Collaborative Stage Site-Specific Instructions - BREAST

Transcription

1 Slide 1 Collaborative Stage Site-Specific Instructions - BREAST In this presentation, we are going to review the CS Data Items and coding instructions for the breast primary site. Slide 2 Reading Assignments As each data item is being discussed, you should stop and read the information in CSv2 Part II and CSv2 Part I, Section 2 for that data item including the associated notes, codes and definitions. 2 It is important that you follow along and make notes in your manual. In addition to reading the slides and the instructor s notes, it is important that you stop and read the related sections in your manual as not every point will be discussed in detail.

2 Slide 3 Collaborative Stage 3 As we go through each data item, don t forget the general rules. They still apply. These will not be discussed in detail. Only those things that are specific to the breast schema will be discussed. Also, don t forget about the information you learned in the AJCC presentation, such as synonyms for in situ.

3 Slide 4 CS Tumor Size Code the size of the invasive tumor Example: Tumor with large in situ component (4 cm) and small invasive component (0.5cm). Code tumor size as 005 (the invasive component). For breast only: If size of the invasive area is not given, code the entire size of the tumor AND note in the text Multiple lesions in one breast One primary Use largest area of invasion If multiple foci of microinvasion, code only the size of the largest focus. (Do not add sizes together.) 4 When coding tumor size, as was just stated, the general rules still apply. The general rule for tumor size is if the tumor has both invasive and in situ components, then code the size of the invasive component even if it is smaller. There is one exception for the breast site only. If the size of the invasive component is not given, then you should code the entire size of the tumor reported in the medical record. (You may want to highlight this sentence in Note 4.) If there are multiple lesions in one breast (and the MP/H rules state it is a single primary), record the size of the largest area of invasion. Microinvasion is defined as cancer cells beyond the basement membrane with no focus more than 0.1 cm (1 millimeter). If multiple foci of microinvasion are present, code only the size of the largest focus. (Do not add sizes together.)

4 Slide 5 CS Tumor Size Special Codes (CS Ext: 950) or or or (includes microscopic foci of in situ only tumors) and and Has priority, even if TS stated 5 There are several special codes for the breast schema. When the mass or tumor cannot be found, then you should code 000. This will most often be when there is metastatic disease and they know the breast is the primary but there is no tumor found in the breast. The CS Extension will also be 950. When reading the code descriptions, it is important to understand how the descriptions are written. For example, for code 990, this code covers 4 different, separate scenarios. The tumor size only needs to meet one of these criteria for this code to apply. Microinvasion; Microscopic focus or foci only, no size given; Described as less than 1 mm; Stated as T1mi, NOS with no other information on size. Even though microinvasion would imply this code is only for invasive tumors, code 990 is the only place to code in situ tumors whose size is microscopic focus or foci only. For breast, you have two additional codes specific to the breast WHEN the tumor is not clinically palpable. If the diagnosis was based on a mammogram study only AND no tumor size is given, then code 996. For code 996, the tumor needs to meet all of the criteria stated. It is important to read through the code descriptions very carefully paying attention to the and s and or s in the statements. This applies to all codes, in all data items, for all schemas. If there was a size given, then you will code that given size. If it was clinically palpable, then the tumor would not be considered as having been seen on mammogram only. It can be confusing as to when all statements must be met or only one statement but thinking about the logic behind the statements can help. If the patient has Paget s disease of the nipple only then code 997. The descriptions in code 998 take precedence over any mention of tumor size. Code 998 if the tumor is described as diffuse or encompasses most of the breast even if a tumor size is stated.

5 Slide 6 CS Tumor Size Special Codes Stated as T with no other information on size IE: Stated as T1c. Code as 992 rather than 999. Tumors described as less than, greater than, or between Use codes in range Use if precise tumor size is not given 6 Multifocal or multicentric tumors Tumor described as X cm with multiple separate microscopic foci Use the largest tumor size to designate the T classification Every effort has been made to avoid the use of code 999 (size unknown) since size is a factor in the derivation of the appropriate T category. The notes and code descriptions provide instructions on how to assign the tumor size when the only information given is the T category. For example, if the only information available is a statement of T1c with no other information on size code as 992 rather than 999. Codes in the range can be used when the exact tumor size is not given, but only described as less than, greater than, or between. These codes also include the various options when only a T category is available. Again, use these codes when an exact tumor size is not available. Note 2 also provides additional instructions if the statement of the T category is T1a or T3, which is not included in the range. You may want to highlight these statements in Note 2.

6 Slide 7 CS Tumor Size Priority Order 1.1cm 1) Pathology Report IF there was no preoperative therapy a) Final diagnosis b) CAP protocol synoptic report or checklist c) Microscopic examination d) Gross examination 2) If preoperative therapy, code the largest size prior to the therapy unless it was larger at the time of surgery Use Eval code to define source of tumor size 7 3) Operative report 1.2cm 1.4cm 4) Imaging: Mammogram, Ultrasound, MRI -Take largest size found from multiple imaging reports 2cm 5) Physical exam Tumor size is very important in assigning stage for breast cancers so the rules provide a very detailed priority order for the which reports have priority over the others. If there are different tumor sizes reported on different types of reports, the order of which report has the priority is important. The general rules states that the size from the pathology report has priority over clinical measurements. However, note that it goes on to say IF there was no preoperative therapy. The issue of pre-operative therapy changing the tumor size prior to surgery applies in CS TS also. Therefore, if preoperative therapy was given, then code the largest size prior to therapy unless it is larger afterwards (at the time of surgery), then you should code the larger size and assigned the eval code of 6 because the pathologic evidence is more extensive. Also, imaging takes precedence over physical exam. If there are multiple tumor sizes reported from the multiple imaging reports, record the largest tumor size stated. There is no priority order for the different sizes reported on different imaging reports just take the largest size stated on any imaging report and this includes mammograms and ultrasounds. Determining the tumor size is a two step process. Decide the largest size from the imaging reports only. THEN, compare that to the sizes reported on these other types of work-up and then apply the priority order. The following is an example of a case where multiple tumor sizes have been reported: Physical exam: 2cm; MMG: 1.2cm; U/S: 1.4cm; Path: 1.1cm MMG and U/S are imaging: Largest size from imaging is 1.4. The size from imaging has priority over the size reported on the physical exam. There was also a tumor size reported on pathology. Based on the priority order, the tumor size on the pathology has priority over imaging. So, final TS coded will be 1.1cm. The evaluation method will be pathologic.

7 Slide 8 CS Extension 000 In situ Behavior code of 2 Code 050 and 070 Paget disease of nipple Without underlying tumor or invasive component Behavior code of 2 or 3 based on pathology description of the Paget disease /2 /2 or / Invasive Behavior code of 3 /3 100 : : For CS Extension we are going to choose the appropriate code based on the farthest documented extension of the primary tumor. This is only for the contiguous spread of the primary tumor only. This does not include discontinuous metastases to distant sites. Code 000 is for tumors that are all in situ. There is no invasive component, including no microscopic foci of invasion. The behavior code must be a 2. If the pathology from the tumor showed only in situ but there were also positive lymph nodes or other mets, do not code CS Extension as in situ. More than likely the area of invasion was missed on the pathology. Use the code for Localized, NOS (code 100) if there is no better information. (CS Extension general instruction #9) Review the discussion on Paget disease in the AJCC presentation for the breast. For Paget disease, the code that is to be assigned is based on whether or not there is an underlying mass and whether that mass is invasive or in situ. The next three slides contain additional information related to coding Paget disease. Codes describe invasive tumors only. The behavior code must be a 3. When the mass or tumor cannot be found, then you should code 950 (CS Tumor Size will be 000). This will most often be when there is metastatic disease and they know the breast is the primary but there is no tumor found in the breast. If there is a known tumor in the breast but the extension is not known and there are no clues such as the T category, then assign a code of 999.

8 Slide 9 Paget Disease (8540/_) AJCC Manual pg 354 CS Manual, Part I Section 2, pg 96 (SSF 24) Histology: Based on statement by pathologist Can be in situ or invasive Usually /3 Change to /2 only if called in situ on pathology report Paget disease is a crusty like tumor of the nipple and areola. Paget is the presence of glandular cells (ductal carcinoma) in the squamous epithelium of the skin of the nipple. The glandular cells had to get to the skin by invasion from a duct. Therefore, it is usually associated with an underlying tumor of the ducts, but not always. Note: Pagetoid spread is a description of the spread and is not the same as Paget's disease of the nipple. Pagetoid spread is the clinically inapparent extension of tumor cells into the surrounding epidermis and has a special code in SSF 24. The presence of Paget disease may be stated on the clinical workup or the pathology. If a physical exam is done or there is pathologic examination of the breast and nipple is stated to be negative or if Paget disease is not specifically mentioned then you can consider that the patient does not have Paget Disease. In the ICD-O-3 (page 81), Paget disease is listed as 8540 with a behavior code of 3 (invasive). There is no listing for in situ. A statement of just Paget disease, without any other description, is correctly coded as behavior code 3. However, Paget disease can be either in situ or invasive. You should code the behavior stated in the pathology report. If the pathology states specifically that it is in situ, then assign a behavior code of /2. The survival rates for these are nearly identical to in situ ductal carcinoma (which is why AJCC groups Paget Disease with Tis), even if the behavior is /3. Paget is grouped with Tis because of its prognosis, not its behavior. Summary Stage in this case would be localized according to SEER. The behavior code for Paget by itself should only be changed to /2 if the pathologist calls it Paget disease in situ. This is also addressed in the breast MPH histology rules. You will see this concept again in the colon CS Extension codes. To summarize, the behavior code is based on what the pathologist calls it on the pathology report. The CS Extension code that is to be assigned is based on whether or not there is an underlying mass and whether that mass is invasive or in situ.

