Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ

Manders, Jennifer B.; Kuerer, Henry Mark; Smith, Benjamin D.; McCluskey, C; Farrar, William B.; Frazier, Thomas G.; Li, Linna; Leonard, Charles E.; Carter, Dennis L.; Chawla, Sheema; Medeiros, Lori E.; Guenther, J. Michael; Castellini, Lauren E.; Buchholz, D.; Mamounas, Eleftherios P.; Wapnir, Irene; Horst, Kathleen C.; Chagpar, Anees B.; Evans, Suzanne B.; Riker, Adam I.; Vali, F.; Solin, Lawrence J.; Jablon, Lisa K.; Recht, Abram; Sharma, Ranjna; Lu, Ruixiao; Sing, Amy P.; Hwang, E. Shelley; White, Julia; Investigators, Study; participants, study

doi:10.1245/s10434-016-5583-7

Cited by 25 publications

(14 citation statements)

References 25 publications

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“…Such a low-cost approach would be beneficial, especially given that economic modeling found no circumstances in which the OncotypeDX assay could be cost-effective in determining who should receive RT ( 145 ). However, incorporating existing risk parameters in concert with a molecular assay could improve the predictive benefit, and a small clinical utility assessment found that patient anxiety and decisional conflict were reduced after receiving assay results ( 146 ).…”

Section: Biomarkers Of Recurrence and Progressionmentioning

confidence: 99%

Ductal Carcinoma In Situ Biology, Biomarkers, and Diagnosis

Gorringe

Fox

2017

Front. Oncol.

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Ductal carcinoma in situ (DCIS) is an often-diagnosed breast disease and a known, non-obligate, precursor to invasive breast carcinoma. In this review, we explore the clinical and pathological features of DCIS, fundamental elements of DCIS biology including gene expression and genetic events, the relationship of DCIS with recurrence and invasive breast cancer, and the interaction of DCIS with the microenvironment. We also survey how these various elements are being used to solve the clinical conundrum of how to optimally treat a disease that has potential to progress, and yet is also likely over-treated in a significant proportion of cases.

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Section: Biomarkers Of Recurrence and Progressionmentioning

confidence: 99%

Ductal Carcinoma In Situ Biology, Biomarkers, and Diagnosis

Gorringe

Fox

2017

Front. Oncol.

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“…With these limitations acknowledged, our group participated in a multicenter study that found that the test may have certain clinical utility 45 . For example, in a patient who meets RTOG 9804 criteria for low risk DCIS (size ≤ 2.5 cm, mammographically detected, and low to intermediate grade), the estimated risk of IBTR is 1%/year treated without radiotherapy based on this trial data.…”

Section: Radiation Therapy For Dcismentioning

confidence: 99%

DCIS Margins and Breast Conservation: MD Anderson Cancer Center Multidisciplinary Practice Guidelines and Outcomes

Kuerer¹,

Smith²,

Chávez-MacGregor³

et al. 2017

J. Cancer

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Recent published guidelines suggest that adequate margins for DCIS should be ≥ 2 mm after breast conserving surgery followed by radiotherapy (RT). Many groups now use this guideline as an absolute indication for additional surgery. This article describes detailed multidisciplinary practices including extensive preoperative/intraoperative pathologic/histologic image-guided assessment of margins, offering some patients with small low/intermediate grade DCIS no RT, the use/magnitude of radiation boost tailoring to margin width, and endocrine therapy for ER-positive DCIS. Use of these protocols over the past 20-years has resulted in 10-year local recurrence rates below 5% for patients with negative margins < 2 mm who received RT. Patients with margins < 2 mm who do not receive RT experience significantly higher local failure rates. Thus, there is not an absolute need to achieve wider negative surgical margins when < 2 mm for patients treated with RT and this should be determined by the multidisciplinary team. Utilization of these multidisciplinary treatment protocols and techniques may not be exportable and extrapolated to all hospitals, breast programs and systems as they can be complex and resource intensive.

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“… 24 , 25 Studies have found that use of the DCIS score can alter adjuvant therapy recommendations in up to 30% of patients, demonstrating the utility of genomic testing in providing additional information beyond clinical and pathologic factors alone. 26 Current assays have not yet been examined in the setting of IORT, and the validity and utility of doing so remains unclear. The results of our experience, however, highlight the need to further optimize patient selection for IORT.…”

Section: Discussionmentioning

confidence: 99%

A Single-Institution Experience in the Preoperative Selection of DCIS Patients for IORT using the ASTRO Consensus Guidelines

Chin

Hirji

Onishi

et al. 2019

Advances in Radiation Oncology

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Purpose Intraoperative radiation therapy (IORT) as a form of accelerated partial breast irradiation (APBI) is controversial given the limited evidence to support its efficacy. However, it remains an attractive option for low-risk patients with ductal carcinoma in situ (DCIS), who derive a small absolute benefit in local control with standard whole breast irradiation (WBI). We examine how the American Society for Therapeutic Radiation Oncology (ASTRO) APBI consensus guidelines (CG) may be applied to the preoperative selection of patients with DCIS for IORT and determine treatment outcomes by CG group. Methods and Materials We identified patients with biopsy-proven pure DCIS enrolled in an institutional prospective registry IORT database using the Zeiss Intrabeam ® device between September 2013 and February 2017. Based on available preoperative clinicopathologic information, patients were deemed suitable, cautionary, or unsuitable for IORT according to the ASTRO CG. Change in CG group based on final pathologic diagnosis was determined, and additional therapy was recommended for unsuitable patients. Outcome in terms of ipsilateral breast tumor recurrence was determined. Results A total of 61 DCIS lesions in 60 patients were treated with IORT. Preoperatively, 21 patients (35%) were suitable and 36 (59%) were cautionary. Four (6%) were unsuitable because of lesion size but declined WBI. Final pathologic diagnosis changed the CG grouping of 10 patients (16%) because of either occult high-grade disease in 2 (3%) or close/positive margins in 8 (13%). Ultimately 12 patients total were considered unsuitable, of whom 8 (66%) accepted additional WBI after IORT. At a median follow-up of 2.2 years, ipsilateral breast tumor recurrence was identified among 2 suitable, 1 cautionary, and no unsuitable patients. Conclusion Further investigation is necessary to refine selection of patients with DCIS who may be optimally treated with IORT alone. High acceptance of additional therapy among unsuitable patients resulted in excellent outcomes. The use of biomarkers in addition to traditional clinical and pathologic factors may help to better select patients for IORT.

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Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ

Cited by 25 publications

References 25 publications

Ductal Carcinoma In Situ Biology, Biomarkers, and Diagnosis

Ductal Carcinoma In Situ Biology, Biomarkers, and Diagnosis

DCIS Margins and Breast Conservation: MD Anderson Cancer Center Multidisciplinary Practice Guidelines and Outcomes

A Single-Institution Experience in the Preoperative Selection of DCIS Patients for IORT using the ASTRO Consensus Guidelines

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