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.

Secondary Invasive Breast Events among Patients with Hormone-Positive Breast Cancer and High-Risk Oncotype DX Recurrence Scores 26–30 and ≥31

Oncology ◽  
2021 ◽  
pp. 1-4
Author(s):  
Natalie F. Berger ◽  
Brittney S. Zimmerman ◽  
Serena Tharakan ◽  
Kelly Suchman ◽  
Krystal P. Cascetta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Endocrine Therapy ◽  
Risk Group ◽  
Early Stage ◽  
Low Risk ◽  
Oncotype Dx ◽  
Intermediate Risk ◽  
Ovarian Suppression ◽  
Significant Difference

<b><i>Background:</i></b> The Oncotype DX Recurrence Score (ODx RS) is the most widely adopted genomic assay used to guide treatment for patients with early-stage, hormone-positive (HR+) breast cancer (BC), with higher scores predicting greater risk of recurrence and benefit from chemotherapy. Patients with ODx RS &#x3e;25 typically recieve adjuvant chemotherapy; however, data regarding efficacy of chemotherapy for reducing recurrence in this population have been mixed. <b><i>Objectives:</i></b> This study aimed to evaluate outcomes of patients with early-stage HR+ BC with high-risk ODx RS (26–30 and ≥31) in order to assess treatment patterns and outcomes. We hypothesized that the benefit of chemotherapy in these groups may be minimal and that select patients may forgo chemotherapy in favor of more aggressive endocrine therapy and ovarian suppression. <b><i>Methods:</i></b> We performed a retrospective analysis of 515 patients with early-stage, HR+ BC with high-risk ODx RS 26–30 and ≥31 treated between 2006 and 2018. Patients were stratified by RS: low-risk (≤10), intermediate-risk (11–25), and high-risk (≥26). The Kaplan-Meier method was used to estimate the time to secondary invasive breast events (SIBE) or distributions overall and among different RS groups with the log rank test used to compare distributions between groups. <b><i>Results:</i></b> Rates of chemotherapy administration were 7% among the low-risk group, 18% among the intermediate-risk group, and 83% among high-risk patients with 41 SIBE (8%) reported. When stratified by ODx RS, 5-year rates of SIBE were 4%, 6%, and 16% for low-risk, intermediate-risk, and high-risk RS, respectively. Among the 27 lymph node (LN)-negative patients with ODx RS 26–30, 74% received chemotherapy. The 5-year rate of SIBE was 25% among patients who received chemotherapy and 33% among those who did not (<i>p</i> = 0.5489). Among the 23 LN-negative patients with ODx RS ≥31, 91% of patients received chemotherapy. The 5-year rate of SIBE was 0% both with and without chemotherapy. <b><i>Conclusions:</i></b> There was no statistically significant difference in SIBE for patients with high-risk ODx RS based on chemotherapy treatment. More aggressive endocrine therapy with ovarian suppression has become an alternative to chemotherapy among patients with intermediate-risk ODx RS (16–25). This approach may be useful among patients with high-risk ODx RS, with additional studies needed in this patient population.

Recurrence risk in early breast cancer as defined by clinicopathologic features.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18581-e18581
Author(s):  
Kristin M. Sheffield ◽  
Jessica R. Peachey ◽  
Michael W. Method ◽  
Brenda R. Grimes ◽  
Jacqueline Brown ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Tumor Size ◽  
Disease Recurrence ◽  
Invasive Disease ◽  
Clinicopathologic Features ◽  
Ki 67 ◽  
Free Survival ◽  
Grade 3

