Breast Synoptic Work Aid

Specimen Laterality:
Right
Left
Not specified

Specimen:
Partial breast
Total breast
Other:

Procedure:
Excision without wire-guided loc
Excision with wire-guided loc
Total mastectomy
Other:

Specimen Integrity:
Single intact specimen
Multiple designated specimens
Fragmented
Other:

Lymph node sampling:
No lymph nodes
Sentinel lymph node(s)
Axillary dissection
Lymph node(s) present within breast
Other:

Specimen size (cm):

Histologic Type:
Ductal
Lobular
Only microinvasion present
Mixed ductal and lobular
Other:

Histologic Grade (SBR/Nottingham):
1 (3-5 points)
2 (6-7 points)
3 (8-9 points)

  Glandular/Tubular Differentiation:
1 (>75% tubules)
2 (10 to 75% tubules)
3 (<10% tubules)

  Nuclear Pleomorphism:
1
2
3

  Mitotic Count:
1
2
3

Invasive carcinoma size (cm):

Tumor focality:
Single
Multiple foci ()
Indeterminate

Size of largest focus:

Extent of tumor:
   Skin not present
   Skin invasion w/o ulceration
   Skin ulceration
   Skin Satellite nodules
   No skin invasion
   No skeletal muscle present
   Skeletal muscle present, no invasion
   Pectoralis muscle invasion
   Chest wall beyond pectoralis invasion
   Nipple Paget disease
   DCIS does not involve nipple epidermis
   In Situ Component:
       None Present
       LCIS
       DCIS
       Mixed DCIS and LCIS:
        DCIS, EIC positive
        DCIS, EIC negative

Lymphovascular invasion at tumor periphery:
Present
Absent

Margins:
   Invasive Carcinoma:
       Margins cannot be assessed
       Margins uninvolved by invasive carcinoma
       Distance from closest margin (mm): at
       Margins involved by invasive carcinoma:
           Superior
           Medial
           Anterior
           Inferior
           Lateral
           Posterior
   DCIS:
       Margins uninvolved by DCIS Distance from closest margin (mm): at
       Margins involved by DCIS:
           Superior
           Medial
           Anterior
           Inferior
           Lateral
           Posterior

Lymph nodes:
       SLNs Examined:
       LNs w/ Micromets
       Total LNs examined
       LNs w/ ITCs
       LNs w/ Macromets
       Size of largest metastatic deposit (mm):

Pathologic Staging:
m: multipler: recurrenty: post txpTX: Primary tumor cannot be assessed pT0: No evidence of primary tumor pTis (DCIS): Ductal carcinoma in situ pTis (LCIS): Lobular carcinoma in situ pTis (Paget): Paget disease of the nipple not associated with invasive carcinoma and/or carcinoma in situ (DCIS and/or LCIS) in the underlying breast parenchyma pT1: Tumor ≤20 mm in greatest dimension pT1mi: Tumor ≤1 mm in greatest dimension (microinvasion) pT1a: Tumor >1 mm but ≤5 mm in greatest dimension pT1b: Tumor >5 mm but ≤10 mm in greatest dimension pT1c: Tumor >10 mm but ≤20 mm in greatest dimension pT2: Tumor >20 mm but ≤50 mm in greatest dimension pT3: Tumor >50 mm in greatest dimension pT4: Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules). Note: Invasion of the dermis alone does not qualify as pT4. pT4a: Extension to chest wall, not including only pectoralis muscle adherence/invasion pT4b: Ulceration and/or ipsilateral satellite nodules and/or edema (including peau d’orange) of the skin which do not meet the criteria for inflammatory carcinoma pT4c: Both T4a and T4b pT4d: Inflammatory carcinomapNX: Regional lymph nodes cannot be assessed (eg, previously removed, or not removed for pathologic study) pN0: No regional lymph node metastasis identified histologically pN0 (i-): No regional lymph node metastases histologically, negative IHC pN0 (i+): Malignant cells in regional lymph node(s) no greater than 0.2 mm and no more than 200 cells (detected by H&E or IHC including ITC) pN0 (mol-): No regional lymph node metastases histologically, negative molecular findings (reverse transcriptase polymerase chain reaction (RT-PCR)) pN0 (mol+): Positive molecular findings (RT-PCR), but no regional lymph node metastases detected by histology or IHC pN1mi: Micrometastases (greater than 0.2 mm and/or more than 200 cells, but none greater than 2.0 mm). pN1a: Metastases in 1 to 3 axillary lymph nodes, at least 1 metastasis greater than 2.0 mm pN2a: Metastases in 4 to 9 axillary lymph nodes (at least 1 tumor deposit greater than 2.0 mm) pN3a: Metastases in 10 or more axillary lymph nodes (at least 1 tumor deposit greater than 2.0 mm)cM0(i+): No clinical or radiographic evidence of distant metastasis, but deposits of molecularly or microscopically detected tumor cells in circulating blood, bone marrow, or other nonregional nodal tissue that are ≤0.2 mm in a patient without symptoms or signs of metastasis pM1: Distant detectable metastasis as determined by classic clinical and radiographic means and/or histologically proven >0.2 mm


