Recurrence rate according to Oncotype Dx recurrence score (RS) in women with estrogen receptor (ER) positive, Her2 negative and 1 to 3 positive nodes: Real-world data in a Mexican private institution.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12536-e12536
Author(s):  
Geovani Amador ◽  
Raul Alejandro Andrade Moreno ◽  
José Fabián Martínez-Herrera ◽  
Raquel Gerson ◽  
Juan Alberto Serrano
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Recurrence Rate ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Comprehensive Cancer Center ◽  
Free Survival ◽  
Gene Assay ◽  
Er Positive

e12536 Background: Oncotype Dx is a 21 gene assay that evaluates de expression of 21 genes associated with recurrence in early breast cancer (EBC). In women with ER positive, HER2 negative and no lymph node involvement, it has demonstrated it prognostic value and has shown to predict the benefit of adjuvant chemotherapy in high-risk patients, sparing toxicity to patients with low risk of recurrence. Nevertheless, in women with ER positive, HER2 negative and 1 to 3 nodes, the role of de 21 gene assay was not clear until recently. Methods: Retrospective review of medical records of patients with ER +, HER2 negative and 1 to 3 positive nodes breast cancer treated at our institution. Clinicopathological characteristics and 21 gene recurrence score (RS) were collected and a survival analysis by the Kaplan-Meier method was performed in patients with RS < 25 and according to menopausal status as in RxPONDER in SPSS v 25.0 IBM. Results: From January 2008 to December 2018, data from 136 patients with EBC clinical stage (IA-IIB), HR +/ HER2-, N0-1 with Oncotype Dx performed were collected, of which only 25 patients had 1-3 nodal involvement and were included in the statistical analysis. Mean age at diagnosis was 54 years (35-73), the most frequent histology in the general population was invasive ductal carcinoma (92.0%), followed by lobular carcinoma (8.0%), 72.0% of patients presented in stage IIA, followed by stage IB in 20.0%. RE were positive in all patients and progesterone receptors were positive in 72.0%, none of the patients had HER2 overexpression, mean Ki-67 expression was 17.4% (4.0-50.0%). Most tumors were modemoderately differentiated (72.0%). Lymphovascular and perineural invasion were present in 44.0% and 24.0% respectively. Follow up data was available for 17 patients of which 12 had a RS of 25 or less. Recurrence was present in only 3 patients in this group of patients representing 25%. During the first 5 years only 1 patient recurred, which represents a 5-year Recurrence rate (RR) of 8.3% with a 5-year RFS of 91.7%. 10-year Recurrence free survival (RFS) was 75.0% with a median RFS that has not been reached. RFS was 80.0% in postmenopausal women compared 71.4% for those premenopausal at 10 years follow-up (p=0.735). None of the patients in this group received adjuvant chemotherapy. Conclusions: We report our experience at a comprehensive cancer center in a time lapse of 10 years. RFS at 5 years was 91.7% and at 10 years of follow up was 75%. This in accordance with the results of RxPONDER trial that reported a 5-year progression free survival of 92.4% in patients with chemo-endocrine adjuvant therapy and 91.0% in patients in the endocrine therapy only arm. This supports the use of this trial for decision making outside of the controlled clinical trials setting.

scholarly journals The effect of Oncotype DX® on adjuvant chemotherapy treatment decisions in early breast cancer

2019 ◽  
Vol 101 (8) ◽  
pp. 596-601
Author(s):  
MA Rabie ◽  
A Rankin ◽  
A Burger ◽  
MMG Youssef
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Treatment ◽  
Recurrence Score ◽  
Treatment Decisions ◽  
Oncotype Dx ◽  
Queen Elizabeth Hospital ◽  
Intermediate Risk ◽  
Gene Assay ◽  
Risk Patients

