The 21-gene breast cancer assay in small (<1cm) tumors.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 33-33
Author(s):  
Christy Ann Russell ◽  
Melissa Conrad Stoppler ◽  
Megan Rothney ◽  
Amy P. Sing
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Early Stage ◽  
Meta Analysis ◽  
Tumor Biology ◽  
Recurrence Score ◽  
Treatment Decision ◽  
Clinicopathologic Factor ◽  
Gene Assay ◽  
Score Result

33 Background: Tumor size is a clinicopathologic factor often used in early stage breast cancer (EBC) management to estimate prognosis and make decisions about therapy. While in general, small tumors have a lower chance of recurring than large tumors, some patients with small tumors have poor outcomes. The 21-gene breast cancer assay (OncotypeDX) yields a Recurrence Score result that predicts the 10-yr risk of distant recurrence (DR) and the likelihood of chemotherapy (CT) benefit in patients (pts) with ER+ EBC. This study reviews the clinical evidence and experience of the 21-gene assay in subcentimeter (subCM) tumors and shows that the Recurrence Score is more reflective of the underlying tumor biology. Methods: A meta-analysis of Genomic Health validation and supportive studies reporting Recurrence Score result and tumor size was conducted in order to describe the distribution of Recurrence Score results. Results: There were 10 GHI-sponsored studies (7,094 pts) that presented Recurrence Score results as a function of tumor size. The studies varied in the recorded tumor sizes, ranging from < = 0.5 cm to > 5 cm. Four studies specifically examined the distribution of Recurrence Score results in subCM tumors and identified a total of 629 pts out of 2,912 pts (21.6%) that fit the size criteria of < 1cm. A broad distribution of score results was observed in subCM tumors in the four studies combined: 61% low, 25% int, 15% high. Conclusions: These results demonstrate that not all pts with subCM tumors have low risk disease, and that the 21-gene assay can help inform the risk of DR more precisely as well as predict the likelihood of CT benefit. Approximately 40% of pts had intermediate or high score results, suggesting an increased potential for DR and CT benefit. The clinical implications of this meta-analysis are that size doesn’t tell the whole story. There is underlying biology reflected in the Recurrence Score that can better inform the treatment decision for pts with ER+ EBC. [Table: see text]

Recurrence Score across the age spectrum: Is there an age discrimination?

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 27-27
Author(s):  
Franz Omar Smith ◽  
Marie Catherine Lee ◽  
Geza Acs ◽  
William J. Fulp ◽  
Ji-Hyun Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Treatment Planning ◽  
Tumor Size ◽  
Predictive Power ◽  
Early Stage ◽  
Recurrence Score ◽  
Positive Lymph Node ◽  
Node Negative

27 Background: Treatment planning for early-stage estrogen receptor (ER) positive, lymph node negative breast cancer was based on prognostic factors with limited predictive power such as age. The Recurrence Score (RS) from the Oncotype DX assay (ODX) provides predictive power transcending age but is rarely applied to the elderly or young patients (pts). We examined our experience with RS along the age continuum. Methods: Retrospective review was conducted of prospectively gathered breast cancer pts having a RS obtained as part of their cancer care. Eligibility for performance of the ODX was based on NCCN guidelines or physician discretion. Comparisons on RS were made by age groups (young: <45yrs; middle: >45yrs -<70yrs: elderly: >70yrs) using general linear regression model and the exact Wilcoxon Rank Sum Test. Results: 677pts had 681 tumors with RS available (89 young, 476 middle and 112 elderly pts). Median RS for the study pts was 17 (range 0-85) and 16, 17, and 15 for the young, middle, and elderly respectively. Median age was 58yrs (range: 27-95); young, middle, and elderly was 42, 58, and 74yrs respectively. Age as a continuous or categorical variable was not predictive of RS (p value = 0.38, 0.58 respectively). No significant differences were seen between age cohorts for histology, mitotic rate, lymphovascular invasion (LVI), grade, nodal status, stage, or strength of ER positivity. Mastectomy rates were higher in the young (57.5%), compared to the middle (42.5%) and elderly (39.6%) (p=0.02). Median invasive tumor size was 1.6, 1.5, and 1.5cm for young, middle, and elderly. Larger tumor size, as a continuous variable, equaled higher RS (p=0.046). Other significant factors predicting higher RS were increased mitosis (p<0.001), LVI (p=0.013), high grade (p<0.001), and weak (<10%) ER positivity (p<0.001). Nodal status, stage, and histology did not affect RS. Conclusions: Age has limited predictive power for treatment planning for breast cancer. Age alone should not preclude recommendations for performance of ODX in estrogen receptor positive lymph node negative early stage breast cancer as the RS distribution across the spectrum of age is well matched.

