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Person with cancer—human epidermal growth factor receptor-2 test result, code N

Identifying and definitional attributes

Metadata item type:Help on this termData Element
Short name:Help on this termHuman epidermal growth factor receptor-2 test result
Synonymous names:Help on this termHER2 test result
METeOR identifier:Help on this term370572
Registration status:Help on this termHealth, Standard 06/03/2009
Definition:Help on this termThe result of a person's human epidermal growth factor receptor-2 (HER2) test, as represented by a code.
Data Element Concept:Person with cancer—human epidermal growth factor receptor-2 test result

Value domain attributes

Representational attributes

Representation class:Help on this termCode
Data type:Help on this termNumber
Format:Help on this termN
Maximum character length:Help on this term1
Permissible values:Help on this term
ValueMeaning
1Positive
2Negative
3Equivocal
Supplementary values:Help on this term
7Unknown (test results not available)
8Not applicable (test not done)

Collection and usage attributes

Guide for use:Help on this term

Record the reported conclusion of the HER2.

If no conclusion is reported use the following guidelines (from the National Breast and Ovarian Cancer Centre and Australian Cancer Network’s pathology reporting guide (3rd ed.) for breast cancer):

CODE 1    Positive

  • For in situ hybridisation:
    Result is more than 6 copies of the HER2 gene per nucleus OR a ratio of HER2 gene signals to chromosome 17 signals of more than 2.2.
  • For Immunochemistry:
    Result is described as 3+ or +++ OR >30% of cancer cells show strong complete membrane staining without cytoplasmic staining and without staining of normal tissue.

CODE 2    Negative

  • For in situ hybridisation:
    Result is less than 4 copies of the HER2 gene per nucleus OR a ratio of HER2 gene signals to chromosome 17 signals of less than 1.8.
  • For Immunochemistry:
    Result described as 0, 1+ or + OR <10% of cancer cells show staining.

CODE 3     Equivocal

  • For in situ hybridisation:
    Result is an average of between 4 and 6 HER2 gene copies per nucleus with a single probe OR a ratio of HER2 gene signals to chromosome 17 signals in the range of 1.8-2.2.
  • For Immunochemistry:
    Result described as 2+ or ++ OR <10% of cancer cells show strong complete membrane staining (rare) OR 10-30% of cancer cells show weak to moderate complete membrane staining OR Strong cytoplasmic staining is present, making assessment of membrane staining difficult.

Supplementary codes

CODE 7     Unknown (test results not available)

Use this code when the test has been performed but the results are not yet available for analysis.

CODE 8   Not applicable (test not done)

This code is used as a validation measure, to show that the reason for the lack of results is due to the test not being performed.

Data element attributes

Collection and usage attributes

Collection methods:Help on this term

For cancer registries, collection of this data item should only be from notification and pathology reports relating to initial diagnosis and not for recurrent or subsequent metastatic disease.

Where different values are available from multiple specimens, the appropriate values to enter are selected according to the following hierarchy of rules:

When multiple HER2 values are available, the value established by the most accurate test is used as per the hierarchy: FISH > CISH/SISH > IHC. (See Person with cancer—HER2 test type, code N) If the HER2 values differ on multiple pathology reports for the same tumour, use the value from the larger specimen.

For multifocal tumours, use the HER2 value from the largest focus or from a metastatic deposit; e.g. Lymph node metastasis. A smaller focus that is HER2 positive may in fact be the source of a metastasis and in this setting the patient would derive benefit from the therapy offered as a result of HER2 positive status.

Comments:Help on this termHuman epidermal growth factor receptor-2 (HER2) promotes the growth of cancer cells. HER2 is also known as c-erB-2 and Her2/neu. Tumours that are HER2-positive tend to grow more quickly than other types of cancer. HER2 status is an important prognostic marker and predicts the response to several therapies.

Source and reference attributes

Origin:Help on this term

National Breast and Ovarian Cancer Centre (NBOCC)

Australasian Association of Cancer Registries (AACR)

Australian Institute of Health and Welfare (AIHW)

Reference documents:Help on this termNational Breast and Ovarian Cancer Centre and Australian Cancer Network. The Pathology reporting of breast cancer. A guide for pathologists, surgeons, radiologists and oncologists (3rd edition). National Breast and Ovarian Cancer Centre, Surry Hills, NSW, 2008.

Relational attributes

Implementation in Data Set Specifications:Help on this term

Breast cancer (Cancer registries) DSS Health, Superseded 01/09/2012

Breast cancer (cancer registries) NBPDS Health, Standard 01/09/2012

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