9 Slide 10 CS Extension Behavior code of 2 or 3 based on description of the Paget disease on PATHOLOGY Behavior /2 /2 or /3 /2 or /3 /3 You can see here in this snapshot of the CS Extension codes for breast, where Paget is classified as in situ in AJCC, but can be either in situ or local depending on the behavior code. Again, the exact code is based on whether or not there is an underlying mass and whether that underlying mass is invasive or in situ. If there is not an underlying mass, then assign code 050. These are the true Paget disease only cases. Again, the behavior can be in situ or invasive depending on what they called the Paget disease on pathology. These are grouped with in situ cases in AJCC due to its prognosis, not its behavior. The tumor size will be 997 Paget disease with no underlying tumor. If there is a palpable mass, but there was no invasive component in that underlying mass on the pathology, then assign code 070. This will map to the in situ component of the underlying mass. Paget disease with a palpable mass and with an invasive component (on pathology) is classified according to the invasive component of the mass. Select the CS Extension code based on the involvement of the invasive underlying tumor. This could be any code 100, 200, etc. based on the underlying tumor only. Something to remember when selecting the code in this situation the Paget Disease itself is not going to be considered skin involvement for code 200 unless there was a specific mention of dermal lymphatic invasion. Also, the tumor size will be coded based on the size of the underlying mass as well. The fact that there was Paget disease is not reflected here but will be recorded in SSF 24.

10 Slide 11 Paget Disease and the MP/H Rules This slide shows how to apply this situation using the MPH rules. If there is Paget Disease only and no underlying tumor, then it is considered a single tumor and single histology and you will use the single tumor module of the rules. The histology code is 8540 (for Paget) and the behavior codes depends on whether it is in situ or invasive on the pathology report. If there IS an underlying tumor, then you should consider these as multiple tumors for both the multiple primary rules and the histology rules. Rule M9 will instruct you to consider these a single primary. Then Rules H24-26 will instruct you as to which combination code of Paget and ductal to use. You can see in the Notes for H25 that if the diagnoses is Paget disease and does not specify whether it is invasive or in situ, then consider it invasive. Therefore, the MP/H manual also serves as a resource for the rule to code the behavior code as invasive even though the AJCC will map to in situ. A common abstracting error is that the combination codes for Paget and intraductal or duct are not being used. Be sure to review the MPH rules thoroughly when assigning the histology code. You can see here how we use the ICD-O-3 and the MPH rules to assign the histology code and then the CS rules to assign CS Extension.

11 Slide 12 Breast -- CS Tumor Size and Extension Examples that map to T1 TS Ext 300 TS Ext 100 TS Ext 100 TS Ext 200 TS Ext Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag These next few slides show a comparison of what AJCC T category will be derived based on what you entered in the CS Size and CS Extension data items. Note that it takes both fields to derive the T, so avoiding unknowns in both of these is very important. Code 100 = local. The 3 tumors assigned to 100 on this slide are all local, but the size of the tumor is different. The exact T subcategory will be based on the tumor size. Code 200 = skin involvement. Code 300 = extends to the tissue under the breast but not to chest wall. Slide 13 Breast -- CS Extension Example that maps to T2 TS Ext Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag The CS Extension code for this tumor is still 100 because the tumor is confined to the breast tissue. The tumor size of 3.1 cm (31 mm) makes it a T2.

12 Slide 14 Breast -- CS Extension Example that maps to T3 TS Ext Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag This is a code 200 because of the involvement of the nipple. The tumor size of 5.5 cm (55 mm) makes it a T3. Slide 15 Breast -- CS Extension Extension to chest wall (T4a) Chest wall includes Ribs Intercostal muscles Serratus anterior muscle Does NOT include Pectoral muscle (Ext 300) 15 Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag Tumors that invade the chest wall are assigned a CS Extension code 400. These tumors may also involve the ribs and/or intercostal or serratus anterior muscle. Tumors in the T4 category can be of any size. The T category is based primarily on the extension at this point. Invasion of the pectoral muscle only would apply to code 300.

13 Slide 16 Inflammatory Breast Carcinoma (T4d) AJCC Manual Usually observed on physical exam Is a clinical diagnosis Need statement of inflammatory carcinoma Involves 1/3 or more of the skin Pre-operative chemo common For inflammatory breast carcinoma (IBC), there is additional information in the AJCC manual. IBC usually involves the majority of the skin of the breast and changes arise very quickly in the affected breast. Often there is no underlying palpable mass. Inflammatory carcinoma is primarily a clinical diagnosis. So, a statement of inflammatory carcinoma will probably be made on reports and dictation other than the pathology report. IBC is believed to be due to lymphatic obstruction from an underlying invasive tumor. The vast majority of cases have a prominent dermal lymphatic infiltration by tumor. However, dermal lymphatic infiltration without the characteristic clinical picture of inflammation is insufficient to qualify as inflammatory carcinoma. There has to be a statement of inflammatory carcinoma in order to assign a code for inflammatory carcinoma. These patients will probably have neo-adjuvant treatment followed by a mastectomy.

14 Slide 17 IBC - Histology Rule Histology Notes Code H13 Final diagnosis of the pathology report specifically states inflammatory carcinoma Record dermal lymphatic invasion in Collaborative Staging 8530 (inflammatory carcinoma) The clinical appearance of inflammatory carcinoma is coded in Collaborative Stage, but never in histology. Inflammatory carcinoma must be specifically stated on the pathology report to use code Example: Physician states there is inflammatory carcinoma on physical exam. Final diagnosis on the pathology reports states infiltrating duct carcinoma. Code to 8500/3. 17 A common coding error is assigning the code 8530 for the histology when the only mention of the IBC is on the clinical workup. Even though inflammatory carcinoma has a code in the ICD-O-3 manual, inflammatory carcinoma is not technically a histologic type. Inflammatory carcinoma is a clinical disease. The clinical appearance of inflammatory carcinoma is coded in the Collaborative Staging extension data item. The CLINICAL appearance of inflammatory carcinoma is NEVER coded in histology. In order to use the code 8530, inflammatory carcinoma must be specifically stated in the final diagnosis of the pathology report. Also, do not use this code if the final diagnosis shows infiltration of dermal lymphatics but the words inflammatory carcinoma are not included in the final diagnostic statement. As mentioned earlier, there has to be a statement of inflammatory carcinoma. From a data management perspective, by coding this way, you can pull cases with a clinical diagnosis of inflammatory carcinoma by using the CS extension code and cases with a pathologic diagnosis inflammatory carcinoma by pulling cases with a histology code of 8530.

15 Slide 18 CS Extension Helpful Hint Codes NO statement of inflammatory carcinoma Codes IS a statement of inflammatory carcinoma Review Notes 6 and 7 No inflammatory carcinoma Inflammatory carcinoma Code : : : : 18 Review Notes 6 and 7 for the CS Extension data item. When there are several codes to choose from and they contain similar wording, it can be helpful to try to identify what separates the codes apart. This helps to narrow down the codes to focus on. For example, codes apply when there is no statement of inflammatory carcinoma, or the involvement does not qualify as inflammatory carcinoma (IBC). Codes apply when there is a statement of inflammatory carcinoma and the involvement qualifies as inflammatory carcinoma. You will still need to review each code in this range carefully to select the appropriate code. But, if you know you have a statement of inflammatory carcinoma, you will already have a general idea of the range of codes that will apply. This will save you from reading the descriptions of codes 410 and below. You should also review the detailed information provided in Notes 6 and 7 and the discussion on IBC in the AJCC breast presentation.

16 Slide 19 Breast -- CS Extension Extensive skin involvement (T4b) Satellite skin nodule Skin ulceration 19 Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag This diagram shows examples of the two conditions assigned to CS Extension code 512. Tumors with satellite skin nodules or skin ulceration have their own code. Both conditions are assigned code 512 and map to T4b.

17 Slide 20 CS Extension No IBC (T4b) Within the range (when there is no statement of inflammatory carcinoma, or the involvement does not qualify as inflammatory carcinoma), many of the codes contain the same criteria, but there is one major difference. The one difference for this range is the amount of involvement. Recognizing this can help you identify the correct code more quickly. In AJCC 7 th edition, the dividing line is now 33%. It was 50% in AJCC 6 th edition. The codes in CS allow for both of these so that the correct 6 th edition and 7 th edition stage can be derived. For each code listed on the screen, the following criteria are the same for each code: First of all, the criteria includes a description of conditions involving the breast that qualify for this code but without a clinical diagnosis of inflammatory carcinoma. Instead, any of the terms in the circles are used to describe the skin involvement such as edema of skin, Erythema, or Inflammation of skin,. All of these skin conditions indicate that the skin of the breast is involved extensively by tumor. However, these skin conditions alone are not a diagnosis of inflammatory carcinoma. So, without a specific statement of IBC, we can t consider it IBC and must use the codes in the range. Also, the criteria for this range of codes also states WITH or WITHOUT dermal lymphatic infiltration. In other words, it can be present but does not have to be to qualify for this code. We are really more interested in the terms below that for skin involvement. The way that it lists it in the codes, sometimes that can be confusing. For Code 600, this involvement falls under the mapping to T4b. Even though there is a statement of inflammatory carcinoma, the amount of involvement (< 1/3), does not meet the AJCC criteria for inflammatory carcinoma and T4d. As you can see all of this circled is the same for each code. Only what is highlighted here is different which is the percent of involvement.

18 Slide 21 CS Extension Combination Codes Code 512: Ulceration or Satellite nodule(s) 514 (< 1/3 of breast) = code (>= 1/3 but <= 1/2 of breast) = code (> 1/2 of breast) = code (amount not stated) = code There are also combination codes available. Combination codes (for example, code 514 plus 512 is assigned to code 516) have been assigned when using the higher of two individual code numbers does not result in the appropriate mapping for all staging systems. If a combination code applies, that combination code has priority over the individual codes. For breast, there are several sets of combination codes based on the combination of involvement. The first set is within the range (when there is no statement of inflammatory carcinoma). When there is ulceration of the skin or satellite nodules (code 512) AND there is also a description of extensive skin involvement as described by codes 514, 518, 520, or 580, then you should assign the combination code. The exact code depends on the amount of involvement. For example, if there is ulceration AND there is skin involvement as described in code 520 (involvement of more than ½ of the breast), then assign code 575.

