Correction to: The Clinical Utility of DCISionRT® on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Shah, Chirag; Bremer, Troy; Cox, Charles P.; Whitworth, Pat W.; Patel, Rakesh; Patel, Anushka; Brown, Erin G.; Gold, Linsey; Rock, David; Riley, Lee B.; Kesslering, Christy; Brown, Sheree; Gabordi, Robert; Pellicane, James; Rabinovich, Rachel; Khan, Sadia; Templeton, Sandra; Majithia, Lonika; Willey, Shawna C.; Wärnberg, Fredrik; Gerber, Naamit K.; Shivers, Steven C.; Vicini, Frank A.

doi:10.1245/s10434-021-10138-3

Cited by 3 publications

(10 citation statements)

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“…Of the 583 patients recommended to not receive RT pre-test, 31% (n = 181/583) were recommended to receive RT post-test. As previously shown, 20 the percentage of patients recommended RT post-test varied with DS, and was 33% for DS <3 and 85% for DS ≥3 (Table 2). Similar results were observed when the impact of the continuum of DS results on treatment recommendations was evaluated, wherein the percentage of patients recommended RT post-test was 29% for DS <2, 66% for DS 2-4, and 91% for DS >4 (Table 3).…”

Section: Resultssupporting

confidence: 64%

“…DCISionRT is a commercial Multianalyte Assay with Algorithmic Analyses (MAAA) by PreludeDx (Laguna Hills, CA) that is performed for women diagnosed with breast ductal carcinoma in situ (DCIS), using a formalin-fixed, paraffin-embedded DCIS tissue specimen. Interim results from the study were published in 2021 20 with 539 patients evaluated. Herein, we present the results after the enrollment of patients was complete.…”

Section: Methodsmentioning

confidence: 99%

“…Sample processing and analytical and clinical test validations have been previously described. [17][18][19][20][21][22] For all patients, demographic information and clinicopathologic characteristics were recorded. RT treatment recommendation was made by clinicians (yes or no RT) prior to the clinician receiving the DCISionRT test result (pre-test recommendation).…”

Section: Methodsmentioning

confidence: 99%

“…17 The test demonstrated high analytical sensitivity, specificity, accuracy, reproducibility, and precision, 18 and was prognostic of IBR risk and predictive of RT benefit in multiple validation studies. 17,[19][20][21][22] These clinical validation studies, which include a large randomized clinical trial (SweDCIS), demonstrate that patients who were classified by DCISionRT as being at low risk received no significant benefit from RT, whereas patients with higher DS results had much higher IBR rates, which were significantly reduced with adjuvant RT. The test had a 99% negative predictive value for RT benefit for patients in the low-risk group, while 96% of all patients benefiting from RT were correctly classified into the high-risk group.…”

Section: Abstract Ductal Carcinoma In Situ • Radiation Therapy • Deci...mentioning

confidence: 97%

“…The impact of patient preference, clinical factors, race/ ethnicity, pathologic features, and low-risk clinicopathologic criteria on the physician's treatment recommendation are also assessed. Interim results from the study were published in 2021, 20 with 539 patients evaluated. Herein, we present results, after the enrollment of patients was complete from the full cohort of more than 2000 patients, to evaluate the change in the radiation recommendation, including…”

Section: Abstract Ductal Carcinoma In Situ • Radiation Therapy • Deci...mentioning

confidence: 99%

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The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study

Shah,

Whitworth,

Vicini

et al. 2024

Ann Surg Oncol

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Background Breast-conserving surgery (BCS) followed by adjuvant radiotherapy (RT) is a standard treatment for ductal carcinoma in situ (DCIS). A low-risk patient subset that does not benefit from RT has not yet been clearly identified. The DCISionRT test provides a clinically validated decision score (DS), which is prognostic of 10-year in-breast recurrence rates (invasive and non-invasive) and is also predictive of RT benefit. This analysis presents final outcomes from the PREDICT prospective registry trial aiming to determine how often the DCISionRT test changes radiation treatment recommendations. Methods Overall, 2496 patients were enrolled from February 2018 to January 2022 at 63 academic and community practice sites and received DCISionRT as part of their care plan. Treating physicians reported their treatment recommendations pre- and post-test as well as the patient’s preference. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendation. The impact of the test on RT treatment recommendation was physician specialty, treatment settings, individual clinical/pathological features and RTOG 9804 like criteria. Multivariate logisitc regression analysis was used to estimate the odds ratio (ORs) for factors associated with the post-test RT recommendations. Results RT recommendation changed 38% of women, resulting in a 20% decrease in the overall recommendation of RT (p < 0.001). Of those women initially recommended no RT (n = 583), 31% were recommended RT post-test. The recommendation for RT post-test increased with increasing DS, from 29% to 66% to 91% for DS <2, DS 2–4, and DS >4, respectively. On multivariable analysis, DS had the strongest influence on final RT recommendation (odds ratio 22.2, 95% confidence interval 16.3–30.7), which was eightfold greater than clinicopathologic features. Furthermore, there was an overall change in the recommendation to receive RT in 42% of those patients meeting RTOG 9804-like low-risk criteria. Conclusions The test results provided information that changes treatment recommendations both for and against RT use in large population of women with DCIS treated in a variety of clinical settings. Overall, clinicians changed their recommendations to include or omit RT for 38% of women based on the test results. Based on published clinical validations and the results from current study, DCISionRT may aid in preventing the over- and undertreatment of clinicopathological ‘low-risk’ and ‘high-risk’ DCIS patients. Trial Registration ClinicalTrials.gov identifier: NCT03448926 (https://clinicaltrials.gov/study/NCT03448926).

