Getting Specific About Site-Specific Factors Part I Section II

Getting Specific About Site-Specific Factors Part I Section II
CS version 0203 Education and Training Team CSv2 Part I Section II: May 1, 2011 Version: 2.03

Overview CSv0202 to CSv0203 changes What are Site-Specific Factors?
Types of Site-Specific Factors Examples Code structures This session is an overview of the Collaborative Stage Data Collection coding instructions in Part I, Section 2: Site-specific Factor Notes and the changes between versions 0202 and In this session we will discuss what site-specific factors do and why they are needed. We will cover the different types of site-specific factors, including examples from many different primary site/histology-specific schemas, and we will provide an overview of the various code structures. CSv2 Part I Section II: May 1, 2011 Version: 2.03

CSv0203 Changes Based on post-publication changes in AJCC Cancer Staging Manual, seventh edition Continued work to make CAP Protocols compatible with registrar abstracting needs Thorough, independent review of codes and format by Data Validation Team There were a few post-publication changes in the AJCC Cancer Staging Manual seventh edition, notably a change in how the testicular tumor markers should be coded. These were published as an errata document in August The review team made sure that any changes in TNM seventh edition were incorporated into CS version 0203. Work continues to make the College of American Pathologists cancer protocols and checklists compatible with the information captured on the cancer registry abstract. The CAP Pathology Electronic Reporting Taskforce (PERT) includes several Certified Tumor Registrars knowledgeable about CS. A set of updated CAP protocols was released on the CAP.org website on February 1, 2011. After the release of CS version 0202, the CS leadership organized a Data Validation Team to thoroughly review the code structures and format of the CS schemas for consistency. Most of the changes in CS version 0203 are the result of this effort. CSv2 Part I Section II: May 1, 2011 Version: 2.03 CSv2 Overview – CSv2 What’s New Presentation Sept 15, 2009 Version: 2.0

Coding of Lab Test Interpretation
Priority of information Code clinician’s interpretation If no MD interpretation, registrar may interpret from reference range listed on lab report If no MD interpretation and no reference range listed, code as 999 Use common sense and code 010 rather than 999 if lab result is extremely abnormal A new guideline was added to the discussion of site-specific factors in Part I Section 1 documentation of CSv It pertains to how the registrar can use information in the medical record when the clinician does not provide an interpretation of lab test results. As a first priority, code the clinician’s interpretation of the lab result, such as a statement of abnormal, elevated, normal, present, absent, and so forth. In addition, the registrar can infer from a physician’s statement of a T, N, or M value whether a lab value used to determine the TNM classification was abnormal or normal. If the clinician makes no statement and the lab report itself is available in the medical record, the registrar can compare the lab result and the reference range information on the lab report and code that information. In the absence of a clinician statement and the lab report itself, code 999 for unknown should be used. Note that there will be some circumstances where the lab result is extremely abnormal and common sense will dictate that the case should be coded as 010 Abnormal rather than 999. CSv2 Part I Section II: May 1, 2011 Version: 2.03

What Are Site-Specific Factors?
Part of CS data set Data fields with different meanings depending on schema Additional information serving many purposes Not all site-specific factors are required A site-specific factor identifies additional information needed to derive TNM or summary stage or records prognostic/predictive factors that have an effect on stage or survival. Site-specific factors, or SSFs, are part of the Collaborative Stage Data Collection System data set. There are 25 site-specific factors in CS version 2. What makes the SSFs different from the 9 core data items (tumor size, extension, lymph nodes fields, mets at diagnosis, and the Eval fields) is that the SSFs have different meanings depending on the site-specific schema. The core data items always mean the same thing from primary site to primary site. For example, extension is always extension and Mets at Dx is always Mets at Dx, even though the individual codes and code definitions may vary from schema to schema. In contrast, Site-specific Factor 1 is Estrogen Receptor Assay for breast and Clinical Assessment of Regional Lymph Nodes for colon and WHO Grade for brain. Thus it is necessary to know not only the primary site schema but also the SSF name in order to understand the meaning of the code stored in that data position. The additional information stored in the site-specific factors serves many purposes in CS. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Site-Specific Factors, cont’d
SSF data sets Breast – 24 Eyelid, lacrimal gland – 15 to 16 Testis – 13 Prostate – 12 Ocular adnexal lymphoma – 12 Head & Neck sites (carcinoma, melanoma) – 9 to 11 Colon and Rectum – 10 CNS – 8 Standards setters determine which SSFs are required If you count all the SSFs for all the site- and histology-specific schemas, there are over 1000 in CSv2. It is true that some SSFs are counted many times in that number, for example SSFs 1 through 9, which are repeated for each of the head and neck sites. Others are counted only once, as they are unique to their schema. As previously mentioned, up to 25 site-specific factors are available for each schema, but no primary site uses all 25. Breast uses the most, but there is a reason for every SSF used. Many of the breast SSFs record various methods of determining HER-2 status. The next highest use of SSFs is in the rare sites of carcinoma of the eyelid and carcinoma of the lacrimal gland. Due to the need to add post-orchiectomy tumor markers for testis, this schema now has 13 site-specific factors. Prostate has 12 active SSFs in CSv2, mostly for supplemental clinical information. Another rare site, ocular lymphoma, is next with 12 SSFs. The head and neck sites vary between 9 and 11, depending on whether the schema is for carcinoma or malignant melanoma. Colon uses 10 and CNS uses 8. Other sites use just a few SSFs. Remember that some SSFs are required to derive the TNM values and others have been listed in the 7th edition chapters as desirable to collect because of their prognostic value. Not all site-specific factors are required to be collected. The standards setters have determined which SSFs are required for their individual purposes. The standards setter lists are available on cancerstaging.org/cstage, and are listed with each site-specific factor in the CSv2 Coding Instructions, Part I Section 2. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Types of Site-Specific Factors
Needed for TNM mapping Prognostic/predictive Tumor markers and lab values Future research/special interest Associated diseases and conditions Schema discriminators Many different types of information are captured in the 25 site-specific factors available. These include: Items needed for TNM mapping, such as the number of positive level I and II axillary lymph nodes for breast, extracapsular extension in lymph nodes for head and neck sites, and the thickness of the lesion for cutaneous melanoma. Prognostic and predictive items, such as the Gleason tertiary pattern for prostate, HER2 for breast, and the prognostic indices and scores for the lymphomas. Tumor markers and lab values, such as CA-125 for ovary; CA19-9 for stomach, pancreas, and bile ducts; Alpha Fetoprotein for liver and testis; hCG for testis; KRAS for colon and rectum; and Ki-67 for central nervous system and ophthalmic sites. Research and special interest items, such as microsatellite instability for GI cancers, circulating and disseminated tumor cells for breast, and tumor infiltrating lymphocytes for Merkel cell carcinoma of skin. Associated diseases and conditions related to the primary cancer, such as a history of asbestos exposure for pleural mesothelioma, the retinoblastoma gene mutation, and association with AIDS or HIV for Kaposi sarcoma. Schema discriminators are necessary in some sets of primary sites to determine which schema should be used to code a case. Some of the site-specific factors included in CSv2 overlap these general categories, such as the prostate specific antigen (PSA), which is both a tumor marker and a data item required for TNM stage grouping in the seventh edition. Rather than go through the site-specific factors on a schema-by-schema basis, we will look at each of these types in more detail and provide examples of site-specific factors that fit each type. CSv2 Part I Section II: May 1, 2011 Version: 2.03

