The performance of the 21-gene assay standard cutpoints of 18 and 31 in HR+, HER2- invasive breast cancer (BC), while waiting for TAILORx mid-range recurrence score results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 537-537 ◽  
Author(s):  
Dave P. Miller ◽  
Valentina I. Petkov ◽  
Steven Shak
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Hormonal Therapy ◽  
Invasive Breast Cancer ◽  
Recurrence Score ◽  
Population Based ◽  
Additional Benefit ◽  
Gene Assay ◽  
Specific Mortality ◽  
Prior Malignancy

537 Background: The Recurrence Score (RS) was shown in NSABP B-20 to predict chemotherapy (CT) benefit for RS ≥31 and no CT benefit for RS <18. The TAILORx results for RS <11 (NEJM 2015) reported excellent outcomes with no opportunity for CT to add additional benefit. As we await TAILORx results for RS 11-25, we characterized BC specific mortality (BCSM) for RS groups (cutoffs of 11, 18, 25, and 31) in the population-based SEER study of pts treated based on RS. Methods: RS results were provided to SEER registries per their methods (npj Breast Cancer 2016). Pts diagnosed (Jan 2004 - Dec 2012) with N0 HR+ HER2- negative BC, and no prior malignancy were eligible. BCSM estimates by CT use were computed using standard cutpoints of 18 and 31 and TAILORx cutpoints of 11 and 25. Results: Among 49,681 with a RS, 9,486 (19%) had RS <11, 17,988 (36%) had RS 11-17, 14,541 (29%) had RS 18-25, 3,805 (8%) had RS 26-30, and 3,861 (8%) had RS ≥31. Reported CT use and 5-y BCSM increased with increasing RS. For pts with both RS <11 and RS 11-17, CT use was uncommon and 5-y BCSM was low regardless of CT use. For pts with RS 18-25, CT use was more common and the 5-y BCSM was about 1% regardless of CT use. For pts with RS of 26-30 or ≥31, CT was common, and lower 5-y BCSM was observed with CT reported yes than with CT reported no or unknown. Conclusions: Pts in real-world clinical practice with RS <11, consistent with TAILORx, and pts with RS 11-17 have low 5-y BCSM with limited CT use, supporting hormonal therapy alone for pts with RS <18. The high end of the TAILORx mid-range (18-25) also showed good 5-y BCSM both with and without CT, highlighting the importance of the randomized results of TAILORx. [Table: see text]

scholarly journals Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study

2016 ◽  
Vol 2 (1) ◽  
Author(s):  
Valentina I Petkov ◽  
Dave P Miller ◽  
Nadia Howlader ◽  
Nathan Gliner ◽  
Will Howe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Size ◽  
Recurrence Score ◽  
Population Based ◽  
Node Negative ◽  
Node Positive ◽  
Breast Cancer Specific Mortality ◽  
Specific Mortality ◽  
Size Grade ◽  
Cancer Specific Mortality

Abstract The 21-gene Recurrence Score assay is validated to predict recurrence risk and chemotherapy benefit in hormone-receptor-positive (HR+) invasive breast cancer. To determine prospective breast-cancer-specific mortality (BCSM) outcomes by baseline Recurrence Score results and clinical covariates, the National Cancer Institute collaborated with Genomic Health and 14 population-based registries in the the Surveillance, Epidemiology, and End Results (SEER) Program to electronically supplement cancer surveillance data with Recurrence Score results. The prespecified primary analysis cohort was 40–84 years of age, and had node-negative, HR+, HER2-negative, nonmetastatic disease diagnosed between January 2004 and December 2011 in the entire SEER population, and Recurrence Score results (N=38,568). Unadjusted 5-year BCSM were 0.4% (n=21,023; 95% confidence interval (CI), 0.3–0.6%), 1.4% (n=14,494; 95% CI, 1.1–1.7%), and 4.4% (n=3,051; 95% CI, 3.4–5.6%) for Recurrence Score <18, 18–30, and ⩾31 groups, respectively (P<0.001). In multivariable analysis adjusted for age, tumor size, grade, and race, the Recurrence Score result predicted BCSM (P<0.001). Among patients with node-positive disease (micrometastases and up to three positive nodes; N=4,691), 5-year BCSM (unadjusted) was 1.0% (n=2,694; 95% CI, 0.5–2.0%), 2.3% (n=1,669; 95% CI, 1.3–4.1%), and 14.3% (n=328; 95% CI, 8.4–23.8%) for Recurrence Score <18, 18–30, ⩾31 groups, respectively (P<0.001). Five-year BCSM by Recurrence Score group are reported for important patient subgroups, including age, race, tumor size, grade, and socioeconomic status. This SEER study represents the largest report of prospective BCSM outcomes based on Recurrence Score results for patients with HR+, HER2-negative, node-negative, or node-positive breast cancer, including subgroups often under-represented in clinical trials.

