽  
Dhruv Chopra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Systemic Chemotherapy ◽  
Package Insert ◽  
Low Risk ◽  
Risk Level ◽  
Administrative Claims ◽  
Individual Agent ◽  
Risk Grade ◽  
Prophylactic Use

e12599 Background: Severe and persistent nausea and vomiting (n/v) impacts quality of life and may lead to treatment discontinuation. While antiemetics assist with minimizing these effects, newer drugs can be expensive and carry their own side effect profile. Prior research has suggested that neurokinin 1 receptor inhibitor(NK-1) antiemetics are overly prescribed. Using the package insert recommendations for aprepitant, an NK-1, we evaluated the frequency of its prophylactic use to prevent emesis in patients receiving systemic chemotherapy(chemo) with moderate to high emetogenic risk. Methods: Patients were identified from a third-party, administrative claims database. Using medical and pharmacy claims, any female with ICD-9/10 codes for both breast cancer and metastases diagnosed between Jan-2013 and Dec-2017, who initiated systemic chemo and received aprepitant prophylactically were selected. Chemo regimen emetogenic potential was scored using the Hesketh scale and aggregated into two cohorts: low risk (grade 1-2 = none- < 30%), and moderate-high risk (grade 3-5: > 30- > 60%). If patients received combination chemo, the assigned risk level was the highest risk of any individual agent. The frequency of NK-1 use for each risk cohort was calculated per line of therapy independent of the previous treatment. Results: 10,342 patients met the selection criteria with 2,868 patients administered moderate-high emetogenic risk chemotherapy regimens. Mean age at initiation of treatment was 61.7 years (SD = 12.12). By line, the aprepitant utilization rate was: 1 line(L) 43% ,2L 27%, 3L 18%, 4L 16%, 5L 11% and 6L 12%. Across all lines of therapy, aprepitant was used prophylactically in 23% of patients treated with high risk chemo regimens and in 2% of patients who had received low risk regimens. Conclusions: Prophylactic use of the NK-1 inhibitor aprepitant was less than 50% in 1L moderate-high emetogenic risk chemotherapy and declined with consecutive lines of treatment. NK-1 use with low risk regimens was minimal. Further research is needed to understand the pattern of use and clinical outcomes between moderate-high emetogenic risk patients who do and don't receive NK-1 antiemetic supportive care.

scholarly journals Spatial Distribution of Breast Cancer in Sudan 2010-2016

2019 ◽  
Author(s):  
Marwa Maweya Abdelbagi Elbasheer ◽  
Ayah Galal Abdelrahman Alkhidir ◽  
Siham Mohammed Awad Mohammed ◽  
Areej Abuelgasim Hassan Abbas ◽  
Aisha Osman Mohamed ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Spatial Distribution ◽  
Spatial Analysis ◽  
High Risk ◽  
Geographical Information ◽  
Risk Level ◽  
Histopathological Diagnosis ◽  
Cross Sectional ◽  
Distribution Maps ◽  
Risk Areas

AbstractBackgroundBreast cancer is the most prevalent cancer among females worldwide including Sudan. The aim of this study was to determine the spatial distribution of breast cancer in Sudan.Materials and methodsA facility based cross-sectional study was implemented in eighteen histopathology laboratories distributed in the three localities of Khartoum State on a sample of 4630 Breast Cancer cases diagnosed during the period 2010-2016. A master database was developed through Epi Info™ 7.1.5.2 for computerizing the data collected: the facility name, type (public or private), and its geo- location (latitude and longitude). Personal data on patients were extracted from their respective medical records (name, age, marital status, ethnic group, State, locality, administrative unit, permanent address and phone number, histopathology diagnosis). The data was summarized through SPSS to generate frequency tables for estimating prevalence and the geographical information system (ArcGIS 10.3) was used to generate the epidemiological distribution maps. ArcGIS 10.3 spatial analysis features were used to develop risk maps based on the kriging method.ResultsBreast cancer prevalence was 3.9 cases per 100,000 female populations. Of the 4423 cases of breast cancer, invasive breast carcinoma of no special type (NST) was the most frequent (79.5%, 3517/4423) histopathological diagnosis. The spatial analysis indicated as high risk areas for breast cancer in Sudan the States of Nile River, Northern, Red Sea, White Nile, Northern and Southern Kordofan.ConclusionsThe attempt to develop a predictive map of breast cancer in Sudan revealed three levels of risk areas (risk, intermediate and high risk areas); regardless the risk level, appropriate preventive and curative health interventions with full support from decision makers are urgently needed.