SSFs Needed for TNM Mapping
Supplementary information Difficult to quantify in core data field May be non-anatomic Usually required by COC and SEER Examples Number of positive axillary nodes (breast) Gleason score (prostate) Systemic symptoms at diagnosis (lymphoma) Items that are needed for TNM mapping supplement information coded in the CS core data items. In some instances, some other aspect of the cancer is more important for deriving the T, N, M or stage group than tumor size or extension, location and number of regional lymph nodes, or the presence of distant metastases. In other instances, the information may be non-anatomic but included in TNM staging in the seventh edition. In most cases, the items needed for TNM mapping are required to be collected by the Commission on Cancer and participants in the SEER Program. The Canadian Council of Cancer Registries defines many of these supplementary TNM items as essential for Canadian cancer registries to collect. Examples include the number of positive Level I and II axillary lymph nodes for breast, which determines whether the N category is pN1a (1-3 positive axillary nodes), pN2a (4-9 positive axillary nodes) or pN3a (10 or more positive axillary nodes) the Gleason score for prostate cancer, which helps to differentiate stage groups I, IIA and IIB systemic symptoms at diagnosis for lymphoma, which differentiates Stages I, II, and III into A (asymptomatic) and B (with “B symptoms”) subcategories. Here are a few other examples. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Cutaneous Melanoma SSF1 – Thickness/Depth of Invasion SSF2 – Ulceration
Cutaneous melanoma site-specific factor 1, the thickness or depth of invasion, is the vertical measurement of the tumor from the surface to the deepest part. Thickness is a variable independent of the diameter of the lesion (tumor size). Thickness determines whether the T category is T1a (less than 1 millimeter thick), T2a (1.01 to 2 mm thick), T3a ( mm thick), or T4a (>4 mm thick). SSF1 is coded in hundredths of millimeters, with code 100 representing a melanoma 1 millimeter in thickness. Site-specific factor 2, ulceration, is another independent non-anatomic variable that makes the difference between “a” and “b” subcategories for melanomas of similar thickness. SSF2 is coded as 000 for ulceration not present or not mentioned, 001 for ulceration present, and 999 for unknown. Both fields are required by COC, SEER, and Canadian registries. From: Melanoma of the Skin. In: Greene, F.L., Compton, C.C., Fritz, A.G., et al., editors. AJCC Cancer Staging Atlas. New York: Springer, 2006: ©American Joint Committee on Cancer. CSv2 Part I Section II: May 1, 2011 Version: 2.03

GIST – Mitotic Count Mitotic count: number of cells actively dividing
<5 mitoses/high power field – low mitotic rate >5 mitoses/high power field – high mitotic rate Source: pathology report/protocol Pathologist instructions: scan slide for area of greatest mitotic activity MITOSIS Mitotic count is SSF6 for gastrointestinal stromal tumor of the esophagus, stomach and small intestine; SSF11 for GIST of appendix, colon and rectum, and SSF2 for GIST of peritoneum. The coding guidelines are the same for all schemas. The mitotic count reports how many cells are actively dividing. This is an indicator of the relative aggressiveness of the tumor. The mitotic count is also called mitotic rate or mitotic activity. Information can be found in the pathology report or CAP checklist or protocol. The CAP protocol has specific instructions for how to count cells in mitosis, but the size of the microscopic field being evaluated differs among the primary sites. The illustration shows the types of cells the pathologist is looking for—cells about to split into two daughter cells. These are what the pathologist counts to determine the mitotic rate. Generally, a finding of 5 or fewer mitoses per high power field is considered a low mitotic rate, while a count of more than 5 is considered a high mitotic rate. Source: In the public domain. CSv2 Part I Section II: May 1, 2011 Version: 2.03

GIST – Mitotic Count Usually documented as mitoses per 50 high power fields (HPF) Standard magnification is 40X Also described as ‘per 5 mm2 ’ (square millimeters) Site-specific factor code Implied decimal between 2nd and 3rd digit .8 mitoses/50HPF 008 5 mitoses/50HPF 050 Microscopes differ in their power and magnification, so there are instructions in the TNM manual as well as in the CAP protocols on how to define the area in which the mitoses are being counted. For the GIST tumors, the number is per 50 high power fields. In other words, the pathologist looks at 50 different areas and counts the number of mitoses in them. (For other tumors such as NET, the number of high power fields may be different.) Some pathologists may report a count per 5 square millimeters. According to CAP, this is equivalent to 50 high power fields, so the registrar does not have to convert anything as long as the pathologist is talking about 5 square millimeters. This is a 3-digit field like all other SSFs. Think of it as two digits, an implied decimal point, and another decimal digit. If the pathology report says 0.8 mitoses per 50 high power fields, code as If the mitotic count is stated as 10 mitoses per 50 high power fields, code as 100. Mitotic count is required by COC, SEER, and the Canadian registries. CSv2 Part I Section II: May 1, 2011 Version: 2.03

GIST – Mitotic Count Criteria for Stage Grouping
Tumor size cut points: 2, 5, 10 cm Mitotic activity cut point: 5 mitoses/50 HPFs ANATOMICAL/PROGNOSTIC STAGE GROUPS Example: Stomach Mitotic Rate Stage IA T N M0 Low Stage IB T3 N M0 Low Stage II T4 N M0 Low T1-2 N M0 High Stage IIIA T3 N M0 High IIIB T4 N M0 High Stage IV Any T N1 M0 Any Any T Any N M1 Any When the CSv2 computer algorithm looks at Mitotic Count to derive the TNM stage group, it groups mitotic activity values into the categories low mitotic rate (0.1 to 5 mitoses per 50 high power fields) and high mitotic rate (6 or more mitoses per 50 high power fields). Low mitotic rates are Stage I or II with any tumor size, negative nodes and no distant metastases. High mitotic rates are Stage II for T1 and T2 tumors or Stage III with higher stage tumors, negative nodes and no distant metastases. Once the tumor has spread to regional nodes or distant sites, the mitotic rate is no longer a determinant of the stage group. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Prognostic/Predictive SSFs
Enhance clinical relevance of TNM and cancer registry data base Prognostic – helps estimate outcomes Predictive – helps determine whether patient will respond to certain types of therapy Examples Estrogen and progesterone receptors (breast) HER2 (breast) Gleason tertiary pattern (prostate) IPI, FLIPI, IPS (lymphoma) Prognostic and predictive items comprise a large proportion of the CSv2 site-specific factors. They provide additional non-anatomic information about the patient’s cancer and enhance the clinical relevance of both TNM staging and the cancer registry data base. If the registry records this type of information, even though the data field is not required by a standards setter, the value of the registry will be increased. A prognostic factor is one that helps estimate the patient’s outcome, whether that be recurrence or overall survival. A predictive factor is one that, as the name implies, predicts whether the patient will respond to a particular drug or type of treatment. Other types of SSFs can be predictive or prognostic, such as lab tests, tumor markers, molecular profiling, and pathologic findings from biopsies or the resected specimen. Most are not required for staging but are clinically relevant, to use the terminology of the AJCC Cancer Staging Manual, seventh edition. Some prognostic and predictive SSFs have been in place since before CS began in Since the mid-1980s, estrogen and progesterone receptors have been an important predictor of whether the patient will respond to hormone therapy. A patient whose resected tumor is estrogen and/or progesterone receptor positive will likely be offered a post-operative course of anti-estrogen therapy, such as Tamoxifen, or another aromatase inhibitor, such as Arimidex, to suppress the growth of any breast cancer cells remaining in the patient’s body. If the patient is estrogen/progesterone receptor negative, the patient will probably be offered chemotherapy instead of hormone therapy should the tumor recur. HER2 is Human Epidermal growth factor Receptor 2, a protein on the surface of cancer cells that accepts growth signals. The presence of too many HER2 receptors (“overexpression”) indicates that the tumor may grow more aggressively and recur sooner than . About 20% of breast cancers overexpress HER2. Overexpression is both a prognostic and predictive factor for breast cancer. The information obtained from these tests plays a critical role in treatment planning, because HER2-positive patients tend to respond favorably to the expensive drugs Herceptin (trastuzumab) or Tykerb (lapatinib), which work by blocking these receptors and preventing growth signals from getting through to the cancer cell. A lack of overexpression indicates patient may not respond to Herceptin or Tykerb. Between 10 and 20 percent of breast cancer patients are “triple negative”, meaning that they are negative for estrogen, progesterone, and HER2 receptors. Although this combined predictive information indicates that it is unlikely that they will respond to hormonal therapy or Herceptin, other drugs can be used to treat the cancer and clinical trials are in progress to investigate alternative treatments for these patients. The Gleason tertiary pattern assesses the presence of high grade adenocarcinoma as a minor component of a prostatectomy specimen. This SSF has negative prognostic implications if Gleason pattern 5 is identified. Three prognostic indices have been promoted for specific types of malignant lymphoma. Each index is based on a series of adverse prognostic factors. A point is scored for each adverse prognostic factor the patient has. Higher point scores correlate with shortened survival rates. For example, the International Prognostic Index for non-Hodgkin lymphoma has five adverse prognostic factors. Patients with 0 or 1 adverse prognostic factors have a 73% 5-year survival. Patients with 4 or 5 adverse prognostic factors have a 26% 5-year survival. Here are other examples of prognostic and predictive site-specific factors. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Colon/Rectum SSF 6 Circumferential Resection Margin
Required by COC, SEER, Canada Radial or mesenteric margin Width of surgical margin at deepest part of tumor in area without serosa Distance in millimeters between leading edge of tumor and margin of resection Not the same as proximal and distal margins Most important predictor of local recurrence in rectum Code 000 Margin involved The circumferential resection margin (CRM) is also called the radial margin or the mesenteric resection margin for colon and rectum cancers. The CRM is defined as the distance from the deepest invasion of the tumor to the closest soft tissue margin of the specimen. In other words, the CRM is the width of the surgical margin at the deepest part of the tumor in an area of the large intestine or rectum without serosa (non-peritonealized rectum below the peritoneal reflection) or only partly covered by serosa (upper rectum, posterior aspects of ascending and descending colon). In areas where there is serosa completely surrounding the bowel, such as the transverse colon, the CRM may be called the mesenteric margin. The CRM is not the same as the distance to the proximal and distal margins of the colon specimen. For rectal cancers, the circumferential resection margin is the most important predictor of local recurrence. CSv2 Part I Section II: May 1, 2011 Version: 2.03

