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Margin status Radiotherapy use Clinical interpretation ≥ 2 mm Yes Optimal balance between local control and cosmetic outcome > 2 mm Yes No evidence that wider margins further reduce recurrence risk < 2 mm Yes Re-excision may be considered based on extent of disease, imaging findings, and surgical feasibility Any margin No Higher risk of ipsilateral breast events; careful patient selection required - Table 2
Key clinical trials evaluating active surveillance and biological risk stratification in DCIS
Study/Trial Population Management strategy Key findings COMET Low-risk, hormone receptor-positive DCIS Active surveillance vs. guideline-concordant standard therapy Non-inferior short-term invasive cancer rates; quality-of-life advantages under evaluation LORIS Screen-detected low- or intermediate-grade DCIS Surgery vs. active surveillance Approximately 20% upgrade to invasive carcinoma at surgical excision LORD Low-grade (grade I–II) DCIS Active surveillance Feasibility demonstrated; long-term oncologic safety pending ECOG-ACRIN E5194/Ontario cohort Selected DCIS treated with excision alone Genomic risk stratification DCIS score™ predicts both invasive and in situ recurrence Risk category Defining features Recommended management approach Low risk Low- to intermediate-grade DCIS, small lesion size, favorable biology, low DCIS score™ Breast-conserving surgery ± endocrine therapy; consideration of treatment de-escalation within clinical trials Intermediate risk Discordant clinicopathologic features, intermediate DCIS score™, close but negative margins Breast-conserving surgery with radiotherapy and/or endocrine therapy; individualized decision-making High risk High-grade disease, comedo necrosis, extensive disease, high DCIS score™, or suspicion of invasion Surgery with radiotherapy ± endocrine therapy; sentinel lymph node biopsy when mastectomy is planned or when invasion can not be excluded







