Table 3 Consensus panel recommendations on ERBB2 scoring for colorectal cancer (HERACLES Diagnostic Criteria)
From: Assessment of a HER2 scoring system for colorectal cancer: results from a validation study
Immunohistochemistry staining a at local pathology | Immunohistochemistry expected pattern | Immunohistochemistry classification | Referral to central pathology | Eligibility to HERACLES trial |
|---|---|---|---|---|
No staining (0) | — | Negative | No | Not eligible |
Faint staining (1+) any cellularity | Segmental or granular | Negative | No | Not eligible |
Moderate (2+) in <50% cells | Any | Negative | No | Not eligible |
Moderate (2+) in ≥50% of cells | Circumferential, basolateral or lateral | Equivocal | Mandatory: re-test immunohistochemistry. | |
If >50% cellularity confirmed, proceed with in situ hybridization | If amplifiedb, eligible | |||
Intense (3+) in ≤10% cells | Circumferential, basolateral or lateral | Negative | No | Not eligible |
Intense (3+) in >10% <50% of cells | Circumferential, basolateral or lateral | Positive | Mandatory: re-test immunohistochemistry. | |
If >10% cellularity confirmed, proceed with in situ hybridization | If amplifiedb, eligible | |||
Intense (3+) in ≥50% of cells | Circumferential, basolateral or lateral | Positive | Confirmatory immunohistochemistry re-test. | |
In situ hybridization not mandatory but recommended for research purposes | Eligible |