On the illustration, the circumferential resection margin would be measured in any area of the resected specimen where there is no serosa. The upper left shows no residual tumor; this would be SSF6 code The lower left shows that there was residual tumor at the margin of resection; this would be code 000, margin involved. The upper right shows that the margin is clear but the amount or distance of normal tissue to the cut edge of the specimen was not stated. This would be code The lower right shows that the pathologist measured the tumor free margin as 2 millimeters. AJCC Cancer Staging Atlas (2006), Springer Science and Business Media, LLC. Used with permission CSv2 Part I Section II: May 1, 2011 Version: 2.03

Codes 000 Margin involved mm Exact size in mm 988 Not applicable: Information not collected 990 No residual tumor 991 Margins clear/negative, distance not stated Nonspecific codes “< xx”, “> yy”, “between xx and yy” 998 No surgery; no histologic confirmation 999 Unknown; CRM not mentioned The CRM is measured in a format similar to tumor size but in tenths of MILLIMETERS. For example, a surgical margin of 1.6 millimeters would be coded as The code structure includes non-specific codes in the range 991 to 996 if the margin is described as less than a number, greater than a number or between two numbers. Other situations allowed in the codes include no residual tumor, no surgery, and CRM not mentioned. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Colon/Rectum SSF 9 – KRAS
Required by COC, SEER Oncogene that predicts response to cetuximab or panitumumab Primarily tested on Stage IV patients Codes 010 Abnormal (mutated); Positive for mutations 020 Normal (wild type); Negative for mutations 988 Not applicable: Information not collected 997 Test ordered, results not in chart 998 Test not done (not ordered and not performed) 999 Unknown; Not documented in patient record KRAS is an oncogene (a gene that, when mutated or overexpressed, helps turn a normal cell into a cancer cell). This is a predictive SSF: mutations of KRAS indicate that a patient may not respond to the expensive targeted anti-EGFR drugs cetuximab (Erbitux) or panitumumab (Vectibix). The American Society of Clinical Oncology (ASCO) recommends that Stage IV colorectal patients be tested for KRAS if anti-EGFR therapy is being considered. There are two types of KRAS genes: normal and mutated. The normal KRAS gene is also called the wild type allele; the mutated gene may be described as abnormal or having an abnormal codon (abnormal DNA sequence). KRAS can also be tested on recurrent colorectal cancer, but this field is intended only for KRAS testing on the initial tumor. CSv2 Part I Section II: May 1, 2011 Version: 2.03

CNS schemas SSF1 – WHO Grade
Required by COC, SEER Code Description 010 Grade I 020 Grade II 030 Grade III 040 Grade IV 999 Clinically diagnosed/grade unknown*; Not documented in medical record No TNM staging is recommended for central nervous system tumors because “traditional” TNM anatomic staging is not appropriate to these sites. The histology and grade of the tumor have more prognostic significance than tumor size. Therefore, the WHO (World Health Organization) grade is part of the brain, other CNS, and intracranial gland schemas. Site-specific Factor 1 is used to code cases that are reported in the pathology report as WHO grade. According to WHO, the classification is more of a “malignancy scale” than a strict histologic grading system. Therefore, the WHO grade is different from the ICD-O grade/differentiation value that is stored with the morphology code—do not use WHO grade to code the sixth digit of the ICD-O morphology code. WHO grade ranges from I (low proliferative potential and possibly surgically curable—essentially benign behavior) through IV (cytologically malignant, mitotically active neoplasms that are rapidly fatal). Most CNS tumors are assigned a WHO grade, so there is usually a one-for-one correspondence between the ICD-O morphology code and the WHO grade. * Code 999 also includes tumors that are not WHO graded. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Brain/Other CNS SSF 4 Methylation of MGMT
Required by COC, SEER MGMT—enzyme that repairs DNA Methylated MGMT repairs less DNA  may prolong survival Codes 010 Yes – Methylated; Hypermethylated; High levels 020 No – Unmethylated; Low levels 988 Not applicable: information not collected 998 No histologic examination of primary site 999 Unknown; Not documented in patient record Approximately two-thirds of glioblastoma multiforme patients express MGMT, and accordingly, are resistant to alkylating agents. The other third of patients benefit postoperatively from alkylating chemotherapy. MGMT is an enzyme that repairs the DNA damaged by chemotherapy, allowing continued tumor cell replication despite treatment. Methylation is a chemical process that changes the composition of an enzyme or protein. Methylation of MGMT reduces the amount of the enzyme available and essentially “shuts down” DNA repair, which allows the damage done to DNA by chemotherapy to continue cytotoxicity and apoptosis. Patients with low tumor MGMT activity may be more likely to respond to alkylating agents such as temozolomide (Temodar) and the nitrosoureas, some of the few drugs effective for brain tumors. This in turn is associated with improved outcome in GBM patients treated with radiation and alkylating chemotherapy. In other words, the presence of methylated MGMT is a predictor that the patient may respond to chemotherapy and consequently have better survival. MGMT methylation is a special (not routine) test done on tumor tissue. It is used primarily for anaplastic oligodendroglioma, anaplastic astrocytoma and glioblastoma multiforme. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Head and Neck SSF7 Upper/Lower Cervical Node Levels
Documents whether involved nodes are above or below level of cricoid cartilage Lower cervical nodes have worse prognosis Level of cricoid cartilage In addition to the specific surgical lymph node levels that are documented in head and neck SSFs 3 to 6, it is important for clinicians to know whether the lymph nodes in the low neck are involved, because low neck node involvement has a much worse prognosis. In this illustration from the AJCC Cancer Staging Atlas, you can see the level of the cricoid cartilage in relation to the surgical lymph node levels. Level V, also called the posterior triangle, is sometimes divided into Level VA above the cricoid cartilage and Level VB below. Level VI, also called the anterior compartment, is more problematic in that it is not defined as upper and lower, so it is important to know which specific nodes in Level VI are involved. Image source: CSv2 User Documentation, Part I Section 2 CSv2 Part I Section II: May 1, 2011 Version: 2.03