Introduction The aim of this study was to objectively establish the value of the Oncotype DX® (ODX) gene assay in adjuvant treatment decisions for intermediate risk patients with early, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, lymph node negative breast cancer at a district general hospital. Methods All patients who underwent surgery for breast cancer between January 2015 and December 2017 at Queen Elizabeth Hospital in King’s Lynn were considered for inclusion in the study. Those who did not meet the criteria for ODX referral were excluded. Patients were divided into two cohorts based on whether they were treated before or after the introduction of ODX testing in this hospital (June 2016): the pre-ODX and post-ODX groups. The primary outcome was the percentage of patients for whom adjuvant chemotherapy (AC) was recommended in each group. Results Of the 462 patients who underwent surgery during the study period, 43 met the eligibility criteria for ODX testing: 18 in the pre-ODX group and 25 in the post-ODX group. AC was recommended and given to 11 (61%) of the patients in the pre-ODX group. In the post-ODX group, AC was recommended for seven patients with an ODX Recurrence Score® (RS) of >25; this was given to six patients (24%). One patient (with a RS of 26) declined AC. ODX testing led to a significant reduction in the proportion of patients who received AC (p=0.015). Conclusions In intermediate risk patients with breast cancer, the results of the ODX gene assay may change the decision for adjuvant treatment. It represents a valuable tool to assist patients’ and clinicians’ decision making regarding adjuvant chemotherapy.

scholarly journals 407 Requesting, Treatment and Outcomes Following Oncotype DX Testing in Breast Cancer

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
H Issa ◽  
J Seward ◽  
N Meara
Keyword(s):  
Breast Cancer ◽  
Recurrence Score ◽  
Distant Recurrence ◽  
Low Risk ◽  
Oncotype Dx ◽  
Intermediate Risk ◽  
Her2 Positive ◽  
Gene Assay ◽  
Er Positive ◽  
Risk Patients

Abstract Aim Oncotype DX (ODX) is a 21-gene assay for invasive breast cancer that yields a recurrence score (RS) value which indicates the risk of distant recurrence and the benefit from chemotherapy. NICE has laid down guidance regarding the criteria for test requesting which include having early breast cancer at an intermediate risk of distant recurrence that is ER-positive, HER2-negative and LN-negative. The aim of this study was to determine whether ODX was appropriately requested and followed. Treatment and outcomes were also observed. Method The study included all patients from The Countess of Chester Hospital who had undertaken ODX testing in the years 2015-2017. Patients were identified and clinicopathological data was obtained from clinic notes and pathology reports. NPI and PREDICT scores were calculated. The ODX original cut-off values were used. Results All 65 patients included in the study were ER-positive, 1 was HER2-positive and 1 was LN-positive. 9 patients had ODX requested inappropriately, all of which were low risk on both NPI and PREDICT. Chemotherapy was received by 1/32 low risk patients (RS 0-17), 6/24 intermediate risk patients (RS 18-30) and 5/5 high risk patients (RS 31-100). 57 patients had no recurrence, 2 patients had local recurrence (intermediate RS), 1 patient had distant recurrence (low RS) and 1 patient had metastasis (low RS). Chemotherapy was not received by any of the patients who experienced recurrence. Conclusions Adherence to NICE guidance regarding ODX requesting needs further emphasising. This would help reduce unnecessary patient investigation, costs, and pathology-lab workload.

scholarly journals Ovarian cycle stage critically affects 21-gene recurrence scores in Mmtv-Pymt mouse mammary tumours

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sarah M. Bernhardt ◽  
Pallave Dasari ◽  
Danielle J. Glynn ◽  
Lucy Woolford ◽  
Lachlan M. Moldenhauer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Menstrual Cycle ◽  
Recurrence Score ◽  
Gene Signature ◽  
Ovarian Cycle ◽  
Oncotype Dx ◽  
Mammary Tumours ◽  
Er Positive ◽  
The Impact