Ancillary Studies (please refer to USS-- for details):

ESTROGEN RECEPTOR (ER):
       Interpretation:
        POSITIVE
        NEGATIVE
        OTHER:
       Not performed
       Pending
       Percentage of cells with nuclear immunoreactivity: %
       Intensity of staining:
        Absent
        Weak
        Medium
        Strong
       Antibody clone: (ER2-123 AND 1D5 COCKTAIL)

PROGESTERONE RECEPTOR (PR):
       Interpretation:
        POSITIVE
        NEGATIVE
        OTHER:
       Not performed
       Pending
       Percentage of cells with nuclear immunoreactivity: %
       Intensity of staining:
        Absent
        Weak
        Medium
        Strong
       Antibody clone: (PGR 1294)

HER-2/NEU IHC (HercepTest):
       Interpretation:
        NEGATIVE (Score )
        EQUIVOCAL (Score )
        POSITIVE (Score )
        OTHER:
       Not performed
       Pending
       Antibody clone: Her-2/neu

Reference range for Her-2/neu IHC:
Positive: ≥ 3
Equivocal: 1.8-2.9
Negative: <1.8

HER-2/NEU FISH:
       Interpretation:
        NOT AMPLIFIED
        EQUIVOCAL
        AMPLIFIED:
               Average number of HER2 gene copies per cell:
               Average number of chromosome 17 per cell:
               Amplification Ratio:
        OTHER:
       Not performed
       Pending
       Name of assay: Abbott Pathvysion

Reference range for Her-2/neu FISH:
Positive for amplification: >2.2
Equivocal for amplification: 1.8-2.2
Negative for amplification: <1.8

Comments:


Comment for triple negative breast cancer: The Her2/neu value is determined to be . This value indicates no significant expression of the Her2/neu protein. Molecular analysis for Her-2/neu gene amplification will be performed by fluorescence in situ hybridization (FISH). Results will be reported as an addendum.
Comment for equivocal Her-2/neu IHC: The Her2/neu value is determined to be . This value may not correlate with increased copy number of the Her2/neu protein. Molecular analysis for Her-2/neu gene amplification will be performed by fluorescence in situ hybridization (FISH). Results will be reported as an addendum.
ER/PR and/or Her-2/neu IHC: COMMENT: Examination of microscopic sections from the referred block confirms the presence of carcinoma in the regions evaluated. Testing was performed on a corresponding level using the FDA approved immunohistochemical assay(s) and the reactivity quantitated by image analysis.
TEST DESCRIPTION: Sample(s) were fixed in for no less than six hours and not exceeding 48 hours prior to processing. Testing was performed on the carcinoma using the DAKO ER/PR PharmDx kit FDA approved immunohistochemical assay(s). The reactivity was analyzed by image analysis. Appropriate positive and negative external and internal controls were acceptable. The performance characteristics were validated by the University of Florida Pathology Laboratories.
Reference range for ER/PR IHC:
Positive: Equal to or greater than 1%
Negative: Less than 1%
Reference range for Her-2/neu IHC:
Positive: equal to or greater than 3
Equivocal: 1.8 to 2.9
Negative: less than 1.8
Her-2/neu FISH: COMMENT: Examination of microscopic sections from the referred block confirms the presence of carcinoma in the regions evaluated. FISH analysis was performed on a corresponding level. The result is expressed as the ratio of Her-2/neu gene copies/chromosome 17. Clinical correlation of these results in conjunction with Her-2/neu immunohistochemical studies, and clinical findings may be of value in determining further therapy.
TEST DESCRIPTION: Fluorescence in situ hybridization (FISH) for the detection of the Her-2/neu gene amplification in paraffin embedded tissue was performed using the Abbott Pathvysion FDA approved assay. FISH analysis was performed on the carcinoma. Using fluorescent microscopy, enumeration was performed on the Her-2/neu gene, located at locus (17p11.2-q12) on chromosome 17, and the alpha satellite DNA sequence, located at the centromeric region of chromosome 17 (17p11.1-q11.1). Gene amplification is based on the ratio of Her-2/neu to chromosome 17 in the tumor tissue. External positive controls were acceptable. FISH Probes: Orange LSI HER-2/neu; Green Chromosome 17: CEP 17. The performance characteristics were validated by the University of Florida Pathology Laboratories.
Reference range:
Positive for amplification: HER2 gene copy greater than 6 or ratio greater than 2.2
Equivocal for amplification: HER2 gene copy 4 to 6 or ratio 1.8 to 2.2
Negative for amplification: HER2 gene copy less than 4 or ratio less than 1.8


REFERENCE(S):
       Hammond, E.H.; et al. ASCO/CAP Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer (unabridged Version). Arch Pathol Lab Med. 2010. 134: e48-e72
       Wolff AC, Hammond ME, Schwartz JN et. al.; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43.
       Hofmann M, Stoss O, Shi D, et al. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008 Jun;52(7):797-805. Epub 2008 Apr 18.
       Path Vysion her-2/neu DNA probe kit (package insert). Downers Grove, III; Vysis, Inc; 2003.