Protocol for Synpotic reporting of Breast excision specimen with diagnosis of Ductal Carcinoma In Situ (DCIS) of the Breast

Protocol applies to DCIS without invasive carcinoma or microinvasion.
The complete pathology report should include following parameters.

Specimen type.

___ 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)

___ No lymph nodes present
___ Sentinel lymph node(s)
___ Axillary dissection (partial or complete dissection)
___ Lymph nodes present within the breast specimen (ie, intramammary lymph nodes)
___ Other lymph nodes (eg, supraclavicular or location not identified)
Specify location, if provided: _________________________

Specimen Integrity

___ Single intact specimen (margins can be evaluated)
___ Multiple designated specimens (eg, main excisions 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: ___ x ___ cm

___ Cannot be determined

Specimen Laterality

___ Right
___ Left
___ Not specified

Size (Extent) of DCIS ( Click here for more info about measuring size of DCIS)

Estimated size (extent) of DCIS (greatest dimension using gross and microscopic evaluation): at least ___ cm
*Additional dimensions ___ x ___ 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.

Histologic Type

___ Ductal carcinoma in situ. Classified as Tis (DCIS) or Tis (Paget)

*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)

Margins (select all that apply)

___ Margins cannot be assessed

___ Margin(s) uninvolved by DCIS

Distance from closest margin: ___ mm

*Specify margins:

*Distance from superior margin: ___ mm

*Distance from inferior margin: ___ mm

*Distance from medial margin: ___ mm

*Distance from lateral margin: ___ mm

*Distance from anterior margin: ___ mm

*Distance from posterior margin: ___ mm

*Distance from other specified margin: ___ mm

*Designation of margin: ______________________

___ Margin(s) positive for DCIS

*Specify which margin(s) and extent of involvement:

*___ Superior margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*___ Inferior margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*___ Medial margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*___ Lateral margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*___ Anterior margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*___ Posterior margin

*___ Focal

*___ Minimal/moderate

*___ Extensive

*Treatment Effect: Response to Presurgical (Neoadjuvant) Therapy

*___ No known presurgical therapy
*___ No definite response to presurgical therapy
*___ Probable or definite response to presurgical therapy

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

Number of sentinel nodes examined: ____
Total number of nodes examined (sentinel and nonsentinel): ____
Number of lymph nodes with macrometastases (>0.2 cm): ____
Number of lymph nodes with micrometastases (>0.2 mm to 0.2 cm and/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: The sentinel 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 (pTNM)

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

___ r (recurrent)
___ y (post-treatment)

Primary Tumor (pT)

___ pTis (DCIS): Ductal 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.

Note: If there has been a prior core needle biopsy, the pathologic findings from the core, if available, should be incorporated in the T classification. If invasive carcinoma or microinvasion were present on the core, the protocol for invasive carcinomas of the breast¹ should be used and should incorporate this information.

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

Note: If internal mammary lymph nodes, infraclavicular nodes, or supraclavicular lymph nodes are included in the specimen, consult the AJCC Staging Manual for additional lymph node categories.

Modifier (required only if applicable)

___ (sn) Only sentinel node(s) evaluated. If 6 or more sentinel nodes and/or nonsentinel nodes are removed, this modifier should not be used.

Category (pN)

___ pNX: Regional lymph nodes cannot be assessed (eg, previously removed, or not removed for pathologic study)

___ pN0: No regional lymph node metastasis identified histologically

Note: Isolated tumor cell clusters (ITC) are defined as small clusters of cells not greater than 0.2 mm or single tumor cells, or a cluster of fewer than 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) 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)

^# Approximately 1000 tumor cells are contained in a 3-dimensional 0.2-mm cluster. Thus, if more than 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 more than 1000 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 and/or histologically proven larger than 0.2 mm

Note: The presence of distant metastases in a case of DCIS would be very unusual. Additional sampling to identify invasive carcinoma in the breast or additional history to document a prior or synchronous invasive carcinoma is advised in the evaluation of such cases.

*Additional Pathologic Findings

*Specify: ____________________________

*Ancillary Studies

*Estrogen Receptor (results of special studies performed on this specimen or a prior core needle biopsy)

*___ Immunoreactive tumor cells present

*___ No immunoreactive tumor cells present

*___ Pending

*___ Not performed

*___ Other (specify): _____________________

*Name of antibody: ___________________

*Name of vendor: ___________________

*Type of fixative: ________________

*Progesterone Receptor (results of special studies performed on this specimen or a prior core needle biopsy)

*___ Immunoreactive tumor cells present

*___ No immunoreactive tumor cells present

*___ Pending

*___ Not performed

*___ Other (specify): _____________________

*Name of antibody: ___________________

*Name of vendor: ___________________

*Type of fixative: ________________

*Microcalcifications (select all that apply)

___ Not identified
___ Present in DCIS
___ Present in non-neoplastic tissue
___ Present in both DCIS and non-neoplastic tissue

*Clinical History (select all that apply)

The 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

*___ Other (specify): ____________________

*___ Prior history of breast cancer

*Specify site, diagnosis, and prior treatment: ______________________

*___ Prior neoadjuvant treatment for this diagnosis of DCIS

*Specify type: ______________________

*Comment(s)

For specimens with a known diagnosis of DCIS (eg, by prior core needle biopsy) it is highly recommended that the entire specimen is examined using serial sequential sampling to exclude the possibility of invasion, to completely evaluate the margins, and to aid in determining extent. If an entire excisional specimen or grossly evident lesion is not examined microscopically, it is helpful to note the approximate percentage of the specimen or lesion that has been examined.

Ref. College of American pathologist.