19 Slide 22 CS Extension Combination Codes Chest wall and skin involvement (T4c) 612: Chest wall plus any : Chest wall plus any code 512 code Adapted from: TNM Atlas, 3rd ed. 2nd rev., by B. Spiessl et al. Springer Verlag Another set of combination codes is available when there is a combination of code 400 (chest wall) and any code in the range (skin involvement). Again, the exact code depends on the amount of skin involvement and code in the range. 612: Any of ( ) + (400) 615: Any of ( ) + (400) For example, when the tumor invades the chest wall (400) and there is ulceration of the skin (code 512), assign code 612.

20 Slide 23 CS Extension IBC (T4d) 23 To use codes in the range there must be a statement of inflammatory carcinoma. Again the codes contain similar criteria, but there is difference in the amount of involvement. For each code listed on the screen, the following criteria are the same for each code: WITH a stated diagnosis of inflammatory carcinoma WITH or WITHOUT dermal lymphatic infiltration The same skin conditions are present: Edema of skin, En cuirasse, Erythema, Inflammation of skin, and/or Peau d'orange ("pigskin"). Again, the one difference is the amount of involvement of these conditions. The difference between codes 600 and 750 is that code 600 is used when the percent of skin involvement is known and is less than one third. Because the cutoff is 1/3, if the involvement is less than 1/3 of the breast (even if there a statement of IBC), it does not meet the criteria for IBC and is mapped to T4b and not T4d.

21 Slide 24 CS Extension Skin Involvement Not a factor in staging Dimpling Tethering Nipple retraction Lymphatic invasion, NOS LVSI, NOS Code 200 Subcutaneous tissue Skin Adherence Attachment Fixation Induration Thickening 24 Code 100 is for localized disease only. These are tumors that are surrounded by normal breast tissue and do not have any of the involvement mentioned in the higher codes. The majority of breast cases that you will abstract will be a code 100. All other codes (200 and higher) describe regional by direct extension. Involvement of the skin described by the terms on this slide do not qualify for codes 512 and higher. In fact, the use of the words dimpling, tethering, and nipple retraction to describe the breast are not a factor at all in staging and do not have a bearing on which code to choose. When referring to the SKIN, the terms listed under code 200 on this slide are considered as clinical evidence of extension to the skin or subcutaneous tissue. Code 200 would also be used when there is "dermal" lymphatic invasion noted without the use of the terms listed in codes 512 and higher: Edema of skin En cuirasse Erythema Inflammation of skin Peau d'orange ("pigskin"). As mentioned earlier, Paget disease alone does not quality for code 200 (unless of course there is a description of dermal lymphatic invasion).

22 Slide 25 Stated as T_, N_, or M_ Code the highest, most specific code Supported by the documentation Include both clinical and pathologic information NOS codes are not more specific IE: Local NOS, Stated as T1 NOS, Stated as N1 NOS Use only if documentation does not support a more specific code Example: Patient has a T1a breast tumor confined to breast tissue. Size not stated. CS Ext: code 100 CS TS: code 005 Remember the goal in CS is to not only code the highest applicable code, but also the most SPECIFIC applicable code. Also, in the CS we can combine all of the information that we have to determine the highest applicable code for each data item regardless of the source of the information (clinical or pathologic). Often, the NOS codes, including the state as codes will have a higher code number than its subcategories. But, they do NOT have priority over more specific codes with lower numbers. Example: Resection shows that a breast tumor is confined to the breast tissue. The physician states that this is a T1a. Possible code choices are: 100 Confined to breast tissue 120 Stated as T1a (notice that the definition for this code also says with no other information on extension ) Code 100 is the most specific choice even though it is a lower code than the stated as T1a code. The T category will be based on the tumor size for T1 tumors. If the tumor size is NOT stated, then you will code the stated as T1a code in the TUMOR SIZE data item only. If you do not have the specific information about the extension and all you have is a stated T, N or M value, then by all means use the stated as code. That is certainly better than coding unknown. And, just a couple of details about the stated as codes:

23 If the schema only gives you a choice of T1, then you can use that for all T1 subcategories, such as T1a, T1b, etc. That works the other way around too. If the AJCC has a choice of T1a or T1b but all that was stated was T1, then assign T1, NOS. That is specific as you can get. Also, remember that it is the cancer registrar who is making the decision about the most appropriate code in the CS data items based on the documentation available in the medical record and obtained from outside sources. One common coding pitfall is trying to force collaborative stage to match the physician assigned TNM stage. This is not the purpose for the CS data collection system. For example, if the physician assigned a case as T1, the registrar should not be trying to find a code that will map to a T1 or assigning the T1 NOS code. Registrars should be using the documentation in the medical record and making their own decision as to the appropriate code. It may also derive a T1, but it may derive something different. That is ok. The CS derived stage and the physician assigned stage will on occasion, not match. There are several reasons for this including that CS combines clinical and pathologic information where the physician will have a strictly clinical or strictly pathologic stage. Also, the available information may be different. More information may become available after the physician assigned the stage in the medical record. These are only a few examples. In situations when there is no information available to use a more specific code, then it is ok to assign the code that corresponds to the T, N, or M information provided in the medical record.

24 Slide 26 CS Extension T Category Only Code Description 110 Stated as T1mi 120Stated as T1a 130Stated as T1b 140Stated ass T1c 170 Stated as T1 [NOS] 180 Stated as T2 [NOS] Code Description 190 Stated as T3 [NOS] 410 Stated as T4a 605 Stated as T4b 680Stated as T4c 780 Stated as T4d 790 Stated as T4 [NOS] with no other information on extension Review CS Extension, general instructions #6 and #7. In CSv2, more codes were added for when just a statement of the T, N or M value are given and the details of the workup are not known. This was done to provide every effort to avoid the use of code 999 (extent unknown) since extension is also a factor in deriving the appropriate T category. The codes and descriptions provide an option for assigning the CS Extension if the ONLY information that is available is a statement of the T category. For example, if the only information available is a statement of T1c with no other information on extension code as 140 rather than 999. Code 170, T1 NOS, should be used when the statement is T1 without a description of the subcategory (T1a, T1b, etc.). This will generally occur when a patient comes to a new facility without a copy of the pathology report from the facility where the original diagnosis was previously made.

25 Slide 27 Obsolete Codes Review Part I, Section 1, pages I-8 to I-9 Examples: Codes 510, 610, 620, 710, 715, 720 Do NOT use 27 Due to the conversions necessary between the various versions of the CS manual, some codes are made obsolete in the most recent version to allow for a more specific description or to divide information among two or more different codes. Because these codes were used in abstracts in a previous version, the manual has provided a way to save that information for data analysis. Some codes are converted to new codes, others are retained and marked as obsolete. Each situation is handled on a code by code basis in the software. Codes marked as obsolete should NOT be used for abstracting new cases. In the mapping table, you will see that this code will create an error when trying to derive the AJCC 7 th edition. This applies to all data items in all schemas.

26 Slide 28 CS Tumor Size/Ext Eval Documents the type of report or procedure from which the information about CS Tumor Size and CS Extension were obtained Use General Instructions Tumor size and extension both determine T 28 Code how worse/higher T category was determined For breast, both the tumor size and the extent of the primary tumor are important for deriving the T category. There are no site-specific notes or rules, so you should use the general instructions. There are many examples of how to apply these codes in the general instructions that you should review when abstracting a case. When tumor size and extension both determine the T category, select the code that best explains what method was used to determine the HIGHEST T category. This may be taken either from the Tumor size field or the extension field depending on the case. For extension codes 100, 200, 300, the tumor size is required to derive the T category. The evaluation code will be based on the tumor size. The exact code depends on whether the evaluation that determined the highest T category was clinical or pathologic. The next slide is a reminder of the AJCC pathologic staging criteria for the breast. Example: Mammogram shows 1.1cm tumor. Lumpectomy specimen shows.9cm tumor. All margins are negative. Assign the eval code of 3 because 1) the pathology has the priority and 2) the procedure meets the criteria for pathologic staging. CS Tumor Size will be 009 and CS Extension will be code 100.

27 Slide 29 PATHOLOGICAL STAGING: BREAST CANCER All data from clinical classification PLUS Surgical resection of tumor with no tumor grossly in the margins (macroscopically positive) the margins can be microscopically positive Resection of at least the low axillary nodes (Level 1) Generally includes 6 or more nodes Generally for invasive tumors, but there are exceptions or 1 or more sentinel lymph nodes resected 29 To assign the Pathologic T (pt), there must be a resection of the tumor. And, the margins on the FINAL surgical resection must be negative or only MICROscopically positive. If the margins are MACROscopically positive, the case does not qualify for pathologic staging. The pt will be a ptx. To assign the Pathologic N (pn), it is recommended that at least the low axillary nodes (level 1) be resected. Usually six or more nodes would ordinarily be included in such a resection. But, remember from the discussion of the general rules, if less than 6 are removed, the status of the nodes that are removed should be coded. Or, instead of an axillary lymph node dissection, one or more sentinel lymph nodes may be resected and examined for pathologic staging. The sentinel node is the first lymph node in the first draining lymph node basin. If it is negative, it is assumed that all the rest of the nodes are negative.

28 Slide 30 CS Lymph Nodes Record the regional lymph node chain involved at the time of diagnosis Code Regional lymph nodes only Ipsilateral nodes only Either clinically or pathologically involved Code 800 Code 600 Record the highest applicable code 30 NCI Visuals Online, Author unknown Lymph node involvement can be determined, either clinically (physical exam, radiology, etc.) or pathologically (biopsy, resection). For CS Lymph Nodes we are going to record the specific regional lymph node chain that is involved by tumor either clinically or pathologically. In general, the regional lymph nodes in the chain closest to the primary site have the lower codes. Nodes farther away from the primary have higher codes. So, you should record the highest applicable code. For example: Supraclavicular nodes (code 800) were considered positive on physical exam. Axillary nodes (code 600) were biopsied and were positive. Code 800 because this chain has a higher code. The eval code will also have to reflect the radiology because this derives the higher N category.

29 Slide 31 CS Lymph Nodes Reading Assignment Read the notes carefully Review CS Lymph Nodes, general rule #3 Review CS Lymph Nodes, general rule #4 Review Coding Regional Lymph Nodes for the breast in Part I, Section 2, pages I-2-68 through I Review discussion on ITC s in AJCC breast presentation The codes for breast that describe the regional lymph node involvement are very detailed. It is important to read the notes and the criteria for each code very carefully. This slide provides additional references to help you assign the code for this data item. You should take the time to read (or re-read) this information now.

