Abstract P4-07-05: Correlation of a Proliferation Index Combined with Progesterone Receptor to Oncotype DX® in Early Stage ER-Positive Breast Cancer

Author(s):  
J Sninsky ◽  
A Iverson ◽  
C Sanitni ◽  
C Sigua ◽  
S Anderson ◽  
...  
2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 309-309
Author(s):  
Michaela Ann Dinan ◽  
Xiaojuan Mi ◽  
Shelby D. Reed ◽  
Gary H. Lyman ◽  
Lesley H Curtis

309 Background: In 2004, the Oncotype DX (ODX) multigene assay became available to help guide physicians in their decision to recommend adjuvant chemotherapy in patients with early stage estrogen receptor (ER) positive breast cancer. ODX utilization within a non-academic, nationally representative breast cancer population has not been previously examined. Methods: Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER)-Medicare data of the association between ODX testing and receipt of chemotherapy in patients diagnosed with invasive, non-metastatic, ER-positive breast cancer between 2004 and 2007. Results: A total of 28,760 Medicare beneficiaries met study criteria. NCCN guidelines were used to stratify patients on the basis of clinical and pathologic features into low (<1 cm tumors, 24.4%), intermediate (≥ 1 cm tumors, 52.0%), and high (node positive, 23.7%) risk disease. In patients with low or intermediate risk disease, receipt of ODX was associated with increased chemotherapy utilization (13% vs. 1% and 19% vs. 8%, respectively; both P < 0.001), but not in high risk patients (30% vs. 39%, P= 0.34). Conclusions: Randomized trials have previously suggested the ability of ODX to decrease chemotherapy utilization. In this study, we observed increased chemotherapy utilization associated with receipt of ODX in patients with low and intermediate NCCN risk disease. Association between ODX and chemotherapy utilization in observational studies may be impacted by preferential administration of ODX testing to patients being considered for chemotherapy. [Table: see text]


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 32-32
Author(s):  
Michaela Ann Dinan ◽  
Xiaojuan Mi ◽  
Shelby D. Reed ◽  
Gary H. Lyman ◽  
Lesley H Curtis

32 Background: The Oncotype DX (ODX) multigene assay has been previously suggested to result in an overall reduction in the use of adjuvant chemotherapy and associated costs for women with early stage, estrogen receptor (ER)-positive breast cancer. However, the association between adoption of ODX and chemotherapy costs has only previously been considered in theoretical models and has not been examined using actual patient outcomes in real world clinical practice. Methods: Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER) -Medicare data of the association between overall and chemotherapy-specific costs associated with adoption of ODX testing in patients diagnosed with invasive, non-metastatic, ER-positive breast cancer between 2005 and 2009. We limited our primary analysis to women ages 66 to75 to include women in which adjuvant chemotherapy would be most likely to be considered. Total Medicare payments were used to calculate direct costs in the year following diagnosis. NCCN guidelines were used to stratify patients on the basis of clinical and pathologic features into low ( < 1.0 cm), intermediate, and high risk (node positive) disease. Results: A total of 21,272 women met study criteria. Average costs in the year following diagnosis were $31,532 in the overall cohort, and was highest for women with NCCN high risk ($45,192) vs. intermediate ($28,642) or low ($23,662) risk disease. Chemotherapy costs followed similar trends ($4,819, $1,157, and $226 respectively). In multivariable analyses, ODX was associated with a relative decrease in chemotherapy costs among high risk women (RR 0.54, 0.37-0.77), but increased costs among low and intermediate risk women (RR1.36, 1.13-1.26 and RR 3.73, 2.13-56.54). Women with high risk disease had significantly lower absolute chemotherapy costs associated with receipt of ODX (-$2,298, -$3,049 to -$1,547; All P < 0.001). Conclusions: Receipt of ODX testing was associated with relative and absolute decreases in chemotherapy costs, but only in women with high NCCN risk disease. Further research is needed to disentangle correlative vs. causative association of ODX testing with patient outcomes and costs.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12520-e12520
Author(s):  
Keerthi Tamragouri ◽  
Ethan M. Ritz ◽  
Ruta D. Rao ◽  
Cristina O'Donoghue