Breast cancer specific mortality in patients with early-stage hormone receptor–positive invasive breast cancer and oncotype DX recurrence score results in the SEER database.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 176-176 ◽  
Author(s):  
Steven Shak ◽  
Valentina Petkov ◽  
Dave P Miller ◽  
Nadia Howlader ◽  
Nathan Gliner ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Invasive Breast Cancer ◽  
Hormone Receptor ◽  
Early Stage ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Large Sample Size ◽  
Breast Cancer Specific Mortality ◽  
Specific Mortality ◽  
Cancer Specific Mortality

176 Background: NCI’s SEER Program provides cancer incidence and survival statistics for ~28% of the US. New research models are needed to characterize the use and impact of genomic tests on patient outcomes. Genomic Health and SEER collaborated to electronically supplement SEER registries with Recurrence Score (RS) results, and have evaluated breast cancer specific mortality (BCSM) in early stage hormone receptor (HR)+ HER2- invasive breast cancer. Methods: Pts were eligible for pre-specified node negative (N-) disease analysis if HR+, HER2- (by RT-PCR), no prior malignancy, 40-85 years of age, and diagnosed between Jan 2004 (Oncotype DX available Jan 2004) and Dec 2011 (SEER survival analysis complete through 2012). BCSM was defined as previously described (Howlader et al, JNCI 2010). Additional analyses of BCSM were performed for pts with N+ disease. Results: Of 169,158 eligible N- pts, 38,568 (23%) had a RS, increasing from 2% in 2004 to 35% in 2011. Pts with RS had median age of 57yr, were 99.4% female, 84% white, 29% grade 1 & 54% grade 2, 25% < 1cm & 53% 1-2cm. Median FU was 39mo. 8,239 pts had > 5yrs follow-up. Among RS < 18 (N = 21,023), RS 18-30 (N = 14,494) and RS ≥ 31 (N = 3,051) pts, chemotherapy use was reported in 7%, 34%, & 69%, respectively, and 5yr N- BCSM was 0.4% (95% CI, 0.3-0.6), 1.4% (95% CI, 1.1-1.7) and 4.4% (95% CI,3.4-5.6), respectively. Multivariate showed that RS was significantly associated with BCSM after adjusting for age, grade, and tumor size (p < 0.001), and when stratified by treatment (p < 0.001). BCSM results in additional N- subgroups (e.g., socioeconomic), and in > 60,000 N+ pts will be presented. Conclusions: 5yr survival outcomes are excellent in the over 21,000 N- pts with RS < 18 disease. RS ≥ 31 disease is associated with greater 5yr mortality despite addition of chemotherapy. The large sample size of this population-based observational study provides important information on prospective outcomes in subsets of pts that are often underrepresented in randomized clinical trials.

Clinical utility and therapeutic implications of oncotype analysis in patients with breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11084-e11084
Author(s):  
Stephanie A. Williams ◽  
Talar Tatarian ◽  
Christine B. Teal ◽  
Anita P. McSwain ◽  
Robert S. Siegel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
Cancer Patients ◽  
Hormonal Therapy ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Radiation Oncologists ◽  
Medical Oncologists ◽  
Gene Assay

e11084 Background: Oncotype DX is a 21-gene assay developed for early stage, hormone receptor positive breast cancer that generates a Recurrence Score which estimates response to chemotherapy and the likelihood of systemic recurrence at 10 years. It differentiates between patients who would benefit from chemotherapy plus hormonal therapy versus hormonal therapy alone. This study’s goal was to determine if the Recurrence Score affected clinical management at our institution and physicians’ accuracy at predicting Recurrence Scores. Methods: A retrospective review was conducted of 116 breast cancer patients treated over a 7 year period. Clinic notes, pathology reports, and additional relevant information were presented to breast surgeons, oncologists, radiation oncologists, and surgical pathologists. Individual physicians estimated recurrence risks and recommended treatment based on those estimates. The Recurrence Score was revealed and changes in therapeutic recommendations were recorded. Results: Treatment recommendations changed in 43% of patients. 29% had a change from chemotherapy followed by hormone therapy to hormone therapy alone due to a low recurrence score, while 14% initially recommended hormonal therapy were changed to chemotherapy plus hormonal therapy due to an intermediate range score. Surgical oncologists accurately predicted Recurrence Scores 52% of the time, medical oncologists 46%, radiation oncologists 45%, and surgical pathologists 15%. A nested mixed model showed that pathologists were statistically significantly worse at predicting recurrence scores than surgical oncologists, medical oncologists, and radiation oncologists. Conclusions: The Oncotype DX assay changes management of breast cancer patients at our institution, frequently downgrading the intensity of systemic therapy. Clinicians were able to accurately estimate recurrence categories about 50% of the time. We recommend the use of Oncotype DX assay along with assessment of clinicopathologic features of an individual’s disease in eligible patients to enhance the selection of appropriate adjuvant therapy.

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