Name of the Procedure:

Breast Oncology mRNA Gene Expression Profiling using Real-time RT-PCR of 21 Genes (Oncotype DX)

Summary

This procedure involves analyzing the activity of 21 specific genes in breast cancer tissue. The test uses a sample of the cancer preserved in formalin-fixed, paraffin-embedded (FFPE) tissue to predict the risk of cancer recurrence using a score generated by an algorithm.

Purpose

The procedure is designed to help determine the likelihood of breast cancer recurrence and guide treatment decisions. It helps assess whether a patient might benefit from chemotherapy, in addition to hormone therapy, based on the gene expression profile.

Indications

• Early-stage, estrogen receptor-positive (ER+), HER2-negative breast cancer.
• Patients who have had surgery to remove the tumor and are deciding on further treatment options.
• When there is a need to gauge the potential benefit of adding chemotherapy to the treatment plan.

Preparation

• No special preparation is needed from the patient as the test is done on tissue already collected during a biopsy or surgery.
• The patient's medical history and previous treatments will be reviewed.

Procedure Description

1. A pathology lab selects a representative block of FFPE tissue from the biopsy or surgical specimen.
2. RNA is extracted from this tissue.
3. The RNA is then converted into complementary DNA (cDNA) using reverse transcription.
4. Real-time RT-PCR is performed to measure the expression levels of 21 genes.
5. The expression levels are analyzed using a proprietary algorithm that calculates a recurrence score.

Duration

The entire analysis process from tissue selection to reporting the recurrence score usually takes about 1-2 weeks.

Setting

The analysis is performed in a specialized laboratory equipped to handle gene expression profiling.

Personnel

• Pathologists
• Medical laboratory technologists
• Molecular biologists
• Oncologists (for interpreting the results and forming a treatment plan)

Risks and Complications

• There are no risks to the patient from the analysis itself, as the procedure is conducted on previously collected tissue samples.
• Possible complications might include the low likelihood of inadequate or inconclusive results due to poor tissue quality or insufficient sample size, which may necessitate repeat biopsy.

Benefits

• Provides personalized information about the risk of cancer recurrence.
• Helps in making informed decisions about the need for chemotherapy.
• Can reduce unnecessary treatment and its associated side effects.

Recovery

• No recovery needed since the test is performed on tissue already obtained.
• Patients can resume normal activities immediately.

Alternatives

• Other gene expression profiling tests (e.g., MammaPrint, PAM50)
• Traditional pathological assessments and clinical criteria
• Pros: More comprehensive treatment assessment.
• Cons: May involve additional costs and time, with varying predictive capabilities.

Patient Experience

The patient will not undergo any discomfort or physical procedure for this test, as it is performed on previously collected tissue samples. The main experience involves waiting for the results, which can be discussed with their oncologist to determine the next steps in their treatment plan.