scholarly journals Impact of Different Modules of 21-Gene Assay in Early Breast Cancer Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
Younger Patients ◽  
Gene Assay ◽  
Risk Patients ◽  
Gene Modules ◽  
The Impact

BackgroundThe 21-gene assay recurrence score (RS) provides additional information on recurrence risk of breast cancer patients and prediction of chemotherapy benefit. Previous studies that examined the contribution of the individual genes and gene modules of RS were conducted mostly in postmenopausal patients. We aimed to evaluate the gene modules of RS in patients of different ages.MethodsA total of 1,078 estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients diagnosed between January 2009 and March 2017 from Shanghai Jiao Tong University Breast Cancer Data Base were included. All patients were divided into three subgroups: Group A, ≤40 years and premenopausal (n = 97); Group B, &gt;40 years and premenopausal (n = 284); Group C, postmenopausal (n = 697). The estrogen, proliferation, invasion, and HER2 module scores from RS were used to characterize the respective molecular features. Spearman correlation and analysis of the variance tests were conducted for RS and its constituent modules.ResultsIn patients &gt;40 years, RS had a strong negative correlation with its estrogen module (ρ = −0.76 and −0.79 in Groups B and C) and a weak positive correlation with its invasion module (ρ = 0.29 and 0.25 in Groups B and C). The proliferation module mostly contributed to the variance in young patients (37.3%) while the ER module contributed most in old patients (54.1% and 53.4% in Groups B and C). In the genetic high-risk (RS &gt;25) group, the proliferation module was the leading driver in all patients (ρ = 0.38, 0.53, and 0.52 in Groups A, B, and C) while the estrogen module had a weaker correlation with RS. The impact of ER module on RS was stronger in clinical low-risk patients while the effect of the proliferation module was stronger in clinical high-risk patients. The association between the RS and estrogen module was weaker among younger patients, especially in genetic low-risk patients.ConclusionsRS was primarily driven by the estrogen module regardless of age, but the proliferation module had a stronger impact on RS in younger patients. The impact of modules varied in patients with different genetic and clinical risks.

Adjuvant Chemotherapy Guidance for pT1-3N0-1 Breast Cancer Patients with HR+, HER2- subtype: a study based on SEER database

2021 ◽  
Author(s):  
juanjuan Qiu ◽  
Li Xu ◽  
Yu Wang ◽  
Jia Zhang ◽  
Jiqiao Yang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Prognostic Factors ◽  
High Risk ◽  
Cancer Patients ◽  
Risk Group ◽  
High Risk Group ◽  
Low Risk ◽  
Rank Test ◽  
Breast Cancer Patients ◽  
Group Score

Abstract Background Although the results of gene testing can guide early breast cancer patients with HR+, HER2- to decide whether they need chemotherapy, there are still many patients worldwide whose problems cannot be solved well by genetic testing. Methods 144 735 patients with HR+, HER2-, pT1-3N0-1 breast cancer from the Surveillance, Epidemiology, and End Results database were included from 2010 to 2015. They were divided into chemotherapy (n = 38 392) and no chemotherapy (n = 106 343) group, and after propensity score matching, 23 297 pairs of patients were left. Overall survival (OS) and breast cancer-specific survival (BCSS) were tested by Kaplan–Meier plot and log-rank test and Cox proportional hazards regression model was used to identify independent prognostic factors. A nomogram was constructed and validated by C-index and calibrate curves. Patients were divided into high- or low-risk group according to their nomogram score using X-tile. Results Patients receiving chemotherapy had better OS before and after matching (p < 0.05) but BCSS was not significantly different between patients with and without chemotherapy after matching: hazard ratio (HR) 1.005 (95%CI 0.897, 1.126). Independent prognostic factors were included to construct the nomogram to predict BCSS of patients without chemotherapy. Patients in the high-risk group (score > 238) can get better OS HR 0.583 (0.507, 0.671) and BCSS HR 0.791 (0.663, 0.944) from chemotherapy but the low-risk group (score ≤ 238) cannot. Conclusion The well-validated nomogram and a risk stratification model was built. Patients in the high-risk group should receive chemotherapy while patients in low-risk group may be exempt from chemotherapy.