30 Slide 32 CS Lymph Nodes Weeding through codes 1. Are there special circumstances? ITCs (see Note 7) Micromets (see Notes 2 and 3) Fixed/matted (see Note 4) Unless nodes are described as fixed or matted, assume they are moveable Nodes other than axillary (see Notes 1 and 5) 2. Do you have sufficient documentation or are you going to have to use a stated as code? 3. What is the most extensive node involvement? 4. Is it based on a clinical or pathologic evaluation method? This slide provides a few tips for weeding through the sea of codes and narrowing down the zone to start reviewing. Hopefully if the codes can be narrowed down to 5 or 6 instead of 20 or 25, then you can more easily and more quickly determine the most specific code. The first step is to eliminate any special circumstances such as isolated tumor cells, micrometastasis, and involvement of nodes other than axillary nodes. Next determine if there is sufficient documentation to select a code or will a stated as code need to be used. Then, determine the most extensive node involvement and whether that was evaluated using clinical or pathologic methods.

31 Slide 33 Regional Lymph Nodes Axillary, NOS: Level I (low, superficial), NOS: Anterior (pectoral) Lateral (brachial) Posterior (subscapular) Nodes against the latissimus dorsi Level II (mid-level, central), NOS: Interpectoral (Rotter s) Subpectoral Intramammary Infraclavicular subclavicular Axillary Level III (high, deep) Apical (subclavian) Axillary vein Internal mammary parasternal Regional node(s), NOS Nodules in axillary fat The regional lymph nodes for the breast are listed on this slide. The breast lymphatics drain by way of three major routes: axillary, transpectoral, and internal mammary. Intramammary lymph nodes are considered with, and coded as, axillary lymph nodes for staging purposes. So, it is listed under the Axillary NOS heading. All of the regional lymph nodes are ipsilateral, meaning they are located on the same side as the primary site. There are several words used to describe the different levels of axillary lymph nodes. The AJCC and Summary Staging manuals are excellent resources for additional information such as this. Nodules in the axillary fat are coded as regional lymph nodes. These are considered axillary nodes that have lost their structure or are intransit mets in the lymphatics. Codes state axillary lymph nodes. When you see axillary lymph nodes stated in the code description, it is referring to level I and level II ipsilateral axillary lymph nodes and ipsilateral intramammary nodes only. Ipsilateral level III axillary lymph nodes, which are also known as infraclavicular or apical nodes, are coded 750 or higher. Axillary lymph nodes also do not include internal mammary or ipsilateral supraclavicular lymph nodes. Reading the operative reports in addition to the path reports is important for identifying which nodes were removed.

32 Slide 34 Synonyms for H&E Hematoxylin and Eosin H = blue and E = red stain Routine stains Standard stains H&E is commonly done The gold standard used on every tissue IHC would be mentioned if done Both would be mentioned on path report If not mentioned, assume it wasn t done NCI Visuals Online, Otis Brawley 34 Most cells have a reproducible staining pattern. H and E refers to the type of staining used to identify the various structures in cells. This picture shows a microscopic view of a malignant tumor using the H&E (or blue and red) stain. If the nodes are examined microscopically, H&E staining was done. This is the standard stain used. IHC and molecular studies are special stains and are not always done. If IHC or molecular studies were done, it would be mentioned on the pathology report. If not mentioned, assume IHC and/or molecular studies were not done. Slide 35 Synonyms for IHC 35 Immunohistochemistry Immunocytochemistry Immunochemistry Cytokeratin Pankeratin Keratin IHC staining AE1/AE3 or AE1/3 (special stains) MNF116 CAM 5.2 This is for reference only. These are some of the other terms you may see used to describe the IHC test.

33 Slide 36 CS Lymph Nodes Size of Mets Code based on how detected Type of metastasis Size IHC H&E (only) Nodes not involved 000 Isolated tumor cells < 0.2 mm Micrometastasis > 0.2 to < 2mm Metastasis (size stated) > 2 mm or higher Mets (size not stated) assume > 0.2mm FOR BREAST Nodes with ITC only are NOT considered positive lymph nodes (pn0(i+)) For melanoma and Merkel cell carcinoma, + ITCs ARE considered pos LN For some codes, the code you choose depends on the size of the metastatic involvement within the lymph node. These are very specific so read all of the information in each code. Remember that one of the things we can weed out is if there are special circumstances such as ITC or micromets. The size of the metastasis in the lymph node determines if the patient has macrometastasis, micromets or ITCs in the lymph nodes. This table shows the breakdown of the codes when the test results are POSITIVE and is based on the size of mets found in the LN. The code also depends on how the mets were detected (IHC or H&E). For example: If nodes were not involved, use code 000. If the behavior code and CS Extension is in situ, CS Lymph Nodes must also be 000. Use code 000 when there are ITCs and they were detected using IHC only. Use code 050 when there are ITCs and they were detected using H&E. Use code 130 if there are micromets and they were detected using IHC only. Use code 150 if there are micromets and they were detected using H&E. Use code 250 or higher when a size of the mets is stated and is greater than 2mm, regardless of how detected. Use code 600 if nodes are positive but size of the mets is not stated. In this case, we are assuming they are greater than 0.2mm and we at least have micromets. This does not say that it can be assumed that the mets is greater than 2.0 mm which is what is needed for code 250. Because there is no specific information about the size of mets, use code 600. See Note 3. For the breast, nodes with ITC are not considered positive lymph nodes. This rule is site-specific. Be sure to review and apply the site specific rules for each site. Also, if you will remember from the CS general rules, the burden of proof for coding the lymph nodes depends on if the lymph node region is considered inaccessible or accessible. The lymph nodes for the breast are considered to be accessible because they can be palpated. For accessible lymph nodes that can be observed, palpated or examined without instruments, such as those for the breast, there should be some description of the regional lymph nodes. Even a very generic statement such as remainder of examination negative is sufficient to code regional lymph nodes as clinically negative. If there is no statement about the nodes clinically or pathologically -, then you should code to unknown.

34 Slide 37 CS Lymph Nodes method of evaluation Codes allow for distinction between clinical and pathologic involvement 37 Only code the clinical findings when: There was no pathological assessment of the lymph nodes (Lymph node biopsy or dissection was not done) There was pre-op treatment and the clinical node involvement was more extensive prior to treatment An important factor for the CS Lymph Nodes data item is to differentiate between whether the nodes were evaluated clinically or pathologically. If the code description states evaluated clinically, that code can only be used if the information related to the lymph node involvement is based on a clinical evaluation. This also applies to nodes evaluated pathologically. If the code description states evaluated pathologically, that code can only be used if the information for the lymph node is based on a pathologic evaluation. If the code description does not specify clinical or pathologic, then the code can be used either type of evaluation. You will primarily only find this for the stated as codes. In the example on the slide, codes 510 and 520 basically refer to the same level of involvement. The difference is whether the involvement was determined clinically or pathologically. Because pathologic confirmation is preferred, codes describing pathologic assessment of nodes will have the higher code and have priority over the clinical findings. You will also see that for the clinical evaluation there is also a note that says you are coding the clinical involvement because neoadjuvant treatment was given or because there was no pathology confirming that involvement. As a general rule, pathological findings take precedence over clinical findings. Only code the clinical assessment of lymph nodes when a biopsy or dissection of those lymph nodes was NOT performed. Also because pre-operative treatment can change the status of the nodes at the time the surgery is done, you should only code the pathologic node involvement if the involvement is more extensive than the pre-treatment clinical assessment. If there was pre-operative treatment, and the pre-treatment clinical assessment is more extensive, then you should code the clinical assessment. In other words, we want to describe the most extensive involvement. The evaluation code will describe where you obtained this information. This allows the clinical findings to be coded and maintained in the stage mapping if it was more extensive than the posttreatment pathological findings. This is the same concept we are very familiar with just now it is specified in the codes. Because the codes related to clinical evaluation and pathologic evaluation skip around, try to determine that before you start reading the codes.

35 Slide CS Lymph Nodes Codes Positive axillary nodes only Level I and II, intramammary only Code 600 No other information describing the involvement, regional NOS Codes Positive internal mammary Level III axillary With and without other nodes Code 750 infraclavicular Code supraclavicular Axillary only Internal Mammary Code : : Codes describe involvement of the axillary nodes only. So, if the only involvement that you have is in the axillary nodes (which will be the majority of the cases), then you will need to assign a code from the range. Refer to the earlier slide that listed what is included in axillary. Even though code 600 is a higher code than , code 600 should be used only if there is no other information describing the lymph node chain involved. If the medical record just states lymph nodes involved or positive and there is no other information describing fixed versus moveable, or micrometastasis, etc., then you should use code 600. You may want to add the phrase no other information to your code 600 box. Note 4: Unless nodes are described as fixed or matted, assume they are moveable. Codes describe when there is involvement of the internal mammary nodes. The exact code that you choose depends on whether or not there is involvement of other chains IN ADDITION TO the internal mammary nodes. In the middle of the internal mammary nodes range, there is code 750 which applies when there are only infraclavicular nodes involved. Code 800 is used when there are supraclavicular nodes involved. The axillary nodes being involved is not a factor for these two codes. They can be involved, but don t have to be.

