Use of the Twelve-Gene Recurrence Score for Ductal Carcinoma in Situ and Its Influence on Receipt of Adjuvant Radiation and Hormonal Therapy.

Abstract

Tumor genomic prognostic assays estimate 10-year local recurrence risk in ductal carcinoma in situ (DCIS) and can guide treatment decisions. This study aimed to evaluate which DCIS patients treated with breast-conserving surgery (BCS) underwent DCIS score genomic testing and the influence of the results on adjuvant treatment recommendations. The study identified patients from the National Cancer Database (NCDB) who had DCIS treated with BCS from 2010 to 2016. Of 141,047 patients, 4255 (3%) had a DCIS score assessed, 0.3% in 2010 increasing to 5.8% in 2016 (p < 0.001). The patients most likely to undergo DCIS score assessment had more favorable tumor features in the multivariable analysis. The DCIS score result was documented for 91.4% of the tested patients (n = 3888): 70.5% of the low-risk, 14.9% of the intermediate-risk, and 14.6% of the high-risk patients. The patients with low-risk scores were less likely to have radiation than those with intermediate- or high-risk scores among the patients with either ER + (35.0% vs 71.0% or 81.1%) or ER- disease (48.1% vs 77.0% or 85.5%) (each p ≤ 0.001). The patients who had ER + disease with high- and intermediate-risk scores were most commonly treated with both radiation and hormone therapy (HT) (57.1% and 52.2%), whereas the most common treatment for those with a low-risk DCIS score was HT alone without radiation (37.1%). Comparison of genomic testing with clinicopathologic features showed an independent influence of genomic testing on treatment. Use of the DCIS score increased over time, predominantly for favorable DCIS. Patients with a low-risk score were significantly less likely to receive radiation, supporting an impact of the DCIS score on treatment de-escalation.