Oncotype DX Breast Recurrence Score

Interpreting the Results

Genomic Health makes understanding Oncotype DX Breast Recurrence Score test results as easy as possible. A detailed Breast Recurrence Score report is generated for each patient. The report contains the Recurrence Score result—a number between 0-100—that assesses the 10-year risk of distant recurrence1 in node-negative patients, 5-year distant recurrence or mortality in node-positive3 patients and the likelihood that chemotherapy will benefit your patient.2, 4

About the report

Most results are available on the physician portal within two weeks after tumor sample arrives in the Genomic Health laboratory. The report is generated according to your patient’s nodal status:

Each report includes:

  • The Recurrence Score result
  • 10-year risk of distant recurrence for node-negative; 5-year risk of recurrence or mortality for node-positive.
  • Likelihood of chemotherapy benefit.
  • Quantitative ER, PR, and HER2 scores by RT-PCR.

Understanding Recurrence Score results

The central piece of the report is the Recurrence Score result- a number between 0-100 – which provides insight into the tumor biology. The Recurrence Score result provides an estimated risk of distant recurrence (10-year for node-negative patients and 5-year risk of recurrence or mortality for node-positive patients)1, 3 and is also associated with the likelihood of chemotherapy benefit.2, 4 A low score means a lower rate of distant recurrence and a smaller benefit from chemotherapy. A high score means a higher rate of distant recurrence and a larger benefit from chemotherapy.

Recurrence Score results can be interpreted using the following:

  • Recurrence Score result less than 18: Your patient has a lower risk of having a recurrence, assuming 5 years of hormonal therapy is given. Chemotherapy is likely to have little or no benefit.
  • Recurrence Score result between 18 and 30: Your patient has a tumor that is in the middle of the risk spectrum reflecting that biology is continuous and not all patients have a low or a high recurrence risk, assuming 5 years of hormonal therapy is given. The likelihood of distant recurrence and benefit from chemotherapy increases with an increase in the Recurrence Score result.
  • Recurrence Score result greater than or equal to 31: Your patient has a high risk of distant recurrence, assuming 5 years of hormonal therapy and is likely to benefit from chemotherapy.

This individualized numeric score makes it easier for patients to understand their level of distant recurrence risk and potential benefit from chemotherapy. As a result, discussing treatment options with your patients can be easier and more efficient, with your patients feeling more confident about their treatment decisions.

The relevance of the ER score

The quantitative ER score by RT-PCR has been shown to be a strong predictor of tamoxifen benefit5 in node-negative patients. While the Recurrence Score result and corresponding average rate of distant recurrence accounts for this effect of tamoxifen (in addition to the tumor’s fundamental prognosis), the single-gene ER score may also help clarify the magnitude of tamoxifen benefit.

How your patient’s score is generated

The Breast Recurrence Score test is a genomic test—that measures the expression of cancer-related genes in your patient’s tumor. Your patient’s score is based on the expression of 21 specific genes from tumor tissue removed during the surgery or core biopsy. Looking at the expression of this unique set of genes the score provides important information about how likely your patient’s cancer is to return and the likelihood of benefit from chemotherapy. Learn more about how the test works.

Getting the results

More than 90% of Recurrence Score results are available within two weeks from the date the specimen is received in the Genomic Health lab. You can access the results through the online physician portal or receive the report by fax.

SAMPLE REPORTS

1

Report Title

2

Patient Identifying Information

3

Breast Recurrence Score Result

  • The patient’s individualized Breast Recurrence Score result from 0-100.
  • A summary of NSABP B-14, the Oncotype DX clinical validation trial used to determine prognosis in women with node-negative breast cancer.
4

Prognosis: 10-Year Risk of Distant Recurrence

  • The likelihood of distant recurrence at 10 years assuming 5 years of tamoxifen – expressed as the average 10-year distant recurrence rate for that result in the clinical trial population that corresponds to your patient’s Breast Recurrence Score result.
  • The likelihood of distant recurrence at 10 years increases with an increase in Breast Recurrence Score result.
1

