Combined pathologic‐genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay

Gage, Michele M.; Mylander, W. Charles; Rosman, Martin; Fujii, Takeo; Du, Fanny Le; Raghavendra, Akshara Singareeka; Sinha, A. K.; Fernandez, Jose Rodrigo Espinosa; James, Anjali; Ueno, Naoto T.; Tafra, Lorraine; Jackson, Rubie Sue

doi:10.1093/annonc/mdy074

Cited by 11 publications

(10 citation statements)

References 18 publications

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“…A multivariate logistic regression analysis of an updated nomogram revealed that all five clinicopathologic variables were significant predictors for a low-risk or a high-risk ODXRS test results with grade and PR status carrying the highest impact. Grade and PR status were also shown by Gage et al [26,34] and Huang et al [35] as significant predictors of ODXRS test results in different ODX prediction models.…”

Section: Discussionmentioning

confidence: 61%

“…Recently published studies implied that ordering of ODX test for every eligible ERþ/HER2-negative/lymph node-negative female patients with invasive breast carcinoma might not contribute to clinical management decisions. Some of these studies suggested that analysis of some of the clinicopathologic data available from pathology reports may select patients for which ODX test results were highly predictable and, therefore, the test could be safely and appropriately avoided [33,34]. We previously developed a "user friendly" nomogram/calculator [14] as a surrogate prediction model for the ODX score.…”

Section: Discussionmentioning

confidence: 99%

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Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

et al. 2019

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Objectives: Oncotype DX (ODX), 21-gene breast cancer (BC) assay, predicts risk of recurrence and benefits of addition of chemotherapy to hormonal therapy for early-stage BC. We previously published a nomogram/calculator that could predict ODX results without performing the test by using clinicopathologic characteristics of BC available from pathology reports. Patients with intermediate-risk (11e25) ODXRS (RS) were excluded from that nomogram. This update tests the predictive value of clinicopathologic variables for forecasting the ODXRS while including intermediate-risk-ODXRS patients and stratifying ODXRS based on recently published TAILORx clinical trial results (0e25 ¼ low-risk, 26 e100 ¼ high-risk-ODXRS; intermediate-risk-ODXRS belongs to the low-risk category). Material and methods: The nomogram was built on 65,754 ODX-tested ERþ/HER2-/lymph-node-negative patients with 6e50 mm tumor, captured by the National Cancer Data Base (NCDB) from 2010 to 2014.Five clinicopathologic variables (age, tumor size, grade, progesterone-receptor status (PR) and BChistologic type) were assessed with logistic regression to predict for a low-risk (0e25) or a high-risk (26e100) ODXRS. Results were validated on a separate 18,585 ODX-tested cohort from 2015. Results: Grade and PR were the highest significant predictors of both low-risk and high-risk-ODXRS, followed by histologic type, tumor size and age. The Receiver Operator Characteristic (ROC) curve showed strong statistical model for both low-risk and high-risk-ODXRS prediction outcomes (cindex ¼ 0.81). Conclusions: An updated nomogram is now developed/validated on the entire population of ODX-tested patients (84,339) captured by the NCDB. The nomogram/calculator, available on-line at the UTMCK/Shiny website (https://utgsm.shinyapps.io/OncotypeDXCalculator/), will continue serving as a surrogate for BC patients for which ODX testing is not affordable, available or necessary.

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Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 99%

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

et al. 2019

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“…On another hand, cost-effectiveness analysis demonstrated that the 21-gene RS testing was only associated with lower cost in patients with clinical high-risk [14,15]. Thus, a surrogate for the 21-gene RS testing is needed for those who have no access to this assay, as well as to relieve the heavy financial burden of patients for whom the testing is not cost-efficient [16]. The NSABP B-20 retrospectively validated that patients with RS > 30 could have better distant recurrence-free survival if they received chemotherapy [17].…”

Section: Discussionmentioning

confidence: 99%

A nomogram to predict the high-risk RS in HR+/HER2-breast cancer patients older than 50 years of age

