Validation of the 21-Gene Recurrence Score Assay in Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer and 0 to 3 Positive Lymph Nodes – Risk Pattern and Outcomes on a Community Level

Breast Care ◽  
2021 ◽  
Author(s):  
Michael Braun ◽  
Antonia Kriegmair ◽  
Nina Szeterlak ◽  
Anne Andrulat ◽  
Simone Schrodi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Nodes ◽  
Endocrine Therapy ◽  
Disease Free Survival ◽  
Recurrence Score ◽  
Nodal Status ◽  
World Population ◽  
Her2 Breast Cancer ◽  
Significant Difference ◽  
Positive Lymph Nodes

Introduction The aim of the present study was to analyze the performance of Oncotype DX® multigene assay (ODX) in patients with 0-3 lymph nodes in a high volume community hospital. Methods Patients with non-metastatic HR+/HER2- EBC and 0-3 positive lymph nodes, who underwent primary surgery at the Red Cross Hospital Munich, Germany and consecutively had ODX testing were included in this retrospective study. The distribution of clinico-pathologic characteristics, recurrence score (RS) risk and use of systemic therapy were compared among patients without positive lymph nodes (N0) and patients with micrometastases or 1 to 3 positive lymph nodes (N1). Disease free survival (DFS) and overall survival (OS) were estimated. Results From 2012 to2017 ODX was consecutively performed in 575 (16.4%) of 3492 women with HR+/ HER- EBC, of which 553 were eligible for this analysis (N0: 60.8%; N1: 39.2%). Among the patients included, 441 (79.7%) had a RS of 0 to 25 and 112 (20.3%) had a RS of 26 or higher. In patients with RS 0 to 25 the rate of chemotherapy use was low, independent from nodal status (N0: 17.1% and N1: 19.1%) and 5y-DFS was 90.5% and 91.7% for N0 and N1 patients, respectively. There was no significant difference in DFS (90.5% vs. 93.3%; p= 0.101) or OS (97.2% vs. 96.0%; p= 0.737) for patients with a RS 0 to 25 when treated with chemo-endocrine therapy or endocrine therapy alone, independent from nodal status. Conclusions The results of the study confirm the observations from randomized studies on the use of the ODX in a real world population in terms of risk distribution and patient outcome. Adjuvant chemotherapy could be safely omitted in patients with HR+/HER2- breast cancer with 0-3 positive lymph nodes and RS<25.

scholarly journals Nodal Status and Clinical Outcomes in a Large Cohort of Patients With Triple-Negative Breast Cancer

2011 ◽  
Vol 29 (19) ◽  
pp. 2628-2634 ◽  
Author(s):  
Leonel F. Hernandez-Aya ◽  
Mariana Chavez-MacGregor ◽  
Xiudong Lei ◽  
Funda Meric-Bernstam ◽  
Thomas A. Buchholz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Clinical Outcomes ◽  
Tumor Size ◽  
Large Cohort ◽  
Nodal Status ◽  
Lymph Node Status ◽  
Significant Difference ◽  
Positive Lymph Nodes

Purpose To evaluate the clinical outcomes and relationship between tumor size, lymph node status, and prognosis in a large cohort of patients with confirmed triple receptor–negative breast cancer (TNBC). Patients and Methods We reviewed 1,711 patients with TNBC diagnosed between 1980 and 2009. Patients were categorized by tumor size and nodal status. Kaplan-Meier product limit method was used to calculate overall survival (OS) and relapse-free survival (RFS). A Sidak adjustment was used for multiple group comparisons. Cox proportional hazards models were fit to determine the association of tumor size and nodal status with survival outcomes after adjustment for other patient and disease characteristics. Results Median age was 48 years (range, 21 to 87 years). At a median follow-up of 53 months (range, 0.7 to 317 months), there were 614 deaths and 747 recurrences. The 5-year OS was 80% for node-negative patients (N0), 65% for one to three positive lymph nodes (N1), 48% for four to nine positive lymph nodes (N2), and 44% for ≥ 10 positive lymph nodes (N3; P < .0001). The 5-year RFS rates were 67% for N0, 52% for N1, 36% for N2, and 33% for N3 (P < .0001). Pairwise comparison by nodal status showed that when comparing N0 with node-positive disease, there was a significant difference in OS and RFS (P < .001 all comparisons). However, when comparing N1 with N2 and N3 disease regardless of tumor size, there were no significant differences in OS or RFS. Conclusion In patients with TNBC, once there is evidence of lymph node metastasis, the prognosis may not be affected by the number of positive lymph nodes.

