Surgical Pathology Cancer Case Summary (Checklist)

Specimen

____ Partial breast

____ Total breast (including nipple and skin)

____ Other (specify): ______________________________

____ Not specified

Procedure

____ Excision without wire-guided localization

____ Excision with wire-guided localization

____ Total mastectomy (including nipple and skin)

____ Other (specify): ______________________________

____ Not specified

Lymph Node Sampling (select all that apply) (required only if lymph nodes are present in specimen)

____ No lymph nodes present

____ Sentinel lymph node(s)

____ Axillary dissection (partial or complete dissection)

____ Lymph nodes present within breast specimen (i.e., intramammary lymph nodes)

____ Other lymph nodes (e.g., supraclavicular or location not identified)

Specify location, if provided: __________________________

^*Specimen Integrity

^*____ Single intact specimen (margins to be evaluated)

^*____ Multiple designated specimens (e.g., main excision and identified margins)

^*____ Fragmented (margins cannot be evaluated with certainty)

^*____ Other (specify): ________________________

Specimen Size (for excisions less than total mastectomy)

Greatest dimension: _____________________ cm

^*Additional dimensions: __________ × __________ cm

____ Cannot be determined

Note: Specimen size is required but may be reported in the gross description.

Specimen Laterality

____ Right

____ Left

____ Not specified

^*Tumor Site: Invasive Carcinoma (select all that apply)

^*____ Upper outer quadrant

^*____ Lower outer quadrant

^*____ Upper inner quadrant

^*____ Lower inner quadrant

^*____ Central

^*____ Nipple

Position: _________ o’clock

^*____ Other (specify): ____________

^*____ Not specified

Tumor Size: Size of Largest Invasive Carcinoma

____ Microinvasion only (≤ 0.1 cm)

Greatest dimension of largest focus of invasion > 0.1 cm: _________ cm

^*Additional dimensions: __________ × __________ cm

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Cannot be determined

Note: The size of the invasive carcinoma should take into consideration the gross findings correlated with the microscopic examination. In some cases, it may be helpful to use information about tumor size from imaging studies. If multiple foci of invasion are present, the size listed is the size of the largest contiguous area of invasion. The size of multiple invasive carcinomas should not be added together. The size does not include adjacent DCIS. If there has been a prior core needle biopsy or incisional biopsy showing a larger area of invasion than in the excisional specimen, the largest dimension of the invasive carcinoma in the prior specimen should be used for T classification, if known. If there has been prior treatment and no invasive carcinoma is present, the cancer is classified as Tis if there is residual DCIS and T0 if there is no remaining carcinoma.

Tumor Focality (required only if > 1 focus of invasive carcinoma is present)

____ Single focus of invasive carcinoma

____ Multiple foci of invasive carcinoma

^*Number of foci:______________

^*Sizes of individual foci:______________

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Indeterminate

Note: If there are multiple invasive carcinomas, size, grade, histologic type, and the results of studies for estrogen receptor (ER), progesterone receptor (PR), and HER2/neu should pertain to the largest invasive carcinoma.

Macroscopic and Microscopic Extent of Tumor (required only if involved structures are present) (select all that apply)

Skin

____ Skin is not present

____ Invasive carcinoma does not invade into dermis or epidermis

____ Invasive carcinoma directly invades into dermis or epidermis without skin ulceration

____ Invasive carcinoma directly invades into dermis or epidermis with skin ulceration (classified as T4b)

____ Satellite microscopically evident skin foci of invasive carcinoma are present (i.e., not contiguous with invasive carcinoma in breast) (classified as T4b)

____ Satellite microscopic skin foci of invasive carcinoma are present (i.e., not contiguous with invasive carcinoma in breast) (does not change T classification)

Note: Dermal lymph-vascular invasion is reported separately.

Nipple

____ DCIS does not involve nipple epidermis

____ DCIS involves nipple epidermis (Paget disease of nipple)

Note: This finding does not change the T classification of invasive carcinomas.

Skeletal muscle

____ No skeletal muscle present

____ Skeletal muscle is present and is free of carcinoma

____ Carcinoma invades skeletal muscle

____ Carcinoma invades skeletal muscle and into chest wall (classified as T4a)

Note: Invasion into pectoralis muscle is not considered chest wall invasion, and cancers are not classified as T4a unless there is invasion deeper than this muscle.

