Patient Selection for Ductal Carcinoma In Situ Observation Trials: Are the Lesions Truly Low Risk?

OBJECTIVE: The purpose of this article is to report on a study conducted to determine whether the lesions in patients with what is deemed to be low-risk ductal carcinoma in situ (DCIS) selected for two large clinical trials are in fact low-risk lesions. CONCLUSION: A retrospective review was conducted to determine whether the eligibility criteria of the two trials are predictive that DCIS is low risk. More than 20% of lesions are upgraded to invasive carcinoma in patients with low-risk DCIS as defined in two large clinical trials. More accurate methods are needed to determine whether patients with a diagnosis of low-grade DCIS can be treated less aggressively.