scholarly journals Impact of the 21-gene assay on treatment decisions in high-risk patients with ER-positive HER2-negative early breast cancer: Results of the KARMA Dx study

2019 ◽  
Vol 30 ◽  
pp. iii9-iii10
Author(s):  
A. Llombart ◽  
R. Andrés ◽  
A. Anton Torres ◽  
N. Martinez ◽  
C. Rodriguez ◽  
...  
2020 ◽  
Vol 302 (6) ◽  
pp. 1461-1467
Author(s):  
Johannes Ettl ◽  
Sophie-Isabelle Anders ◽  
Alexander Hapfelmeier ◽  
Stefan Paepke ◽  
Aurelia Noske ◽  
...  

Abstract Purpose Prospectively collected outcome data of patients (pts) whose adjuvant systemic therapy recommendation was based on the clinico-molecular test EndoPredict® (EP) are presented. Methods Pts with ER-positive, HER2-negative early breast cancer with 0–3 positive lymph nodes were enrolled. The EP was carried out on all tumor samples. Pts were evaluated for treatment compliance, local recurrence, distant metastases and overall survival. Censored time-to-event outcomes were analysed by Cox proportional hazards models. Additional estimates of the event-free-survival were calculated by the Kaplan–Meier method. Hypothesis testing was conducted on two-sided exploratory 5% significance levels. Results 373 consecutive pts were enrolled. EP classified 238 pts (63.8%) as low risk and 135 pts (36.2%) as high risk. Median follow-up was 41.6 months. Risk for disease recurrence or death in EPclin high-risk patients was twofold higher in comparison with EPclin low-risk patients (hazard ratio (HR) 2.05 (95% CI 0.85–4.96; p = 0.110). Patients with EPclin high risk were at significant higher risk of distant metastases than patients with EPclin low risk (HR 5.18; 95% CI 1.04–25.74; p = 0.0443). EPclin high-risk patients who actually underwent adjuvant CTX had a 3-year-DFS of 96.3% (95% CI 92.2–100) in contrast to EPclin high-risk patients without CTX (3-year-DFS: 91.5% (95% CI 82.7–100%); HR 0.32; 95% CI 0.10–1.05; p = 0.061). Conclusion These first prospective outcome results show that EP, in clinical routine, is a valid clinico-molecular test, to predict DFS and to guide decision of adjuvant CTX use in ER-positive, HER2-negative early breast cancer pts with 0–3 positive lymph nodes. Adjuvant CTX seems to be beneficial for EPclin high-risk patients.


1998 ◽  
Vol 34 ◽  
pp. S40 ◽  
Author(s):  
M. Andersson ◽  
C. Kamby ◽  
C. Rose ◽  
J. Andersen ◽  
M.-B. Jensen ◽  
...  

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  

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, >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 >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 >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.


2020 ◽  
Vol 30 (11) ◽  
pp. 6052-6061 ◽  
Author(s):  
Ruxandra Iulia Milos ◽  
Francesca Pipan ◽  
Anastasia Kalovidouri ◽  
Paola Clauser ◽  
Panagiotis Kapetas ◽  
...  

Abstract Objectives MRI is an integral part of breast cancer screening in high-risk patients. We investigated whether the application of the Kaiser score, a clinical decision-support tool, may be used to exclude malignancy in contrast-enhancing lesions classified as BI-RADS 4 on breast MRI screening exams. Methods This retrospective study included 183 consecutive, histologically proven, suspicious (MR BI-RADS 4) lesions detected within our local high-risk screening program. All lesions were evaluated according to the Kaiser score for breast MRI by three readers blinded to the final histopathological diagnosis. The Kaiser score ranges from 1 (lowest, cancer very unlikely) to 11 (highest, cancer very likely) and reflects increasing probabilities of malignancy, with scores greater than 4 requiring biopsy. Receiver operating characteristic (ROC) curve analysis was used to evaluate diagnostic accuracy. Results There were 142 benign and 41 malignant lesions, diagnosed in 159 patients (mean age, 43.6 years). Median Kaiser scores ranged between 2 and 5 in benign and 7 and 8 in malignant lesions. For all lesions, the Kaiser score’s accuracy, represented by the area under the curve (AUC), ranged between 86.5 and 90.2. The sensitivity of the Kaiser score was high, between 95.1 and 97.6% for all lesions, and was best in mass lesions. Application of the Kaiser score threshold for malignancy (≤ 4) could have potentially avoided 64 (45.1%) to 103 (72.5%) unnecessary biopsies in 142 benign lesions previously classified as BI-RADS 4. Conclusions The use of Kaiser score in high-risk MRI screening reliably excludes malignancy in more than 45% of contrast-enhancing lesions classified as BI-RADS 4. Key Points • The Kaiser score shows high diagnostic accuracy in identifying malignancy in contrast-enhancing lesions in patients undergoing high-risk screening for breast cancer. • The application of the Kaiser score may avoid > 45% of unnecessary breast biopsies in high-risk patients. • The Kaiser score aids decision-making in high-risk breast cancer MRI screening programs.


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