scholarly journals Distribution of the 21-Gene Breast Recurrence Score in Patients with Primary Breast Cancer in Germany

2020 ◽  
Vol 80 (06) ◽  
pp. 619-627
Author(s):  
Vincent P. Walter ◽  
Florin-Andrei Taran ◽  
Markus Wallwiener ◽  
Armin Bauer ◽  
Eva-Maria Grischke ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Clinical Practice ◽  
Recurrence Score ◽  
Routine Clinical Practice ◽  
Ki 67 ◽  
Node Negative ◽  
Hormone Receptor Positive ◽  
High Clinical Risk ◽  
Breast Recurrence

Abstract Background Multigene assays are being used increasingly to aid in decision-making about chemotherapy in breast cancer. Here, we present the 21-gene recurrence score (RS) of patients tested in routine clinical practice in Germany. Patients and Methods In a retrospective analysis, 4695 patients with hormone receptor-positive and HER2-negative early breast cancer (pT1 – 3, pN0 – 1, M0) were included in whom RS testing was conducted in Germany between November 2015 and July 2018. RS groups as defined in the TAILORx trial (RS result 0 – 10; 11 – 25; 26 – 100) were used. Results Of these patients, 21% were assigned to the low RS group, 63% to the midrange RS group, and 15% to the high RS group. 1772 (81%) of 2175 node-negative patients over 50 years of age were grouped either into the low RS group or the midrange RS group. The portion of patients with a low or midrange RS was 90% among node-positive patients (1284 of 1432 patients), 79% among patients with Ki-67-high (≥ 20%) tumors (1829 of 2310 patients), 86% vs. 70% among patients with G2 and G3 tumors (3244 of 3762 patients and 368 of 522 patients), respectively, 88% among patients with a tumor size of > 5 cm (140 of 159 patients), and 82% among node-negative patients at high clinical risk (1110 of 1352). Conclusions The distribution of the 21-gene RS in German patients that were tested in routine clinical practice indicates that, according to the results of the TAILORx trial, chemotherapy may not be beneficial in most of these.

A retrospective study of 21-gene recurrence score assay compared with clinicopathological markers in node-negative, hormone receptor-positive, HER2-negative breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12023-e12023
Author(s):  
Junqing Chen ◽  
Xiaojia Wang ◽  
Zhanhong Chen
Keyword(s):  
Breast Cancer ◽  
Retrospective Study ◽  
Hormone Receptor ◽  
Recurrence Score ◽  
Tumor Grade ◽  
Breast Cancer Patients ◽  
Ki 67 ◽  
Node Negative ◽  
Hormone Receptor Positive ◽  
Er Expression

e12023 Background: The 21-gene recurrence score assay is a validated genomic predictor of cancer recurrence and the benefits of adjuvant chemotherapy in hormone receptor-positive, HER2-negative early breast cancer patients. However, the assay is rather expensive and complex, and many patients in our country can not afford it. We performed a retrospective study to evaluate the association between traditional clinicopathological features and 21-gene recurrence score in patients with node-negative, hormone receptor-positive, HER2-negative breast cancer. Methods: A total of 76 consecutive patients with node-negative, hormone receptor-positive, HER2-negative breast cancer who underwent 21-gene recurrence score testing in our hospital from 2015 to 2016 were enrolled. Data including age, tumor size, histological type, tumor grade were collected. Estrogen receptor (ER) expression, progesterone receptor (PR) expression, Ki-67 index, p53 and androgen receptor (AR) expression were detected by immunohistochemical assay. 21-gene recurrence score assay was performed by RT-PCR. The correlation between clinicopathological characteristics and 21-gene recurrence score assay was analyzed by using nonparametric tests. Results: Among the 76 patients, 43 (56.6%) had a low recurrence score of < 18, 13 (17.1%) had an intermediate recurrence score of 18-31, and 20 (26.3%) had a high recurrence score of ≥31. There was a significant difference in recurrence score in patients divided by PR expression ( P=0.027). Patients with low PR expression (<20%) had a higher recurrence score as compared to those with high PR expression. Tumor grade was observed to be significantly correlated with recurrence score ( P=0.004). No significant associations were found between recurrence score and age, tumor size, histological type, ER expression, Ki-67 index, p53 or AR expression in this study. Conclusions: Our study shows that low PR expression is associated with higher 21-gene recurrence score, and PR expression may be a promising predictor of 21-gene recurrence score assay in node-negative, hormone receptor-positive, HER2-negative breast cancer patients.