Head and Neck SSF7 Upper/Lower Cervical Node Levels
Codes 000 No lymph nodes involved 010 Upper level lymph nodes involved Levels I, II, III, VA, “Other groups” 020 Lower level lymph nodes involved Levels IV, VB, VII 030 Upper and lower level lymph nodes involved 040 Unknown level lymph nodes involved Code “mid neck” and levels V, VI here if not specified as upper or lower 999 Unknown, not stated If not obvious, refer to list in Part I, Section 2 of CS User Documentation Based on which lymph node levels are involved, code upper, lower or both levels as appropriate. Some lymph node chains are unequivocally above or below the cricoid cartilage, which is the boundary between upper cervical and lower cervical nodes, but levels V and VI cross that boundary. Part I of the CS Manual contains an extensive list of head and neck lymph node chains along with their levels and whether they are considered upper cervical or lower cervical. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Part I Section 2 Table I-2-3 Example Lymph Nodes of the Head and Neck Showing Level and Site-Specific Factor Positions Name Level SSF7 Code SSF3-6 Position This is an excerpt from the table of head and neck lymph nodes showing the surgical lymph node level, the SSF7 code (above or below the cricoid cartilage), and the position in SSFs 3-6 where the involved lymph nodes should be coded. Refer to this table if you are unsure whether the involved lymph nodes are high or low in the neck. Note 1. Look for a statement of upper or lower cervical nodes or that the involved nodes are above or below the lower border of the cricoid cartilage and code appropriately. If no further information, use code 40 in SSF 4. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Tumor Markers and Lab Values
Codes actual value or interpretation of test (or both) Pathologic values Blood tests Examination of tissue Confirm diagnosis AFP, HCG Document tumor volume CEA CA 19-9 Prognostic CA-125 Some SSFs are tumor markers or lab values—measurements based on blood tests or examination of tissue. Estrogen and progesterone receptors (previously discussed as a predictive factor) are among the most common tumor markers used in oncology. The field may record either the actual value of the test or the clinician’s interpretation of the test. Some markers and lab tests have two fields, one for the value and one for the interpretation. Most tumor markers and lab values are not needed for deriving T, N, M, or stage group, but provide the clinician with important information about the cancer. Some of these markers confirm the diagnosis, some help document the tumor volume, and some are of prognostic significance. Unless stated otherwise in the site-specific factor, record the highest pre-treatment value for a tumor marker or lab value. If the field records the interpretation of the test, look for a statement by the clinician. Examples of tumor markers and lab values collected in CS include Alpha fetoprotein and human chorionic gonadotropin—AFP and hCG measured before treatment are used to assess the histology of the tumor because various germ cell tumors will show positivity for either AFP or hCG or both, and this helps differentiate the type of tumor. Measured post-orchiectomy, persistence of elevated tumor markers indicates residual testicular tumor and helps determine whether the patient should receive post-operative chemotherapy. Carcinoembryonic antigen--CEA is a protein molecule found in many different cells of the body and is used as a tumor marker especially for gastrointestinal cancers. Colorectal cancer is the most frequent cause for an increased/elevated CEA. CEA is also elevated by biliary obstruction, alcoholic hepatitis and heavy smoking. CEA level is most frequently tested on blood serum, but it may be tested in body fluids and or biopsy tissue. An abnormally high CEA level prior to tumor resection is expected to fall following successful removal of the cancer. An increasing value indicates possible recurrence. CA 19-9—This is another non-specific marker found in blood serum. It is an important tumor marker in the management of gastrointestinal and hepatobiliary malignancies. CA 19-9 is produced in excess by adenocarcinomas and released into the blood. It is elevated in pancreatic (70-80%), hepatobiliary (60%), and gastric (50-60%) malignancies. Levels above 1000 U/mL indicate the presence of metastases and probably unresectable tumor. CA 19-9 is also elevated in acute pancreatitis, cholangitis, cirrhosis and other conditions, so it is not useful as a screening test but has value in monitoring for possible recurrence of known cancer. Unlike most tumor markers that are measured in nanograms per milliliter, CA-19-9 is recorded in Units per milliliter. CA-125—This marker found in blood serum is not specific to ovarian or primary peritoneal cancer. CA-125 can be elevated in many diseases affecting the peritoneal lining of the abdominal and pelvic cavity, so it is not a screening test for women who have no history of cancer. Any value over 35 is highly correlated with cancer and about 80% of ovarian cancers show an elevated CA However, a result in the normal range does not rule out cancer. Values up to 65 U/ml may be considered borderline, and values over 200 are unlikely to be due to a benign condition. CA-125 monitors for success of treatment and recurrence. After obtaining a baseline value prior to treatment, a lower result on a subsequent test indicates a response to treatment, and an increasing value indicates possible recurrence. Here are some other tumor markers and lab values. CSv2 Part I Section II: May 1, 2011 Version: 2.03

CNS schemas SSF 2 – Ki-67 / MIB-1
Tumor marker that indicates percentage of cells that are actively dividing Separates good prognosis and poor prognosis Codes % (exact Labeling Index percentage) 200 Labeling Index (LI) normal 300 LI slightly elevated, no percentage provided 400 LI elevated, no percentage provided 988 Not applicable: information not collected 997 Test ordered, results not in chart 998 Test not done (not ordered and not performed) 999 Unknown or no information; Not documented Ki-67 is a tumor marker found in the brain, other CNS, intracranial gland, conjunctiva, lacrimal gland, and ocular adnexal lymphoma schemas. It is a monoclonal antibody that reacts with an antigen expressed only by proliferating human cells. This marker has many names: Ki-67 proliferation marker, Ki-67 labeling index, KI-67 antigen expressing fraction, Ki-67 growth fraction, MIB 1-3, MIB-1, MIB-1 labeling index, labeling index fraction, labeling index (LI) percentage, MKI67 antigen. Ki-67 detects cells that are actively growing and dividing. High growth rate (high proliferative index) is associated with response to chemotherapy as well as decreased survival. Ki-67 is non-specific to neural tumors or lymphomas and can be used on any type of malignant tumor. The Ki-67 labeling index is the proportion of cells that react to the monoclonal antibody. The MIB-1 antibody measures Ki-67 expression. Its advantage is that MIB-1 can be used on formalin-fixed paraffin embedded tissue, whereas Ki-67 must be used on fresh tissue. If an exact percentage is given in the pathology report for the Ki-67 labeling index, code it in the range 001 to If the labeling index is not given as a percentage but is stated as normal, slightly elevated or elevated, code as 200, 300 or 400 respectively. This marker is not required by any of the standards setters, so it may be coded as 988, not applicable: information not collected. CSv2 Part I Section II: May 1, 2011 Version: 2.03