Comparison of the sensitivity to endocrine therapy of PR+/ER- patients and ER+/PR- patients with HER2+ breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11558-e11558
Author(s):  
X. Hao ◽  
Y. Liu ◽  
R. Hui ◽  
J. Zhang
Keyword(s):  
Breast Cancer ◽  
Survival Rate ◽  
Endocrine Therapy ◽  
Disease Free Survival ◽  
Her2 Breast Cancer ◽  
Significant Difference ◽  
Her 2 ◽  
Disease Free Survival Rate ◽  
Post Menopausal

e11558 Background: Her2 and PR expression are important indicators for prognosis of breast cancer. Aslo, it's proved that their expression could guide chemotherapy, endocrine therapy and targeted therapy in many studies. Methods: Collected 3,677 primary breast cancer cases from 2002 to 2004 in Tianjin University Cancer Hospital. All of the cases were confirmed by pathohistological method. All patients are female, aged from 15 to 92 years old, with median age 50 years old. Median follow-up time is 40 months. Her-2, PR and ER expression were detected by immunohistochemical methods. Results: 1. With Her2+ breast cancer, 168 patients are PR+/ER- and 211 patients are ER+/PR-. 2. All patients treated with anthracycline-based adjuvant chemotherapy with 6 cycles and then given endocrine therapy: Pre-menopausal patients were given TAM (10mg P.O Bid); Post-menopausal patients were given AI (letrozole 2.5m po. bid or anastrozole 1 mg P.O Qd). Median follow-up time is 45 months. With Her2+ BC, 3-year DFS(disease-free survival rate) of PR+/ER- patients is 94.53%, higher than that of PR-/ER+ ones (91.81%).With Her2- BC, 3-year DFS of PR+/ER- patients is lower than that of PR-/ER+ (p<0.05). 3. Total of 1853 cases with 5-year followed up, and 1297 cases have been given endocrine therapy. 5-year overall survival rate was 83.41%. With Her2+ BC, it's significant difference that 5-year OS of PR+/ER- patients is higher than that of PR-/ER+ ones. However, there's no difference of 5- year OS between them with Her2- BC. Conclusions: With Her2+ breast cancer, 3-year DFS of PR+/ER- patients is higher than ER+/PR- and also PR+/ER- patients may more sensitive to endocrine therapy than ER+/PR- patients. No significant financial relationships to disclose.

Adjuvant treatment decision in patients with node-negative, ER+/Her2-, early stage breast cancer with Oncotype DX (ODX) recurrence score (RS) of 11-30: Impact of clinicopathologic features.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12022-e12022
Author(s):  
Gwenalyn Garcia ◽  
Shiksha Kedia ◽  
Nishitha Thumallapally ◽  
Elias Moussaly ◽  
Saqib Abbasi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Early Stage ◽  
Univariate Analysis ◽  
Prospective Trial ◽  
Recurrence Score ◽  
Clinicopathologic Features ◽  
Node Negative ◽  
Her2 Breast Cancer ◽  
Node Negative Breast Cancer

e12022 Background: The ODX RS predicts the risk of distant recurrence and the benefit of adjuvant chemotherapy (CT) in patients with ER+/Her2- breast cancer. High RS predicts a large benefit whereas low RS predicts minimal benefit from CT. A prospective trial showed that patients with low RS of 0-10 may be safely spared adjuvant CT. Recommendations in patients with intermediate RS are less clear. We performed a retrospective study of adjuvant therapy decision in patients with RS 11-30. Methods: We identified patients with ER+/Her2-, node-negative breast cancer with ODX RS 11-30 treated at our center from 2010-2016. Data on patient age, type of surgery, tumor size, grade, lymphovascular invasion (LVI), RS and treatment were collected. Statistical associations were tested using Chi square/Fisher's exact test and t test. Logistic regression analysis was used to determine odds ratios (OR). Results: 76 patients were identified. 86% (65/76) of them received adjuvant endocrine therapy alone and 14% (11/76) received adjuvant CT plus endocrine therapy. Patient characteristics are shown in the table. Using univariate analysis, significant predictors of receiving CT included RS, LVI, and ER positivity. In the patients who received CT, RSs were all ≥ 18 whereas in the group who did not receive CT, 42% (27/65) patients had RS 11-17. Increase in RS was associated with increase in the likelihood of receiving CT (OR 1.40, 95% CI 1.14-1.74, p=0.00017). Decrease in ER positivity was correlated with increased likelihood of receiving CT (OR 0.922, 95% CI 0.856-0.992, p=0.03). The presence of LVI increased the likelihood of receiving CT (OR 26.24, 95% CI 4.16-165.43, p=0.0005). Conclusions: In patients with ER+/Her2-, node-negative breast cancer with RS 11-30, the majority received endocrine therapy alone. RS and some clinicopathologic features (LVI, ER) impacted the decision to receive CT. [Table: see text]

scholarly journals Effects of the number of removed lymph nodes on survival outcome in patients with sentinel node-negative breast cancer

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Calogero Cipolla ◽  
Antonio Galvano ◽  
Salvatore Vieni ◽  
Federica Saputo ◽  
Simona Lupo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Nodes ◽  
False Negative ◽  
False Negative Rate ◽  
Disease Free Survival ◽  
Axillary Staging ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Relevant Difference ◽  
Significant Difference

