Protocol for the Examination of Specimens From Patients With Invasive Carcinoma of the Breast

The College of American Pathologists offers these protocols to assist pathologists in providing clinically useful and relevant information when reporting results of surgical specimen examinations. The College regards the reporting elements in the “Surgical Pathology Cancer Case Summary (Checklist)” portion of the protocols as essential elements of the pathology report. However, the manner in which these elements are reported is at the discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice.The College developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information. It did not issue the protocols for use in litigation, reimbursement, or other contexts. Nevertheless, the College recognizes that the protocols might be used by hospitals, attorneys, payers, and others. Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the checklist elements of the protocols as part of its Cancer Program Standards for Approved Cancer Programs. Therefore, it becomes even more important for pathologists to familiarize themselves with these documents. At the same time, the College cautions that use of the protocols other than for their intended educational purpose may involve additional considerations that are beyond the scope of this document.This protocol applies to all invasive carcinomas of the breast, including ductal carcinoma in situ (DCIS) with microinvasion. The 7th edition TNM staging system for carcinoma of the breast of the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) is recommended.Select a Single Response Unless Otherwise Indicated.* 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.Specimen (note A)__ Partial breast__ Total breast (including nipple and skin)__ Other (specify): ______ Not specifiedProcedure (note A)__ Excision without wire-guided localization__ Excision with wire-guided localization__ Total mastectomy (including nipple and skin)__ Other (specify): ______ Not specifiedLymph Node Sampling (select all that apply) (note B)__ 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 (note C)__ Single intact specimen (margins can be evaluated)__ Multiple designated specimens (eg, main excision and identified margins)__ Fragmented (margins cannot be evaluated with certainty)__ Other (specify): ____Specimen Size (for excisions less than total mastectomy) (note C)Greatest dimension: __ cm* Additional dimensions: __ × __ cm__ Cannot be determinedSpecimen Laterality__ Right__ Left__ Not specified*Tumor Site: Invasive Carcinoma (select all that apply) (note D)*__ Upper outer quadrant*__ Lower outer quadrant*__ Upper inner quadrant*__ Lower inner quadrant*__ Central*__ Nipple* Position: __ o'clock* Other (specify): ____*__ Not specifiedTumor Size: Size of Largest Invasive Carcinoma (note E)__ Microinvasion only (≤0.1 cm)Greatest dimension of largest focus of invasion greater than 0.1 cm: __ cm* Additional dimensions: __ × __ cm__ No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ Cannot be determined (see Comment)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 size of invasion are the size is the size of the largest of The size of invasive carcinomas should not be The size not a or a of invasion than in the the largest dimension of the invasive carcinoma in the specimen should be used for if and invasive carcinoma is the is as if is residual and if is (note Single focus of invasive Multiple of invasive carcinoma of __ of individual ______ No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ are invasive and the results of for and should to the largest invasive invasive carcinomas in of these this information may be in the and of (select all that apply) (note is not present__ Invasive carcinoma not into the or Invasive carcinoma into the or without Invasive carcinoma into the or with as of invasive carcinoma are present (ie, not with the invasive carcinoma in the as not involve the nipple nipple of the not the No present__ is present and is of Carcinoma Carcinoma into and into the as into is not and are not as is invasion than this Carcinoma In (note No is present__ is present __ __ __ is present after presurgical (neoadjuvant) of size of dimension by gross and microscopic is at __ cm* Additional dimensions: __ × __ cm* of with of The size of is an of the of breast by information may be helpful for with a of (eg, with but may not be for of invasive (select all that nipple Other (specify): Not or Carcinoma In Not of Invasive Carcinoma (note carcinoma in situ with carcinoma in situ with carcinoma in situ nipple with Invasive ductal carcinoma or not Invasive Invasive carcinoma with ductal and Invasive Invasive Invasive Invasive Invasive Invasive Invasive cannot be No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ (specify): The to the largest of are of invasion of a this information should be (note of to of of present No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ cannot be with in size in with breast in than with and in size and with in size and with and present No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ cannot be (see (see (see present No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ cannot be of of __ of or of or of or present No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ cannot be The to the largest of are of invasion of a this information should be (select all that apply) (note cannot be by invasive carcinoma __ Specify __ __ __ __ __ __ other __ of ______ by __ Specify __ __ __ __ __ __ other __ of ______ for invasive carcinoma Specify Specify and of for Specify Specify and of Response to (note the No presurgical No to presurgical in the invasive or to presurgical in the invasive No residual invasive carcinoma is present in the breast after presurgical the Lymph No presurgical No lymph nodes No to presurgical in or to presurgical in No lymph to lymph with complete No lymph and in the (note Not No Not only if lymph nodes are present in the (note of lymph nodes of lymph nodes and of lymph nodes with of lymph nodes with