e18581 Background: While most patients (pts) with HR+, HER2- early breast cancer (EBC) do not experience disease recurrence, those with high risk clinicopathologic features may have recurrence within the first few years on adjuvant endocrine therapy (AET). This study estimates risk of recurrence in pts with EBC based on clinicopathologic features and evaluates the medical need for more efficacious treatments using US oncology practice data. Methods: This retrospective study used the nationwide Flatiron Health electronic health record derived deidentified database. The cohort included pts with HR+, HER2- stage I-III breast cancer, diagnosed Jan 2011-Mar 2020, who received surgery and AET. Clinicopathologic features were used to identify a ‘high risk (HiR) group’ (≥ 4 positive axillary lymph nodes (LN), or 1-3 positive axillary LN and ≥ 1 of the following: Grade 3, tumor size ≥ 5 cm, or Ki-67 ≥ 20%) and ‘low risk (LoR) group’ (pts who do not meet above criteria, including a subset with node negative (N0) disease). Cox proportional hazards regression models compared invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) from AET initiation between groups according to a sequential gatekeeping strategy and stepwise analysis: first compare HiR group to N0 pts; if significant then compare HiR to LoR group. Results: 557 (13.8%) pts were in the HiR group and 3,471 (86.2%) in the LoR group (including 2,867 N0 pts). The study population (median age 64 yrs) was predominantly female (99.2%), white (69.4%) and postmenopausal (75.6%) with median follow-up of 39.6 months. Pts in the HiR group were younger and more likely premenopausal, have a BRCA mutation, invasive lobular carcinoma and less likely to have received an Oncotype DX test compared to LoR pts. Of the 557 HiR pts, 231 (41.5%) had ≥ 4 positive LN and 326 (58.5%) had 1-3 positive axillary LN with additional risk factor(s): tumor size ≥ 5 cm (11.7%), histologic grade 3 (32.0%), and/or Ki-67 ≥ 20% (31.6%). Most HiR pts received radiotherapy (82.4%) and chemotherapy (68.1%). Significant differences in IDFS and DRFS were observed between HiR group and N0 and LoR groups (logrank test p < .0001 for all). The 2-year IDFS rate was 88.1% in the HiR group, compared to 97.4% in N0 pts and 97.1% in the LoR group; 2-year DRFS rates were 89.0% compared to 97.9% and 97.7%, respectively. Pts in the HiR group had significantly higher hazard of invasive disease recurrence or death compared to N0 (HR = 3.42, 95% CI: 2.69-4.34, p < .0001) and LoR group (HR = 3.07, 95% CI: 2.46-3.84, p < .0001). Similar results observed for DRFS (HiR vs N0: HR = 3.46, 95% CI: 2.70-4.44, p < .0001; HiR vs LoR HR = 3.16, 95% CI: 2.50-3.98, p < .0001). Conclusions: Approximately 12% of pts with EBC and high risk clinicopathologic features experienced invasive disease recurrence or death within 2 years of initiating AET. Optimal use of standard therapies and novel treatment options are needed to prevent early recurrence and metastases in these pts.

Value of clinical treatment score post-5 years (CTS5) for late relapse risk assessment in patients with early-stage HER2+ breast cancer (BC) in the north central cancer treatment group (NCCTG) N9831 (Alliance) trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 529-529
Author(s):  
Tanmayi Pai ◽  
Angelica Gil ◽  
Yaohua Ma ◽  
Zhuo Li ◽  
Pooja Advani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Tumor Size ◽  
Cox Regression ◽  
Early Stage ◽  
Low Risk ◽  
Late Relapse ◽  
Intermediate Risk ◽  
Relapse Risk ◽  
Significant Difference

529 Background: Multiple prognostic models exist to predict late relapse risk in early stage hormone receptor-positive (HR+) breast cancer (BC). The CTS5 is one such model that has been validated in HR+ HER2-negative BC. The value of this model in HR+ HER2+ has not been established. Here, we assessed CTS5 in patients (pts) with early stage HER2+ BC treated in the NCCTG N9831 (Alliance) trial. Methods: Pts with stage I-III HER2+ HR+ BC who survived ≥ 5 years were included. The online CTS5 calculator was used to determine CTS5 score and risk group (low, intermediate, and high) based on age, tumor size, grade, and number of involved nodes. Kaplan-Meier (KM) estimates, Cox regression models, and C index were used for analysis. Results: From 3,130 pts, 1,204 pts met the criteria and were included. Median age was 49 (22-79) years and median tumor size was 2.4 (0.1-12) cm. 63.6% had grade 3 tumors, 33.6% grade 2, and 2.8% grade 1. Median follow up was 10.89 (5.01-15.32) years. Based on CTS5, 821 (68.2%) pts were classified as high risk, 289 (24%) as intermediate risk, and 94 (7.8%) as low risk. Overall, using univariate Cox regression analysis, there was no statistically significant difference in recurrence free survival (RFS) among pts with intermediate vs. low (HR 0.47 95%CI 0.18-1.22, p = 0.12) and high vs. low (HR1.23 95%CI0.57-2.67, p = 0.6) with the C index of 0.58. Among pts who received concurrent trastuzumab (H) with HR+ BC, there was also no statistical difference in RFS between high vs. low (HR 0.68 95%CI0.24-1.97, p = 0.48) with the C index of 0.55. Paradoxically, pts with intermediate risk had better RFS than low risk (HR 0.18 95%CI0.03-0.97, p = 0.05). As a continuous variable, there is also no significant improvement in RFS per 1 unit increase in CTS5 score (HR 1.19 95%CI 0.73-1.96, p = 0.49) with the C index of 0.54. After 5 years, 7.06% (n = 30/425) of HR+ pts treated with concurrent H recurred. Conclusions: The CTS5 model is not prognostic in pts with early stage HR+ HER2+ BC receiving adjuvant H. While most HR+ HER2+ pts are classified as high risk by CTS5, the recurrence between years 5-10 was low in pts who received adjuvant H. This study highlights the need to develop a new predictive model for risk of late relapse in this specific group of pts to enable clinicians to determine which pts would benefit from extended adjuvant endocrine therapy. Support: BCRF-19-161, U10CA180821, Genentech. https://acknowledgments.alliancefound.org Clinical trial information: NCT00005970 .