Abstract Background Sentinel lymph node biopsy is the gold standard surgical technique for axillary staging in patients with clinically node-negative. However, it is still uncertain what is the optimal number of sentinel lymph nodes (SLNs) to be removed to reduce the false-negative rate. The aim of this study was to investigate whether patients with a single negative SLN have a worse prognosis than those with two or more negative SLNs. Methods A retrospective review was conducted on a large series of SLN-negative breast cancer patients. Survival outcomes and regional recurrence rate were evaluated according to the number of removed SLNs. Secondly, the contribution of different adjuvant therapies on disease-free survival was explored. Statistical analysis included the chi-square, Wilcoxon–Mann–Whitney test, and Kaplan–Meier survival analysis. Results A total of 1080 patients were included in the study. A first group consisted of 328 patients in whom a single SLN was retrieved, and a second group consisted of 752 patients in whom two or more SLNs were retrieved. There was no relevant difference in median DFS (64.9 vs 41.4) for SLN = 1 vs SLN > 1 groups (HR 0.76, CI 95% 0.39–1.46; p = 0.38). A statistically significant difference in mDFS was showed only for HT-treated patients who were SLN = 1 if compared to SLN > 1 (100.6 months versus 35.3 months). Conclusions There is likely a relationship between the number of resected SNL and mDFS. Our results, however, showed no relevant difference in median DFS for SLN = 1 vs SLN > 1 group, except for a subset of the patients treated with hormone therapy.

Mammostrat as an immunohistochemical multigene assay for prediction of early relapse risk in the TEAM pathology study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 516-516
Author(s):  
John M. S. Bartlett ◽  
Kenneth J. Bloom ◽  
Tammy Robson ◽  
Thomas J. Lawton ◽  
Cornelis J. H. Van De Velde ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Disease Free Survival ◽  
Postmenopausal Breast Cancer ◽  
Nodal Status ◽  
Endocrine Treatment ◽  
Breast Cancer Patients ◽  
Additional Information ◽  
Er Positive

516 Background: Some postmenopausal patients with hormone sensitive early breast cancer remain at high risk of relapse despite endocrine therapy, and might benefit additionally from adjuvant chemotherapy. The challenge is to prospectively identify such patients. The Mammostrat test uses five immunohistochemical markers to stratify patients regarding recurrence risk, and may inform treatment decisions. We tested the efficacy of this panel in the TEAM trial. Methods: Pathology blocks from 4598 TEAM patients were collected and TMAs constructed. The cohort was 47% node positive and 36% were also treated with adjuvant chemotherapy. Triplicate 0.6mm2 TMA cores were stained and positivity for p53, HTF9C, CEACAM5, NDRG1, SLC7A5 assessed. Cases were assigned a Mammostrat risk score, and distant relapse free (DRFS) and disease free survival (DFS) analysed. Results: In multivariate regression analyses, corrected for conventional clinicopathological markers, Mammostrat provided significant additional information on DRFS after endocrine therapy in ER positive node negative patients (N=1226) not receiving chemotherapy (p=0.004). Further analyses in all patients not exposed to chemotherapy, irrespective of nodal status (N=2559) and in the entire cohort (N=3837) showed Mammostrat scores provide additional information on DRFS in these groups (p=0.001 and p<0.0001 respectively; multivariate analyses). No differences were seen between the two endocrine treatment regimens. Conclusions: The Mammostrat score predicts DRFS for both exemestane and tamoxifen-exemestane treated patients irrespective of nodal status and chemotherapy. The ability of this test to provide additional outcome data following treatment provides further evidence for its’ utility in risk stratification of ER positive postmenopausal breast cancer patients.

CDK4/6 Inhibitors: Paving the Way for HR-Positive, HER2-Negative Early Breast Cancer

2021 ◽  
Vol 12 (8) ◽  
Author(s):  
Kristi Orbaugh, RN, MSN, RNP, AOCN ◽  
Val R. Adams, PharmD, FCCP, BCOP, FHOPA ◽  
Theresa W. Gillespie, PhD, MA, RN, FAAN
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Early Stage ◽  
Growth Factor Receptor ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Free Survival ◽  
Her2 Breast Cancer ◽  
Oral Agents

Cyclin-dependent kinase (CDK) 4/6 inhibitors are revolutionizing care for patients with advanced and metastatic hormone receptor–positive (HR+) and human epidermal growth factor receptor 2–negative (HER2–) breast cancer. These oral agents, often combined with other hormone-based therapy, have demonstrated considerable success in clinical trials and are used widely in oncology practices. CDK4/6 inhibitors are also being investigated for the treatment of early stage HR+, HER2– breast cancer. The addition of abemaciclib to adjuvant endocrine therapy improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone in patients with HR+, HER2–, node-positive, high-risk early breast cancer, and is now FDA-approved as adjuvant treatment in this setting. Here we review recent clinical data supporting the use of CDK4/6 inhibitors in both early and metastatic breast cancer. In addition, an expert faculty panel will discuss practical strategies to promote and improve adherence and side effect management in patients being treated with oral CDK4/6 inhibitors.

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