e12520 Background: Oncotype Dx (ODX) is a commercial diagnostic test primarily used to predict the likely benefit from chemotherapy in ER+, HER2-, and node negative breast cancer. The prognostic value (recurrence risk) has also been demonstrated to apply to early stage lymph node positive (LN+) disease in a number of retrospective and prospective studies. The ongoing RxPONDER trial aims to clarify the predictive value of RS in LN+ population. In light of the initial results, we analyzed the practice patterns and outcomes for HR+/Her2 -/node positive breast cancer patients receiving ODX testing in the years from 2010-2017 with RS 14-25 in a retrospective observational study of the NCDB. Methods: Women with HR+/Her2 -/node positive breast cancer receiving ODX testing from 2010-2017 were identified in the NCDB using TAILORx and RxPONDER patients’ inclusion criteria: ages 18-75, 6-50mm invasive tumors, N1, M0, ER+/HER2 -. The impact of ODX results in the high-intermediate range (14-25) and other clinico-pathologic variables on the receipt of chemotherapy were compared. Additionally, we examined the impact of chemotherapy on overall survival (OS). Frequencies, Kaplain-Meier analysis, and changepoint analysis using the Contal and O’Quigley method were utilized. Results: There were 109,652 T1-2 and N1 patients of whom 32,506 (29.6%) received ODX testing. 13,461 (41.4%%) women had scores in the high-intermediate (14-25) range. The majority tended to have only 1 LN involved (1LN: 77.2%, 2LNs: 17.5%, 3LNs: 5.3%), had a mean age of 57.8y, were Caucasian (86.4%), and were preferentially tested at academic or comprehensive community cancer programs (79.2%). 6,610 (49.3%) patients were recommended chemotherapy, the median ODX score for all women who were recommended chemotherapy was 20 compared to 17 for those whom chemotherapy was not recommended. 5,068 (76.7%) women had documentation of receiving chemotherapy which correlated with improved OS regardless of age. Conclusions: In the group of women with HR+/Her2 -/node positive breast cancer, clinicians appear to utilize ODX testing in less than one-third of patients, possibly finding RS to be most useful in guiding adjuvant therapy recommendations when only 1LN is involved. Both the recommendation and receipt of chemotherapy correlated linearly with increasing RS, as expected based on the current NCCN guideline recommendations. We identified an OS benefit when chemotherapy was administered, regardless of patient age. Long-term follow-up in the RxPONDER trial will likely continue to clarify the predictive value of RS < 25 in the ER+/HER2-/node positive breast cancer population.


Author(s):  
Stephen R. Johnston

Overview: Adjuvant endocrine therapy for early-stage breast cancer has had the single biggest impact on improving survival from the disease—with tamoxifen alone contributing to saving many thousands of lives. In postmenopausal women, additional progress has been made by the incorporation of aromatase inhibitors into the treatment of early-stage, estrogen receptor (ER)–positive breast cancer, as several large well-conducted trials have established either “up-front” or “switch” strategies that are now widely used. To date, both have been shown to be beneficial when compared with tamoxifen alone, although controversy exists as to which approach is superior. Increasingly, extended adjuvant therapy is being considered, as “longer may be better” for some women who have an ongoing risk of recurrence beyond 5 years. However, controversy remains as to how long adjuvant endocrine therapy should be given for; in clinical practice, clinicians balance the level of risk for individual patients versus any ongoing toxicity concerns. For premenopausal women, with ER-positive breast cancer, tamoxifen remains the gold standard with uncertainty in the added overall benefit of ovarian suppression. Important clinical trials have recently been completed that may help answers this question, including whether complete estrogen deprivation using a luteinizing hormone releasing hormone (LHRH) agonist plus aromatase inhibitors (AIs) is of added benefit. In recent years, molecular profiling of ER-positive breast cancer has started to distinguish those women with a low risk of recurrence on endocrine therapy who may not need chemotherapy. Thus, with more therapy options and greater tumour stratification, modern, adjuvant endocrine therapy is becoming increasingly personalised to suit each individual patient's risk.


2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 171-171 ◽  
Author(s):  
K. K. L. Yap ◽  
D. N. Efiom-Ekaha

171 Background: Oncotype DX Score is a 21-gene expression analysis that has been validated clinically as a reliable predictor of breast cancer recurrence for ER-positive, node-negative breast cancers. Obesity is recognized as a risk factor for many cancers, including breast cancer. Additionally obesity has been shown to be an independent prognostic factor in breast cancer. The primary objective of this study is to determine the correlation between obesity and Oncotype DX score, hence the relationship between obesity and breast cancer recurrence in ER-positive breast cancer. The secondary objective is to investigate the association between weight gain after diagnosis and breast cancer recurrence. Methods: An IRB-exempted retrospective chart review of female patients at Wellspan Group with ER-positive breast cancer who had Oncotype DX analysis in 2008 and 2009. Data collected included Oncotype DX score and BMI (at diagnosis, 6 months and 12 months). Data were analyzed to determine the correlation between Oncotype DX score and BMI at diagnosis, at 6 months and at 12 months. The correlation between Oncotype DX score and BMI changes at 12 months also was determined. Results: A total of 125 patients were identified; 103 had BMI recorded at diagnosis, 88 had BMI recorded at 6 months and 87 had BMI recorded at 12 months. Of these, we were able to determine the BMI changes at 12 months for 82 patients. The Pearson correlation scores were 0.091 (p = 0.361), 0.074 (p = 0.492), and 0.047 (p = 0.669) for BMI at diagnosis, at 6 months and at 12 months respectively. The Pearson correlation score was 0.007 (p = 0.948) for BMI changes at 12 months. Conclusions: Obesity and weight gain are not independent predictors of recurrence in patients with ER-positive breast cancer. The reported adverse prognostic associations may be more prominent in ER-negative breast cancers. This is consistent with the reports suggesting a higher rate of ER-negative, high-grade cancers in obese women as well as a greater magnitude of benefit from dietary and weight reduction interventions seen in women with ER-negative cancers.


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