Ductal Carcinoma In Situ (DCIS) (select all that apply)

____ No DCIS present

____ DCIS is present

^*____ Extensive intraductal component (EIC) negative

^*____ EIC positive

^*____ Only DCIS is present after presurgical (neoadjuvant) therapy

^*Size (extent) of DCIS

^*____ Estimated size (extent) of DCIS (greatest dimension using gross and microscopic evaluation) is at least_________ cm

^*____ Additional dimensions: __________ × _________ cm

^*____ Number of blocks with DCIS: __________

^*____ Number of blocks examined: __________

Note: The size (extent) of DCIS is an estimation of the volume of breast tissue occupied by DCIS. This information may be helpful for cases with a predominant component of DCIS (e.g., DCIS with microinvasion) but may not be necessary for cases of EIC negative invasive carcinomas.

^*Architectural patterns (select all that apply)

^*____ Comedo

^*____ Paget disease (DCIS involving nipple skin)

^*____ Cribriform

^*____ Micropapillary

^*____ Papillary

^*____ Solid

^*____ Other (specify): _____________________

^*Nuclear grade

^*____ Grade I (low)

^*____ Grade II (intermediate)

^*____ Grade III (high)

^*Necrosis

^*____ Not identified

^*____ Present, focal (small foci or single cell necrosis)

^*____ Present, central (expansive “comedo” necrosis)

^*Lobular Carcinoma In Situ (LCIS)

^*____ Not identified

^*____ Present

Histologic Type of Invasive Carcinoma

____ Ductal carcinoma in situ with microinvasion

____ Lobular carcinoma in situ with microinvasion

____ Ductal carcinoma in situ involving nipple skin (Paget disease) with microinvasion

____ Invasive ductal carcinoma (no special type or not otherwise specified)

____ Invasive lobular carcinoma

____ Invasive carcinoma with ductal and lobular features (“mixed-type carcinoma”)

____ Invasive mucinous carcinoma

____ Invasive medullary carcinoma

____ Invasive papillary carcinoma

____ Invasive micropapillary carcinoma

____ Invasive tubular carcinoma

____ Invasive cribriform carcinoma

____ Invasive carcinoma; type cannot be determined

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Other(s) (specify): __________________

Note: Histologic type corresponds to the largest carcinoma. If there are smaller carcinomas of a different type, this information should be included under “Additional Pathologic Findings.” Inflammatory carcinoma requires the presence of clinical findings of erythema and edema involving at least 1/3 of skin of breast.

Histologic Grade: Nottingham Score

Glandular (acinar)/tubular differentiation

____ Score 1: > 75% of tumor area forming glandular/tubular structures

____ Score 2: 10-75% of tumor area forming glandular/tubular structures

____ Score 3: < 10% of tumor area forming glandular/tubular structures

____ Only microinvasion present (not graded)

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Score cannot be determined

Nuclear pleomorphism

____ Score 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform chromatin, little variation in size

____ Score 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape

____ Score 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms

____ Only microinvasion present (not graded)

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Score cannot be determined

Mitotic count

____ Score 1 (≤ 3 mitoses per mm²)

____ Score 2 (4-7 mitoses per mm²)

____ Score 3 (≥ 8 mitoses per mm²)

____ Only microinvasion present (not graded)

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Score cannot be determined

^*Number of mitoses per 10 high-power fields: __________

^*Diameter of microscope field: __________ mm

Overall grade

____ Grade 1: Scores of 3, 4, or 5

____ Grade 2: Scores of 6 or 7

____ Grade 3: Scores of 8 or 9

____ Only microinvasion present (not graded)

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Score cannot be determined

Note: Grade corresponds to largest area of invasion. If there are smaller foci of invasion of a different grade, this information should be included under “Additional Pathologic Findings.”