scholarly journals Risk-Adapted Postmastectomy Radiotherapy Decision Based on Prognostic Nomogram for pT1-2N1M0 Breast Cancer: A Multicenter Study

2020 ◽  
Vol 10 ◽  
Author(s):  
Ming Li ◽  
Jinbo Yue ◽  
Xiangbo Wan ◽  
Bin Hua ◽  
Qiuan Yang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Locoregional Recurrence ◽  
Risk Group ◽  
High Risk Group ◽  
Low Risk ◽  
Moderate Risk ◽  
Primary Tumor Site ◽  
Free Survival ◽  
Significant Difference

PurposeThe aim of this study was to develop a widely accepted prognostic nomogram and establish a risk-adapted PMRT strategy based on locoregional recurrence for pT1-2N1M0 breast cancer.Methods and MaterialsA total of 3,033 patients with pT1-2N1M0 breast cancer treated at 6 participating institutions between 2000 and 2016 were retrospectively reviewed. A nomogram was developed to predicted locoregional recurrence-free survival (LRFS). A propensity score-matched (PSM) analyses was performed in risk-adapted model.ResultsWith the median follow-up of 65.0 months, the 5-year overall survival (OS), disease free survival (DFS) and LRFS were 93.0, 84.8, and 93.6%, respectively. There was no significant difference between patients who received PMRT or not for the entire group. A nomogram was developed and validated to estimate the probability of 5-year LRFS based on five independent factors including age, primary tumor site, positive lymph nodes number, pathological T stage, and molecular subtype that were selected by a multivariate analysis of patients who did not receive PMRT in the primary cohort. According to the total nomogram risk scores, the entire patients were classified into low- (40.0%), moderate- (42.4%), and high-risk group (17.6%). The 5-year outcomes were significantly different among these three groups (P&lt;0.001). In low-risk group, patients who received PMRT or not both achieved a favorable OS, DFS, and LRFS. In moderate-risk group, no differences in OS, DFS, and LRFS were observed between PMRT and no PMRT patients. In high-risk group, compared with no PMRT, PMRT resulted in significantly different OS (86.8 vs 83.9%, P = 0.050), DFS (77.2 vs 70.9%, P = 0.049), and LRFS (90.8 vs. 81.6%, P = 0.003). After PSM adjustment, there were no significant differences in OS, DFS, and LRFS in low-risk and moderate-risk groups. However, in the high-risk group, PMRT still resulted in significantly better OS, DFS and improved LRFS.ConclusionsThe proposed nomogram provides an individualized risk estimate of LRFS in patients with pT1-2N1M0 breast cancer. Risk-adapted PMRT for high-risk patients is a viable effective strategy.

scholarly journals Wide local excision under local anaesthetic for early breast cancer: A surgical option for the medically unfit

2014 ◽  
Vol 12 ◽  
pp. S18
Author(s):  
Deepak Selvakumar ◽  
Christopher Davies ◽  
Rahul Chotai ◽  
Muhammad Asad Parvaiz ◽  
Brian Isgar
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Local Excision ◽  
Local Anaesthetic ◽  
Wide Local Excision ◽  
Surgical Option

scholarly journals Impact of Oncotype DX testing on ER+ breast cancer treatment and survival in the first decade of use

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Evelien Schaafsma ◽  
Baoyi Zhang ◽  
Merit Schaafsma ◽  
Chun-Yip Tong ◽  
Lanjing Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Temporal Trends ◽  
Recurrence Score ◽  
Low Risk ◽  
Oncotype Dx ◽  
Risk Scores ◽  
Breast Cancer Patients ◽  
Risk Patients