SEER study of breast cancer specific mortality (BCSM) in patients with lobular tumors treated based on recurrence score results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11568-11568
Author(s):  
Frederick L. Baehner ◽  
Steven Shak ◽  
Dave P. Miller ◽  
Valentina I. Petkov
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Multivariable Analysis ◽  
Recurrence Score ◽  
Tumor Grade ◽  
Nodal Status ◽  
Large Sample Size ◽  
Lobular Breast Cancer ◽  
Gene Assay ◽  
Actuarial Methods

11568 Background: Linking the 21-gene assay RS result to the SEER Registries demonstrated very low 5-y BCSM with low RS and high 5-y BCSM with high RS across subgroups, such as nodal status, age, tumor size and grade (npj Breast Cancer 2016). Given the large sample size and interest in outcomes as a function of tumor characteristics, we characterized the relationship between RS results and BCSM in patients reported by SEER with lobular morphology. Methods: Patients with RS and lobular morphology based on the registry ICD-O-3 code 8520 were eligible if node negative (N0) or node positive up to 3 positive nodes (N+mic,1-3), HR+, HER2- negative, no prior malignancy, and diagnosed between Jan 2004 and Dec 2012. No information in SEER is available regarding lobulars, ie., trabecular, alveolar, solid and pleomorphic. 5-y BCSM was estimated using actuarial methods. Results: There were 6,075 eligible patients reported with lobular morphology (11% of cases). Median age was 59 years; 88%/12% were N0/N+; 31%/62%/7% grade 1/2/3; 61%/39% ≤2 cm/>2 cm. Median follow-up was 44 months. A minority (8%) had RS >25. Chemotherapy (CT) use and BCSM increased with increasing RS. In multivariable analysis in N0 disease, continuous RS result and tumor size predicted BCSM (p=0.003 and p=0.04, respectively), whereas age and tumor grade were non-significant. In multivariable analysis in N+ disease, continuous RS result alone predicted BCSM (p=0.002). Conclusions: In these analyses the prognosis of patients with lobular breast cancer treated based on RS results depends on both nodal status and the RS result. The 5-y BCSM for lobular breast cancer is excellent with RS of 25 or less, and increases for RS >25. [Table: see text]

A prospective study of the impact of the 21-gene recurrence score assay on treatment decisions in N-, ER+ early stage breast cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11008-11008 ◽  
Author(s):  
N. Ben-Baruch ◽  
A. Hammerman ◽  
S. Klang ◽  
N. Liebermann
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Early Stage ◽  
Significant Proportion ◽  
Recurrence Score ◽  
Treatment Decision ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
The Impact

