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Ductal Carcinoma In Situ Active Monitoring Trials: Do Eligibility Criteria Identify Patients at Low Risk for Upgrade
Dana K Ataya1, K Ruwani M Fernando2, Jasmine Brainerd3
1Division of Breast Imaging. Department of Diagnostic Imaging and Interventional Radiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Background:
Ongoing active monitoring (AM) trials for women with ductal carcinoma in situ (DCIS) are investigating the safety and efficacy of monitoring DCIS lesions vs the current standard of care (surgical treatment). The frequency of upgrade in women undergoing AM for DCIS remains unknown.
Objective:
To evaluate the frequency of upgrade of DCIS at core-needle biopsy to invasive carcinoma at surgical excision among women who meet eligibility criteria for AM trials.
Methods:
A retrospective review between 2010 and 2023 was performed of women at an National Cancer Institute-designated comprehensive cancer center with a diagnosis of DCIS at core-needle biopsy who underwent subsequent surgical excision. Medical records were reviewed for clinical presentation, imaging findings, core biopsy, and final surgical pathology. Each patient was evaluated for AM trial eligibility based on published criteria for the LORD, LORIS, and COMET trials. Fisher's exact test compared proportions, with a P-value <.05 considered statistically significant.
Results:
Of 264 women, 10/264 (3.8%) were eligible for the LORD trial, 24/264 (9.1%) for the LORIS trial, and 64/264 (24.2%) for the COMET trial. Invasive carcinoma was found at surgical excision in 1/10 (10%) patients eligible for the LORD trial, 2/24 (8.3%) for the LORIS trial, and 9/64 (14.1%) for the COMET trial. All occult invasive carcinomas detected at surgical excision in trial-eligible patients were node-negative, with a median size of invasive cancer measuring 3.5 mm (interquartile range, 1-7 mm).
Conclusion:
A subset of women who meet eligibility criteria for DCIS AM trials are at risk for occult invasive carcinoma, with frequency of upgrade ranging from 8% to 14%.
Clinical Impact:
More precise criteria and predictive biomarkers are needed to better stratify DCIS lesions and exclude women harboring invasive carcinomas from AM regimens.