Association between androgen receptor expression, Ki-67 and the 21-gene recurrence score in non-metastatic, lymph node-negative, estrogen receptor-positive and HER2-negative breast cancer

2015 ◽  
Vol 68 (10) ◽  
pp. 839-843 ◽  
Author(s):  
Francisco E Vera-Badillo ◽  
Martin C Chang ◽  
Gordana Kuruzar ◽  
Alberto Ocana ◽  
Arnoud J Templeton ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Androgen Receptor ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Recurrence Score ◽  
Receptor Expression ◽  
Ki 67 ◽  
Node Negative

BackgroundThe mechanisms underlying the favourable prognosis of androgen receptor (AR) expression in breast cancer are unknown.MethodsThe associations between the 21-gene recurrence score (RS), AR, grade, mitotic score, Ki-67 and estrogen receptor (ER) and progesterone receptor (PgR) expression were explored in sequential women with lymph node-negative, ER-positive and HER2-negative breast cancer. Statistical significance of this exploratory study was defined as p<0.10.ResultsAnalysis comprised 70 women. Most tumours had high AR expression (97% had scores >3). Median RS was 15 (range 1–53). AR expression showed a minimally significant positive correlation with ER (R=0.37), but no correlation with Ki-67 (R=−0.18). In univariable analysis, AR (p=0.01), ER (p<0.001) and PgR (p<0.001) had significant negative associations with RS. Ki-67 (p=0.16), grade (p=0.40) and mitotic score (p=0.23) showed no association with RS. Multivariable analysis showed similar associations.ConclusionsAR is associated with lower RS, but not with Ki-67.

scholarly journals Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update

2017 ◽  
Vol 35 (24) ◽  
pp. 2838-2847 ◽  
Author(s):  
Ian Krop ◽  
Nofisat Ismaila ◽  
Fabrice Andre ◽  
Robert C. Bast ◽  
William Barlow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Systemic Therapy ◽  
Hormone Receptor ◽  
Early Stage ◽  
Adjuvant Systemic Therapy ◽  
Node Negative ◽  
Clinical Risk ◽  
Hormone Receptor Positive ◽  
High Clinical Risk ◽  
Positive Breast Cancer

Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility. Recommendations If a patient has hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-negative breast cancer, the MammaPrint assay may be used in those with high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good-prognosis population with potentially limited chemotherapy benefit. Women in the low clinical risk category did not benefit from chemotherapy regardless of genomic MammaPrint risk group. Therefore, the MammaPrint assay does not have clinical utility in such patients. If a patient has hormone receptor–positive, HER2-negative, node-positive breast cancer, the MammaPrint assay may be used in patients with one to three positive nodes and a high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy. However, such patients should be informed that a benefit from chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. The clinician should not use the MammaPrint assay to guide decisions on adjuvant systemic therapy in patients with hormone receptor–positive, HER2-negative, node-positive breast cancer at low clinical risk, nor any patient with HER2-positive or triple-negative breast cancer, because of the lack of definitive data in these populations. Additional information can be found at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .

scholarly journals The 21-Gene Recurrence Score Assay and Prediction of Chemotherapy Benefit: A Propensity Score-Matched Analysis of the SEER Database

Cancers ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1829
Author(s):  
In Sil Choi ◽  
Jiwoong Jung ◽  
Byoung Hyuck Kim ◽  
Sohee Oh ◽  
Jongjin Kim ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Propensity Score ◽  
Early Stage ◽  
Recurrence Score ◽  
Node Negative ◽  
Hormone Receptor Positive ◽  
Breast Cancer Specific Mortality ◽  
Real World Evidence ◽  
Specific Mortality ◽  
Cancer Specific Mortality

Background: To evaluate the performance of the 21-gene recurrence score (RS) assay in predicting chemotherapy benefit in the Surveillance, Epidemiology, and End Results population, we aimed to assess breast cancer-specific mortality (BCSM) by chemotherapy use within each of the RS categories. Methods: Data on breast cancer (BC) cases diagnosed between 2004 and 2015 with available RS results were released. Our analysis included patients with hormone receptor-positive, node-negative early-stage BC (n = 89,402), and three RS groups were defined; RS < 11, low; RS 11–25, intermediate; RS > 25, high. A propensity score matched-analysis was performed to assess and compare BCSM. Results: Chemotherapy was significantly associated with a reduced risk of BC death among patients in the high RS group (hazard ratio = 0.782; 95% CI, 0.618–0.990; p = 0.041). However, in the low and intermediate RS groups, there were no significant differences in BCSM between patients who received chemotherapy and those who did not. Among those with RS 11–25, chemotherapy benefit varied with tumor size (p = 0.001). Conclusions: Our findings provide real-world evidence that the 21-gene RS assay is predictive of chemotherapy benefit among patients in clinical practice. More refined risk estimates would be needed for patients with an intermediate RS.

