- Two Stage Groups
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- Anatomic – based solely on TNM and should only be used when grade, ER/PR and HER2 are not available. The Anatomic Stage Group should only be used in regions of the world where tumor grading and/or biomarker testing for HER2, ER and PR are not routinely available.
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- Prognostic – utilizes both anatomic (TNM) and biomarker information (grade, ER/PR, HER2, multigene panels). The Prognostic Stage Group tables should be used as the primary staging system in countries where these biomarker tests are routinely performed for patient care. Cancer Registries in the U.S. must use the Prognostic Stage Group tables for case reporting. If biomarkers are not available, the cancer should be reported as unstaged.
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- Clinical Prognostics:
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- Uses clinical tumor (T), node (N) and metastases (M) information based on history, PE findings, any imaging performed (not necessary for clinical staging), relevant biopsy results and biomarker information.
- For cases with lymph node involvement with no evidence of primary tumor (e.g. T0 N1, etc.) or with breast ductal carcinoma in situ (e.g. Tis N1, etc.), the grade, HER2, ER, and PR information from the tumor in the lymph node should be used for assigning stage groups.
- For cases where HER2 is determined to be “equivocal” by ISH (FISH or CISH) testing under the 2013 ASCO/CAP HER2 testing guidelines, the HER2 “negative” category should be used for staging in the Clinical Prognostic Stage Group table.
- With addition of biomarker information the clinical prognostic stage ranges from 1B to 2B for:
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- T0N1M0
- T1N1M0
- T2N0M0
- Previously all would have been classified as a Stage 2A by anatomic staging.
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- Pathological Prognostics:
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- Only applies to patients who have undergone definitive surgical resection as their initial treatment.
- Includes all information used for clinical staging plus findings at surgery and pathological findings from surgical resection.
- Does not apply to patients treated with systemic or radiation prior to surgical resection (neoadjuvant therapy).
- With addition of biomarker information the pathological prognostic stage ranges from 1B to 3C for:
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- T0N2M0
- T1N2M0
- T2N2M0
- T3N1M0
- T3N2M0
- Previously all would have been classified as a Stage 3A by anatomic staging.
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- Includes biomarker information with grade, ER/PR and HER2.
- Includes Multigene Panels/Genomic Profile Assays – AJCC 8th edition only includes Oncotype Dx when applicable.
- LCIS is considered to be benign and removed from Tis. (LCIS will still be reportable disease).
- Clarifications throughout have been updated.