Atypical Ductal Hyperplasia and Those Bordering on Ductal Carcinoma In Situ Should Be Included in the Active Surveillance Clinical Trials

Abstract

Objectives Women with atypical ductal hyperplasia (ADH), unlike those with ductal carcinoma in situ (DCIS), are denied eligibility for active surveillance clinical trials. Methods We applied the inclusion criteria of the Comparison of Operative to Monitoring and Endocrine Therapy (COMET) trial to the cases of women (n = 165) at the Roswell Park Cancer Institute who had a diagnosis of ADH, ADH bordering on DCIS, or low- to intermediate-grade DCIS on core biopsy taken during screening mammography. Upgrade of lesions to high risk was based on invasive carcinoma, high-grade DCIS, or DCIS with comedo necrosis. Results In total, nine (5.5%) lesions were upgraded: two (1.7%) reported ADH, one (5.9%) reported ADH bordering on DCIS, and six (19.4%) reported DCIS (P = .002); and two (1.6%) reclassified ADH vs seven (17.1%) reclassified DCIS (P < .001). In multivariate analysis, only increased number of foci had the potential to predict high risk (odds ratio: 1.39; P = .06). Conclusions We conclude that ADH and ADH bordering on DCIS have lower upgrade rates than DCIS. We recommend opening an active surveillance clinical trial for women with these diagnoses.

Atypical Ductal Hyperplasia after Vacuum-Assisted Breast Biopsy: Can We Reduce the Upgrade to Breast Cancer to an Acceptable Rate?

“…Future studies involving multiple centers with different practices are needed to better describe the natural history of ADH and avoid unnecessary surgical interventions. A hypothetical trial specifically designed for ADH may randomize patients to surgical excision vs active surveillance or active surveillance combined with endocrine treatment (e.g., low dose tamoxifen), based on the results already achieved by other studies [ 40 , 41 ].…”

B3 lesion upgrade rates in a tertiary Australian breast centre: a 8‐year experience (2012–2019)

“…4,[21][22][23][24] Some studies suggest ADH may be overtreated by open surgical excisional biopsy, 4,[23][24][25] thus new approaches have been made based on surveillance, especially if all microcalcifications are removed using VAEB or if co-existing columnar cell lesion is present. 23,26,27 Management of ADH may have implications for DCIS, as ADH is regarded as a precursor lesion to DCIS. 5,[21][22][23] To date, there are several large prospective randomized controlled trials investigating active surveillance for low-risk DCIS compared to conventional surgery with or without adjuvant radiotherapy or hormonal therapy: LOw Risk DCIS study (LORD, Europe), The LOw RISk DCIS trial (LORIS, UK) and Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET, USA).…”

“…The upgrade rates for ADH are very variable, ranging between 7% and 45% 4,21–24 . Some studies suggest ADH may be overtreated by open surgical excisional biopsy, 4,23–25 thus new approaches have been made based on surveillance, especially if all microcalcifications are removed using VAEB or if co‐existing columnar cell lesion is present 23,26,27 . Management of ADH may have implications for DCIS, as ADH is regarded as a precursor lesion to DCIS 5,21–23 .…”

Atypical ductal hyperplasia on percutaneous breast biopsy: Scoring system to identify the lowest risk for upgrade

“…Separating ADH from low-risk DCIS can be controversial and arbitrary, fraught with interobserver variability and lacking biological validation. [25] Some accept Tavassoli's de nition of DCIS being >2mm [26], regardless of the number of involved ducts and others prefer Page's original proposal that DCIS must include at least two fully involved duct cross-sections. [27] In our patient population, when ADH upgraded to malignancy, the majority (n=10, 77%) met criteria for low-risk DCIS, acceptable for randomization in the above mentioned trials (grade I-II and hormone-receptor positive).…”