Artificial Intelligence for the Online Prediction of the Cool-down Time in a Subsea Pipeline After an Unplanned Shutdown

2021 ◽  
Author(s):  
Alberto Gerri ◽  
Ahmed Shokry ◽  
Enrico Zio ◽  
Marco Montini
Keyword(s):  
High Risk ◽  
Operating Conditions ◽  
Low Risk ◽  
Minimum Time ◽  
Computational Time ◽  
Risk Level ◽  
Support Vector ◽  
Svm Classifier ◽  
The Novel ◽  
Subsea Pipelines

Abstract Hydrates formation in subsea pipelines is one of the main reliability concerns for flow assurance engineers. A fast and reliable assessment of the Cool-Down Time (CDT), the period between a shut-down event and possible hydrates formation in the asset, is of key importance for the safety of operations. Existing methods for the CDT prediction are highly dependent on the use of very complex physics-based models that demand large computational time, which hinders their usage in an online environment. Therefore, this work presents a novel methodology for the development of surrogate models that predict, in a fast and accurate way, the CDT in subsea pipelines after unplanned shutdowns. The proposed methodology is, innovatively, tailored on the basis of reliability perspective, by treating the CDT as a risk index, where a critic CDT threshold (i.e. the minimum time needed by the operator to preserve the line from hydrates formation) is considered to distinguish the simulation outputs into high-risk and low-risk domains. The methodology relies on the development of a hybrid Machine Learning (ML) based model using datasets generated through complex physics-based model’ simulations. The hybrid ML-based model consists of a Support Vector Machine (SVM) classifier that assigns a risk level (high or low) to the measured operating condition of the asset, and two Artificial Neural Networks (ANNs) for predicting the CDT at the high-risk (low CDT) or the low-risk (high CDT) operating conditions previously assigned by the classifier. The effectiveness of the proposed methodology is validated by its application to a case study involving a pipeline in an offshore western African asset, modelled by a transient physics-based commercial software. The results show outperformance of the capabilities of the proposed hybrid ML-based model (i.e., SVM + 2 ANNs) compared to the classical approach (i.e. modelling the entire system with one global ANN) in terms of enhancing the prediction of the CDT during the high-risk conditions of the asset. This behaviour is confirmed applying the novel methodology to training datasets of different size. In fact, the high-risk Normalized Root Mean Square Error (NRMSE) is reduced on average of 15% compared to the NRMSE of a global ANN model. Moreover, it’s shown that high-risk CDT are better predicted by the hybrid model even if the critic CDT, which divides the simulation outputs in high-risk and low-risk values (i.e. the minimum time needed by the operator to preserve the line from hydrates formation), changes. The enhancement, in this case, is on average of 14.6%. Eventually, results show how the novel methodology cuts down by more than one hundred seventy-eight times the computational times for online CDT predictions compared to the physics-based model.

scholarly journals Does Mode of Surgical Intervention Based on Oncotype DX Score Influence Disease Recurrence in Early Breast Cancer?

2020 ◽  
Vol 06 (02) ◽  
pp. e135-e138
Author(s):  
T. M. Aherne ◽  
M. R. Boland ◽  
D. Catargiu ◽  
K. Bashar ◽  
T. P. McVeigh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Local Excision ◽  
Wide Local Excision ◽  
Surgical Intervention ◽  
Disease Recurrence ◽  
Low Risk ◽  
Oncotype Dx ◽  
Significant Difference