Margins (select all that apply)

____ Margins cannot be assessed

____ Margins uninvolved by invasive carcinoma

Distance from closest margin: __________ mm

^*Specify margins: ________

^*Distance from superior margin: __________ mm

^*Distance from inferior margin: __________ mm

^*Distance from anterior margin: __________ mm

^*Distance from posterior margin: __________ mm

^*Distance from medial margin: __________ mm

^*Distance from lateral margin: __________ mm

^*Distance from other specified margin: __________ mm

^*Designation of margin: ____________

____ Margins uninvolved by DCIS (if present)

Distance from closest margin: __________ mm

^*Specify margins

^*Distance from superior margin: __________ mm

^*Distance from inferior margin: __________ mm

^*Distance from anterior margin: __________ mm

^*Distance from posterior margin: __________ mm

^*Distance from medial margin: __________ mm

^*Distance from lateral margin: __________ mm

^*Distance from other specified margin: __________ mm

^*Designation of margin: _______________________

_____ Margin(s) positive for invasive carcinoma

^*Specify margin(s): __________________________

^*Specify margin(s) and extent of involvement

^*____ Superior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Inferior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Anterior margin

^*____ Focal

^*____ Minimal/invasive

^*____ Extensive

^*____ Posterior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Medial margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Lateral margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

____ Margin(s) positive for DCIS

^*Specify margin(s): __________________________

^*Specify margin(s) and extent of involvement

^*____ Superior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Inferior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Anterior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Posterior margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Medial margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*____ Lateral margin

^*____ Focal

^*____ Minimal/moderate

^*____ Extensive

^*Treatment Effect: Response to Presurgical (Neoadjuvant) Therapy

^*In breast

^*____ No known presurgical therapy

^*____ No definite response to presurgical therapy in invasive carcinoma

^*____ Probable or definite response to presurgical therapy in invasive carcinoma

^*____ No residual invasive carcinoma is present in breast after presurgical therapy

^*In lymph nodes

^*____ No known presurgical therapy

^*____ No lymph nodes removed

^*____ No definite response to presurgical therapy in metastatic carcinoma

^*____ Probable or definite response to presurgical therapy in metastatic carcinoma

^*____ No lymph node metastases; fibrous scarring, possibly related to prior lymph node metastases with pathologic complete response

^*____ No lymph node metastases and no prominent fibrous scarring in nodes

^*Lymph-Vascular Invasion

^*____ Not identified

^*____ Present

^*____ Indeterminate

^*Dermal lymph-vascular invasion

^*____ No skin present

^*____ Not identified

^*____ Present

^*____ Indeterminate

Lymph Nodes (required only if lymph nodes are present in specimen)

Number of sentinel lymph nodes examined: _________

Total number of lymph nodes examined (sentinel and nonsentinel): _________

Number of lymph nodes with macrometastases (> 0.2 cm): _________

Number of lymph nodes with micrometastases (> 0.2 mm to 2.0 cm &/or > 200 cells): _________

Number of lymph nodes with isolated tumor cells (≤ 0.2 mm and ≤ 200 cells): _________

Size of largest metastatic deposit (if present): _________

Note: Sentinal node is usually the first involved lymph node. In the unusual situation in which a sentinel node is not involved by metastatic carcinoma but a nonsentinel node is involved, this information should be included in a note.

^*Extranodal extension

^*____ Present

^*____ Not identified

^*____ Indeterminate

^*Method of evaluation of sentinel lymph nodes (select all that apply)

^*____ Hematoxylin and eosin (H&E), 1 level

^*____ H&E, multiple levels

^*____ Immunohistochemistry

^*____ Sentinel lymph node biopsy not performed

^*____ Other (specify): ______________________________

Pathologic Staging (based on information available to the pathologist) (pTNM)

TNM descriptors (required only if applicable) (select all that apply)

____ m (multiple foci of invasive carcinoma)

____ r (recurrent)

____ y (post-treatment)

Primary tumor (invasive carcinoma) (pT)

____ pTX: 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 nipple not associated with invasive carcinoma &/or carcinoma in situ (DCIS &/or LCIS) in 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 chest wall &/or to skin (ulceration or skin nodules)

Note: Invasion of dermis alone does not qualify as pT4.

____ pT4a: Extension to chest wall, not including only pectoralis muscle adherence/invasion

____ pT4b: Ulceration &/or ipsilateral satellite nodules &/or edema (including peau d’orange) of skin, which does not meet criteria for inflammatory carcinoma

____ pT4c: Both T4a and T4b

____ pT4d: Inflammatory carcinoma##

#For the purposes of this checklist, these categories should only be used in the setting of preoperative (neoadjuvant) therapy for which a previously diagnosed invasive carcinoma is no longer present after treatment.