Breast Recurrence Score Result

  • The patient’s individualized Breast Recurrence Score result from 0-100.
  • A summary of NSABP B-20, the Oncotype DX clinical validation trial used to determine prediction of chemotherapy benefit in women with node-negative breast cancer.
2

Prediction of Chemotherapy Benefit

  • The Breast Recurrence Score result is associated with the magnitude of chemotherapy benefit for the NSABP B-20 clinical trial population. The likelihood of chemotherapy benefit increases with an increase in Breast Recurrence Score result.
  • Top graph: prediction of chemotherapy benefit associated with the individual Breast Recurrence Score result is shown as the difference between the rate of distant recurrence for tamoxifen (Tam) compared to tamoxifen + chemotherapy (Tam + Chemo).
  • The bottom graph: the absolute benefit of chemotherapy at 10 years by Breast Recurrence Score risk group. The mean benefit for each group is shown as +/- standard error.
1

Single-Gene Scores

  • Quantitative ER, PR, and HER2 scores by RT-PCR. ER, PR and HER2 are among the 21 genes whose expression is analyzed to generate the Breast Recurrence Score result.
  • ER score has been shown to be a strong predictor of tamoxifen benefit* in node-negative patients. While the Breast Recurrence Score result and corresponding average rate of distant recurrence already reflect this effect of tamoxifen (in addition to the tumor’s fundamental prognosis), the single-gene ER score may help clarify the magnitude of tamoxifen benefit.
1

Report Title

2

Patient Identifying Information

3

Breast Recurrence Score Result

  • The patient’s individualized Breast Recurrence Score result from 0-100.
  • A summary of SWOG 8814, the clinical validation trial used to determine the association of the Breast Recurrence Score result with prognosis and chemotherapy benefit in women with node-positive (1-3 N+) breast cancer.
4

Prognosis and Chemotherapy Benefit: 5-Year Risk of Recurrence or Mortality

  • Shows the relationship of the Breast Recurrence Score result to the likelihood of recurrence or mortality at 5 years, plus chemotherapy benefit for the SWOG 8814 clinical trial population.
  • Study patients were randomized to either tamoxifen (Tam) alone or CAF chemotherapy followed by Tam (CAF-T).
  • For individual Breast Recurrence Score results between 0 and 50, the difference between the rates of recurrence or mortality for tamoxifen (Tam) compared to tamoxifen + chemotherapy (Tam + Chemo) is shown.
1

Single-Gene Scores

Quantitative ER, PR, and HER2 scores by RT-PCR. ER, PR and HER2 are among the 21 genes whose expression is analyzed to generate the Breast Recurrence Score result.

1

Report Title

2

Patient Identifying Information

3

Breast Recurrence Score Result

  • The patient’s individualized Breast Recurrence Score result from 0-100.
  • A summary of SWOG 8814, the clinical validation trial used to determine the association of the Breast Recurrence Score result with prognosis and chemotherapy benefit in women with 4 or more node-positive (> 4 N+) breast cancer.
4

Prognosis and Chemotherapy Benefit: 5-Year Risk of Recurrence or Mortality

  • Shows the relationship of the Breast Recurrence Score result to the likelihood of recurrence or mortality at 5 years, plus chemotherapy benefit for the SWOG 8814 clinical trial population randomized to either tamoxifen (Tam) alone or CAF chemotherapy followed by Tam (CAF-T).
  • For individual Breast Recurrence Score results between 0 and 50, the difference between the rate of recurrence or mortality for tamoxifen (Tam) compared to tamoxifen+ chemotherapy (Tam + Chemo).
1

Single-Gene Scores

Quantitative ER, PR, and HER2 scores by RT-PCR. ER, PR and HER2 are among the 21 genes whose expression is analyzed to generate the Breast Recurrence Score result.


REFERENCES

1. Paik et al. N Engl J Med. 2004.
2. Paik et al. J Clin Oncol. 2006.
3. Dowsett et al. J Clin Oncol. 2010.
4. Albain et al. Lancet Oncol. 2010.
5. Kim et al. J Clin Oncol. 2010.

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