36 Slide 39 CS Lymph Nodes -- Internal Mammary Not clinically apparent codes 710, 720, 730 no palpable or suspicious nodes on clinical workup positive only on node biopsy sentinel node bx of internal mammary node positive exact code depends on axillary node involvement 39 Clinically apparent codes 740, 745, 760, 763, 764, 765 detected by imaging studies or by clinical examination imaging (CT, CXR, etc) but not lymphoscintigraphy physical exam (palpable) visible nodes on gross pathology exact code depends on axillary and infraclavicular node involvement If you will notice beginning with code 710 and continuing through 765 the terminology for evaluated clinically changes to clinically apparent and not clinically apparent. The AJCC manual also provides a definition of each of these terms in the breast chapter. The exact code for identifying the internal mammary node involvement depends on whether the internal mammary nodes were clinically apparent or not. Within this division, the exact code depends on whether or not the axillary and/or infraclavicular nodes are involved IN ADDITION TO the internal mammary nodes. Clinically apparent means that the nodes were determined to be involved on either imaging studies or on the clinical examination. For the codes that specify clinically apparent, they could have also been positive on pathology, but it is more important to document that there was clinical involvement for correct mapping. Notice that clinical involvement maps to N3b where not clinically apparent maps to N2b. So if the internal mammary nodes were positive clinically and positive on pathology as well, then code the clinically apparent findings. For it to be classified as not clinically apparent, there had to have been no evidence of node involvement on imaging studies or clinical examination. Therefore, the only evidence of involvement would have to be the pathologic findings. Lymphoscintigraphy: mapping of sentinel lymph nodes using radioisotopes to identify nodes for removal by sentinel node biopsy. That does not count as a imaging study for identifying involved nodes.

37 Slide 40 CS Lymph Nodes -- Internal Mammary Code 735 versus codes New code added in CS v02.03 Allows for new rules for coding intent of lymph node procedure Review the general instructions on coding the intent of the lymph node procedure for the CS LN Eval data item. Code 735 is a new code added in CS v02.03 which went into effect in The difference between codes 735 and codes 740 and 745 is that code 735 allows for the new concept of coding the intent of the lymph node procedure. Code 735 states the primary tumor was not resected meaning the sentinel lymph node biopsy would be a clinical evaluation and not a pathologic evaluation. Code 735 is needed to capture those cases in which a sentinel lymph node biopsy was done and the intent was a clinical evaluation. This special code is only needed for the internal mammary nodes because clinically apparent or not is an important factor in staging just for these nodes.

38 Slide 41 CS Lymph Nodes -- Supraclavicular Nodes SEER vs TNM Positive supraclavicular lymph nodes are coded to regional lymph nodes, code 800 Considered regional nodes in TNM Considered distant nodes in SEER Summary Stage 41 For the purpose of deriving summary stage, supraclavicular nodes are distant. If you look in the SS2000 column, there is a D for distant and it is the only D in this column. In AJCC, supraclavicular nodes are considered regional because patients with positive supraclavicular lymph nodes experience the same prognosis and outcomes as those with positive axillary lymph nodes. So, it is included in the regional LN data item in CS. If the supraclavicular nodes are involved (regardless of what other nodes are involved), you should record the code 800 in this data item. The algorithm will derive the correct stage for each staging system.

39 Slide 42 CS Lymph Nodes Statement of the AJCC N category only Code based on the physician s statement of N Special codes in the CS Lymph Nodes Data Item Examples: Code 260: Stated as N1 Code 610: Stated as N2, clinical only Code 620: Stated as N2, pathologically Code 510: Stated as N2a, clinical only Code 820: Stated as N3 42 Coding Unknown versus Not Involved Regional nodes for the Breast are accessible Need statement of evaluation to code not involved No palpable adenopathy Remainder of exam negative There are special codes for the physician s statement of the N category. This is used only when there is not enough information in the chart to assign the specific code. If all that is stated is N1 and you cannot obtain better information, then assign code 260. Also, if you will remember from the CS general rules, the burden of proof for coding the lymph nodes depends on if the lymph node region is considered inaccessible or accessible. The lymph nodes for the breast are considered to be accessible because they can be palpated. For accessible lymph nodes that can be observed, palpated or examined without instruments, such as those for the breast, there should be some description of the regional lymph nodes. Even a very generic statement such as remainder of examination negative is sufficient to code regional lymph nodes as clinically negative. If there is no statement about the nodes, then you should code to unknown.

40 Slide 43 CS Lymph Nodes Eval Specifies which diagnostic methods were used to determine farthest Regional Lymph Node involvement Very Important! Record the report or procedure from which information on the highest N category was obtained May not be numerically highest eval code Must also consider the intent of the procedure 43 CS Lymph Nodes Eval records how the code for the CS Lymph Nodes item was determined or evaluated, based on the diagnostic methods employed. Select the code that documents the report or procedure that determined the HIGHEST N category. This may not be the numerically highest eval code. Remember from the general rules that the lymph nodes eval also take into consideration the INTENT of the procedure. When the intent is workup, the staging basis is clinical, and when the intent is treatment, the staging basis is pathologic. There are many examples in the general rules that you should review when abstracting to ensure you are applying this code correctly. For the most part, the codes are the same and have the same meaning for Lymph Nodes Eval as they did for TS/Ext eval. The difference is you are looking at the evaluation of the regional lymph nodes and not the primary site. To use a code 3, there must have been removal of at least one regional lymph node. The pathological evaluation must meet the criteria for pathological staging which can vary by site. You should refer to your AJCC manual for clinical vs pathological staging criteria. Or, any microscopic assessment of a regional node in the highest N category qualifies as pathologic staging, code 3. For breast, this would be the supraclavicular nodes.

41 Slide 44 Regional Nodes Positive Regional Nodes Examined 44 Use the general instructions Regional nodes only Examined by a pathologist Cumulative from all procedures recorded even if preoperative treatment Do not count nodes with only ITCs If size of mets not stated, assume > 0.2 mm and count as positive This field includes ALL regional lymph nodes (those listed in CS Lymph Nodes) examined by a pathologist. Do not include any lymph nodes considered distant. Lymph nodes with only isolated tumor cells (ITCs) are NOT counted as positive lymph nodes. Only lymph nodes with metastases greater than 0.2mm (micrometastases or larger) should be counted as positive. If the pathology report indicates that nodes are positive but size of the metastases is not stated, assume the metastases are > 0.2mm and code the lymph nodes as positive in this field.

42 Slide 45 CS Mets at Dx Code 05: Special studies identify circulating tumor cells, M0(i+) Code 10 Any contralateral or bilateral nodes is considered distant Cervical lymph nodes are considered distant Supraclavicular nodes are coded under CS Lymph Nodes 45 Code 42 Further contiguous (direct) extension to the skin Other codes (40 & 44) describe discontinuous metastases This field identifies the distant site(s) of metastatic involvement at the time of diagnosis. Use code 05 if there are no other evidence of mets but special studies identify circulating tumor cells 0.2mm or less. Refer to the AJCC manual for more information on circulating and disseminated tumor cells. This will also be discussed in more detail in the SSF slides. Distant nodes include any contralateral or bilateral node involvement, including contralateral axillary nodal involvement. Supraclavicular node involvement was included in the CS Lymph Nodes field. It is not coded again here. Direct extension to certain areas of the skin are considered distant. Those areas are listed in code 42. All other codes describe discontinuous metastases (2 or more separate tumor masses). Use code 44 when the specific areas listed in the description are involved. For all other discontinuous mets, use code 40. Code 50 is a combination code and is used if distant lymph nodes AND any other distant site is involved. Remember that a clinical M only requires a history and physical. Extensive testing does not have to be done to assign a cm. You can infer a cm0 unless known to be cm1.

43 Slide 46 CS Mets at Dx Code 40 Applies when the site of mets is known but is not any of those listed in codes Code 60: Non-specific Applies when there are mets, but the exact site of mets is not known At first glance, it appears that codes 40 and 60 are basically the same. For most sites, code 40 includes statements of metastases to specific named structures. Code 60 includes when there is mets to a nonspecific site such as a statement of M1 only with no further information about exactly which sites were involved. Code 60 does not take priority over lower codes. If you know the exact sites, then one of the lower codes will most likely apply because it is more specific than code 60.

44 Slide 47 CS Mets Eval Documents the diagnostic method used to determine CS Mets at Dx Use General Rules Documents report or procedure from which highest M category was determined May not be numerically highest eval code 47 This data item follows many of the same concepts as CS Tumor Size/Ext Eval and CS Lymph Nodes Eval. This eval field describes how the code for the CS Mets at DX data field was determined based on the diagnostic methods employed. Since both clinical and pathologic evidence might be available for assessing distant metastasis, the coding of the Eval field can be confusing. The goal is to assign the Eval code that indicates the best evidence used to determine the HIGHEST M category. In other words, what you want to do is select the eval code that describes what procedure was used to determine the highest M category. Keep in mind this may not be the numerically highest eval code. If there was any pathological evidence for the highest M1 category, select an Eval code that will derive a p staging basis. If it is the clinical evidence that will derive the highest M1 category, select an Eval code that will derive a c staging basis. Any positive biopsy or resection of distant metastasis meets the requirement for pathologic staging basis and is Code 3. This is different than the other eval fields so you may want to make a note of that in the description for code 3. Because we have to code ANY positive biopsy as a code 3, biopsies are not part of Code 1, as with the other eval fields. Code 1 for this eval field includes endoscopies and observations at surgery where distant metastasis are NOT biopsied. Clinical M only requires a history and physical. Extensive testing does not have to be done to assign a cm. You can infer a cm0 unless known to be cm1.

45 Slide 48 CS Mets Eval There is no pathologic M0 (pm0) A biopsy or removal of a distant site Pathology report is negative Maps to M0 Assign Eval code 1 (cm0) 48 Don t forget, there is no pathologic M0. For the TS/Ext eval and the Lymph Nodes eval fields, code 3 was the pathologic assessment. AJCC does not recognize a pathologic M0 category since it is not possible to rule out all possible metastatic sites. There is no way to resect every tissue in the body to rule out mets. Therefore, if the patient has a biopsy or even if they remove an entire distant site and the pathology report is negative, this does not meet the criteria of pathologic staging. This will map to M0. You should assign the Eval code 1 to derive a clinical M0. This only applies to M0, not to all M categories. You can have a pathologic M1. If they remove a distant site and it is positive, this would be a pm1, eval code 3.