NET schemas – Chromogranin A
Source: clinical lab report or path report Other names Serum chromogranin A, CGA, chromogranin Marker for neuroendocrine tumors Specific but not sensitive immunostain for neuroendocrine cells. Positive more often for well-differentiated NET (carcinoid) than poorly-differentiated NET (neuroendocrine carcinoma). Site-specific Factor note Record the highest CgA lab value recorded in the medical record prior to treatment. Example: pretreatment CgA of 400 nanograms per milliliter (ng/ml); record as 400 Chromogranin A is a marker for a family of proteins in secretory granules found throughout the neuroendocrine system. It is a site-specific factor for the three pancreas schemas and the six neuroendocrine tumor schemas. This is a required SSF for COC and SEER for the neuroendocrine tumor schemas except carcinoid of the appendix. The presence of chromogranin helps differentiate a neuroendocrine tumor from a carcinoma in the same site. There are two ways to identify this marker, a clinical laboratory report can test for chromogranin in blood serum or the pathologist can apply a special stain to tissue. Normal values for the serum test will vary from laboratory to laboratory, so review the clinical lab report for the normal range. The immunohistochemical stain will be reported on the pathology report as either positive or negative. The notes above the code table state that chromogranin will tell you that there are neuroendocrine cells present in the patient’s body but it can’t tell you where those neuroendocrine cells are. Chromogranin differentiates between carcinoids and carcinomas, and also differentiates well differentiated neuroendocrine tumor (true carcinoid) and poorly differentiated NET such as small cell carcinoma or neuroendocrine carcinoma. Record the highest pre-operative or pre-treatment lab value in nanograms per milliliter. CSv2 Part I Section II: May 1, 2011 Version: 2.03