##Inflammatory carcinoma is a clinical-pathologic entity characterized by diffuse erythema and edema (peau d’orange) involving 1/3 or more of the skin of the breast. The skin changes are due to lymphedema caused by tumor emboli within dermal lymphatics, which may or may not be obvious in a small skin biopsy. However, a tissue diagnosis is still necessary to demonstrate an invasive carcinoma in the underlying breast parenchyma or at least in the dermal lymphatics, as well as to determine biological markers such as ER, PR, and HER2 status. Tumor emboli in dermal lymphatics without the clinical skin changes described above do not qualify as inflammatory carcinoma. Locally advanced breast cancers directly invading the dermis or ulcerating the skin without the clinical skin changes also do not qualify as inflammatory carcinoma. Thus the term “inflammatory carcinoma” should not be applied to neglected locally advanced cancer of the breast presenting late in the course of a patient’s disease. The rare case that exhibits all the features of inflammatory carcinoma but in which skin changes involve less than 1/3 of the skin should be classified by the size and extent of the underlying carcinoma.

Regional lymph nodes (pN) (choose a category based on lymph nodes received with specimen; immunohistochemistry &/or molecular studies are not required)

If internal mammary lymph nodes, infraclavicular nodes (level III axillary), or supraclavicular lymph nodes are included in specimen, consult the AJCC Cancer Staging Manual for additional lymph node categories.

Modifier (required only if applicable)

____ (sn): Only sentinel node(s) evaluated; if ≥ 6 sentinel nodes &/or supraclavicular lymph nodes are removed, this modifier should not be used

Category (pN)

____ pNX: Regional lymph nodes cannot be assessed (e.g., previously removed or not removed for pathologic study)

____ pN0: No regional lymph node metastasis is identified histologically

Note: Isolated tumor cell clusters (ITC) are defined as small clusters of cells ≤ 0.2 mm or single tumor cells, or < 200 cells in a single histologic cross section.# ITCs may be detected by routine histology or by immunohistochemical (IHC) methods. Nodes containing only ITCs are excluded from the total positive node count for purposes of N classification but should be included in the total number of nodes evaluated.

____ pN0(i-): No regional lymph node metastases histologically, negative IHC

____ pN0(i+): Malignant cells in regional lymph node(s) ≤ 0.2 mm and < 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 (> 0.2 mm &/or > 200 cells, but none > 2.0 mm)

____ pN1a: Metastases in 1-3 axillary lymph nodes (at least 1 metastasis > 2.0 mm)

____ pN2a: Metastases in 4-9 axillary lymph nodes (at least 1 tumor deposit > 2.0 mm)

____ pN3a: Metastases in 10 or more axillary lymph nodes (at least 1 tumor deposit > 2.0 mm)

#Approximately 1,000 tumor cells are contained in a 3-dimensional 0.2 mm cluster. Thus, if > 200 individual tumor cells are identified as single dispersed tumor cells or as a nearly confluent elliptical or spherical focus in a single histologic section of a lymph node, there is a high probability that > 1,000 cells are present in the lymph node. In these situations, the node should be classified as containing a micrometastasis (pN1mi). Cells in different lymph node cross sections or longitudinal sections or levels of the block are not added together; the 200 cells must be in a single node profile even if the node has been thinly sectioned into multiple slices. It is recognized that there is substantial overlap between the upper limit of the ITC and the lower limit of the micrometastasis categories due to inherent limitations in pathologic nodal evaluation and detection of minimal tumor burden in lymph nodes. Thus, the threshold of 200 cells in a single cross section is a guideline to help pathologists distinguish between these 2 categories. The pathologist should use judgment regarding whether it is likely that the cluster of cells represents a true micrometastasis or is simply a small group of isolated tumor cells.

^*Distant metastasis (M)

^*____ Not applicable

^*____ 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 no larger than 0.2 mm in a patient without symptoms or signs of metastasis

^*____ pM1: Distant detectable metastasis as determined by classic clinical and radiographic means &/or histologically proven larger than 0.2 mm

Note: The MX designation has been eliminated from the AJCC/UICC TNM system.