Abstract Background The Oncotype DX breast recurrence score has been introduced more than a decade ago to aid physicians in determining the need for systemic adjuvant chemotherapy in patients with early-stage, estrogen receptor (ER)+, lymph node-negative breast cancer. Methods In this study, we utilized data from The Surveillance, Epidemiology, and End Results (SEER) Program to investigate temporal trends in Oncotype DX usage among US breast cancer patients in the first decade after the introduction of the Oncotype DX assay. Results We found that the use of Oncotype DX has steadily increased in the first decade of use and that this increase is associated with a decreased usage of chemotherapy. Patients who utilized the Oncotype DX test tended to have improved survival compared to patients who did not use the assay even after adjusting for clinical variables associated with prognosis. In addition, chemotherapy usage in patients with high-risk scores is associated with significantly longer overall and breast cancer-specific survival compared to high-risk patients who did not receive chemotherapy. On the contrary, patients with low-risk scores who were treated with chemotherapy tended to have shorter overall survival compared to low-risk patients who forwent chemotherapy. Conclusion We have provided a comprehensive temporal overview of the use of Oncotype DX in breast cancer patients in the first decade after Oncotype DX was introduced. Our results suggest that the use of Oncotype DX is increasing in ER+ breast cancer and that the Oncotype DX test results provide valuable information for patient treatment and prognosis.

Concordance between 21-gene score (Oncotype DX) and clinical-pathologic prognostic models in early-breast cancer in Medellín, Colombia.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12521-e12521
Author(s):  
Mauricio Lujan ◽  
Mauricio Lema ◽  
Diego Moran ◽  
Beatriz Preciado ◽  
Jorge Egurrola ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Predictive Models ◽  
Recurrence Score ◽  
Low Risk ◽  
Oncotype Dx ◽  
Stage I ◽  
Risk Scores ◽  
Operating Characteristics ◽  
Luminal Type

e12521 Background: The genomic-based 21-gene recurrence-score assay (Oncotype DX, Genomic Health)(ODx) is used to decide on the use of adjuvant chemotherapy (ACT) in luminal-type Early-Breast Cancer (LT-EBC). Patients with low RS can safely avoid ACT. Other predictive models based on standard clinical and histopathological (C&H) variables also have been developed. These include, Magee equations (ME), Predict model (PM), and Tennessee nomogram score (TNS). This study aims to establish the concordance between ODx and ME, PM and TNS models in a set of patients with EBC in Medellín, Colombia. Methods: Patients with unifocal, stage I and IIA, LT-EBC (HR+/Her2-) with results for ODx were included. For inclusion, key standard C&H variables needed to be available as to allow accurate assessment of ME, PM and TNS predictive models. ODx was used as the reference test and the predictive models as index tests. Low-risk (LR) was defined < 18 in all three ME; < 3% in the PM; and a probability calculated for LR > 90% in the TNS. A second analysis was performed in the > 50 years-old cohort (+50C), using standard and a modified criteria. In the last one, intermediate-risk (IR) patients were either excluded or grouped with high-risk scores for analysis. Concordance between the models and the ODx was evaluated using Cohen's kappa index (K). The degree of concordance was classified according to the categories established by Landis and Koch. AUROC (area under receiver operating characteristics) was estimated. Statistical analyses were performed with Stata v16. Results: 122 patients were included. Median age: 58 (IQR 49-66). Main histology was ductal carcinoma (85.2%), and median size was 15 mm (IQR 10-20). LR was adjudicated in 80.3%, 57.4%, 89.3% and 69.7% with ODx, ME, PM and TNS, respectively. Concordance between the ODx and ME and PM in the all patient population was fair, with K of 0.35 (95% CI: 0.18-0.50; p < 0.001), and 0.24 (95% CI: 0, 04 - 0.45; p < 0.001), respectively. Concordance of ODx and TNS was inferior with a K of 0.16 (95% CI: 0.03-0.34, p = 0.04). AUC for ME, PM, and TNS was 0.61 (95% CI: 0.49-0.73), 0.61 (95% CI: 0.52-0.70) and 0.59 (95% CI: 0.48-0.70), respectively. 85 patients were included in the +50C (69.7%). For one analysis, 41 patients with IR with either ME or PM were excluded. Concordance between the ME and the ODx was fair. LR in both ME and ODx was found 41/43 patients (95.5%, 95% CI 87.9-100). As for PM and TNS, the degree of concordance with ODx were low, and non-significant, respectively. Concordance between ODx LR was found in 36/37 patients with LR in all three ME, PM and TNS (97.3%, 95% CI: 90.7-100). Discrimination capacity: 79%. Conclusions: The high cost of ODx can be safely avoided in stage I/IIA luminal-type EBC and > 50 year-old with low-risk scores in all three ME, PM, and TNS.

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