11008 Background: The Oncotype DX™ Recurrence Score (RS) assay predicts distant recurrence risk and benefit of chemotherapy (CT) in N-, ER+ breast cancer patients (pts). In February 2006, Clalit Health Services in Israel (CHS) was the first public health insurer to reimburse the assay outside the USA. Methods: CHS requires a pre-authorization form with data on biological parameters and specification of treatment (Rx) recommendation (1) before knowledge of RS and (2) the Rx planned according to each of 3 possible RS risk levels. For the first 200 reimbursed assays, we compared: (1) the Rx offered without RS knowledge, (2) the Rx the patient actually received after RS, and (3) the planned Rx stated on the form to be given according to the RS. Results: 200 pts. Median age: 57 yrs (34–81). RS: Low risk (RS<18), 37.5%; Intermediate (int) risk (RS 18–30), 44.5%; High risk (RS≥31), 18%. In 20 pts, Rx recommendations before RS were not specified. Before the RS, CT was offered in 106/180 (59%) and hormonal therapy (HT) in 74/180 (41%). In 71/180 pts (39%) the actual Rx changed from the recommendation before RS - CT to HT in 62 pts (low risk: 37, int risk: 21, high risk: 4) and HT to CT in 9 pts (int risk: 4, high risk: 5). Suggested therapy by RS was not specified in 19 pts. In 30/181 (17%) actual Rx differed from planned - CT to HT in 20 pts (int risk: 17, high risk: 3) and HT to CT in 10 pts (low risk: 4, int risk: 6). Conclusions: RS changed the treatment decision in a significant proportion of pts (39%), mostly from CT to HT. In 58% of pts originally offered CT, knowledge of RS changed the Rx to HT. 12% of pts originally offered HT were treated with CT. Rx decisions in intermediate RS are sometimes not obvious. In 26% of intermediate RS, final Rx differed from original plan; in these cases, patients’ preferences might have had a major impact on decision making. No significant financial relationships to disclose.

Cost-benefit of recurrence score–guided treatment using an Oncotype DX 21-gene assay: A single institution analysis.

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 29-29
Author(s):  
Kamal Kant Singh Abbi ◽  
Nauman Shahid ◽  
Muhammad Khurram Hameed ◽  
Brian Fink ◽  
Colette Gaba ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Early Stage ◽  
Recurrence Score ◽  
Cost Benefit ◽  
Node Negative ◽  
Gene Assay ◽  
Estrogen Receptor Positive ◽  
The Cost

29 Background: In 2010 the National Comprehensive Cancer Network recommended a 21-gene assay recurrence score (RS) to aid in the adjuvant treatment decision among patients with estrogen receptor positive, lymph node negative early stage breast cancer. Early-decision impact studies show that the RS can reduce overall chemotherapy use by 27%. This study was performed to assess the cost-benefit of the test for the patients diagnosed and treated an academic institute before 2010. Methods: Data from early breast cancer estrogen-receptor–positive and lymph-node–negative patients (n = 87), who were diagnosed and treated at our center from 2004-2010 were analyzed. All patients had the 21-gene recurrence test done to guide in their management. Cost of chemotherapy, adverse effects, and supportive care costs were calculated from previously published articles. Results: 66 patients with stage I breast cancer and 21 patients with stage II were analyzed. All but one patient had a tumor size more than 5mm. In total, 27 patients received chemotherapy. Characteristics of patients receiving chemotherapy are shown in the table. Cost of 21 gene recurrence score assay was $4,000. Savings for each patient who did not receive chemotherapy was $21,715 after accounting for cost of the test. The total savings for 60 patients who did not receive chemotherapy was $1,302,900. Conclusions: Use of the 21-gene assay in patients with early stage lymph node negative breast cancer improves health outcomes by avoiding chemotherapy-related adverse events. It also appears to add no incremental costs. This study emphasizes the cost-saving potential of the Oncotype Dx 21 gene assay. [Table: see text]

Correlation between Oncotype Dx score with histologic grade, tumor size and Ki67 in patients with early stage breast cancer: A single academic institution experience.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 146-146 ◽  
Author(s):  
Kate Ida Lathrop ◽  
Marcela Mazo- Canola ◽  
Jonathan Gelfond ◽  
Barbara Hinojosa ◽  
Jay C Shiao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Early Stage ◽  
Recurrence Score ◽  
Academic Institution ◽  
Histologic Grade ◽  
Oncotype Dx ◽  
Coefficient Of Determination ◽  
Ki 67 ◽  
Grade One

