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Oncotype DX breast cancer recurrence score can be predicted with a novel nomogram using clinicopathologic data.

ABSTRACT: Oncotype DX (ODX) recurrence score (RS) breast cancer (BC) assay is costly, and performed in only ~1/3 of estrogen receptor (ER)-positive BC patients in the USA. We have now developed a user-friendly nomogram surrogate prediction model for ODX based on a large dataset from the National Cancer Data Base (NCDB) to assist in selecting patients for which further ODX testing may not be necessary and as a surrogate for patients for which ODX testing is not affordable or available.Six clinicopathologic variables of 27,719 ODX-tested ER+/HER2-/lymph node-negative patients with 6-50 mm tumor size captured by the NCDB from 2010 to 2012 were assessed with logistic regression to predict high-risk or low-risk ODXRS test results with TAILORx-trial and commercial cut-off values; 12,763 ODX-tested patients in 2013 were used for external validation. The predictive accuracy of the regression model was yielded using a Receiver Operator Characteristic analysis. Model fit was analyzed by plotting the predicted probabilities against the actual probabilities. A user-friendly calculator version of nomograms is available online at the University of Tennessee Medical Center website (Knoxville, TN).Grade and progesterone receptor status were the highest predictors of both low-risk and high-risk ODXRS, followed by age, tumor size, histologic tumor type and lymph-vascular invasion (C-indexes-.0.85 vs. 0.88 for TAILORx-trial vs. commercial cut-off values, respectively).This is the first study of this scale showing confidently that clinicopathologic variables can be used for prediction of low-risk or high-risk ODXRS using our nomogram models. These novel nomograms will be useful tools to help physicians and patients decide whether further ODX testing is necessary and are excellent surrogates for patients for which ODX testing is not affordable or available.

SUBMITTER: Orucevic A

PROVIDER: S-EPMC5387031 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Oncotype DX breast cancer recurrence score can be predicted with a novel nomogram using clinicopathologic data.

Orucevic Amila A Bell John L JL McNabb Alison P AP Heidel Robert E RE

Breast cancer research and treatment 20170227 1

<h4>Purpose</h4>Oncotype DX (ODX) recurrence score (RS) breast cancer (BC) assay is costly, and performed in only ~1/3 of estrogen receptor (ER)-positive BC patients in the USA. We have now developed a user-friendly nomogram surrogate prediction model for ODX based on a large dataset from the National Cancer Data Base (NCDB) to assist in selecting patients for which further ODX testing may not be necessary and as a surrogate for patients for which ODX testing is not affordable or available.<h4>M ...[more]

PMID: 28243897

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Project description:The Oncotype DX 21-gene test can be used to predict chemotherapy efficacy in patients with estrogen receptor (ER)-positive and HER2-negative breast cancer; however, the data on the 21-gene recurrence score (RS) for mucinous breast carcinoma (MBC) are limited. The present study aimed to evaluate the distribution pattern and clinical value of the 21-gene RS in patients with MBC. A total of 38 pure MBC (PMBC) and 11 mixed MBC (MMBC) cases were retrospectively analyzed, and a total of 29 ER-positive and HER2-negative MBCs underwent the Oncotype DX 21-gene test. There were no statistically significant differences between the PMBCs and MMBCs in age, tumor size and molecular subtype; however, patients with MMBC showed a significantly higher incidence rate of nodal metastases compared with that in patients with PMBC (72.7 vs. 16.2%, respectively). Following surgery, 87.8 and 59.2% of the enrolled patients received endocrine therapy and chemotherapy, respectively. With a median follow-up of 65.6 months, the 5-year disease-free survival and overall survival rates were 97.0 and 100.0%, respectively. The 21-gene test revealed that the proportions of patients with MBC categorized into low (RS <18), intermediate (RS ≥18-30) and high (RS ≥30) risk groups were 51.7, 44.8 and 3.5%, respectively, and there was no statistically significant difference between the PMBC and MMBC cases. Notably, among the genes in the 21-gene RS testing, the expression levels of cathepsin V, progesterone receptor (PR) and CD68 were significantly higher in the PMBC group compared with that in the MMBC group. In conclusion, the current study demonstrated that patients with MBC had a favorable prognosis, and both PMBC and MMBC cases had a low- and intermediate-risk RS, which suggests that a considerable proportion of patients may be able to avoid chemotherapy. In addition, the high expression level of PR, based on the 21-gene test in PMBCs, indicated that they may have a more favorable response to endocrine therapy than MMBCs.

Project description:The Oncotype Dx assay is frequently used to test if breast cancer patients can be spared from chemotherapy without negative effects for their future clinical course. However, due to conflicting data on the assay utility, in the recent past its reimbursement situation in Germany was revised; due to continued requests by clinicians for predictive values, our group decided to implement an Oncotype Dx like alternative assay with the objective of obtaining quality and cost optimization. Customized RT2-Profiler assays covering the 21 gene panel of the Oncotype Dx assay were applied to a pilot cohort of breast cancer patients with known Oncotype Dx Recurrence Score (RS). The Ct values obtained with RT2-Profiler-assays were used to calculate the unscaled Recurrence Score (RSu) values and the thereon based RS according to the Oncotype DX assay rules if available. Despite consistent assay performance it was impossible to establish correlations between RT2-Profiler recurrence scores with the respective Oncotype DX values not to mention exact matches. By following the Oncotype DX assay and its interpretation as close as possible we faced several obstructions such as lack of information on RNA amount used, missing units in the single gene expression report, missing references cited in the original study that should explain the determination of the recurrence score formula, and vague information on the normalization of the gene expression impeding the reproduction of Oncotype Dx results in other laboratories. Unfortunately, the Oncotype Dx assay cannot be confirmed by the customized RT2-profiler assay, not least because of the fact that the individual gene measurements are not provided in the medical report, although these are mandatory for the RS calculation. In fact, the "single gene report" only contains unscaled scores of the ER, PR, and Her2 genes without any internationally accepted unit used to describe a transcript quantity. Therefore a direct comparison with the in-house measurement to evaluate its performance is impossible. With regard to our findings and the fact that the Oncotype RS represents a likelihood of the risk of relapse it thus remains impossible to assess the clinical necessity of this assay.

Dataset Information

Oncotype DX breast cancer recurrence score can be predicted with a novel nomogram using clinicopathologic data.

Publications

Oncotype DX breast cancer recurrence score can be predicted with a novel nomogram using clinicopathologic data.

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