to of lymph nodes with and of largest The is the lymph In the in which a is not by but a is this information should be in a Not of of Sentinel Lymph (select all that Sentinel lymph not Other (specify): on information to the (note only if (select all that of invasive cannot be No of carcinoma in carcinoma in of the nipple not with invasive carcinoma carcinoma in situ in the breast in in dimension but in but in but in but in in of size with to the to the or of the not as to not including only (including of the which not the for and the of this these should only be used in the of (neoadjuvant) for which a invasive carcinoma is present after carcinoma is a by and or more of the of the The are to by within which may or may not be in a However, a is to an invasive carcinoma in the breast or at in the as as to as and in without the not as breast the or the without the and in not as the carcinoma should not be to of the breast in the of a The that all the of but in which involve less than of the should be by the size and of the Lymph a on lymph nodes with the are not lymph or supraclavicular lymph nodes are in the the Cancer for additional lymph only if or more nodes nodes are this should not be lymph nodes cannot be (eg, or not for No lymph identified are as of not greater than or or a of than in a may be by or by only are the total for of but should be in the total of nodes No lymph in lymph greater than and more than by or including No lymph findings findings but lymph by or than more than but greater than in to lymph at greater than in to lymph nodes greater than in or more lymph nodes greater than are in a if more than individual are identified as or as a or focus in a of a lymph is a that more than are present in the In these the should be as a in lymph or or of the are not the be in a even if the into It is that is the of the and the of the of in and of in lymph the of in a is a to pathologists these The should use it is that the of a or is a of Not No or of but of or in or other that are in a patient without or of as determined by and or and (note (note results on invasive carcinoma on this specimen or a or on this on specimen Specify specimen ______ Not No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ Other (specify): present ______ than present__ No present__ Other (specify): and of other than results for invasive carcinoma on this specimen or a or on this on specimen Specify specimen ______ Not No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ Other (specify): present ______ than present__ No present__ Other (specify): and for invasive carcinoma on this specimen or a or on this on specimen Specify specimen ______ Not No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ Other (specify): Other (specify): ______ and In for on this on specimen Specify specimen ______ Not No residual invasive carcinoma after presurgical (neoadjuvant) therapy__ Other (specify): Not or to or to or of __ of __ Other (specify): of for invasive carcinoma on this specimen or a or on this on specimen Specify specimen of (select all that Not in in invasive in in carcinoma and (select all that apply) (note The breast findings for which this is or Other (specify): ____*__ Other (specify): ____*__ of breast Specify and ____*__ presurgical (neoadjuvant) for this of invasive carcinoma Specify of breast specimens and may be reported with the breast without the of the The nipple is not with specimens designated and a is by or a is to the location of the or may be used to the of the in the The specimen and the results of the should be to the when by or not the if it clinically only by without excisions are for or to the nipple to nipple of all breast including the nipple and of a total mastectomy without of lymph is a total mastectomy with of the nipple and only a of is a total mastectomy without of or The is and the nipple if by of a total mastectomy with an In the the breast and lymph specimens are portion of is of a total mastectomy with of the and of specimen and can be on the checklist as checklist is intended for reporting the specimen with the largest focus of invasive additional excisions are in the same the findings for these specimens can be in the additional of invasive carcinoma are present in the main excision or in the of these carcinomas (ie, and should be Additional on of carcinoma are if the carcinomas are of or additional excisions are in a (eg, on and a of invasive carcinoma is not the checklist not be a patient invasive carcinomas in excisions the same the checklist should be used for the invasive The findings for the may be reported without the a patient invasive carcinomas in excisions in on the checklist should be used for the carcinoma and the to this a patient breast these be reported in information other specimens is in the checklist (eg, the results of a or the of lymph on a lymph this be in the and the of the other should be of specimens should not be reported by this (including of a after of of the for specimens with invasive carcinoma the The or for which the be the is a the specimen additional may be to the the or the with the should be in a for the specimen of with complete of the or at a the is to additional of invasion other gross in the specimen be designated be evaluated for by invasive carcinoma and the specimen is or this should be as this the to the of may be for or that not involve the of the (eg, only when in a as to not the of the invasive carcinoma and lymph nodes for and with invasive carcinoma lymph nodes of Lymph Sentinel lymph nodes are identified by the by of or or nodes may be Axillary lymph nodes are by of The nodes are into to the of the the and of the and the lymph and or to the of the and to the may to or more of these nodes are present within breast and are in the outer nodes may be lymph nodes are with nodes for supraclavicular and nodes are for breast are present in these are specific (see Cancer Node The size of nodes should be to of invasion is in the to the breast, without of residual lymph are as lymph Sampling be to all as are to (ie, all each