NET schemas – Chromogranin A
Code Description 000 0 ng/ml 001 1 or less ng/ml ng/ml 980 980 or greater ng/ml 988 Not applicable: information not collected for this case 997 Test ordered, results not in chart 998 Test not done (test was not ordered and was not performed) 999 Unknown or no information Not documented in patient record The code structure for Chromogranin A is typical of most tumor markers and lab values coded in CS version 2. Record whole numbers in the range 002 to Any measurement higher than 980 nanograms per milliliter is coded The usual codes in the upper ranges are included in this field as well. If your registry does not collect this information, use code 988, which also includes cases diagnosed prior to 2010 when this field was not used. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Heme-Retic SSF1 – JAK-2 Other Names
JAK2, Janus kinase 2, Exon 12 Acquired gene mutation increases susceptibility to several myeloproliferative neoplasms (MPNs). Polycythemia vera – positive in > 90% Essential thrombocythemia – positive in ~ 50% Also primary myelofibrosis, CMML JAK2 does not identify which specific MPN is present – clinical correlation needed Required for COC and SEER JAK-2, a gene found in all humans, is involved in the development of blood cells. If JAK-2 has mutated, the person is more susceptible to develop a myeloproliferative disorder (MPD). The JAK-2 mutation, which is acquired rather than inherited, is found in as many as 90% of patients with polycythemia vera (PV), about half of patients with essential thrombocythemia (ET), and slightly fewer patients with primary myelofibrosis (also known as agnogenic myeloid metaplasia and other terms). JAK-2 is used by clinicians to help classify MPDs but is not diagnostic of a specific neoplasm. Additional tests, such as a bone marrow biopsy, are necessary to determine the specific MPD histology. This is a required field for COC and SEER. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Heme-Retic SSF 1 – JAK-2 Coding Guidelines
Code JAK-2 test as documented in a laboratory test (whole blood or bone marrow) or elsewhere in the medical record. Code for any hematopoietic disease for which JAK-2 is tested. If JAK-2 not mentioned, use code 999 for a Heme-Retic schema disease such as leukemia or multiple myeloma where JAK-2 is not normally tested. If JAK-2 is positive but the specific mutation is not stated, code as 850. Testing for the JAK-2 mutation is done on whole blood. Code the result of the JAK-2 test as documented in a laboratory test or elsewhere in the medical record. Code this field for any hematopoietic, reticuloendothelial, immunoproliferative, myeloproliferative, or myelodysplastic disease for which JAK-2 is tested. For those diseases where JAK-2 is not mentioned in the record, or for a Heme-Retic schema disease such as leukemia or multiple myeloma where JAK-2 is not normally tested, code as 999. If JAK-2 is positive but the specific mutation is not stated, code as 850. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Heme-Retic SSF1 – JAK-2 Codes 000 JAK-2 test result stated as negative
010 JAK2 test performed, positive for mutation V617F in exon 14 020 JAK2 test performed, positive for mutation of exon 12 800 JAK2 test performed, positive for other specified mutation 810 JAK2 test performed, positive for more than one mutation 850 JAK2 test performed, positive NOS; specific mutation(s) not stated The principal JAK-2 test looks for a change (mutation) in an amino acid at a specific place on the JAK-2 gene called V617F. If the V617F test is negative, other JAK-2 mutation tests, such as those in exon 12 or 13 may be ordered to investigate a possible diagnosis of polycythemia vera. (An exon is a segment of a gene that contains instructions for making a protein.) Refer to the site-specific factor for additional codes, including code 988, which can be used in registries where this field is not required. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Future Research/Special Interest SSFs
Tests infrequently performed Applicable in limited circumstances May be collected prospectively Examples CTCs and DTCs (breast) TILs (Merkel cell) Involvement of Corpus Spongiosum/Corpus Cavernosum (penis) A limited number of site-specific factors have been included for special interest or future research. The subjects covered in these items are generally of a very specific nature. While clinically significant, the tests may be infrequently performed or may be applicable only in limited circumstances. A few are being collected prospectively because the incidence of these cancers is rare and information gathered on a population basis will contribute to the understanding of these tumors. Examples of SSFs of special interest or future research include: Circulating tumor cells (CTCs) and disseminated tumor cells (DTCs) for breast cancer. CTCs are isolated tumor cells detected in the circulating blood of the patient. DTCs are isolated tumor cells detected in the patient’s bone marrow or a distant organ. The clinical significance of these non-localized tumor cells is not well understood. In patients with already disseminated disease, CTCs and DTCs predict shorter survival. Newly diagnosed operable breast cancer patients have also been shown to have CTCs, but the threshold that will trigger a change in adjuvant treatment is unknown. By collecting information about CTCs, DTCs, and how they were detected, cancer registries can contribute to future knowledge about this aspect of breast cancer. Tumor Infiltrating Lymphocytes (TIL) for Merkel cell carcinoma. TILs are specialized cancer-fighting cells of the immune system believed to represent the immune reaction/response to Merkel cells, which are a rare, aggressive type of skin carcinoma. TILs surround and disrupt tumor cells at the base of the vertical growth phase. The presence of TILs at the growth edges of a tumor is associated with a more favorable prognosis. The pathologist takes a semi-quantitative measurement of the number of TILs present and categorizes the response as brisk, non-brisk, or absent. Involvement of corpus spongiosum/corpus cavernosum for penis. Most tumors of the penis begin on the outer surface. As tumor invades more deeply it may involve the major internal structures of the penis, which are the median corpus spongiosum surrounding the urethra and the two lateral corpora cavernosa. ICD-O topography codes do not distinguish between the corpus cavernosum and the corpus spongiosum, but involvement of these structures has prognostic implications because of the increased likelihood of nodal and distant metastases when there is invasion of the cavernosum or spongiosum. This site-specific factor allows researchers to do more detailed analysis in the future. Here are some additional examples of future research and special interest SSFs. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Microsatellite Instability
SSF7 in colon, rectum and appendix schemas SSF5 in small intestine schema Pathologic test Determines likelihood of a specific gene mutation for hereditary non-polyposis colorectal cancer (HNPCC)/Lynch syndrome Codes 020 MSI Stable; No microsatellite instability 040 MSI unstable low; Positive, low – not genetic 050 MSI unstable high; Positive, high – genetic 060 MSI unstable, NOS; Positive, NOS 988 Not applicable: Information not collected Microsatellite instability is a pathology test that looks for a gene mutation associated with a particular type of hereditary colorectal cancer called HNPCC or Lynch syndrome. HNPCC is estimated as less than 5% of all colorectal cancers. A high level of microsatellite instability is suggestive of HNPCC. This test will not be performed for every patient, and the field is not required by any of the standards setters. However, for patients with a family history of colon cancer, it is an important piece of information to obtain. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Lung SSF 2 – Visceral Pleural Invasion/Elastic Layer
For tumor < 3 cm, invasion of visceral pleura upstages T PL1-PL2  T2 PL3  T3 Involvement of the visceral pleura (the pleural layer covering the lung; CS Extension codes 420 and 430) upstages a tumor less than 3 cm in size from T1 to T2 in the absence of other evidence of extension. Involvement of the parietal pleura (the pleural layer lining the thoracic cavity) increases the extension to 600 (maps to T3). This image illustrates the various layers of visceral pleural invasion. Only PL1, PL2 and PL3 are considered pleural invasion. The precise level of pleural invasion, categorized as PL0 through PL3, is listed in the seventh edition of the AJCC Cancer Staging Manual as an item that is clinically significant. This information is collected in lung site-specific factor 2. Unfortunately, the 2010 lung cancer protocol developed by the College of American Pathologists records visceral pleural invasion as either “not identified”, “present”, or “indeterminate.” A revision of the protocol has been proposed to record the PL0 – PL3 descriptions instead. Until the protocol is updated, the information about visceral pleural invasion may not be available in the medical record. However, you can take this opportunity to inform your pathologists that you have a way to capture and analyze this information if it is provided by the pathologist. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Lung SSF 2 – Visceral Pleural Invasion/ Elastic Layer
Required by COC, SEER Codes 000 No evidence of visceral pleural invasion; not through elastic layer (PL0) 010 Beyond visceral elastic pleura, limited to pulmonary pleura; through elastic layer (PL1) 020 To surface of pulmonary pleura; Extends to surface of visceral pleura (PL2) 030 Extends to parietal pleura (PL3) 040 Invasion of Pleura, NOS 988 Not applicable: Information not collected 998 No histology of pleura 999 Unknown if visceral pleural invasion is present; Not documented in patient record The code structure for lung SSF2 provides good definitions of the various layers of pleura. Code 000 (PL0) does not alter the mapping of the T category. Code 010 (PL1) and 020 (PL2) upstage the case as previously described from T1 to T2a or T2b depending on tumor size, and code 030 (PL3) makes the case T3, if all other aspects of the tumor are negative. At the present time, this information is being collected by COC and SEER but is not an integral part of deriving the T category for seventh edition mapping. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Associated Diseases and Conditions
Items selected by TNM chapter authors Complete clinical picture of cancer Examples History of asbestos exposure (mesothelioma) Retinoblastoma gene mutation (retinoblastoma) AIDS/HIV status (lymphoma, Kaposi sarcoma) As part of the clinical relevance initiative in the seventh edition of the AJCC Cancer Staging Manual, the authors of the various staging chapters listed informational items that expand the clinical picture of the cancer. Some of these items report diseases associated with the primary cancer, others capture information about related conditions. For example, Asbestos exposure is the most common risk factor for mesothelioma, and the latency period between exposure and development of the tumor is 20 years or more. History of asbestos exposure has been included as site-specific factor 3 for pleura, and documents whether or not the patient had a history of asbestos exposure. Of the new retinoblastomas diagnosed each year, about 40% are hereditary, meaning that the child inherited the retinoblastoma gene from one of its parents. The child may be born with the defective gene, or it may mutate as the infant develops. Patients with inherited retinoblastoma are at greatly increased risk of developing second cancers, particularly osteosarcoma, melanoma, and acute myelogenous leukemia. Malignant lymphoma and Kaposi sarcoma are malignancies that have several causes. Patients with AIDS or HIV are severely immunocompromised, and that puts them at increased risk for lymphoma and Kaposi sarcoma. Although information about AIDS and HIV status is extremely confidential, documenting which lymphomas or Kaposi cases are severely immune deficient when that information is available can help clinicians make treatment decisions that are best for the individual patient. Here are some additional examples of other site-specific factors that pertain to associated diseases and conditions for various types of cancers. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Head and Neck SSF 10 HPV Status
Required by COC, SEER and Canada for some H&N sites Human papilloma virus (HPV) infection may be a favorable risk factor for oral and other mucosal cancers Highest risk strains for cancer are types 16 and 18 Code results from any tissue, not just primary site Many codes—read carefully An increase in the incidence of certain types of head and neck cancer has been associated with human papilloma virus (HPV) infection. The upside of this association is that a history of HPV infection, particularly type 16, has been shown to offer improved overall and disease-free survival in men under age 50 with oropharyngeal squamous cell cancer of the lingual and palatine tonsils who have no history of alcohol or tobacco use. Testing for HPV infection may be done for prognostic purposes, so this field allows for information to be recorded from any type of pathology specimen, including primary site, regional nodes, or a metastatic site. It is important to read the code definitions carefully. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Head and Neck SSF 10 HPV Status
Codes 000 HPV test neg; Negative, NOS; High risk neg, low risk unstated 010 LOW RISK pos (all pos type(s) low risk) 020 HIGH RISK pos, spec type(s) other than 16 or 18* 030 HIGH RISK pos for HPV 16 WITHOUT pos results for HPV 18 or pos of HPV 18 unknown* ^ 040 HIGH RISK pos for HPV 18 WITHOUT pos results for HPV 16 or pos of HPV 16 unknown* ^ 050 HIGH RISK pos for HPV 16 AND HPV 18 * ^ 060 HIGH RISK positive, NOS, type(s) not specified 070 Positive, NOS, risk and type(s) not stated 988 Not applicable: Information not collected 997 Test ordered, results not in chart 998 Test not done (not ordered and not performed), including no path specimen available for HPV testing 999 Unknown or no information; Not documented * WITH or WITHOUT positive results for low risk type(s) ^ WITH or WITHOUT positive results for other high-risk types The code structure, while complex, is intended to identify two particular high risk types of HPV, 16 (code 030) and 18 (code 040), alone or together (code 050). Other codes identify low risk types generically (code 010) or other types of high risk (code 020). If the HPV test is completely negative, use code If the test is positive for high risk HPV but the type is not known, use code If the only information available is that the patient is HPV positive, use code 070. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Brain SSF 3 Karnofsky Performance Score/Scale
Functional status at time of diagnosis Code physician statement in record; do not interpret description of status If information not collected, use 988. If no stated score, use 999. General categories 80 – 100 Able to carry on normal activity and to work; no special care needed 50 – 70 Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed 10 – 40 Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly 0 Dead The Karnofsky Performance Scale is a 100 point scale that describes the patient’s functional neurologic status or level of functional impairment. The 11 categories in the scale range from 0 (dead) to 100 (normal activities; able to perform activities of daily living without complaint). The scale can provide an estimate of prognosis for individual patients and assist in making treatment decisions. This field is not required by any standards setter but can be used to analyze and compare the effectiveness of different therapies. Because the Karnofsky Score is an overall assessment of the patient’s current abilities to function, this is not a data item that the registrar can interpret from nursing notes and other information in the medical record. Rather, the registrar should code the score stated by the clinician. If no score is stated, code 999. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Schema Discriminators
Determines which schema to display for a case Extra information stored in SSF25 Schema discriminators needed for Hepatic ducts vs. cystic duct vs. common bile duct Nasopharynx vs. pharyngeal tonsils (adenoids) Stomach vs. esophagus-GE junction Ciliary body vs. iris Lacrimal gland vs. lacrimal sac Peritoneum (sarcomas, male/female) vs. female peritoneum (carcinomas) A new concept in CSv2 is the schema discriminator, a data field that tells the computer algorithm which schema to display for the registrar. When there are multiple schemas for a particular organ, more information is necessary to determine which schema should be used. This extra information is stored in site-specific factor 25 for sites where the ICD-O primary site and histology codes do not provide enough information for the computer algorithm to determine which schema to present to the abstractor. For example, the CS version 1 schema for extrahepatic bile ducts was split into three schemas in CSv2: perihilar bile ducts, cystic duct, and distal bile duct, all of which have the same ICD-O primary site code. Sorting this out requires some extra programming that is transparent to the abstractor, who simply codes the verbal description of the primary site location in the “schema discriminator” field, site-specific factor 25. The computer algorithm determines from that information which schema to bring to the screen. For nasopharynx, code C11.1 includes both the posterior wall of the nasopharynx and the pharyngeal tonsils or adenoids. The posterior wall is included with other surfaces in the nasopharynx schema, but the adenoids are staged with the oropharynx, so a schema discriminator is necessary to identify which specific structure is the primary site. Adenocarcinomas of the stomach that involve the gastroesophageal junction are staged as esophageal cancers, so a schema discriminator is necessary to identify the precise location of a stomach cancer. More on this in a moment. In the ophthalmic sites, there are separate TNM stagings for ciliary body and iris (both coded to C69.4), and the lacrimal gland has a staging system, but lacrimal sac does not, so a schema discriminator is necessary to indicate which of these rare sites should be mapped to TNM. In another type of schema discriminator, the gender of the patient is necessary to “discriminate” between the schemas for peritoneum (primarily soft tissue sarcomas for males and females) and female genital peritoneum, which also includes carcinomas like primary peritoneal carcinoma (similar to ovarian carcinoma and staged similarly). CSv2 Part I Section II: May 1, 2011 Version: 2.03