46 Slide 49 Mets at Dx-Metastatic Sites 4 separate fields Bone excluding marrow Lung excluding pleura and pleural fluid Brain excluding spinal cord and other CNS Liver Code 0 when CS Mets at Dx is The four Mets at Dx fields are supplementary fields and will be coded when CS Mets at Dx is not coded as 00. If Mets at Dx is coded as 00, code these fields as 0, no distant metastases, except for sites where Mets at Dx is coded 88 or 99. These four fields are used for analysis of specific metastatic sites. There is not a data item with codes and coding instructions repeated in each sitespecific schema. You will have to refer back to the Part I, Section I for this information. There is one field for bone metastases excluding bone marrow, one field for lung only (excluding pleural and pleural fluid metastases), one field for brain only (spinal cord and other CNS sites excluded) and one for liver metastases. The code structure is simple: 0 for No 1 for Yes (metastases are present at this site) 8 for not applicable (certain primary sites) and 9 for unknown (for example, when metastases are reported as "carcinomatosis but the specific location(s) of the metastases are unknown. While these codes will be redundant for a few sites where metastases in specific sites are coded as part of CS Mets at Dx, they will provide better information for researchers looking at treatment of solitary metastases and other therapeutic advances.

47 Slide 50 SSF Reading Assignment As each SSF is discussed, read the related information in Part I, Section 2 for the breast. Note: Not all SSF s have additional information 50 Breast is one of the few sites that use almost all of the SSF fields. There are 24 SSFs collected for breast. For this learning process, we will discuss all SSFs. However, it is important to note that the standard setting agency that you report to may not require that all SSFs be collected. You should check with your reporting requirements when abstracting as to which SSF you are required to collect.

48 Slide 51 SSF 1 and 2 SSF 1: Estrogen Receptor Assay (ERA) SSF 2: Progesterone Receptor Assay (PRA) Code 010 ER-positive PR-positive Code 020 ER-negative PR-negative ER/PR + ER/PR - ER + / PR - ER - / PR + Favorable 51 Unfavorable SSF 1 and 2 are used to record the ERA and PRA results. Certain tumor cells have receptors for hormones such as estrogen and progesterone, which means that the cells will bind to these hormones. Since these hormones play an important role in the development, treatment, and prognosis of certain tumors, an important step in the evaluation of a person with breast cancer is to test for the presence of these hormone receptors. Knowing the hormone receptor status of a breast cancer helps guide treatment. Breast cancers that are hormone receptor positive tend to have a better prognosis than those without hormone receptors and are more likely to respond to hormonal therapy. Breast cancers that contain estrogen receptors are referred to as ER-positive (estrogen receptor positive) tumors. Those that do not are referred to as ER-negative. And the same goes for progesterone receptors. Listed on this slide are some of the common phrases you may see to describe the estrogen and progesterone receptor assays. The results of positive and negative can be found in any combination. If both hormone receptors are found, they are called ER/PR positive. Or, they can both be negative (ER/PR negative) if neither receptors are found. Or, one can be positive and the other one negative. ERA findings are coded in site-specific factor 1. ER+ = code 010, ER- = code 020. PRA findings are coded in site-specific factor 2. PR+ = code 010, PR- = code 020.

49 Slide 52 SSF 3: Number of Positive Ipsilateral Axillary Lymph Nodes Axillary Level I II INTRAmammary Axillary Level III Infraclavicular 52 Level I and II, INTRAmammary ONLY Code 098 (LNs not examined) Internal Mammary In the Regional Nodes Positive and Examined fields, the total number of REGIONAL lymph nodes are coded. This could be from any of the chains listed on the slide. For CS LN s and SSF 3, only code the number of positive AXILLARY lymph nodes in Level I and II only. This also includes the INTRAmammary nodes. Level III lymph axillary nodes are not included. The code structure is similar to Regional Nodes Positive except that it is 3 digits instead of 2. This number cannot be greater than the number recorded in Regional Nodes Positive. The most important clarification for SSF3 is that Level III ispilateral lymph nodes are not included here BUT the intramammary nodes are. Also, remember that SSF 3 is based on the pathologic findings only.

50 Slide 53 SSF 4: IHC of Regional Nodes Negative on H and E Looking for isolated tumor cells (ITC) Codes Regional lymph nodes are negative CS Lymph Nodes must = 000 Code 000 Not stated if IHC was done Nodes not examined pathologically Code Regional lymph nodes are positive CS Lymph Nodes NOT = 000 In the IHC process, the pathologist is looking for isolated tumor cells or a single tumor cell in the lymph node. Under normal pathological examination, if the lymph nodes were negative, they may choose to go one step further by staining these cells using the IHC process to see if they can identify any isolated tumor cells. For this data item, we must first know if the lymph nodes were positive or negative on routine pathological examination (H&E). If the regional lymph nodes were negative, then use codes The CS Lymph Nodes field must also be coded to 000 when choosing from this range of codes. If the nodes were negative and the IHC study was done, then choose the appropriate code ( ) that describes the findings (IHC negative, IHC positive size stated, IHC positive - size not stated). If it is not stated that IHC testing was done, then assume it was not done and use code 000. Also, if the lymph nodes were not pathologically examined at all, then also use code 000. Use code 987 if the regional lymph nodes were positive on pathological exam. The CS Lymph Nodes field cannot be 000 if choosing this code. More than likely, the majority of the time, you will code either 000 or 987.

51 Slide 54 SSF 5 Molecular Studies of Regional Nodes Also called RT-PCR Negative on H and E Looking for isolated tumor cells (ITC) Codes Regional lymph nodes are negative CS Lymph Nodes must = 000 Code 000 Not stated if RT-PCR was done Nodes not examined pathologically 54 Code 987 Regional lymph nodes are positive CS Lymph Nodes NOT = 000 Again, if the lymph nodes were negative, they may choose to go one step further by staining these cells, but instead with a molecular study process to see if they can identify any isolated tumor cells or a single tumor cell in the lymph node. The molecular method is RT-PCR: Reverse Transcriptase Polymerase Chain Reaction. Usually either the IHC (SSF 4) OR the Molecular Studies (SSF 5) will be done not both. Molecular studies are less commonly done. If there was no statement of whether molecular tests were done, assume they were not done. If the regional lymph nodes were negative, then use codes The CS Lymph Nodes field must also be coded to 000 when choosing from this range of codes. If the molecular study was done, then choose the appropriate code ( ) that describes the findings. Also, if the lymph nodes were not pathologically examined at all, then also use code 000. Use code 987 if the regional lymph nodes were positive on routine pathological exam. The CS Lymph Nodes field cannot be 000 if choosing this code.

52 Slide 55 SSF 6 Size of Tumor Invasive Component Record how the tumor size was determined - the invasive component and/or in situ components Pure only invasive or only in situ Code 000 invasive Code 010 in situ Mixed both invasive and in situ components Code 020 size of invasive coded in tumor size Codes entire tumor size coded with description of in situ as minimal or extensive Codes proportions or size unknown 55 Clinical size Code 987 unknown if mixed or pure Clinical size coded This field is for analytic purposes and does not affect the stage grouping algorithm. Special codes to describe if the tumor is: Mixed : a tumor with both invasive and in situ components. "Pure : a tumor containing only invasive or only in situ carcinoma.

53 Slide 56 SSF 6: Size of Tumor Pure only invasive or only in situ Codes 000 (all invasive) 010 (all in situ) Mixed both invasive and in situ components Codes Code proportions or size unknown OR Code 060 means that you KNOW invasive and in situ component are definitely present, you just don t have a tumor size to code, not even the entire tumor size which would fall under code 050. As a result, you had to code 999 in the CS TS field. If the tumor size is unknown AND you don t know if invasive or in situ components are present, then the correct code is 987. If you don t have a PATHOLOGICAL tumor size and the tumor size recorded in CS Tumor Size is the clinical tumor size, then the correct code is also 987. According to NOTE 1, this SSF is based on the PATHOLOGICAL tumor size. So, these 2 statements listed are 2 separate statements. Unknown if inv/insitu OR clinical TS coded. There is no way you would know if there was an in situ component without a pathologic examination. Also, code 000 would be for cases that are all Paget s invasive and no underlying tumor. For this data item, do not do your own calculations. For example, total tumor size: 1.2cm in greatest dimension. DCIS present, size of DCS is 0.4cm. Don t assume the invasive component is the difference between the total tumor size and the size of the DCIS. CS Tumor size should be coded to 012 and SSF 6 would be code 050 (invasive and in situ, entire TS coded because size of invasive component not stated).

54 Slide 57 SSF 7: Nottingham or Bloom- Richardson Score/Grade Coding instructions in Part I, Section 2 Scores for each of the three factors range from 1-3 Total score ranges from 3-9 Record total score if given, codes If any of the factors are described as low, intermediate or high, do not translate to a number 57 The AJCC and College of American Pathologists recommend the Nottingham or Bloom-Richardson score and/or grade as the preferred method for reporting histologic grade for breast cancers. The score based on three factors: degree of tubule formation (histologic grade), mitotic activity, and nuclear pleomorphism (nuclear grade). Each of the factors receives a score of 1, 2, or 3, based on specific pathologic criteria. Since each of the factors receives a score of 1,2,or 3, the minimum score is a 3 while the maximum score is a 9. If the report describes any of the factors with words (low, intermediate, high) rather than numbers, do NOT attempt to translate these words into a number. The priority is to code the BR total score. There are detailed coding instructions in Part I, Section 2 that you should refer to that describes how to handle cases where the total score is not given. The appropriate score will be reflected in the second digit of the code.

55 Slide 58 SSF 7: Nottingham or Bloom- Richardson Score/Grade If BR score not given Look for BR grade, Nottingham grade, or Nottingham-Tenovus grade Grades are expressed as: Low grade (scores 3-5) Intermediate grade (scores 6,7) High grade (scores 8,9) If only grade is stated Record grade, codes Grades are based on the scores as shown above, but only the grade itself may appear in the chart or in the CAP Protocol. If no score is given, but a grade is given code the grade accordingly. The first digit of 1 indicates that this is a grade rather than a score while the second digit reflects the actual grade. Clinical only diagnoses should be coded as 998 reflecting the fact that there is no histologic specimen to score.