Abstract Background The Oncotype DX 21-gene Recurrence Score is predictive of adjuvant chemotherapy benefit for women with early-stage, estrogen receptor (ER)-positive, HER2-negative breast cancer. In premenopausal women, fluctuations in estrogen and progesterone during the menstrual cycle impact gene expression in hormone-responsive cancers. However, the extent to which menstrual cycling affects the Oncotype DX 21-gene signature remains unclear. Here, we investigate the impact of ovarian cycle stage on the 21-gene signature using a naturally cycling mouse model of breast cancer. Methods ER-positive mammary tumours were dissected from naturally cycling Mmtv-Pymt mice at either the estrus or diestrus phase of the ovarian cycle. The Oncotype DX 21-gene signature was assessed through quantitative real time-PCR, and a 21-gene experimental recurrence score analogous to the Oncotype DX Recurrence Score was calculated. Results Tumours collected at diestrus exhibited significant differences in expression of 6 Oncotype DX signature genes (Ki67, Ccnb1, Esr1, Erbb2, Grb7, Bag1; p ≤ 0.05) and a significant increase in 21-gene recurrence score (21.8 ± 2.4; mean ± SEM) compared to tumours dissected at estrus (15.5 ± 1.9; p = 0.03). Clustering analysis revealed a subgroup of tumours collected at diestrus characterised by increased expression of proliferation- (p < 0.001) and invasion-group (p = 0.01) genes, and increased 21-gene recurrence score (p = 0.01). No correlation between ER, PR, HER2, and KI67 protein abundance measured by Western blot and abundance of mRNA for the corresponding gene was observed, suggesting that gene expression is more susceptible to hormone-induced fluctuation compared to protein expression. Conclusions Ovarian cycle stage at the time of tissue collection critically affects the 21-gene signature in Mmtv-Pymt murine mammary tumours. Further studies are required to determine whether Oncotype DX Recurrence Scores in women are similarly affected by menstrual cycle stage.

scholarly journals Evaluation of the 12-Gene Molecular Score and the 21-Gene Recurrence Score as Predictors of Response to Neo-adjuvant Chemotherapy in Estrogen Receptor-Positive, HER2-Negative Breast Cancer

2020 ◽  
Vol 27 (3) ◽  
pp. 765-771 ◽  
Author(s):  
Hatem Soliman ◽  
Susanne Wagner ◽  
Darl D. Flake ◽  
Mark Robson ◽  
Lee Schwartzberg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Recurrence Score ◽  
Long Term Outcome ◽  
Predictors Of Response ◽  
Er Positive ◽  
Neo Adjuvant Chemotherapy ◽  
Molecular Score

Abstract Background Neo-adjuvant chemotherapy (NaCT) facilitates complete surgical resection in locally advanced breast cancer. Due to its association with improved outcome, complete pathologic response (pCR) to neo-adjuvant treatment has been accepted as a surrogate for long-term outcome in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive, triple-negative, or luminal B breast cancer patients. In contrast, NaCT is effective in only ~ 7–10% of estrogen receptor (ER)-positive, HER2-negative disease. Response biomarkers would enable such patients to be selected for NaCT. Methods Two commercially available breast cancer prognostic signatures [12-gene molecular score (MS) and the 21-gene Recurrence Score (RS)] were compared in their ability to predict pCR to NaCT in ER-positive, HER2-negative breast cancer in six public RNA expression microarray data sets. Scores were approximated according to published algorithms and analyzed by logistic regression. Results Expression data were available for 764 ER-positive, HER2-negative breast cancer samples, including 59 patients with pCR. The two scores were well correlated. Either score was a significant predictor of pCR (12-gene MS p = 9.4 × 10−5; 21-gene RS p = 0.0041). However, in a model containing both scores, the 12-gene MS remained significant (p = 0.0079), while the 21-gene RS did not (p = 0.79). Conclusions In this microarray study, two commercial breast cancer prognostic scores were significant predictors of response to NaCT. In direct comparison, the 12-gene MS outperformed the 21-gene RS as a predictive marker for NaCT. Considering pCR as surrogate for improved survival, these results support the ability of both scores to predict chemotherapy sensitivity.

5-Year Results of Dose-Intensive Sequential Adjuvant Chemotherapy for Women With High-Risk Node-Positive Breast Cancer: A Phase II Study

1999 ◽  
Vol 17 (4) ◽  
pp. 1118-1118 ◽  
Author(s):  
C. Hudis ◽  
M. Fornier ◽  
L. Riccio ◽  
D. Lebwohl ◽  
J. Crown ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Dose Dense ◽  
Disease Free