should be at and all should be for microscopic examination. At be Additional of as additional or additional nodes with or However, the of these nodes be in a that can be evaluated and more than is in the same each should be a for developed as an for lymph The used for this cannot be be identified Therefore, can only be used for other if all can be identified by examination. and results can with The of a for a lymph is Lymph of nodes The total of nodes nodes and intramammary the of and nodes is less than the is Size of are into the are as or of not than and more than in a with of (eg, or or are used to the lymph nodes should be designated as or as are not in the total of nodes for more than but not more than more than in a only are the is at is nodes with are in the total for more than cases, if are the be In cases, only nodes can if the is by is not by or if is or if is of the to the should be in the some cases, the can be to Multiple of within a lymph 1, The of the for is on the largest of However, when the of is to that of the (eg, a with of each the use or in the The size and of used for are to be and not It is that the for the in the be in a of lymph 1, invasive may as individual and not as It can be to the of present for of cases, an of in for is is to the invasion 1, carcinoma may the lymph into with the of or when and is a for should be when the size of a lymph The size of the the and the (ie, the not be within in the without invasion of is not in 1, carcinoma can a lymph of invasive carcinoma in can be as lymph be and carcinoma to is not the carcinoma is by breast is the of invasion is more to be a carcinoma in breast and should not be as carcinoma to a lymph after The of carcinoma in lymph nodes after is an important In to the information of (eg, within an of should be reported (see is that the of carcinoma be in a intact the specimen or is it may not be to invasive carcinoma is present in more than it may be or to the size of the invasive carcinoma or the of invasive carcinomas specimen size to the main specimen that to the It not additional excisions for The size of these specimens should be in the gross the specimens are the results of the can be in the not the findings can be reported of an invasive carcinoma is helpful to when by the to with (eg, a or with The can be by by the location on a can be determined in a However, it is to with the as determined in of in the specimen be on the (ie, the to the It is helpful to the carcinoma with to the or when the patient presurgical (neoadjuvant) and is residual invasive the to the location of the invasive carcinoma (ie, the size of an invasive carcinoma is an important The dimension of the largest invasive carcinoma is used to The size for should use information gross and microscopic of size is as carcinomas into The size by of a with invasion of into with a should be to the The is to the size to the that is to the for a size of be reported as or a size of be reported as some cases, the size may be to size only the largest of invasion of is not in the size the invasive carcinoma in the excision is (ie, and is to a it is that the size of the carcinoma In cases, it is helpful to the largest size on the with the size of the by to the size for However, the on the and in the excision should not be as this the size of the size of the largest carcinoma is used for The of invasive carcinomas should not be The is used to the of invasive can be to invasive carcinoma carcinomas to gross and of carcinomas are required. with can be In some cases, invasive carcinoma (eg, is not by gross or by The of invasion may be by the of the of In some cases, the to use or in the an invasive carcinoma is a and is present in more than of it may be or to the size or the of carcinomas the carcinoma is present at the of the a by the carcinoma be as the total of cannot be a size be with a that the size may be The in specimens of a carcinoma should not be In cases, the size on breast may be helpful in the Size should be determined is for or for is by the as invasion 0.1 or less in more than focus of is the of an of the or a that the of is to should be In some cases, for may be helpful to of invasion and the size of the invasive with of invasion may be into the carcinoma in situ with of invasion is with of The invasive carcinomas are in and the is the of invasive Invasive carcinoma with of invasion carcinoma is by of In cases, the of may be to of the carcinoma into which in the of In cases, the are in and to the Invasive carcinoma with invasion Additional of invasion may of (ie, an intramammary The carcinomas are in and Multiple invasive carcinomas with are at for The carcinomas may or may not be in and Invasive carcinomas after with a to present as residual within a (see The of invasion are in and of a carcinoma into invasive carcinoma is present in of a of carcinoma should be with and findings can be helpful to the size for and to or not to a specific (ie, and the results of and should be for the largest invasive carcinoma in the carcinomas in or this information should be and additional are for these to all carcinomas (eg, lymph can be reported in the of the with invasive carcinomas a of lymph However, it not that invasive carcinomas the of for with lymph is on the carcinoma with the largest are the is on the carcinoma with the with of invasive carcinoma are by the in to with a focus of can into the or into the on their size and into and is used for and these findings may be used for about The of is important for the of that be to are that breast carcinoma can involve the can the into the without the not the of the invasive invasion with the of a carcinoma to the and may be with or nipple not the the with However, can be with It is if a as to carcinomas of size without with are as of invasive carcinoma within the the main is with is as present within in the is correlated with the of carcinoma and or more of the and be as In the of the of this a but is to a as is may be present at the The of that the excision to the into should be reported as this may be used