56 Slide 59 SSF 7: Nottingham or BR Score/Grade If two scores are given Code highest score (even if only a focus, or from the smaller resected specimen) Code total score You can add for the total score if you have all three grade factors Nottingham Score: = Score 7 (code 070) Use the Nottingham Score from the biopsy if neoadjuvant therapy was given. Codes (scores) take priority over codes ( stated as grades) An instruction has been added to clarify that you should use the highest score. The grade plays a role in determining treatment and prognosis, so it is important to have the highest score recorded, even if only a small part of the tumor was more aggressive since this affects survival. If the score is not stated, but you are given the grades for each of the three factors, you may add these to get a total score if it isn t added on the pathology report. Example: Glandular/tubular differentiation score: 3 Nuclear score: 2 Mitotic score: provided as a range of 1-2 we will take the highest the score of 2 for a total Score =7 (coded 070) Neoadjuvant therapy can change the grade, so take the Nottingham Score from the Breast biopsy if neoadjuvant therapy was given. This instruction can be found in the FORDS and SEER manual for coding grade. If a BR score is given and a BR grade is given, code the score. The score has priority over the grade.

57 Slide 60 SSF 7: Nottingham or (BR) Score/Grade Code 999: Only documentation is grade 1, 2, 3 or 4 Only statement is low, intermediate or high grade Only code in SSF 7 if you KNOW the term is related to the Nottingham score. Do not assume. BR can still be converted to Grade/Differentiation CSv0203 still says use FORDS 2010 conversion table Do not record in GPV/GPS data items Part I - Section 2 - Page 87 does instruct that we can use the specific codes if the grade is stated as low, intermediate or high grade. However, we can only use these codes when we know that the score is a Nottingham score and more specific information regarding the score is not available. If the only information is "high grade," then we cannot assume that it is Nottingham's and the appropriate code would be 999 for unknown. The same applies to a stated grade (Note 4). If only a grade of 1 through 4 is given with no information on the score and it is unclear if it is a Nottingham or BR Grade, code 999. Do not assume. Many questions have arisen when the BR conversion table was taken out of the front of the FORDS. Appendix C in the FORDS states it was because this is described elsewhere. The CS manuals says this is described in the FORDS A question posted to the CAForum and the reply from the NCDB was: The instruction for coding Grade has NOT been changed, except only the labels of grading systems were swiped out; but the logic of conversion is the same. You should continue to use the table in the FORDS 2010 until we receive different instructions. Do not record BR score in the new grade path value and system data items. Only in rare instances would a breast case be reported numerically as grade 1/3 or grade II/IV, and that is the only situation where Grade Path Value/System would be coded something other than blank for breast cases. To take that a step further, Part I section 1 p84 #1a states to code GPV and GPS from the SAME information used to code the grade/differentiation data field. So, if a BR is stated, that will be coded in the grade/differentiation data item. If for example, the grade is also given as a numeric grade 1/3, you still would not use this in the GPV and GPS data items since that is not what you used to code the 6 th digit grade/differentiation data item. The GPV and GPS fields would be left blank. The only time you can code a grade such as 1/3 in the GPV and GPS is if that is the ONLY grade given and a NH or BR score is not given which will be rare.

58 Slide 61 SSF 8-15 HER2 Test Lab Values and Interpretations SS Factors 8-9: HER2 IHC Test SS Factors 10-11: HER2 FISH Test SS Factors 12-13: HER2 CISH Test SS Factor 14: Other HER2 Test 61 SS Factor 15: Her2 Summary Results Eight SSFs are devoted to HER2 Test Results and Interpretation. 2 each for IHC, FISH, and CISH, 1 for any other or unknown which test, and a summary of the results of all HER2 Testing since patients may have multiple tests performed, especially if the result of the first test is borderline or equivocal. Slide 62 SSF 8-15: HER2 Testing Human Epidermal growth factor Receptor 2 May be referred to as: HER2, HER2neu, erbb2, c-neu 62 Usually only one test will be performed Immunohistochemical (IHC) Fluorescence In Situ Hybridization (FISH) Chromogenic In Situ Hybridization (CISH) Usually only one test is performed to determine the HER2 status. If the results of either the IHC or FISH or CISH test is equivocal, the American Society of Clinical Oncology guidelines recommend that a second test be performed.

59 Slide 63 SSF 8-15: HER2 Testing Four known HER proteins: HER1, 2, 3, and 4 Testing for overexpression of HER2 63 HER2 overexpression and/or dysregulation may lead to increased/uncontrolled proliferation decreased apoptosis (programmed cell death) enhanced tumor cell motility angiogenesis For these SSFs, we are only interested in the HER2 results. Overexpression indicates tumor may grow more aggressively. A lack of overexpression indicates patient may not respond to certain therapies such as Herceptin which is designed to turn off or deregulate the overexpression of HER2. Slide 64 SSF 8-15 Interpretation of Test Results Results of many tumor markers and laboratory tests vary according to laboratory conducting test 64 In priority order: 1. Code the clinician s/pathologist s interpretation of the lab test 2. In the absence of a doctor s interpretation, use the reference range for the lab listed on the test report 3. If neither is available, code as unknown Definitions of positive/negative vary from one lab to another. Each may have a different range for normal values. Look first for the clinician/pathologist interpretation at your facility and if not found, look on the actual lab report for that particular lab s reference values. If neither a physician interpretation or lab reference range can be found, do not attempt to interpret the results. Code as unknown.

60 Slide 65 SSF 8-9 HER2: IHC Test Determines whether there are additional copies of the HER2/neugene in the tumor cells compared to control Results reported as a SCORE If results are equivocal, FISH test may be performed 65 HerceptTest common IHC test IHC, or ImmunoHistoChemistry, is a special staining process performed on fresh or frozen breast cancer tissue removed during biopsy. IHC is used to show whether or not the cancer cells have HER2 receptors and/or hormone receptors on their surface. This information plays a critical role in treatment planning. IHC for HER2 testing IHC is the most commonly used test to see if a tumor has too much of the HER2 receptor protein on the surface of the cancer cells. With too many receptors, the cells receive too many growth signals. The medication Herceptin (chemical name: trastuzumab) works by blocking these receptors and preventing the growth signals from getting through to the cancer cell. The IHC test gives a score of 0 to 3+ that indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. If the tissue scores 0 to 1+, it s called HER2 negative. If it scores 2+ or 3+, it s called HER2 positive. People with HER2-positive scores tend to respond favorably to Herceptin. The medication is not considered effective for tumors with IHC scores of 0 or 1+. It's important to note that results on the IHC test may vary from lab to lab and that some labs are more experienced with testing for HER2 than others. The IHC test results are most reliable for fresh or frozen tissue samples. IHC tends to be an unreliable way to test tissue that's preserved in wax or other chemicals.

61 Slide 66 SSF 8 HER2: IHC Test Lab Value Code Description 000 Score Score Score Score The actual overexpression score is reflected in the 3 rd digit. A score of 0 indicates no overexpression. If it is documented that an IHC test was ordered, but the results cannot be found in the chart, use code 998. Slide 67 SSF 9 HER2: IHC Test Interpretation Code Description 010 Positive/elevated 020 Negative/normal; within normal limits 030 Borderline; equivocal; undetermined whether positive or negative 67 If an IHC test was performed and the results are interpreted in the chart, record as positive, negative or borderline. Note: 1+ or 2+, etc. should be read as 1 plus or 2 plus and not as 1 positive or 2 positive, etc. to mean the test was positive. If the test results are in the chart but there is no interpretation and no laboratory guideline given, record as unknown.

62 Slide 68 SSF HER2: FISH Test Determines whether there are additional copies of the HER2 receptor protein in the tumor cells compared to the normal number Results are reported as a RATIO between the number of copies of the HER2 receptors and the control 68 If the test is equivocal, an IHC test may be ordered The FISH test is another method of testing for overexpression of the HER2 gene requiring different laboratory techniques which are more expensive than IHC but also thought to be more accurate. The result is expressed as a ratio rather than as a score. Slide 69 Example of FISH Report For HER2 FLUORESCENCE IN SITU HYBRIDIZATION SPECIMEN: Breast mass, left. CLINICAL HISTORY/REFERRING DIAGNOSIS: Ductal adenocarcinoma GROSS DESCRIPTION: Block 1A. 69 TEST PERFORMED/PROBES USED: HER-2/neu gene locus specific probe (17q11.2-q12) Chromosome 17 alpha satellite DNA specific probe (17p11.1- q11.1) RESULTS: The ratio of HER2 fluorescent signals to chromosome 17 centromere signals was 1.4 which does not indicate amplification of HER2neu gene. Negative for HER-2/neu gene amplification. nuc ish 17p11.1-q11.1(D17Z1 x 2.2),17q11.2-q12(HER2 x 3.1)[30/30] Both the ratio (1.4) and the result (negative) are given in the results.

63 Slide 70 SSF 10 HER2: FISH Test Lab Value Code Description Ratio of 1.00 to 9.86 (enter exact ratio to two decimal places) 987 Ratio of 9.87 or greater 70 The ratio from the example report of 1.4 would be recorded as 140. Slide 71 SSF 11 HER2: FISH Test Interpretation Code Description 010 Positive/elevated 020 Negative/normal; within normal limits 030 Borderline; equivocal; undetermined whether positive or negative 71 For FISH, the definition of positive, negative or borderline varies from lab to lab. If a FISH test was performed and the results are interpreted in the chart, record as positive, negative or borderline. If the test results are in the chart but there is no interpretation and no laboratory guideline given, code as unknown

64 Slide 72 SSF HER2: CISH Test Chromogenic in-situ hybridization (CISH) Only recently (spring 2009) licensed by the FDA Less expensive Unlike fluorescence, does not fade over time 72 The CISH test has the advantage of being less expensive and more durable than FISH, and now that it has been licensed in the United States, it is thought that it will rapidly replace FISH testing. It is already in wide-spread use in Canada. Slide 73 Example of CISH Report For HER2 CHROMOGENIC IN SITU HYBRIDIZATION HER-2/ne gene (SPOT-Light Her2 probe) Number of tumor cell nuclei counted: 60 Number of HER-2/neu gene copies: 253 Mean HER-2/neu gene copy number: 4.22 CONCLUSION Negative: No HER 2/neu gene amplification Note: Borderline negative result (within borderline 4-6 gene copy range) 73 Analytic Test Information Zymed Laboratories SPOT-Light CISH Her-2 neu gene probe, CEP17 probe and detection kits are employed in this laboratory. Results are expressed as the mean number of HER-2/neu gene copies per cell. In this example it is the ratio of the number of copies detected, divided by the number of tumor cell nuclei counted in this case 253/60 = In this case, the conclusion was negative, but if the reference range of this lab is considered (4-6) the results were borderline negative, meaning that the results were on the low (negative) end of borderline. Nevertheless, the results should be coded as borderline rather than negative.