Huang

et al. 2021

J Transl Med

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Background The 21-gene recurrence score (RS) testing can predict the prognosis for luminal breast cancer patients. Meanwhile, patients > 50 years with RS > 25 have improved survival with adjuvant chemotherapy. The current study aimed to develop a nomogram with routine parameters to predict RS. Methods We included patients diagnosed with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative who underwent the 21-gene RS testing and aged > 50 years. The primary outcome was high-risk RS (> 25). Univariate and multivariate analyses were performed to identify significant predictors. A predictive nomogram based on logistic model was developed and evaluated with receiver operating characteristic (ROC) curves. The nomogram was internally validated for discrimination and calibration with bootstrapping method, and externally validated in another cohort. We then assessed the nomogram in different subgroups of patients and compared it with several published models. Results A total of 1100 patients were included. Five clinicopathological parameters were used as predictors of a high-risk RS, including tumor grade, histologic subtype, ER expression, PR expression, and Ki-67 index. The area under the curve (AUC) was 0.798 (95% CI 0.772–0.825) and optimism adjusted AUC was 0.794 (95% CI 0.781–0.822). External validation demonstrated an AUC value of 0.746 (95% CI 0.685–0.807), which had no significant difference with the training cohort (P = 0.124). Calibration plots indicated that the nomogram-predicted results were well fitted to the actual outcomes in both internal and external validation. The nomogram had better discriminate ability in patients who had tumors > 2 cm (AUC = 0.847, 95% CI 0.804–0.890). When compared with four other existing models, similar AUC was observed between our nomogram and the model constructed by discriminate Lee et al. Conclusions We developed a user-friendly nomogram to predict the high-risk RS in luminal breast cancer patients who were older than 50 years of age, which could guide treatment decision making for those who have no access to the 21-gene RS testing.

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“…This is currently recommended by NICE with the use of PREDICT or NPI. Gage et al [ 68 ] analysed information about 1268 breast cancer patients from the University of Texas MD Anderson Cancer Center database. The mean age of the group was 54.8 years.…”

Section: Discussionmentioning

confidence: 99%

The Potential Use of Tumour-Based Prognostic and Predictive Tools in Older Women with Primary Breast Cancer: A Narrative Review

2020

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A move is under way towards personalised cancer treatment, where tumour biology of an individual patient is examined to give unique predictive and prognostic information. This is extremely important in the setting of older women, who have treatment-specific goals which may differ from their younger counterparts, and may include conservation of quality of life rather than curative intent of treatment. One method employed to assist with this is the use of tumour-based prognostic and predictive tools. This article explores six of the most common tumour-based tools currently available on the market: MammaPrint, Oncotype DX, Mammostrat, Prosigna, EndoPredict, IHC4. The article discusses the creation and validation of these tools, their use and validation in older women, and future directions in the field. With the exception of Oncotype Dx, which has also been licensed for prediction of response from adjuvant chemotherapy, these tools have been licensed for use as prognostic tools only, mainly in the setting of adjuvant therapy following surgery. The evidence base for use in older women is strongest for Mammostrat and PAM50, although overall the evidence is much weaker than that in younger women. Where older women have been included in validation studies, this is often in small numbers, or the exact proportion of older women is unknown. In practice, all six of the tools are recommended to be utilised on surgical excision specimens, as well as in core needle biopsy (CNB) specimens in all of the tools except Mammostrat. This is extremely important in the setting of older women, of whom a large proportion do not undergo surgery. The suggested nature of the sample is formalin-fixed paraffin-embedded in all the tools except MammaPrint, which can also be performed on fresh-frozen samples. Future development of prognostic tools in older women with breast cancer should focus on treatment dilemmas specific to this population. This includes the decision of primary treatment between surgery or endocrine therapy and decisions regarding adjuvant therapy, in particular, chemotherapy.

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Combined pathologic‐genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay

Cited by 11 publications

References 18 publications

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

A nomogram to predict the high-risk RS in HR+/HER2-breast cancer patients older than 50 years of age

The Potential Use of Tumour-Based Prognostic and Predictive Tools in Older Women with Primary Breast Cancer: A Narrative Review

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