as an for present is into this is not as this into the to be as However, are in mastectomy carcinoma in situ with invasive carcinoma the of It is more important to the of when in situ is (eg, of with or with is a of the invasive the of the less Therefore, of the reporting elements for are and should be used at the discretion of the pathology should is carcinomas are in carcinoma in situ is a within the of invasive carcinoma and is present in the breast is with a or invasive carcinoma (ie, the invasive carcinoma is for to of the carcinomas are with an of when the surgical are not evaluated or The of less when not to some cases, can be present the of invasive carcinoma the carcinoma not the for In cases, of the of present can be of be relevant for of with and relevant for invasive for the of when to a size by the specimen in and in of or the of with The checklist additional information on the of reported for However, and the of are more of of is determined by of is correlated with the of (ie, of carcinoma in situ that as as can be as The portion of an ductal is by an of that is at and are is with (ie, it can with of or at or should be which can be with but not protocol applies to all invasive carcinomas of the The of breast carcinoma is the protocol not the use of other or may be on the without the use of ductal not carcinoma carcinoma Carcinoma with Carcinoma with Carcinoma with carcinomas and other with carcinoma and carcinoma carcinoma carcinoma carcinomas carcinomas carcinoma with carcinoma carcinoma clinically as an of carcinoma be present to a carcinoma as invasive breast carcinomas should be The of should be used for each is a and the of the of and the is a of 1, or and the are to a The is determined by the of in in the part of the should be or are of in the size be determined for each and the determined It is that the size be by a However, the of an can be by the a to the of a can be used to a on the the of the is the of a can be for other by the of the is the of the which can be used to the of the the microscopic or the of the is can be used to the of to the specimen should be for the to specific is important for excisions less than total when it may be for the to residual at a specific (eg, or of surgical of the the carcinoma and specific should be evaluated for by carcinoma and may be by or on the specimen or by other of and and should be in the pathology report. can be identified in including the use of by the in specific or by the each as a should be to into the or microscopic of surgical by invasive carcinoma or should be in the report. the specimen is the specific of should be the should the the to the are with the should the of the invasive carcinoma and to the of the of in the ductal a but not the of in the on the specimen is the specific of (eg, should be may be at the of additional breast beyond this by is (eg, on a mastectomy for is to However, invasive carcinoma at the if with is an for may be the and may not be additional breast beyond this However, some breast can be in and the of residual breast is to the of the is important to the of of the specimen should be as it can the to the of the the surgical should be used with and for that this for (eg, is helpful to the of of carcinoma at the or more of carcinoma at the carcinoma present at the a may be with or surgical excision presurgical or The of the invasive carcinoma to is a for and to and the is for these developed to or protocols may by of these The after is with and determined after are by the carcinomas with a may or in greater of the carcinoma and may be present as of invasion a The is determined by the largest focus of invasive The is used to that of invasive carcinoma are The should not of within the The of additional as the which invasive carcinoma is the of of invasive or the of or with invasive may be helpful in the of residual residual invasive carcinoma is present in the breast, the checklist can be used to residual carcinoma in lymph is residual carcinoma in the breast or in the lymph a College of American Pathologists checklist not be used for carcinomas are of the same after In a cases, the be of In cases, the carcinoma be of The of a in after not is that and be on invasive carcinomas after as in a of invasion is with and is the of invasion is important of its with the findings of breast for the of invasion may be in and can be for if the the staging system by the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) is of a is on information and by the additional and of The additional and of and by is by use of a of the is on of the a of the with at the same or an at of the size and of the to the or of lymph nodes of a of lymph nodes to that is to if The not in as for and a At with or of by is for staging of into a is as with a in a is as a The size of the not the size of the is used for the for the as or may in lymph nodes that may not identified without the use of the Single or of are as The for is a of not more than in with only in lymph nodes are as applies to with findings of or their by as or of the of a for at the is an and the may not be of the of can only be at However, the of to a by TNM may be or or (eg, or with a of a that as or or by or are as to the of these findings and to the to the and and for which are or is may the of at the of the by or is useful to the of to may important information to and the of or and are by the same as for or staging for the and the findings are by the (eg, The is used for the after and the is used for the for that surgical after The should be by the clinically or is when is for a that after a The at the of and not when the or The use of this staging for or is with the information at the of should be used in the are of the same in the with the is the for and and the or the of is in for or in the are as in or in the same or in are as a with the TNM are not with the the of the this or of residual after is by the and the of in without consideration of and can be by the which with the after In some with with

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