Clinicopathologic predictors of the 21-gene assay in a Hispanic cohort

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22209-e22209
Author(s):  
A. Khan ◽  
C. Rodriguez ◽  
Y. E. Tovar ◽  
B. Rajabi ◽  
Z. D. Mulla ◽  
...  

e22209 Background: The 21-gene recurrence score (RS) assay became commercially available (Oncotype DX) in January 2005. It is used to predict the likelihood of distant recurrence in women with estrogen-receptor (ER)-positive, lymph node-negative invasive breast cancer treated with adjuvant tamoxifen. We aimed to identify clinicopathologic predictors of an elevated recurrence score in a group of women with invasive breast cancer living in a predominantly Hispanic population on the Texas-Mexico border. Methods: A retrospective cohort study of 60 consecutive patients with primary ER-positive, lymph node-negative invasive breast cancer who had an Oncotype DX assay performed by Genomic Health, Inc. on paraffin-embedded tumor between March 2006 and November 2008. ER, PR and HER-2 was performed by immunohistochemistry. Patients were classified as low RS (<18), intermediate RS (18–30), or high RS (≥31). Ordinal logistic regression was used to calculate odds ratios (OR) for an increasing RS. Patient age and tumor pathological features were documented in each group. There was no selection bias in ordering the assay. Results: 95% of the cohort was Hispanic. Average age was 55.5 years. 29 patients (48%) had a low RS, 15 (25%) had an intermediate RS, while 16 (27%) had a high RS. HER-2 was amplified in 8 patients (13%). HER-2 positivity was strongly associated with a high RS (p<0.0001). Tumor grade and Ki-67 proliferative index were correlated with one another in a positive fashion (weighted kappa=0.46, p<0.05) and in univariate analyses both factors were significant predictors of a higher RS: tumor grade 3 vs. 1 OR=26.6 (p<0.0001) and Ki-67 proliferative index high vs. low OR=6.59 (p=0.0033). After adjustment, neither OR was significant. A negative progesterone receptor (PR) status was a strong risk factor for a higher RS (adjusted OR=21.64, p=0.0002). Univariate and multivariate ORs for higher RS for invasive ductal vs. invasive lobular carcinoma were, respectively, 4.3 (p=0.051) and 2.23 (p=0.4). Conclusions: Initially, a tumor grade of 3 and a high Ki-67 proliferative index were strong risk factors for a higher RS. However, after controlling for multiple factors, neither tumor grade nor Ki-67 proliferative index had an impact on RS in this predominantly Hispanic cohort. No significant financial relationships to disclose.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22188-e22188
Author(s):  
A. Khan ◽  
Y. E. Tovar ◽  
C. Rodriguez ◽  
A. L. Huerta ◽  
B. Rajabi ◽  
...  

e22188 Background: In daily oncology practice, triple-negative invasive breast cancer is defined by negative immunohistochemistry for ER, PR and HER-2. Patients with this phenotype experience poor prognosis due to limited treatment options and intrinsic tumor biology. In a population-based case-control study, the Carolina Breast Cancer Study (Carey et al, JCO, 2004: suppl; abstr 9510), the triple-negative phenotype in African-American women represented 33.9% of the tumors. We aimed to identify the incidence of triple-negative invasive breast cancer in a group of women living in a predominantly Hispanic population on the Texas- Mexico border. Methods: We collected retrospective data for all invasive breast cases diagnosed between January 2005 and December 2008 at our affiliated county hospital. Clinical and pathological features were summarized. ER, PR and HER-2 was performed by immunohistochemistry. Results: 309 patients with invasive breast cancer were identified. 23.9% (74 patients) of all breast cancer patients were triple-negative. 70 of the 74 subjects (94.6%) were Hispanic. There was equal distribution of patients over and under the age of 50. Histologically all cases were invasive ductal carcinoma. The vast majority had grade 3 tumors (82%) with a high Ki-67 proliferative index (97%). Lymphovascular invasion was present in 38 patients (51.4%). Distant metastases at diagnosis was found in 4 patients (5.4%). Conclusions: In our population-based study the proportion of triple-negative invasive breast cancer phenotype was not as high as in the Carolina Breast Cancer Study, but does reflect that a quarter of the patients with invasive breast cancer in this growing Hispanic population may carry this phenotype. The triple-negative phenotype was strongly associated with high tumor grade and proliferative index. No significant financial relationships to disclose.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12023-e12023
Author(s):  
Junqing Chen ◽  
Xiaojia Wang ◽  
Zhanhong Chen

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.