Only the applicable T, N, or M category is required for reporting; the definitions need not be included in the final report.

^*Additional Pathologic Findings

^*____ Specify:______________

Ancillary Studies

(These elements are required only in the primary report of the results)

Estrogen receptor

Specimen used for this assay (required only if results were obtained on a specimen other than the one currently being reported)

____ Performed on this specimen

____ Performed on another specimen

^*Specify specimen (accession number):______________

____ Pending

____ Not performed

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Other (specify):______________

Results and interpretation

____ Positive (________ % of tumor cells with nuclear positivity)

____ Negative (< 1% of tumor cells with nuclear positivity)

____ Negative (no tumor cells with nuclear positivity)

____ Results unknown

____ Other (specify):______________

Average intensity of tumor cell nuclei staining

____ Absent

____ Weak

____ Moderate

____ Strong

____ Unknown

____ Other (specify):______________

Progesterone receptor

Specimen used for this assay (required only if results were obtained on a specimen other than the one currently being reported)

____ Performed on this specimen

____ Performed on another specimen

^*Specify specimen (accession number): ________________________

____ Pending

____ Not performed

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Other (specify): ______________________________

Results and interpretation

____ Positive (__________ % of tumor cells with nuclear positivity)

____ Negative (< 1% of tumor cells with nuclear positivity)

____ Negative (no tumor cells with nuclear positivity)

____ Results unknown

____ Other (specify): _________________

Average intensity of tumor cell nuclei staining

____ Absent

____ Weak

____ Moderate

____ Strong

____ Unknown

____ Other (specify): ______________________

Note: It is optional to provide additional information using other scoring systems.

HER2 (results for invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy)

Immunoperoxidase studies

Specimen used for this assay (required only if results were obtained on a specimen other than the one currently being reported)

____ Performed on this specimen

____ Performed on another specimen

^*Specify specimen (accession number): ____________________

____ Pending

____ Not performed

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Other (specify): ____________________

Results

____ Negative (score 0)

____ Negative (score 1+)

____ Equivocal (score 2+)

____ Positive (score 3+)

____ Other

Specify: _________________

____ Results unknown

Fluorescence in situ hybridization (FISH) for HER2

Specimen used for this assay (only required if results were obtained on a specimen other than the one currently being reported)

____ Performed on this specimen

____ Performed on another specimen

^*Specify specimen (accession number): ______________________

____ Pending

____ Not performed

____ No residual invasive carcinoma after presurgical (neoadjuvant) therapy

____ Other (specify): __________________

Results

____ Not amplified (HER2 gene copy < 4.0 or ratio < 1.8)

____ Equivocal (HER2 gene copy 4.0-6.0 or ratio 1.8-2.2)

____ Amplified (HER2) gene copy > 6.0 or ratio > 2.2

^*Average number of HER2 gene copies per cell: __________

^*Average number of CEP17 per cell: __________

^*Ratio: __________

____ Results unknown

____ Other (specify): __________________________

^*Other ancillary studies (results for invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy)

^*____ Performed on this specimen

^*____ Performed on another specimen

^*Specify specimen (accession number): ____________________

^*Name of test: _________________________

Results: ____________________

^*Microcalcifications (select all that apply)

^*____ Not identified

^*____ Present in DCIS

^*____ Present in invasive carcinoma

^*____ Present in nonneoplastic tissue

^*____ Present in both carcinoma and nonneoplastic tissue

^*Clinical History (select all that apply)

^*Current clinical/radiologic breast findings for which this surgery is performed include

^*____ Palpable mass

^*____ Radiologic finding

^*____ Mass or architectural distortion

^*____ Calcifications

^*____ Other (specify): __________________________

^*____ Nipple discharge

^*____ Prior history of breast cancer

^*Specify site, diagnosis, and prior treatment: ____________________

^*____ Prior presurgical (neoadjuvant) therapy for this diagnosis of invasive carcinoma

^*Specify type: _________________

^* Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management. Adapted with permission from College of American Pathologists, “Protocol for the Examination of Specimens from Patients with Invasive Carcinoma of the Breast.” Web posting date: October 2009, www.cap.org.