Estrogen Receptor and Progesterone Receptor
- ER and PR Percent Positive or Range is percent of cells staining ER and PR positive by IHC
- ER and PR Total Allred Score is based on the percentage of cells that stain positive by IHC for estrogen receptor (ER) and progesterone receptor (PR) and the intensity of that staining
The clinician’s statement takes priority; however, if the physician does not state what the Allred score is and both components of the Allred score (intensity score) are available, then the registrar can calculate it.
*The registrar should not calculate the intensity score unless both components are available (proportion score and intensity)
For more information about Allred Score, click here.
Examples of calculating ER/PR Total Allred Score
HER2
- HER2 IHC Summary is the summary score for HER2 testing by IHC
- HER2 ISH Summary is the summary score for results of testing for ERBB2 gene copy number by any ISH method.
- HER2 ISH Single Probe Copy Number is HER2 copy number based on a single probe test
- Single probe test will report average number or mean signals per cell for HER2. Record the HER2 average number or mean signals per cell in this data item. The average number or mean signals per cell also called the copy number
- Registrars are not to calculate the copy number
- HER2 ISH Dual Probe Copy Number is HER2 copy number based on a dual probe test
- Dual probe test will report average number or mean signals per cell for both HER2 and CEP17, the latter used as a control. Record the HER2 average number or mean signals per cell in this data item. The average number or mean signals per cell is also called the copy number
- Registrars are not to calculate the copy number
- HER2 ISH Dual Probe Ratio is the summary score for HER2 testing using a dual probe. The test will report results for both HER2 and CEP17 (CEN17), The latter used as a control.
- The Single Probe and Dual Probe tests are two different tests. If only a Single Probe test is done, then the Dual Probe test cannot be coded. The Dual Probe test is based on CEP-17 or CEN-17.
For more information about Single/Dual Probes click here.
Examples of ISH Single Probe (SP) and Dual Probe (DP) Copy Number
HER2/CEP-17 ratio: 1.36
Number of tumor cells analyzed: 20
Average number of HER2/neu copies per cell: 2.8
Average number of CEP17 copies per cell: 2.05
HER2 ISH SP Copy Number = XX.9
HER2 ISH DP Copy Number = 2.8
HER2 ISH DP Ratio = 1.3
HER2 FISH: Negative. Interpretation:
Average HER2 signals/nucleus: 2.7
Average CEN-17 signals/nucleus: 2.5
HER2/CEN17 signal ratio: 1.1
Number of Observers:1
HER2 ISH SP Copy Number = XX.9
HER2 ISH DP Copy Number = 2.7
HER2 ISH Dual Probe Ratio = 1.1
HER2(ERBB2) gene is NOT AMPLIFIED by FISH:
Ratio of HER2(ERBB2): centromere 17 signals – 1.7
Mean Number of HER2(ERBB2) signals per cell = 3.1
Mean Number of 17 centromere signals per cell = 1.9
HER2 ISH SP Copy Number = XX.9
HER2 ISH DP Copy Number = 3.1
HER2 ISH DP Ratio = 1.7
HER2(SISH): Positive. Interpretation:
Number of tumor cell nuclei counted: 60
Number of HER2 gene copies: 418
Mean HER2 gene copy number: 6.9
HER2 ISH SP Copy Number = 6.9
HER2 ISH DP Copy Number = XX.9
HER2 ISH DP Ratio = XX.9
Multigene Signature Method and Results
- Multigene testing is usually done for node-negative female breast cancer patients to predict risk of recurrence within a specified time period or predict the likelihood that the patient will respond to specific types of chemotherapy. Some examples are:
- Mammaprint
- PAM50 (Prosigna)
- Breast Cancer Index
- EndoPredict
- In Collaborative Stage Oncotype was included in these two data items. This is no longer included with this data item. ONCOTYPE DX is coded elsewhere
Oncotype Dx Tests
- Oncotype Dx Recurrence Score – DCIS is genomic test that estimates the likelihood of local recurrence (DCIS or invasive) for a patient with DCIS. The results may be used clinically to evaluate benefits of radiation therapy following surgery
- Oncotype Dx Risk Level – DCIS stratifies Oncotype Dx recurrence score in low, intermediate, and high risk of local recurrence
- Oncotype Dx Recurrence Score – Invasive is a numeric score of a genomic test to predict the likelihood of distant recurrence of invasive breast cancer based on assessment of 21 genes
- Oncotype Dx Risk Level – Invasive stratifies Oncotype Dx recurrence score in low, intermediate, and high risk of distant recurrence
Ki-67 (MIB-1)
- is a marker of cell proliferation
- Examples:
- Ki-67 reported as 14% = code 14.0
- Ki-67 reported as 8.6% = code 8.6