PURPOSE: We conducted a phase II pilot study of dose-intensive adjuvant chemotherapy with doxorubicin followed sequentially by high-dose cyclophosphamide to determine the safety and feasibility of this dose-dense treatment and to estimate the disease-free and overall survival in breast cancer patients with four or more involved axillary lymph nodes. PATIENTS AND METHODS: Seventy-three patients received adjuvant treatment with four cycles of doxorubicin 75 mg/m2 as an intravenous bolus every 21 days, followed by three cycles of cyclophosphamide 3,000 mg/m2 every 14 days with granulocyte colony-stimulating factor support. RESULTS: Seventy-one patients were assessable, and all but two completed all planned chemotherapy. There was no treatment-related mortality. The most common toxicity was neutropenic fever, which occurred in 39% of patients. Median disease-free survival is 66 months (95% confidence interval, 34 to 98 months), and median overall survival has not yet been reached. At 5 years of follow-up, the disease-free survival is 51.7%, and overall survival is 60.0%. There is no long-term treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed. CONCLUSION: Our pilot study of doxorubicin followed by cyclophosphamide demonstrates the safety and feasibility of the sequential dose-dense plan. Long-term follow-up, although noncomparative, is promising. However, this regimen is associated with a higher incidence of toxicity (and also higher costs) than the standard dose and schedule of doxorubicin and cyclophosphamide, and therefore it should not be used as conventional therapy in the absence of demonstrated improvement of outcome. Randomized trials testing the dose-dense approach have been completed but not yet reported. Because the sequential plan can decrease overlapping toxicities, it is an appropriate platform for the addition of newer active agents, such as taxanes or monoclonal antibodies.

Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy

2013 ◽  
Vol 31 (22) ◽  
pp. 2783-2790 ◽  
Author(s):  
Mitch Dowsett ◽  
Ivana Sestak ◽  
Elena Lopez-Knowles ◽  
Kalvinder Sidhu ◽  
Anita K. Dunbier ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Growth Factor Receptor ◽  
Recurrence Score ◽  
Risk Groups ◽  
Distant Recurrence ◽  
Oncotype Dx ◽  
Prognostic Information ◽  
Node Negative ◽  
Risk Of Recurrence ◽  
Er Positive

Purpose Risk of distant recurrence (DR) among women with estrogen receptor (ER) –positive early breast cancer is the major determinant of recommendations for or against chemotherapy. It is frequently estimated using the Oncotype DX recurrence score (RS). The PAM50 risk of recurrence (ROR) score provides an alternative approach, which also identifies intrinsic subtypes. Patients and Methods mRNA from 1,017 patients with ER-positive primary breast cancer treated with anastrozole or tamoxifen in the ATAC trial was assessed for ROR using the NanoString nCounter. Likelihood ratio (LR) tests and concordance indices (c indices) were used to assess the prognostic information provided beyond that of a clinical treatment score (CTS) by RS, ROR, or IHC4, an index of DR risk derived from immunohistochemical assessment of ER, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and Ki67. Results ROR added significant prognostic information beyond CTS in all patients (Δ LR-χ2 = 33.9; P < .001) and in all four subgroups: node negative, node positive, HER2 negative, and HER2 negative/node negative; more information was added by ROR than by RS. C indices in the HER2-negative/node-negative subgroup were 0.73, 0.76, and 0.78 for CTS, CTS plus RS, and CTS plus ROR, respectively. More patients were scored as high risk and fewer as intermediate risk by ROR than by RS. Relatively similar prognostic information was added by ROR and IHC4 in all patients but more by ROR in the HER2-negative/node-negative group. Conclusion ROR provides more prognostic information in endocrine-treated patients with ER-positive, node-negative disease than RS, with better differentiation of intermediate- and higher-risk groups.

Abstract Submission

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 526-526 ◽  
Author(s):  
L. J. Goldstein ◽  
R. Gray ◽  
B. H. Childs ◽  
D. Watson ◽  
S. G. Rowley ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Recurrence Score ◽  
Recurrence Risk ◽  
Oncotype Dx ◽  
Axillary Lymph Nodes ◽  
Axillary Lymph ◽  
Breast Cancers ◽  
Free Survival ◽  
Increased Risk