Stomach/Esophagus GE Junction SSF25 – Schema Discriminator
Necessary because of shift of C16.0, parts of C16.1 and C16.2 to esophagus TNM staging Esophagogastric junction (EGJ) tumors: If midpoint (epicenter) within 5 cm of EGJ and also extends into esophagus, classify and stage as esophagus Stage all others with midpoint in stomach > 5 cm from EGJ or those within 5 cm of the EGJ with no extension into esophagus as gastric carcinoma Adenocarcinomas of the stomach that involve or extend past the esophago-gastric or gastroesophageal junction are handled as esophageal cancers, even though the EG junction and proximal stomach are included with the stomach codes. The authors of the 7th edition esophagus and stomach chapters came to agreement that any tumor of the upper stomach that extends into the lower esophagus should be classified and staged as an esophageal tumor. This includes the cardia or GE/EG junction (C16.0) and the proximal 5 centimeters of the fundus (C16.1) and body (C16.2) of the stomach. Tumors in the fundus and body that do not extend to or beyond the GE junction are classified and staged as stomach tumors. CSv2 Part I Section II: May 1, 2011 Version: 2.03 CSv2 Overview – CSv2 What’s New Presentation Sept 15, 2009 Version: 2.0

Stomach/Esophagus GE Junction SSF25 – Schema Discriminator
Esophagogastric Junction Gastroesophageal Junction The area in the red box is coded using the new Esophagus GE Junction schema. As you can see, the area includes part of the fundus of the stomach C16.1 and part of the body of the stomach C16.2 within 5 centimeters of the cardia or GE Junction. As noted, any tumor in this 5 cm area of the upper stomach that involves the GE junction or extends into the lower esophagus is now coded with the esophagus-GE Junction schema in CSv2. A tumor in this area that does not involve the lower esophagus or GE junction is coded with the stomach schema. From Edge et al. Used with permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, seventh edition (2009) published by Springer Science and Business Media LLC, CSv2 Part I Section II: May 1, 2011 Version: 2.03 CSv2 Overview – CSv2 What’s New Presentation Sept 15, 2009 Version: 2.0

SSF 25: Involvement of Cardia and Distance from GE Junction
000 No involvement of esophagus or EGJ Stomach 010 Tumor located in Cardia or EGJ EsophGEJ 020 Esoph or EGJ involved AND tumor midpoint from EGJ ≤ 5 cm EsophGEJ 030 Esoph or EGJ involved AND tumor midpoint from EGJ > 5 cm Stomach 040 Esoph or EGJ involved AND tumor midpoint from EGJ unknown EsophGEJ 050 Esoph and EGJ not involved but tumor midpoint from EGJ is ≤ 5 cm Stomach 060 Esoph involved or esoph involvement unknown AND tumor midpoint from EGJ > 5 cm or unknown AND MD stages case using esoph definitions EsophGEJ 999 Involvement of esoph not stated, unk or no info, not documented Stomach Blank for Stomach cases C16.3-C16.9 Stomach Blank for Cardia/EGJ cases C16.0 EsophGEJ This is the “schema discriminator” field that tells the registry software program which schema to present to the coder. You can see that it is important to know how far from the esophagogastric junction is the center or midpoint of the adenocarcinoma. This field is left blank if the primary site code is something other than C16.1 or C It defaults to the Esophagus GEJunction schema if the esophagus or GE junction is involved and the distance to the junction is unknown, and defaults to stomach if involvement of the esophagus is not stated. CSv2 Part I Section II: May 1, 2011 Version: 2.03 CSv2 Overview – CSv2 What’s New Presentation Sept 15, 2009 Version: 2.0

Melanoma Ciliary Body/Melanoma Iris SSF25 Schema Discriminator
Code Description Schema 010 Ciliary Body MelanomaCiliaryBody Includes Crystalline lens, Sclera, Uveal tract, Intraocular, Eyeball 020 Iris MelanomaIris 100 OBSOLETE DATA MelanomaCiliaryBody RETAINED V0200 C originally coded in CSv1 The schema discriminator for melanomas of the ciliary body and iris is considerably simpler, but still necessary because all of the listed eye structures have the same ICD-O-3 primary site code, C69.4. Image source: Malignant Melanoma of the Conjunctiva. In: Edge SB, Byrd DR, Compton CC, eds. AJCC Cancer Staging Manual. seventh ed. New York, NY: Springer, 2009 (546). CSv2 Part I Section II: May 1, 2011 Version: 2.03