146 Background: Oncotype DX is an RT-PCR based assay that calculates a recurrence score (RS) to predict chemotherapy benefit in patients with breast cancer. Some authors have proposed using Ki-67, receptor status, Nottingham grade, and tumor size as histo-pathologic variables that could potentially substitute for the RS. Comprehensive and larger reviews are still lacking in this filed. To our knowledge this is the largest retrospective review of cases in a single academic institution. Methods: We retrospectively reviewed and reported baseline patient demographic characteristics (including age, race and gender) and routine pathological features such as histologic grade, Ki-67, tumor size, and histologic type. All patients included in this study had an Oncotype Dx ordered between 2007 and 2014. Results: Our analysis included 252 patients of which 248 were females and 4 were males, median age was 56, median tumor size of 2.1 cm. The majority of cases were grade 2 with 49.4%, followed by grade 3 with 28.1% and grade one represented 22.5% of the sample. Ki-67 ranged from 2-98 %. Three variables correlated significantly with Oncotype Dx: tumor size (p = 0.0115), Ki-67 (p = 1.509e-09) and grade (p = 0.0307). Using these three variables together, the percentage of variance on the Oncotype Dx score was 0.35 (R2- coefficient of determination). Conclusions: While tumor size, grade and Ki-67 individually correlate significantly with Oncotype Dx score, taken together, they cannot reliably predict the RS. Also, the capability of these three factors to predict the RS decreases for tumors with high RS. Therefore, we conclude the RS can provide additional valuable information and should not be replaced by analysis of routine histologic variables alone.

Obesity at diagnosis and breast cancer (BC) recurrence risk based on the 21-gene assay recurrence score (RS).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 555-555 ◽  
Author(s):  
Kimberly Ridolfi ◽  
Chong Zhang ◽  
Adedayo A. Onitilo ◽  
Wendy M. Ledesma ◽  
Molly Andreason ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Univariate Analysis ◽  
Menopausal Status ◽  
Tumor Biology ◽  
Recurrence Score ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Significance Level ◽  
Wilcoxon Rank Sum Test ◽  
Gene Assay

555 Background: Obesity at diagnosis has been associated with poorer overall survival in BC patients. The Oncotype Dx 21-gene assay RS has been shown to predict the risk of distant recurrence in estrogen receptor (ER) positive BC. This study aimed to evaluate if an association exists between body mass index (BMI) and RS. Methods: Retrospective chart review of patients (pts) with BC diagnosed 2005-2010 and a 21-gene assay was performed. Risk factors including BMI, hormone use, and menopausal status were collected as well as tumor characteristics such as ER/PR/HER2 status, stage, and grade. Univariate analysis of the association between BMI level (<30 vs ≥30), and RS (≤18 vs >18), stage (I vs II), and grade (1 vs 2 vs 3) was conducted using Chi square test. Correlation of BMI with RS (0-100) was also assessed via Spearman’s correlation. All tests were at a two sided significance level of 0.05. Results: Of 495 pts with a RS value, 482 had a BMI within 6 months of diagnosis. Median BMI was 27.7 kg/m2 (range 17-63). BMI for pts presenting with stage 2 disease is significantly higher (30±6.9) than those with stage 1 (29±7.8), p=0.04 (Wilcoxon rank sum test). No association was found between BMI level and stage, grade or RS. See Table. Mean RS was 18.8 vs 18.2 (BMI <30 vs ≥30), p=0.79 (Wilcoxon rank sum test). Conclusions: This is the largest study of the association between BMI and the RS. Obesity (BMI≥30) has been associated with increased recurrence and death from BC. However, we found no association between BMI and RS. This suggests that poorer outcomes among obese ER+ breast cancer patients may not be due to intrinsic tumor biology (as reflected in the RS), but to other non-tumor factors, whether higher circulating estrogen levels, reduced efficacy of aromatase inhibitors, other comorbidities, difficulty with chemotherapy or other unidentified factors. Further study is warranted. [Table: see text]

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