Significance of Removing Comedonecrosis as an Exclusion Criterion in Mammary Low-Risk Ductal Carcinoma In Situ Managed in an Active Surveillance Clinical Trial.

Objectives This study aims to investigate the consequences of comedonecrosis omission as an exclusion criterion of the Comparison of Operative vs Monitoring and Endocrine Therapy (COMET) trial. Methods The clinical inclusion criteria of the COMET trial were applied on women who were mammographically screened between 2007 and 2017 and had a diagnosis of low- or intermediate-grade ductal carcinoma in situ (DCIS). The percentage of ductal diameter occupied by necrosis was calculated. Results Twenty-six of 129 (20.2%) cases were upgraded. Larger calcification span correlated with upgrade (P = .02), with the best cutoff of 1.1 cm, and negative predictive value of 86%. When solely analyzing cases with no comedonecrosis (n = 76), none of the variables correlated with upgrade. Comedonecrosis was significantly correlated with upgrade to invasive carcinoma (P = .041), with the best cutoff of 53% of ductal diameter occupied by necrosis. Conclusions Results indicate that comedonecrosis and span of mammographic calcifications could be risk factors in women managed with active surveillance.