Do Eligibility Criteria for Ductal Carcinoma In Situ (DCIS) Active Surveillance Trials Identify Patients at Low Risk for Upgrade to Invasive Carcinoma?

BACKGROUND: Clinical trials are currently ongoing to determine the safety and efficacy of active surveillance (AS) versus usual care (surgical and radiation treatment) for women with ductal carcinoma in situ (DCIS). This study aimed to determine upgrade rates of DCIS at needle biopsy to invasive carcinoma at surgery among women who meet the eligibility criteria for AS trials. METHODS: A retrospective review was performed of consecutive women at an academic medical center with a diagnosis of DCIS at needle biopsy from 2007 to 2016. Medical records were reviewed for mode of presentation, imaging findings, biopsy pathology results, and surgical outcomes. Each patient with DCIS was evaluated for AS trial eligibility based on published criteria for the COMET, LORD, and LORIS trials. RESULTS: During a 10-year period, DCIS was diagnosed in 858 women (mean age 58 years; range 28-89 years). Of the 858 women, 498 (58%) were eligible for the COMET trial, 101 (11.8%) for the LORD trial, and 343 (40%) for the LORIS trial. The rates of upgrade to invasive carcinoma were 12% (60/498) for the COMET trial, 5% (5/101) for the LORD trial, and 11.1% (38/343) for the LORIS trial. The invasive carcinomas ranged from 0.2 to 20 mm, and all were node-negative. CONCLUSIONS: Women who meet the eligibility criteria for DCIS AS trials remain at risk for occult invasive carcinoma at presentation, with upgrade rates ranging from 5 to 12%. These findings suggest that more precise criteria are needed to ensure that women with invasive carcinoma are excluded from AS trials.