65 Slide 74 SSF 12 HER2: CISH Lab Test Value Code Description Mean of 1.00 to 9.86 (enter exact mean to two decimal places) 987 Mean of 9.87 or greater 74 Record the exact mean to two decimal places, but do not include the decimal point. A mean of 4.22 (as in the sample report) should be recorded as 422.

66 Slide 75 SSF 13 HER 2: CISH Test Interpretation 010 Positive/elevated 020 Negative/normal; within normal limits 030 Borderline; equivocal; undetermined whether positive or negative 75 For CISH, the definition of positive, negative or borderline varies from lab to lab. If a CISH test was performed and the results are interpreted in the chart, record as positive, negative or borderline. Usually, the results will be either positive or negative since if the results of counting the mean number of gene copies per cell from 30 cells is between 4.0 and 6.0, another 30 cells are counted and the mean from those 60 cells is interpreted according to the following scoring guideline: Non-amplification: 1 5 signals/nucleus in tumor cells Amplification: >5 signals/nucleus, or cluster of amplified signals/nucleus in >50% of tumor cells Result: Non-amplification ( 5) (negative) Amplification (>5) (positive) Slide 76 SSF 14 - HER2: Interpretation Of Other Or Unknown Test Silver in-situ hybridization (SISH) Patient is HER2 negative no other information 76 Other tests may also be performed. The most likely scenario will be a statement in the CAP Protocol or elsewhere in the chart that the patient is HER2 positive or HER2 negative, with no indication of how this information was determined and no test results in the chart. This may be particularly true for cases diagnosed elsewhere.

67 Slide 77 SSF 14 - HER2: Interpretation of Other or Unknown Test Code Description 010 Positive/elevated 020 Negative/normal; within normal limits 030 Borderline; equivocal; undetermined whether positive or negative 77 Code the statement of HER2 status by the clinician/pathologist if no specific test information is given in the chart. If specific test other than IHC, FISH, or CISH, for example SISH, record clinician/pathologist interpretation of that specific test. Slide 78 SSF 15 HER2: Summary Result of Testing If multiple HER2 tests are given, geneamplification (molecular) test should take precedence If IHC is given to clarify the results of a borderline/equivocal gene-amplification test, take IHC results 78 Gene-amplification tests are considered to be a more reliable test of the over-expression of the HER2 gene. Thus, if both an IHC and a gene-amplification test (FISH, CISH, etc.) were given, record the result of the gene-amplification test in this field. However, if the gene-amplification test is given first and the result is borderline/equivocal and an IHC is done to clarify these equivocal results, take the result of the IHC.

68 Slide 79 SSF 15 HER2: Summary Result of Testing Code Description 010 Positive/elevated; amplified 020 Negative/normal; within normal limits, not amplified 030 Borderline; equivocal; undetermined whether positive o negative 79 This factor can be derived from SS Factors 9,11,13, and 14.

69 Slide 80 SSF 16 HER2: Combinations of ER, PR, HER2 ER PR HER2 80 Code Description Negative ER, Negative PR, Negative HER2 Positive ER, Positive PR, Positive HER2 One or more tests unknown if performed One or more tests unknown or borderline Not documented in patient record This SSF provides a summary of the ER, PR and HER2 results. The first digit reflects the result of ER testing, the second of PR testing, and the third HER2 testing. For each combination of codes, 0 represents a negative test result, 1 a positive test result. The major purpose of this factor is to rapidly identify those women who are triple negative, which is code 000. Code 111 identifies women who are triple positive. While 010 would be ER-, PR+, HER2-. If the results of any of the three tests is borderline/equivocal, unknown, or not performed, code to 999. Note: can be derived from CS Site-Specific Factors 1,2, and 15

70 Slide 81 SSF 17 Circulating Tumor Cells (CTC) and method of detection Categorizes the results of 2 named tests and 2 unnamed tests 1. RT-PCR test 2. immunomagnetic separation (IMS) test 3. other test type 4. unknown test type 81 There are two named tests identified in this data item RT-PCR and IMS. There may be other tests that are not specifically named in the code choices (other test type). Or, you may know that the test was done, but the exact type is unknown. For codes , the first digit indicates the results: 0 negative 1 positive 2 borderline The second digit indicates the type of test: 1 - RT-PCR test 2 - immunomagnetic separation (IMS) test 3 - other test type 4 - unknown test type The third digit is always a 0. The code is based on the type of test and the results. A definition of IMS can be found in Part I, Section 2.

71 Slide 82 SSF 18 Disseminated Tumor Cells (DTC) and Method of Detection Categorizes the results of 2 named tests and 2 unnamed tests 1. RT-PCR test 2. immunohistochemical separation (IHC) test 3. other test type 4. unknown test type 82 The code structure is the same for SSF 18 as it is for SSF 17. Note however that in SSF 17, one of the named tests is IMS. In SSF 18 it is IHC. Slide 83 SSF 19: Assessment of Positive Ipsilateral Axillary Nodes Identifies the procedure that was used to determine positive nodes Ipsilateral Axillary Nodes only Level I and II Intrammammary Corresponds with SSF 3 83 This site-specific factor provides supplemental information on how the number of positive level I and II (and intramammary) lymph nodes was determined for site-specific factor 3, the N category and the stage group. Codes with a 0 in the first digit represent single procedures only. For codes , the first digit is based on the sentinel node biopsy and the second digit is based on the lymph node dissection. If all nodes examined were negative, assign 000.

72 Slide 84 SSF 20: Assessment of Positive Distant Mets Identifies the procedure that was used to determine positive metastasis Based on positive findings only from: CS Mets at Dx CS Mets at Dx Bone CS Mets at Dx - Lung CS Mets at Dx - Liver CS Mets at Dx - Brain 84 This Site-Specific Factor evaluates how the information regarding positive metastasis in CS Mets at Dx and CS Mets to the bone, lung, liver, and brain were determined. If multiple diagnostic methods were used, utilize the highest code. If distant metastasis is coded as 000 no positive metastasis, this field must also be coded to 000. For example, if the patient has a negative bone scan or a negative chest x-ray, do not code 020. This field is only to be used to document POSITIVE findings. Slide 85 SSF 21 Response to Neoadjuvant Therapy Code Description Complete Response (CR) Partial Response (PR) No Response (NR) No neoadjuvant therapy Unknown if response Unknown, Not documented Look in the medical record for a specific statement as to the response to neoadjuvant therapy. Do not try to interpret or infer a response based on the medical record. Code 020 includes cases where it is indicated that there was a response to neoadjuvant therapy but it was not stated if it was a complete or partial response.

73 Slide 86 SSF 22 Multigene Signature Method Multiple tests IHC- based Multigene Predictors FISH-based Predictors RT-PCR-based Multigene Predictors Genomic Microarray-based Multigene Predictors Oncotype Dx MammaPrint 86 Many different types of genetic testing available. Usually this is done on node negative, ER+, patients, but recent studies indicate that these tests may also be helpful in planning treatment and predicting recurrence in node positive women with small tumors. Code whether or not a multigene test was done and the type. The most common multigene test method is the Oncotype DX. According to the manufacturer s website, the Oncotype DX is a unique diagnostic test that looks at the genomic profile of a breast tumor to predict the likelihood that early-stage, estrogen receptor-positive, lymph node-negative breast cancer will return, or recur (distant recurrence). This test also provides information about a woman's likelihood of benefiting from adding chemotherapy to hormonal treatment. New research from the 2007 San Antonio Breast Cancer Symposium shows that Oncotype DX may also be informative for postmenopausal women with ER+, node-positive stage II to III breast cancer. It is a test that examines a breast cancer patient s tumor tissue at a molecular level, and gives information about her individual disease. This information can help tailor treatment for her breast cancer. Oncotype DX is the first and only gene expression test that has been accepted as demonstrating the ability to predict a patient s benefit from chemotherapy as well as her risk of recurrence. Oncotype DX has been included in the 2007 American Society of Clinical Oncology (ASCO) Clinical Guidelines on Use of Tumor Markers in Breast Cancer. This represents a significant step forward for the role of molecular diagnostics in breast cancer treatment planning. Oncotype DX has also been included in the National Comprehensive Cancer Network (NCCN) 2008 Breast Cancer Treatment Guidelines. This inclusion reinforces the significance of molecular diagnostics in breast cancer treatment planning and, in particular, the potential value of the individualized information provided by Oncotype DX.

74 Slide 87 SSF 23 Multigene Signature Score/Result Code 000 Description No multigene tests performed Actual score Low risk of recurrence (good prognosis) High risk of recurrence (poor prognosis) Unknown, Not documented 87 Patients will generally be given a score ranging from 1 to 100. Record the actual score if given. If any tests results in a score of 100 or higher, code as 100. Results of the MammaPrint test are given as either Low risk or High risk but may also be stated as good prognosis or poor prognosis. Slide 88 Example of an OncotypeDx Report The report is a three page report. Recurrence score shown in orange circle. Ranges from Chart below score translates the score into average rate of distant recurrence at 10 years. Usually will find ER, PR, and HER2 scores on third page. However, do not use these data for SS Factors 1, 2 or To see the entire report on the Oncotype Dx website, go to:

75 Slide 89 Example of a MammaPrint Report Result is reported as low risk (of recurrence). Slide 90 SSF 24 - Paget Disease Code Description Paget disease absent Paget disease present Unknown, Not documented 90 SSF24 documents the presence or absence of Paget disease. This information will be found in the pathology report/cap Protocol. If there is no underlying tumor, this information will also be coded in the morphology field. Record any mention of Paget disease, whether clinical or pathological, giving priority to the pathologic assessment. Interpret a negative exam of the nipple as Paget disease not present. Code unknown when no examination of the nipple, clinical or pathologic, is available in the medical record.