What is a 21-gene assay?

The 21-gene expression assay (OncotypeDX; GenomicHealth Inc) provides a recurrence score, which is frequently used to estimate the 10-year distant recurrence risk and the likely advantages of adjuvant chemotherapy for patients with estrogen receptor (ER)– or progesterone receptor (PR)–positive, node-negative, tamoxifen …

What is 21-gene recurrence score?

The 21-gene recurrence score (RS) assay provides prognostic information for distant recurrence in hormone–receptor-positive, ERBB2-negative early breast cancer that is independent of clinicopathologic features,1 and is also predictive of chemotherapy benefit when the RS is high.

How is Oncotype score determined?

The Oncotype DX Breast DCIS Score Test analyzes the activity of 12 genes that can influence how likely the DCIS is to come back, either as another DCIS or as invasive breast cancer. The Oncotype DX Breast DCIS Score Test assigns a Recurrence Score — a number between 0 and 100 — to the DCIS.

Has anyone had recurrence with low Oncotype?

Previous studies of Oncotype indicated that early-stage breast cancer patients with low scores (0 to 10) had little to gain by taking chemotherapy; their prognosis was excellent regardless; the TAILORx investigators reported that only around 2% with low Oncotype scores would develop distant recurrences (metastases) …

What does an Oncotype score of 15 mean?

A score of 15 or smaller means you have a low risk of the cancer returning if you get hormone treatment. You probably will not benefit from receiving chemotherapy. A score between 16 and 20 means you have a low to medium risk of the cancer returning if you get hormone treatment.

What does an Oncotype score of 25 mean?

A score between 0 and 25 means you have a low risk of the cancer returning if you get hormone treatment. With this score you probably will not benefit from receiving chemotherapy. A score between 26 and 100 means you have a higher risk that the disease might come back.

What is a recurrence score?

The Recurrence Score is a continuous variable that provides an individualized estimate of 9-year distant recurrence risk and the likelihood of adjuvant chemotherapy benefit. The 21-gene Recurrence Score assay is extensively validated in clinical studies, which are well supported by real-world registry studies.

When to use the 21 gene recurrence score?

The 21-gene recurrence score (RS) assay is prognostic among women with early-stage estrogen receptor–positive (ER+) and human epidermal growth factor receptor 2–negative (HER2−) breast cancer and is used to inform recommendations for chemotherapy. Women ≤ 40 years of age represent a minority of patients studied using gene expression profiles.

Is the RS assay a prognostic tool for breast cancer?

The RS assay is prognostic among young women with node-negative and limited node-positive breast cancer, representing a valuable tool for risk stratification.

How is the recurrence score used in cancer treatment?

The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only).

How is the Oncotype DX breast recurrence score calculated?

Finally, the Recurrence Score® result is calculated from the gene expression results. The Oncotype DX assay analyses the expression of a panel of 21 genes from a tumour specimen using a technique called RT-PCR. A high-throughput, real-time RT-PCR method was developed to analyse the expression of select genes simultaneously.