Abstract Introduction Routine utilization of multigene assays to inform operative decision-making in early breast cancer (EBC) treatment is yet to be established. In this pilot study, we sought to establish the potential benefits of surgical intervention in EBC based on recurrence risk quantification using the Oncotype DX (ODX) assay. Materials and Methods Consecutive ODX tests performed over a 9-year period from October 2007 to May 2016 were evaluated. Oncotype scores were classified into high (≥31), medium (18–30), or low-risk (0–17) groups. The primary outcome was breast cancer recurrence. Subgroup analysis offered assessment of the recurrence effect of mode of surgical intervention for patient groups as defined by the oncotype score. Results In total 361 patients underwent ODX testing. The mean age and follow-up were 55.25 (± 10.58) years and 38.59 (± 29.1) months, respectively. The majority of patients underwent wide local excision (86.7%) with 8.9 and 4.4% patients having a mastectomy or wide local excision with completion mastectomy, respectively. Fifty-one percent of patients fell into the low risk ODX category with a further 40.2 and 8.5% deemed to be of intermediate and high risk. Five patients (1.38%) had disease recurrence. Comparative analysis of operative groups in each oncotype group revealed no difference in recurrence scores in the low- (p = 0.84) and high-risk groups (p = 0.92) with a statistically significant difference identified in the intermediate risk group (p = 0.002). Conclusion To date we have been unable to definitively identify a role for ODX in guiding surgical approach in EBC. There is, however, a need for larger studies to examine this hypothesis.

Risk-Based Inspection Analysis for High Pressure Hydrogenation Cracking Unit

2006 ◽  
Author(s):  
Jian-Ping Zhao
Keyword(s):  
High Pressure ◽  
High Risk ◽  
Risk Level ◽  
Aromatic Plant ◽  
Inspection Plan ◽  
Medium Risk ◽  
Quantitative Analysis Method ◽  
Equipment Unit ◽  
Risk Situation ◽  
Risk Grade

High pressure hydrogenation cracking unit is the core equipment system in the aromatic plant, which is subjected simultaneously to the action of hydrogen and high pressure and high temperature. In this paper, quantitative analysis method of RBI was carried out by Orbit-Onshore software, which was developed by DNV corporation. In API 581, the risk situation for a certain equipment unit were classified into four grades, such as low risk grade and medium risk grade and medium-high risk grade and high grade, which is expressed as risk matrix. The whole risk distribution of 553 equipment and piping items was obtained, and in which the hydrocracking reactors and the reactor effluent air coolers are belong to ‘medium-high risk’ grade. Based on the RBI results, an optimum inspection plan was developed by the author to reduce the risk level for the hydrogenation cracking unit. It is concluded that the optimum inspection plan was completely satisfied with the engineering specification of the aromatic plant, after the validation of the inspection activity in 2004.

Survival advantage of adjuvant chemotherapy in high-risk node-negative breast cancer: ten-year analysis--an intergroup study.

1998 ◽  
Vol 16 (11) ◽  
pp. 3486-3492 ◽  
Author(s):  
E G Mansour ◽  
R Gray ◽  
A H Shatila ◽  
D C Tormey ◽  
M R Cooper ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Group ◽  
Low Risk ◽  
Significant Prognostic Factor ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Disease Free

PURPOSE Preliminary analysis showed that adjuvant chemotherapy is effective in improving disease-free survival (DFS) among high-risk breast cancer patients. This report updates the analysis of the high-risk group and reports the results of the low-risk group. METHODS Patients who had undergone a modified radical mastectomy or a total mastectomy with low-axillary sampling, with negative axillary nodes and either an estrogen receptor-negative (ER-) tumor of any size or an estrogen receptor-positive (ER+) tumor that measured > or = 3 cm (high-risk) were randomized to receive six cycles of cyclophosphamide, methotrexate, fluorouracil, and prednisone (CMFP) or no further treatment. Patients with ER+ tumors less than 3 cm (low-risk) were monitored without therapy. RESULTS DFS and overall survival (OS) at 10 years were 73% and 81%, respectively, among patients who received chemotherapy, as compared with 58% and 71% in the observation group (P=.0006 for DFS and P=.02 for OS). Chemotherapy was beneficial for patients with large tumors, both ER+ and ER-, showing a 10-year DFS of 70% versus 51 % (P=.0009) and OS of 75% versus 65% (P=.06). Ten-year survival was 77% among low-risk patients, 85% among premenopausal patients, and 73% in the postmenopausal group. CONCLUSION The observed 37% reduction in risk of recurrence and 34% reduction in mortality risk at 10 years, associated with a 15.4% absolute benefit in disease-free state and 10.1% in survival, reaffirm the role of adjuvant chemohormonal therapy in the management of high-risk node-negative breast cancer. Tumor size remains a significant prognostic factor associated with recurrence and survival in the low-risk group.