SSF Codes for Lab Values
Lab tests result 001 – 979 Actual value units or greater 988 Not applicable: Information not collected 997 Test ordered, results not in chart 998 Test not done (not ordered and not performed) 999 Unknown or no information Every effort has been made to assure consistency across schemas in the formats for similar site-specific factors, although a few revisions were made between CSv1 SSFs 1 – 6 and CSv2 SSFs For example, SSFs for lab values such as CA 19-9, PSA, and CEA capture the actual value of the test up to 979 units and use code 980 for an actual value of 980 units or more. The code 988 means Not applicable: information not collected for this site-specific factor. This code is present in nearly every site-specific factor. However it is very important to note that the code cannot be used if the site-specific factor is required by a standards setter that the registry reports to. For example, in the rectum schema, KRAS is a site-specific factor required by the Commission on Cancer and cancer registries in SEER program areas. Registries in COC facilities and/or in SEER Program areas cannot use code 988 to code KRAS, but a registry in an NPCR area or in Canada can use code 988 to indicate that a local decision was made not to collect that particular item. (Registries in NPCR areas or Canada do have the option to collect KRAS information if it is available.) Three additional codes are uniform across SSFs that record lab values, lab value interpretations and ranges of lab values means that the test was done but the results are not in the medical record. This code can be used to code the lab value field when there is an indication in the record, such as a comment “PSA was elevated” but the exact value is unknown. You know the test was done because the clinician provided an interpretation of the results, but the exact value is unknown. Code 998 (Test not done) should be used when there is a statement in the medical record that the test was not ordered and not performed. Code 999 is the uniform code for unknown or no information. Use code 999 when there is no information in the record about the site-specific factor. If a test is required by a standards setter, code 999 rather than 988 should be used if the information is not available. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Codes for Other SSF Types
Lab Value Interpretation 010 Positive/elevated 020 Negative/normal; within normal limits 030 Borderline; undetermined if pos or neg 988 Not applicable 997, 998, 999 Same as other SSFs Site-specific factors for lab value interpretations have not changed much from CS version 1. Code 010 means that the lab value was interpreted as positive or elevated, code 020 means that the lab value was interpreted as negative or normal. A code for borderline or indeterminate is available at 030 but is infrequently used. The other codes 988, 997, 998, and 999 have the same definitions as previously discussed. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Size/depth 000 Not found 001 – 979 Actual measurement (cm, mm) units or greater 988 Not applicable: Information not collected 990 Microscopic focus [or related terms] 991 – 997 Measurement ranges less than y units, more than x units, between x and y units 999 Unknown or no information Site-specific factors for measurements are similar to the lab value SSFs. Measurements can include sizes, such as the second and third dimensions for bone tumors, size of metastasis in lymph nodes, or depth of invasion for melanomas. The unit of measurement will vary according to the schema—read the notes before the SSF table carefully. Code 000 means that the item in question was not found; in other words, there was no tumor size for example. Codes in the 001 to 979 range are for actual measurements. Code 980 is the upper limit of actual measurements and also means the measurement was larger. Codes 988 and 999 are included, with the same meaning as for other SSFs. The size/depth SSFs include a series of special codes means an unmeasured microscopic focus (if the focus is measured, record the actual size). Codes 991 to 997 are ranges to be used when the measurement is not precise. These are similar to CS Tumor Size definitions but can go as high as 997, which means “greater than 6” units. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Conditions/History of disease 000 Condition not present/No hx of disease 010 Condition present/Hx of disease Variations of condition present 988 Not applicable 998 No histologic examination of primary site 999 Unknown or no information Site-specific factors for items capturing information about associated conditions or “history of” diseases, procedures, or other clinical aspects are basically yes/no fields. If the condition, disease or procedure was not present, use code If the condition or disease is present, use code Variations of the condition may be listed in additional codes, such as “yes – present and minimal”, “yes – present and moderate”, or yes – present and severe.” Fields that record information from the pathology report also have a different meaning for code 998 to indicate that the test/condition/disease could not be documented because there was no histologic examination of the primary site. Other codes used in this type of site-specific factor have the standard definitions. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Use of SSF 900 Series Codes 987 Not applicable (case does not meet
criteria for SSF) 988 Not applicable: information not collected for this case 997 Test ordered, results not in chart 998 Test not ordered OR No histologic examination of primary site 999 Unknown; not documented Site-specific factor codes in the range 980 to 999 have special meanings, and individual codes other than 999 are not used in every schema. These are the general uses for some of these codes: Code 987 usually means “not applicable” because the case does not meet the criteria for the site-specific factor. For example, breast SSF4 Immunohistochemistry of regional nodes includes 987 as a code to use when the case has positive lymph nodes and IHC of negative nodes is not applicable. Code 988 means “Not applicable: information not collected for this case.” This code should not be used when the individual site-specific factor is required by one of the standards setters that the registry reports to. The code can be used if the site-specific factor is not required by the standards setter. For example, HER2 fields are required by all US standards setters, so code 988 cannot be used for a case without generating an error message. In contrast, the site-specific factor for CA 19-9 for stomach is not required by any standards setter. If a registry chooses not to collect this information, code 988 is appropriate. Code 997 means “Test ordered, results not in chart” for most schemas where the code appears. This code can be used when the lab results are not in the medical record. For example, if a tumor marker is mentioned in the medical record but the SSF requires a coded value, use code 997 to indicate that the test was performed but an actual value could not be coded. Code 998 in many schemas means “no histologic examination of primary site” and should be used when the site-specific factor captures pathologic information and there was none for the case. It can also mean “test not done; test not ordered and not performed.” This code can be used when there is a statement in the medical record that the test was not done. For example, if there is not enough tissue from breast tumor to send for ER, PR, and HER2 evaluation, code 998 is appropriate. In either case, code 998 indicates why there is no test result for the site-specific factor. Code 999 means “not documented,” “no information available in medical record,” or “unknown.” This is the default code when the site-specific factor cannot be coded because the information simply is not available. Use these codes sparingly. If better information is available, use that as a priority. CSv2 Part I Section II: May 1, 2011 Version: 2.03

Coding Rules for Lab Test and Tumor Marker Interpretation Fields
Reference ranges for background only Code clinician’s/pathologist’s interpretation of test. Examples: Abnormal – Elevated Normal – Equivocal Present – Absent Physician statement of T, N, or M value or stage group  implied interpretation of a lab value If no interpretation, use reference range listed on test report If no interpretation and no description of reference range, code 999 In CS version 2, the coding rules for site-specific factors were greatly expanded in Part I Section 2, and this was carried forward into CS version Many examples were added to illustrate the rules. As stated earlier, the rules for coding fields that record the interpretation of lab tests and tumor markers were clarified in version Always refer to the notes above the SSF code table for coding instructions as well as the information in Part I Section 2. The normal reference range and notes are included in the CSv2 coding instructions as background information only. Whenever possible, code the clinician’s/pathologist’s interpretation of the lab test. This would include statements of “abnormal”, “elevated”, “normal”, “equivocal”, “present”, “absent”, and so forth. In addition, the physician's statement of a T, N, or M value or stage group for the case would constitute an implied interpretation of any lab value used to determine the TNM classification. In the absence of a physician’s interpretation of the test, if the reference range for the lab is listed on the test report, the registrar may use that information to assign the appropriate code. When there is no clinician/pathologist interpretation of the lab test and no description of the reference range in the medical record the registrar should code 999 (not documented, unknown) to code the SSF. Do not code the lab value interpretation based on background information provided in this manual for the SSF. There will be some cases where an interpretation may be inferred from the background information in the CS User Documentation because the lab result is extremely abnormal. In such cases, common sense would dictate that the case should be coded as 010 (elevated) rather than 999. CSv2 Part I Section II: May 1, 2011 Version: 2.03

REMINDER Site-Specific Factors
If information regarding SSF is not in path report or medical record, Registrar is not required to go looking for it Information may not be available in some facilities Not registrar’s role to enforce practice standards Instructions included in schemas on how to code missing information Perhaps the most important thing to understand about the site-specific factors is that the registrar is not required to go looking for any site-specific data item that is not included in the pathology report or the medical record. The 7th edition editors acknowledge that certain types of information may not be available in some facilities, particularly those items of prognostic or research interest. Furthermore, both the clinicians and the American College of Surgeons recognize that it is not the registrar’s role to enforce practice standards. The CS Manual includes instructions how to code missing information. The corollary to not finding information in the medical record is that the clinicians and pathologists may not realize that certain types of information are capture in the cancer registry. Furthermore, practice standards within facilities do change as new tests and equipment are acquired. Therefore it is very important that the registrar communicate the ability to collect the site-specific factors and other data in a standardized manner to the cancer committee, oncology physicians, and the facility’s pathologists. It may be that the information is available but not in the medical record simply because no one has asked for it before. This is an opportunity for the registry to reinforce its ability to stay current and provide information of interest to clinicians. CSv2 Part I Section II: May 1, 2011 Version: 2.03

www.cancerstaging.org/cstage Website includes
Coding instructions (downloadable PDFs) Implementation Guide Standards setters requirements for SSFs Installation program for bookmarked and hyperlinked Part I and Part II documents Site-specific schema Natural order (online) Alphabetic order (online) Schema Groups (downloadable PDFs) Access to software Access to I&R Information about educational initiatives The official source of information about version 2 of the Collaborative Stage Data Collection System software, coding instructions, implementation guidelines, standards setter requirements and other aspects of the system is (the American Joint Committee on Cancer’s website). For quick access to CSv2, enter in your browser. CSv2 Part I Section II: May 1, 2011 Version: 2.03 CSv2 Overview – CSv2 What’s New Presentation Sept 15, 2009 Version: 2.0

CAnswer Forum Submit questions to CS Forum
Located within the CAnswer Forum Provides information for all Allows tracking for educational purposes Includes archives of Inquiry & Response System CS Forum: CS Web Site: CSv2 Bladder, Kidney & Testis June Lecture Version: 1.0

Getting Specific About Site-Specific Factors Part I Section II

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Getting Specific About Site-Specific Factors Part I Section II

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