Ductal Carcinoma In Situ (DCIS)
Ductal Carcinoma in situ (DCIS) is a heterogeneous group of neoplastic lesions confined to the breast ducts and lobules. It is one of the most commonly diagnosed breast conditions, accounting for approximately 25% of newly diagnosed breast cancers in the United States.1 Women diagnosed with DCIS are at risk for local recurrence, which may be either DCIS or progression to invasive breast carcinoma. The management of patients with DCIS is an area of controversy and historically treatment has included both surgical excision and radiation therapy.2 Following surgical excision alone local recurrences occur in approximately 25% to 30% of women by 10 years.3 The addition of radiation therapy has been reported to reduce recurrence risk by approximately 50% but has not been demonstrated to prolong overall or disease free-survival.3 Therefore treating all women with radiation therapy following surgical excision may represent overtreatment for many given that the majority of cases do not recur following surgery alone. Clinical and pathologic features do not reliably predict the risk of recurrence and therefore validated biomarkers are needed that identify patients at low risk of local recurrence for whom less treatment is indicated and conversely distinguishes patients at high risk of progression to invasive disease for whom more intensive treatment regimens are appropriate.
The Oncotype DX® Breast DCIS Score is the first clinically validated genomic assay to provide an individualized prediction of the 10-year risk of local recurrence in women with DCIS treated with breast-conserving surgery. The Breast DCIS Score result is an important advancement that provides previously unavailable insights into each patient’s individual tumor biology to help guide treatment decisions. The test is a multi-gene, quantitative reverse transcription polymerase chain reaction (RT-PCR) assay that measures the expression of 7 cancer-related and 5 reference genes from fixed paraffin-embedded breast cancer tissue. The resulting gene expression data is used to calculate a DCIS Score result.
- DCIS is one of the most commonly diagnosed breast conditions, accounting for approximately 20% of newly diagnosed breast cancers in the United States.
- The Oncotype DX Breast DCIS Score has been clinically validated in 2 independent studies in patients with ductal carcinoma in situ. The Breast DCIS Score result has been shown to be a strong predictor of the 10-year risk of local recurrence among women with DCIS treated with breast-conserving surgery alone (no radiation therapy).
- The Breast DCIS Score result has been reported to change treatment recommendations, and health economic studies indicate the assay to be cost-effective.
- The Oncotype DX Breast DCIS Score is the first clinically validated commercial genomic assay for women with DCIS. The assay reflects each patient’s individual tumor biology beyond clinical and pathologic factors and quantitates recurrence risk to help guide and tailor treatment.
Next: Development and Clinical Validation