Impact of the EndoPredict-clin score on risk stratification in ER-positive, HER2-negative breast cancer after considering clinical guidelines.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 542-542
Author(s):  
Martin Filipits ◽  
Peter Christian Dubsky ◽  
Margaretha Rudas ◽  
Jan C. Brase ◽  
Ralf Kronenwett ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Clinical Guidelines ◽  
Risk Groups ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Er Positive

542 Background: Many ER-positive, HER2-negative breast cancer patients are treated by adjuvant chemotherapy according to current clinical guidelines. We retrospectively assessed whether the combined gene expression/ clinicopathological EndoPredict-clin (EPclin) score improved the accuracy of risk classification in addition to considering clinical guidelines. Methods: Three clinical breast cancer guidelines (National Comprehensive Cancer Center Network (NCCN), German S3 and St. Gallen 2011), and the EPclin score - assessed by quantitative RT-PCR in formalin-fixed paraffin-embedded tissue - were used to assign risk groups in 1,702 ER-positive, HER2-negative breast cancer patients from two randomized phase III trials (Austrian Breast and Colorectal Cancer Study Group 6 and 8) treated with endocrine therapy only. Results: Although all analyzed clinical guidelines identified a low-risk group with improved metastasis-free survival, the overwhelming majority of all patients (81-94%) were classified as intermediate / high risk. In contrast to that, the EPclin classified only 37% of all patients as high risk and that stratification resulted in the best separation between low and high risk groups (p < 0.001, HR = 5.11 (3.48-7.51). Consequently, the majority of all patients deemed intermediate / high risk by the clinical guidelines was re-classified as low risk by the EPclin score. Kaplan Meier analyses demonstrated that the re-classified subgroups (47 to 57% of all patients) had an excellent 10-year metastasis-free survival of 95% comparable to the clinical assigned low-risk groups although encompassing a higher proportion of the trial patients. Conclusions: The EPclin score predicted distant recurrence more accurately than all three clinical guidelines and is especially useful to reclassify patients considered as intermediate / high risk by the guidelines. The data suggests that the EPclin score provides clinically useful prognostic information beyond common clinical guidelines and can be used to accurately identify the clinically relevant group of patients who are adequately and sufficiently treated with adjuvant endocrine therapy alone.

Breast Cancer Index and risk stratification in luminal subtypes: A trans-ATAC study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 534-534
Author(s):  
Ivana Sestak ◽  
Yi Zhang ◽  
Catherine A. Schnabel ◽  
Jack M. Cuzick ◽  
Mitchell Dowsett
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cox Regression ◽  
Early Stage ◽  
Risk Groups ◽  
Low Risk ◽  
Luminal A ◽  
Prognostic Information ◽  
Prognostic Performance ◽  
Breast Cancer Index