Ki-67 is a Luminal B marker that identifies a high-risk subgroup in hormone receptor positive and node negative breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10521-10521
Author(s):  
M. Cheang ◽  
D. Voduc ◽  
S. Leung ◽  
D. Turbin ◽  
P. S. Bernard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Poor Prognosis ◽  
Cox Regression ◽  
Breast Cancers ◽  
Ki 67 ◽  
Node Negative ◽  
Luminal B ◽  
Poor Outcome ◽  
Hormone Receptor Positive

10521 Background: Gene expression profiling studies have revealed prognostically significant intrinsic breast cancer subtypes, designated Luminal A, Luminal B, Basal and Her2. Expression of ER and associated genes characterizes the luminal breast cancers. The Lum B subgroup is associated with poor outcome, but we lack immunohistochemical (IHC) markers to distinguish Lum A and Lum B subgroups. MKI67 is one gene known to be highly expressed in Lum B tumors, encoding the Ki-67 protein, a robust marker of cell proliferation. In this study, we perform IHC analysis of Ki-67 in a large breast cancer tissue microarray. Methods: Our patient cohort consists of 2222 consecutive cases of invasive breast cancer referred to the BC Cancer Agency from 1986 to 1992. Archival paraffin tissue blocks were used to construct a tissue microarray that was then stained for Ki-67 using a commercially available mouse monoclonal antibody. Ki-67 staining was scored quantitatively by automated image analysis and a tumor was positive if the percent positive nuclei was >30%’ Results: Of the 2,222 patients, there are 1,437 Luminal tumors as defined by IHC (ER or PR positive). As Her2 positive status is an established marker of poor prognosis, we excluded these tumors from our analysis. Of the remaining tumors, 9% were Ki-67 positive when using a ki-67 cut off of 30% positive nuclei. In survival analysis of patients ER/PR positive and Her2 negative, we found that Ki-67 identifies a population with poor prognosis (10-yr BCSS 60% vs. 80%). In a multivariate Cox regression we found that Ki-67 is independently prognostic. We repeated Cox regression analysis including only node negative patients and again found that Ki-67 is an independent predictor of poor outcome. Conclusions: Ki-67 has prognostic significance on multivariate survival analysis. Hormone receptor positive and node negative status is typically associated with a favorable outcome for breast cancer. However, Ki-67 is able to identify a small, but clinically significant subgroup with a particularly poor outcome. Defining the Luminal B subtype as (ER or PR) positive and (HER2 or Ki-67) positive, results in a subgroup that contains 18% of hormone receptor positive breast cancers with 10-yr BCSS of 61%. No significant financial relationships to disclose.

Cost-effectiveness of the 21-gene recurrence score assay in the setting of multifactorial decision making for chemotherapy in early-stage breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1525-1525
Author(s):  
Shelby D. Reed ◽  
Michaela A Dinan ◽  
Kevin A. Schulman ◽  
Gary H. Lyman
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Estrogen Receptor ◽  
Cost Effectiveness ◽  
Recurrence Score ◽  
Risk Groups ◽  
The United States ◽  
Node Negative ◽  
Estrogen Receptor Positive ◽  
Positive Breast Cancer

1525 Background: The objective of this study was to incorporate evidence from two recently-published studies to reevaluate the cost-effectiveness of the 21-gene Recurrence Score (RS) assay (Oncotype DX) in the context of multifactorial decision making to guide the use of chemotherapy for node-negative, estrogen receptor–positive breast cancer in the United States from the societal and healthcare system perspectives. Methods: We developed a decision-analytic model to first cross-classify hypothetical patients by clinicopathologic characteristics according to the Adjuvant! using risk groups and RS risk groups. We generated estimates of long-term costs, survival, and quality-adjusted survival for the RS-guided and non–RS-guided strategies using a probabilistic state transition model. In addition to costs for the 21-gene assay, we assigned attributable costs for chemotherapy, hormonal therapy, monitoring for disease recurrence, and distant recurrence. For the societal perspective, we also considered incremental patient time costs. Costs and survival were discounted at 3% annually. Results: With the RS-guided strategy, 40.4% of patients were expected to receive chemotherapy relative to 47.3% in the non–RS-guided strategy. Targeted use of chemotherapy in the RS-guided strategy was expected to increase survival by 0.19 years (95% CI, 0.09 to 0.32) and 0.16 QALYs (95% CI, 0.08 to 0.28). Lifetime direct medical costs were expected to be $2692 (95% CI, 1546 to 3821) higher with the RS-guided strategy. The incremental cost-effectiveness ratios (ICERs) were $14,059 per life-year saved (95% CI, $6840-$28,912) and $16,677 per QALY (95% CI, $7613-$37,219). When incorporating lower indirect costs of $950 per patient, the ICERs were $9095 per life-year saved (95% CI, dominant-$23,397) and $10,788 per QALY (95% CI, $6840-$30,265). In probabilistic sensitivity analysis, more than 99% of the ICERs were less than $50,000 per life-year saved and per QALY. Conclusions: Our updated cost-effectiveness estimates are supportive of the economic value of the 21-gene RS assay in the setting of node-negative, estrogen receptor–positive breast cancer.

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