2015 ◽  
Vol 2 (1) ◽  
pp. 37-42
Author(s):  
Vanda Farahmand Torous ◽  
Sophia K Apple

The 21-gene Recurrence Score (RS) assay (Oncotype DX®) predicts the risk of recurrence and benefit from chemotherapy in estrogen receptor (ER) positive, Her-2/neunegative, node negative and, more recently, limited node-positive (≤3) breast cancer. The 21-gene RS is divided into low, intermediate and high risk groups corresponding to a likelihood of recurrence within 10 years of initial diagnosis. Clinicians utilize 21-gene RS to guide treatment, particularly whether to add adjuvant chemotherapy to endocrine therapy. This study aimed to determine if 21-gene RS accurately predicts the rate of recurrence with respect to each category. A cohort of 236 patients was studied retrospectively and analyzed, based on correlation between histologic and immunohistochemical (IHC) findingsversus21-gene RS stratification in relation to clinical outcomes.In the cohort examined, no deaths occurred in all the patients studied. Six patients had recurrence or metastatic disease. Of these six patients, only one had been stratified to the high risk group by 21-gene RS analysis, while four were stratified to the low risk group, and one to the intermediate risk group. 21-gene RS accurately predicted 97% of the low RS stratified patients to avoid receiving chemotherapy. However, addition of chemotherapy in the treatment regimen for node positive, Her-2/neupositive, high Ki-67, and PR negative tumors may be beneficial regardless of 21-gene RS. Our investigation found that there is a high concordance rate between 21-gene RS and IHC of ER, progesterone receptor (PR), and Her-2/neu.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 542-542
Author(s):  
Takeo Fujii ◽  
Hiroko Masuda ◽  
Yee Chung Cheng ◽  
Fei Yang ◽  
Aysegul A. Sahin ◽  
...  

542 Background: The TAILORx trial demonstrated that adjuvant endocrine and chemoendocrine therapies had similar efficacy in patients with hormone receptor-positive, HER2-negative, node-negative breast cancer with an Oncotype DX recurrence score (RS) of 11-25. However, a predictive strategy is needed to identify patients with intermediate RS who may benefit from adjuvant chemoendocrine therapy. Curebest 95GC Breast (95GC) is a 95-gene signature that can stratify patients into two groups with high (95GC-H) and low (95GC-L) groups to predict the risk of recurrence. Our primary objective was to show that 95GC can classify patients with intermediate RS into binary recurrence risk groups. Methods: Patients with ER-positive, HER2-negative, node-negative invasive breast cancer and RS 11-30 who underwent definitive surgery and adjuvant endocrine therapy were included. RNA was derived from archived formalin-fixed, paraffin-embedded samples, and 95GC was calculated as reported previously. The Fisher exact and Brunner-Munzel tests were used to compare variables between 95GC groups. A Kaplan-Meier estimate with a log-rank test was used for recurrence-free survival (RFS) analysis. Results: The analysis included 178 patients from five institutions. The 5-year RFS rate in patients with RS 18-30 was higher in the 95GC-L group (n = 129, 96.3%) than in the 95GC-H group (n = 49, 90.9%; p = 0.002), which was consistent with results in an independent Japanese population (n = 224; p < 0.001). RFS rates significantly differed between the groups among patients with RS 11-25 as well (95GC-L, 97.4%; 95GC-H, 87.1%; p = 0.001). RFS rates did not differ between patients with RS 18-25 (94.8%) and those with RS 26-30 (93.8%; p = 0.33). Conclusions: 95GC can predict recurrence risk in patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS. Further prospective retrospective studies in the TAILORx population are warranted to confirm that 95GC can identify patients who may benefit from adjuvant chemoendocrine therapy.


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