534 Background: The Breast Cancer Index (BCI) is a gene-expression based signature that provides prognostic information for overall (0-10 years) and late (5-10 years) distant recurrence (DR) and prediction of extended endocrine benefit in hormone receptor positive (HR+) early stage breast cancer. The current analysis aims to further characterize, correlate and compare the prognostic performance of BCI in luminal subtypes based on immunohistochemical classification. Methods: 670 postmenopausal women with HR+, LN- disease from the TransATAC cohort were included in this analysis. Luminal A-like tumors (LumA) were identified as those with ER+ and/or PR+ and HER2 -, and Ki67 < 20% by IHC. All other tumors were classified as Luminal B-like (LumB) for this analysis. Primary endpoint was DR. Cox regression models were used to examine BCI prognostic performance according to luminal subtype, adjusting for the clinicopathological model Clinical Treatment Score (CTS). Results: 452 (67.5%) patients were classified as LumA and 218 (32.5%) as LumB. BCI was highly prognostic in LumA cancers (adjusted HR = 1.57 (1.23-1.96), P < 0.001, ΔLR-χ2= 14.09), but not in LumB tumors (adjusted HR = 1.20 (0.94-1.52, P = 0.14, ΔLR-χ2= 2.23). In LumA, 10-year DR risks in BCI intermediate and high risk groups were very similar (25.6% (16.4-38.6) and 25.3% (13.5-44.3), respectively) and significantly different from BCI low (3.9% (2.1-7.0); HR = 7.47 (3.50-15.96) and HR = 8.13 (3.27-20.23), respectively). In LumB, 10-year DR risks in BCI low and BCI intermediate risk groups (13.8% (6.8-26.9) and 14.6% (8.3-24.9), respectively) were very similar and significantly lower than for the BCI high (29.1% (20.0-41.1)). Lum subtyping was only prognostic in the BCI low risk group (LumA vs. LumB: HR = 4.27 (1.65-11.02)) but not in the other two BCI risk groups. Conclusions: BCI provided significant prognostic information in Lum A subtype. These results show that BCI intermediate and high risk had similar risk of DR in LumA tumors, while shared similarly low risk of DR as BCI-low in LumB tumors. Further evaluation is needed to elucidate the distinct mechanisms underlying each classification system.

Comparative performance of Breast Cancer Index (BCIN+) and CTS5 in hormone receptor-positive (HR+) lymph node-positive (N+) breast cancer patients with one to three positive nodes (N1).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 555-555
Author(s):  
Dennis Sgroi ◽  
Yi Zhang ◽  
Catherine A. Schnabel
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Tumor Size ◽  
Risk Groups ◽  
Cox Proportional Hazards ◽  
Low Risk ◽  
Intermediate Risk ◽  
Breast Cancer Patients

555 Background: Identification of N+ breast cancer patients with a limited risk of recurrence improves selection of those for which chemotherapy and/or extended endocrine therapy (EET) may be most appropriate to reduce overtreatment. BCIN+ integrates gene expression with tumor size and grade, and is highly prognostic for overall (0-10yr) and late (5-10yr) distant recurrence (DR) in N1 patients. Clinical Treatment Score post-5-years (CTS5) is a prognostic model based on clinicopathological factors (nodes, age, tumor size and grade) and significantly prognostic for late DR. The current analysis compares BCIN+ and CTS5 for risk of late DR in N1 patients. Methods: 349 women with HR+, N1 disease and recurrence-free for ≥5 years were included. BCIN+ results were determined blinded to clinical outcome. CTS5 was calculated as previously described (Dowsett et al, JCO 2018; 36:1941). Kaplan-Meier analysis and Cox proportional hazards regression for late DR (5-15y) were evaluated. Results: 64% of patients were > 50 years old, 34% with tumors > 2cm, 79% received adjuvant chemotherapy and 64% received up to 5 years of ET. BCIN+ stratified 23% of patients as low-risk with 1.3% risk for late DR vs those classified as high-risk with 16.1% [HR 12.4 (1.7-90.4), p = 0.0014]. CTS5 classified patients into 3 risk groups: 29% of patients as low-risk (4.2% DR), 37% as intermediate-risk (10.6% DR), and 34% as high-risk (22.1% DR) [HR intermediate vs. low: 2.3 (0.7-7.0), p = 0.16; high vs. low: 5.3 (1.8-15.5), p = 0.002]. In a subset of patients who completed 5 years of ET (N = 223), BCIN+ identified 22% of patients as low-risk with a late DR rate of 2.1%, while CTS5 identified 29% and 37% of patients as low- and intermediate-risk with late DR rates of 5.2% and 10.3%, respectively. Conclusions: BCIN+ classified N1 patients into binary risk groups and identified 20% patients with limited risk of late DR ( < 2%) that may be advised to forego EET and its attendant toxicities/side effects. In comparison, CTS5 classified patients into 3 risk groups, with low- and intermediate-risk of late DR of 4-5% and 10%, wherein the risk-benefit profile for extension of endocrine therapy is less clear.

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