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Section: Resultssupporting

confidence: 64%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Abstract Ductal Carcinoma In Situ • Radiation Therapy • Deci...mentioning

confidence: 97%

Section: Abstract Ductal Carcinoma In Situ • Radiation Therapy • Deci...mentioning

confidence: 99%

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The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study

Shah,

Whitworth,

Vicini

et al. 2024

Ann Surg Oncol

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Benefits and harms of breast cancer screening revisited: a large, retrospective cross-sectional study quantifying treatment intensity in women with screen-detected versus non-screen-detected cancer in Australia and New Zealand

Dempsey,

Costa,

Brennan

et al. 2023

bmjonc

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ObjectivesNon-mortality benefits of breast cancer screening are rarely considered in assessments of benefits versus harms. This study aims to estimate the rate of overdiagnosis in women with screen-detected breast cancer (SDBC) by allocating cases to either possibly overdiagnosed (POD) or not overdiagnosed categories and to compare treatment recommendations for surgery and adjuvant treatments by category, age at diagnosis and cancer stage.Methods and analysisRetrospective secondary analysis of 10 191 women diagnosed with breast cancer in Australia and New Zealand in 2018. Treatment recommendations for 5226 women with SDBC and 4965 women with non-SDBC (NSDBC) were collated and analysed. Descriptive statistics were used to calculate proportions and risk ratios (RRs).ResultsThe POD rate was 15.8%. Screening detected 66.3% of stage 0 tumours, 59% of stage 1, 40% of stage 2 and 27.5% of stage 3 tumours. Women with SDBC were less likely than their NSDBC counterparts to receive chemotherapy (RR 0.60 Aus/0.53 NZ), immunotherapy (mostly human epidermal growth factor 2 receptor therapy) (RR 0.58 Aus/0.82 NZ), mastectomy (RR 0.55 Aus/0.63 NZ) and axillary lymph node dissection (RR 0.49 Aus/0.52 NZ), or to require both mastectomy and radiotherapy (RR 0.41 Aus/0.34 NZ). Less than 1% of POD women were recommended chemotherapy, 9.5% radiotherapy, 6.4% endocrine therapy, 2.2% mastectomy and 0.5% axillary lymph node dissection.ConclusionsWomen with SDBCs required less intensive treatment; rates of possible overtreatment of SDBCs are relatively low and may be minimised through multidisciplinary discussion and shared decision-making. Reduced treatment intensity should be considered when balancing the potential benefits and harms of screening.

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Analytical validation of the 7-gene biosignature for prediction of recurrence risk and radiation therapy benefit for breast ductal carcinoma in situ

et al. 2023

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PurposeDuctal carcinoma in situ (DCIS), is a noninvasive breast cancer, representing 20-25% of breast cancer diagnoses in the USA. Current treatment options for DCIS include mastectomy or breast-conserving surgery (BCS) with or without radiation therapy (RT), but optimal risk-adjusted treatment selection remains a challenge. Findings from past and recent clinical trials have failed to identify a ‘low risk’ group of patients who do not benefit significantly from RT after BCS. To address this unmet need, a DCIS biosignature, DCISionRT (PreludeDx, Laguna Hills, CA), was developed and validated in multiple cohorts. DCISionRT is a molecular assay with an algorithm reporting a recurrence risk score for patients diagnosed with DCIS intended to guide DCIS treatment. In this study, we present results from analytical validity, performance assessment, and clinical performance validation and clinical utility for the DCISionRT test comprised of multianalyte assays with algorithmic analysis.MethodsThe analytical validation of each molecular assay was performed based on the Clinical and Laboratory Standards Institute (CLSI) guidelines Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays and the College of American Pathologists/American Society of Clinical Oncology (CAP/ASCO) recommendations for analytic validation of immunohistochemical assays.ResultsThe analytic validation showed that the molecular assays that are part of DCISionRT test have high sensitivity, specificity, and accuracy/reproducibility (≥95%). The analytic precision of the molecular assays under controlled non-standard conditions had a total standard deviation of 6.6 (100-point scale), where the analytic variables (Lot, Machine, Run) each contributed <1% of the total variance. Additionally, the precision in the DCISionRT test result (DS) had a 95%CI ≤0.4 DS units under controlled non-standard conditions (Day, Lot, and Machine) for molecular assays over a wide range of clinicopathologic factor values. Clinical validation showed that the test identified 37% of patients in a low-risk group with a 10-year invasive IBR rate of ~3% and an absolute risk reduction (ARR) from RT of 1% (number needed to treat, NNT=100), while remaining patients with higher DS scores (elevated-risk) had an ARR for RT of 9% (NNT=11) and 96% clinical sensitivity for RT benefit.ConclusionThe analytical performance of the PreludeDx DCISionRT molecular assays was high in representative formalin-fixed, paraffin-embedded breast tumor specimens. The DCISionRT test has been analytically validated and has been clinically validated in multiple peer-reviewed published studies.

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Correction to: The Clinical Utility of DCISionRT® on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Cited by 3 publications

References 0 publications

The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study

The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study

Benefits and harms of breast cancer screening revisited: a large, retrospective cross-sectional study quantifying treatment intensity in women with screen-detected versus non-screen-detected cancer in Australia and New Zealand

Analytical validation of the 7-gene biosignature for prediction of recurrence risk and radiation therapy benefit for breast ductal carcinoma in situ

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