526 Background: Evidence suggests modern chemotherapy (CT) regimens are only marginally more effective in HR-pos breast cancer (Berry et al. JAMA 2006: 295: 1658). Genomic classifiers may be useful for selection of high-risk subjects for more aggressive CHT. Methods: A case-cohort sample of 776 patients enrolled on E2197 who did (N=179) or did not have a recurrence after CT (if HR-neg) or CHT (if HR-pos) and had available tissue were evaluated for Oncotype DX™ Recurrence Score (RS). E2197 included 2885 evaluable patients with 0–3 positive nodes treated with four 3-week cycles of doxorubicin (60 mg/m2) plus cyclophosphamide 600 mg/m2 (AC) or docetaxel 60 mg/m2 (AT) and hormonal therapy (if HR-pos). Median follow-up was 76 months. Results: There was no difference in DFS between treatment arms. In multivariate analysis, RS was a significant predictor of recurrence in HR-pos disease (p=0.0007, recurrence risk 21% lower for each 10 point drop in RS, 95% confidence intervals 9% to 31%). Recurrence risk was significantly elevated for an intermediate RS 18–30 (n=138, hazard ratio [HR] 2.96 [p=0.0002]) or a high RS ≥ 31 (n=108, HR 4.00, p=0.0001) compared with low RS < 18(n=196), but not for high compared with intermediate RS (HR 1.34, [p=0.32]); results were similar if only HER2-neg disease was included. The 5-year relapse free interval(RFI), breast cancer free survival (BCFS), disease-free survival (DFS), and overall survival (OS) for patients with HR-pos, HER2-neg disease are shown below (%); patients with both node-neg or node-pos breast cancers whose RS was < 18 had excellent outcomes. Conclusions: Oncotype DX™ RS identifies individuals with HR-pos, HER2-neg breast cancer with 0–3 positive axillary lymph nodes at 3–4-fold increased risk of relapse despite standard CHT, and may serve as a means to distinguish between those who do well with standard CHT (RS <18) from those who may be suitable candidates for clinical trials evaluating alternative CT regimens or other strategies (RS ≥ 18). [Table: see text] [Table: see text]

10-year update of E2197: Phase III doxorubicin/docetaxel (AT) versus doxorubicin/cyclophosphamide (AC) adjuvant treatment of LN+ and high-risk LN- breast cancer and the comparison of the prognostic utility of the 21-gene recurrence score (RS) with clinicopathologic features.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1021-1021 ◽  
Author(s):  
Joseph A. Sparano ◽  
Anne O'Neill ◽  
Robert James Gray ◽  
Edith A. Perez ◽  
Lawrence N. Shulman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Recurrence Score ◽  
Phase Iii ◽  
Clinicopathologic Characteristics ◽  
Accurate Predictor ◽  
Gene Assay ◽  
Node Positive Disease

1021 Background: At 5 years, AT did not improve disease free survival or overall survival and RS was a more accurate predictor of relapse than standard clinicopathologic characteristics for patients with hormone receptor (HR) positive tumors. Methods: A Phase III Intergroup trial tested adjuvant AT vs. AC. Women with 1-3 N + or N - and T-size > 1cm were randomized to 4 cycles of AT (60 mg/m2/60 mg/ m2) or AC (60 mg/m2/600 mg/m2) q 3 wk x 4. Patients(pts) with ER + and/ or PR + tumors received tam for 5 yrs. Pts were stratified by nodal, HR (ER+ PR+, ER+PR-, ER-PR+, ER-PR-, ER/PR unk) and menopausal status. The primary endpoint was DFS. A sample of 465 pts with HR + breast cancer with 0 to 3 positive axillary nodes who did (N =116) or did not have a recurrence had tumor tissue evaluated using the 21- gene assay. Grade and HR expression were evaluated locally and centrally. Results: 2952 pts were randomized between 7/30/98 and 1/21/00. 2883 were eligible and analyzable. Arms were balanced for age, HR, menopause, nodes, surgery, grade and T-size: median age 51; 64% ER +; 65% LN-; grade: 10% low, 38% int., 46% high; and median T-size - 2.0 cm. At a median follow-up of 11.5 years the DFS/OS results are shown in the table below. RS was a highly significant predictor of recurrence including node negative and node positive disease (P < .0001) and predicted recurrence more accurately than clinical variables. Conclusions: At 11.5 yrs. median follow-up, there remains no difference in DFS or OS, although there continue to be fewer events in the AT arm in the prespecified ER/PR negative subgroup. At 10 years, the RS continues to be a more accurate predictor of relapse than standard clinical features. [Table: see text]

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